MEDICINES CONTROL AGENCY

Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Telephone 0171-273 0422, or 0425 Product Licences Authorised

Product Licence Number	Company Name	Product Name	Active Ingredients	Indications	Date of Authorisation
00010/0249	Bayer PLC	Lipobay 400 Microgram Tablets	Cerivastatin Sodium 400.000 mcg	Primary Hypercholesterolaemia (Types IIa + IIb); The treatment of hypercholesterolaemia in patients who have not responded adequately to an appropriate diet. Prescription Only Medicine	7th December 1999
00010/0252	Bayer PLC	Vaslip®400 Microgram Tablets	Cerivastatin Sodium 400.00 mcg	(See PL 00010/0249). Prescription Only Medicine	8th December 1999
00010/0253	Bayer PLC	Liposterol® 400 Microgram Tablets	Cerivastatin Sodium 400.00 mcg	(See PL 00010/0249). Prescription Only Medicine	8th December 1999
00010/0254	Bayer PLC	Zenas® 400 Microgram Tablets	Cerivastatin Sodium 400.00 mcg	(See PL 00010/0249). Prescription Only Medicine	8th December 1999
00012/0339	May & Baker Limited	Clexane 150 mg/ml	Enoxaparin Sodium 15.000 % w/v	The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopaedic or general surgery. The treatment of deep vein thrombosis with or without pulmonary embolism. The treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin. The prevention of thrombus formation in the extracorporeal circulation during haemodialysis. Prescription Only Medicine	16th December 1999
00014/0576	The Boots Company PLC	Athlete’s Foot Powder (Miconazole)	Miconazole Nitrate 2.000 % w/w	For the treatment of athlete’s foot and other fungal skin conditions eg intertrigo, fungal nappy rash, dhobie itch. Pharmacy Medicine	28th March 2000
00015/0231	Boehringer Ingelheim Limited	Rinatec Nasal Spray 0.06%	Ipratropium Bromide Monohydrate .626 mg/ml	For the symptomatic relief of rhinorrhoea associated with the common cold. Prescription Only Medicine	2nd December 1999
00025/0374	Merck Sharp & Dohme Limited	Fortzaar	Hydrochlorothiazide 25.000 mg Losartan Potassium 100.000 mg	For the treatment of hypertension in patients whose blood pressure has been stablised on losartan and hydrochlorothiazide given separately in the same proportion. Prescription Only Medicine	22nd December 1999
00030/0151	Novartis Consumer Health UK Limited	NCH Chesty Cough	Guaifenesin 50.000 mgRelief of chesty coughs, hoarseness and sore throats. Helps loosen mucus (catarrh) to make breathing easier.General Sales List	22nd March 2000
00030/0152	Novartis Consumer Health UK Limited	NCH Cough & Cold	Chlorphenamine Maleate 2.000 mg Pholcodine 5.000 mg Pseudoephedrine Hydrochloride 20.000 mg	A cough suppressant and decongestant.Pharmacy Medicine	22nd March 2000
00030/0153	Novartis Consumer Health UK Limited	NCH Daytime	Pholcodine 4.000 mg	Cough suppressant. Pharmacy Medicine	22nd March 2000
00030/0156	Novartis Consumer Health UK Limited	Calcium-D-Sandoz	Calcium Carbonate 1500.000 mg Cholecalciferol 100000 IU/G .010 mg	Correction of combined vitamin D3 and calcium deficiencies. Vitamin D3 and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients where combined calcium and vitamin D deficiencies have been diagnosed or at high risk of such deficiencies. Pharmacy Medicine	22nd March 2000
00031/0558	Roche Products Limited	Pain Relief Powders	Acetylsalicylic Acid 530.000 mg Aloxiprin 140.000 mg Caffeine Citrate 110.000 mg	The relief of mild to moderate pain including headache, migrane, neuralgia, toothache, sore throat, period pains, aches and pains. The symptomatic relief of influenza, feverishness, feverish colds. The symptomatic relief of sprains, strains, rheumatic pain, backache, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. General Sales List	9th March 2000
00037/0265	Abbot Laboratories Limited	Vancomycin Sterile Powder for Solution for Infusion	Vancomycin Hydrochloride 512.500 mg	Indicated in potentially life-threatening infections which cannot be treated with other effective, less toxic antimicrobial drugs, including the penicillins and cephalosporins. Vancomycin is useful in the therapy of severe staphyloccoccal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins, or who have infections with staphylococci resistant to other antibiotics. Vancomycin is used in the treatment of endocarditis and as prophylaxis against endocarditis in patients at risk from dental or surgical procedures. Its effectiveness has been documented in other infections due to staphylococci, including osteomyelitis, pneumonia, septicaemia and soft tissue infections. Vancomycin may be used orally for the treatment of staphylococcal enterocolitis and pseudomembranous colitis due to Clostridium difficile. Prescription Only Medicine	28th March 2000
00037/0266	Abbott Laboratories Limited	Vancomycin Sterile Powder for Solution for Infusion	Vancomycin Hydrochloride 1.025 gm	(See PL 00037/0265)Prescription only medicine	28th March 2000
00037/0290	Abbott Laboratories Limited	Propofol 10 mg/ml emulsion for intravenous injection or infusion	Propofol 10.000 mg	Propofol 10 mg/ml is a short-acting intravenous anaesthesia agent suitable for induction and maintenance of general anesthesia. Propofol 10 mg/ml may also be used for sedation of ventilated patients receiving intensive care, for a period of up to three days. Prescription Only Medicine	3rd March 2000
00041/0103	Bioglan Laboratories Limited	Glyceryl Trinitrate Spray 400 micrograms/dose	Glyceryl Trinitrate .700 %w/w	Treatment of acute angina pectoris. Prevention of inducible angina (e.g., physical effort, emotional stress, exposure to cold). Pharmacy Medicine	22nd February 2000
00142/0494	A H Cox & Company Limited	Precortisyl 1 mg Tablets	Prednisolone 1.000 mg	Managment of all conditions deemed likely to benefit from short or long term glucocorticoid therapy. These include: Alergic states: Severe, incapacitating allergies unresponsive to conventional treatment; asthma serum sickness; drug hypersensitivity reactions. Collagen disorders; E.g. systemic lupus erythematosus, polymyositis, polymyalgia rheumatica and temporal (giant cell) arteritis, mixed connective tissue disease syndrome, acute rheumatic carditis. Rheumatic disorders; Usually given as an adjunctive therapy for short term administration during an acute episode or exacerbation of rhematoid arthritis, psoriatic arthritis. Skin conditions; Life-threatening or incapacitating skin conditions such as pemphigus and exfoliative dermatitis. Neoplastic disease: Leukaemias and lymphomas in adults, acute leukaemia of childhood. Gastro-Intestinal disease; During acute exacerbation in ulcerative colitis and regional ileitis (Crohn’s Disease). Respiratory disease; Sarcoidosis (especially with hypercalcaemia), fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy. Haematological disorders; Various blood dyscrasias e.g. selected cases of haemolytic anaemia, thrombocytopenic purpura. Miscellaneous; Nephrotic syndrome. Prescription Only Medicine	8th March 2000
00142/0495	A H Cox & Company Limited	Precortisyl 5 mg Tablets	Prednisolone 5.000 mg	(See PL 00142/0494) Prescription Only Medicine	8th March 2000
00156/0095	Martindale Pharmaceuticals Ltd	Indomethacin Suppositories BP 100 mg	Indomethacin 100.000 mg	For the treatment of active rheumatoid arthritis, osteo-arthritis, ankylosing spondylitis and acute gout. They are also indicated for the treatment of severe acute periarticular disorders such as bursitis, tendinitis, synovitis, tenosynovitis and capsulitis. Prescription Only Medicine	10th March 2000
00173/0177	Diomed Developments Limited	Happinose	Menthol 0.300 % w/w	By topical administration to the nasal passages for the symptomatic relief of nasal congestion associated with the common cold, catarrh, head colds and hay fever. If desired, Happinose may also be rubbed onto the lips, nose, throat and chest and between the shoulders. General Sales List	20th December 2000
00440/0131	Galen Limited	Beclo-aqua Hayfever Nasal Spray Beclometasone Dipropionate Hayfever Aqueous Nasal Spray Zonivent Hayfever Aquanasal Spray 50 mcg	Beclometasone Dipropionate 0.385 mg/ml	For the prevention and treatment of allergic rhinitis. Pharmacy Medicine	6th March 2000
00440/0132	Galen Limited	Beclo-aqua 50 Nasal Spray Beclometasone Dipropionate Aqueous Nasal Spray 50 mcg Zonivent Aquanasal Spray 50 mcg	Beclomethasone Dipropionate 0.039 % w/v	Prevention and treatment of allergic seasonal or perennial rhinitis and vasomotor rhinitis. Prescription Only Medicine	6th March 2000
00440/0133	Galen Limited	Calcette 500 mg	Calcium Carbonate 1250.00 mg	For use as a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high. As an adjunct to conventional therapy in the treatment of osteoporosis. As a phosphate binder in patients with renal failure undergoing renal dialysis. Pharmacy Medicine	6th March 2000
00493/0179	E Merck Limited	Cardicor 1.25 mg Film-coated Tablets	Bisoprolol Fumarate 1.250 mg	Treatment of stable chronic moderate to severe heart failure with reduced systolic ventricular function (ejection fraction }35%, based on echocardiography) in addition to ACE inhibitors, and diuretics, and optionally cardia glycosides. Prescription Only Medicine	24th December 1999
00493/0180	E Merck Limited	Cardicor 2.5 mg Film-coated Tablets	Bisoprolol Fumarate 2.500 mg	See PL00493/0179. Prescription Only Medicine	24th December 1999
00493/0181	E Merck Limited	Cardicor 3.75 mg Film-coated Tablets	Bisoprolol Fumarate 3.750 mg	See PL00493/0179. Prescription Only Medicine	24th December 1999
PL00493/0182	E Merck Limited	Cardicor 5.0 mg Film-coated Tablets	Bisoprolol Fumarate 5.000 mg	See 00493/0179. Prescription Only Medicine	24th December 1999
PL00493/0183	E Merck Limited	Cardicor 7.5 mg Film-coated Tablets	Bisoprolol Fumarate 7.500 mg	See PL00493/0179. Prescription Only Medicine	24th December 1999
PL00493/0184	E Merck Limited	Cardicor 10.0 mg Film-coated Tablets	Bisoprolol Fumarate 10.000 mg	See PL00493/0179. Prescription Only Medicine	24th December 1999
PI00576/0150	Global Pharmaceuticals Ltd	Imigran 100 mg Tablets Sumatriptan 100 mg Tablets	Sumatriptan Succinate 140.000 mg	Asthma. Prescription Only Medicine	21st February 2000
00790/0124	Clonmel Healthcare Limited	Betahistine Hydrochloride Tablets 8 mg	Betahistine Hydrochloride 8.000 mg	Vertigo, tinnitus and hearing loss associated with Ménière’s syndrome. Prescription Only Medicine	23rd March 2000
00790/0125	Clonmel Healthcare Limited	Betahistine Hydrochloride Tablets 16 mg	Betahistine Hydrochloride 16.000 mg	(See PL 00790/0124). Prescription Only Medicine	23rd March 2000
02848/0197	Antigen International Limited	Bupivacaine Hydrochloride Infusion Solution 0.1%w/v	Bupivacaine Hydrochloride .106 gm	Bupivacaine Hydrochloride Infusion Solution 0.1% w/v may be used for continuous infusion lumbar epidural analgesia to relieve pain during labour. Prescription Only Medicine	9th March 2000
02848/0198	Antigen International Limited	Bupivacaine Hydrochloride Infusion Solution 0.125%w/v	Bupivacaine Hydrochloride .132 gm	(See PL 02848/0197) Prescription Only Medicine	9th March 2000
PI03243/0344	Munro Wholesale Medical Supplies Ltd	Trusopt 2% Ophthalmic Solution	Dorzolamide Hydrochloride 22.260 mg/ml	The reduction of elevated intra-ocular pressure. Prescription Only Medicine	7th March 2000
PI03243/0384	Munro Wholesale Medical Supplies Ltd	Voltarol Retard 100 mg Tablets	Diclofenac Sodium 100.000 mg	Relief of pain and inflammation. Prescription Only Medicine	21st February 2000
PI03787/0655	Swingward Limited (t/a Mediheath)	Quinapril 5 mg Tablets	Quinapril 5.000 mg	Hypertension; congestive heart failure. Prescription Only Medicine	14th March 2000
PI03787/0674	Swingward Limited (t/a Medihealth)	Lisinopril 2.5 mg Tablets	Lisinopril 2.500 mg	Treatment of all grades of essential hypertension and renovascular hypertension. Prescription Only Medicine	3rd March 2000
PI03787/0682	Swingward Limited (t/a Medihealth)	Sertraline 50 mg Tablets	Sertraline 50.000 mg	Treatment of depressive illness, including accompanying symptons of anxiety. Prescription Only Medicine	29th February 2000
PI03787/0685	Swingward Limited t/a Medihealth	Duovent Inhaler	Fenoterol Hydrobromide 100.00 mcg Ipratropium Bromide 40.000 mcg	Reversible airways obstruction. Prescription Only Medicine	18th February 2000
PI03787/0694	Swingward Limited t/a Medihealth	Fosinopril Sodium 20 mg Tablets	Fosinopril Sodium 20.000 mg	1. Hypertension. 2. Treatment of heart failure in combination with a diuretic. Prescription Only Medicine	2nd March 2000
PI03787/0718	Swingward Limited t/a Medihealth	Simvastatin 20 mg Tablets	Simvastatin 20.000 mg	1. Coronary heart disease in patients with a plasma cholesterol level of 5.5 mmol/l or greater. 2. Hyperlipidaemia. Prescription Only Medicine	14th March 2000
PI03787/0734	Swingward Limited t/a Medihealth	Amlodipine 5 mg Tablets	Amlodipine Besylate 6.944 mg	Hypertension. Prescription Only Medicine	14th February 2000
04077/0183	M & A Pharmachem Limited	Dihydrocodeine Tablets 30 mg BP	Dihydrocodeine Tartrate 30.000 mg	Dihydrocodeine tablets are indicated for the relief of moderate to severe pain. Prescription Only Medicine	16th March 2000
04416/0368	Lagap Pharmaceuticals Limited	Chlorpheniramine Elixir BP	Chlorpheniramine Maleate 2.000 mg	For the relief of symptoms caused by allergic conditions such as hay fever, allergic rhinitis, perennial rhinitis, urticaria and skin rashes, food allergy, insect bites etc., which are responsive to antihistamines. Pharmacy Medicine	7th March 2000
04416/0373	Lagap Pharmaceuticals Limited	Propain Tablets	Paracetamol BP 400.00 mg Codeine Phosphate BP 10.00 mg Diphenhydramine HCL BP 5.00 mg Caffeine Anhydrous BP 50.00 mg	As an analgesic in the treatment of headache, migraine, muscular pain, period pain and toothache. Also for the symptomatic relief of influenza, feverishness and colds. Pharmacy Medicine	7th March 2000
PI04423/0309	Doncaster Pharmaceuticals Group Limited	Aeroline CR 4 mg Tablets	Salbutamol 4.000 mg	Treatment of asthma, bronchospasm and/or reversible airways obstruction. Prescription Only Medicine	22nd February 2000
PI04423/0310	Doncaster Pharmaceuticals Group Limited	Aeroline CR 8 mg Tablets	Salbutamol Sulphate 9.640 mg	Asthma, bronchospasm and/or reversible airways obstruction. Prescription Only Medicine	22nd February 2000
04569/0456	Generics (UK) Limited	Doxazosin Tablets 1 mg	Doxazosin Mesilate 1.213 mg	Hypertension. Prescription Only Medicine	24th February 2000
04569/0457	Generics (UK) Limited	Doxazosin Tablets 2 mg	Doxazosin Mesilate 2.426 mg	Hypertension. Prescription Only Medicine	24th February 2000
04569/0458	Generics (UK) Limited	Doxazosin Tablets 4 mg	Doxazosin Mesilate 4.852 mg	Hypertension. Prescription Only Medicine	24th February 2000
04984/0033	Leiras Oy	Propofol 10 mg/m. Emulsion for Injection or Infusion	Propofol 10.000 mg	Induction and maintenance of general anaesthesia. Sedation during intensive care. Sedation for surgical and diagnostic procedures with regional or local anaesthesia. Prescription Only Medicine	28th March 2000
PI05513/0528	Eurochem Limited	Anafranil SR 75 mg Tablets	Clomipramine Hydrochloride 75.000 mg	The symptoms of depressive illness. Prescription Only Medicine	16th March 2000
PI05513/0534	Eurochem Limited	Zoladex LA 10.8 mg Injection	Goserelin Acetate 10.800 mg	Treatment of prostate cancer suitable for hormonal manipulation. Prescription Only Medicine	11th February 2000
PI05513/0561	Eurochem Limited	Calcipotriol 50 microgram/ gram Cream Dovonex 50 microgram/gram Cream	Calcipotriol 50.000 mcg	Psoriasis vulgaris. Prescription Only Medicine	14th February 2000
PI05513/0746	Eurochem Limited	Cisapride 5 mg/5 ml Suspension	Cisapride Monohydrate 1.040 mg	Symptoms associated with gastro-oesophageal reflux; dyspepsia where peptic ulcer or other lesions have been excluded from the diagnosis. Prescription Only Medicine	24th March 2000
PI05513/0755	Eurochem Limited	Fosamax Tablets	Alendronate Sodium 13.050 mg	Osteoporosis. Prescription Only Medicine	20th March 2000
PI05513/0757	Eurochem Limited	Lisinopril 20 mg Tablets Zestril 20 mg Tablets	Lisinopril Dihydrate 21.780 mg	Hypertension, congestive heart failure, acute myocardial infarction. Prescription Only Medicine	22nd February 2000
PI05513/0766	Eurochem Limited	Adalat LA 60 mg Tablets	Nifedipine 60.000 mg	Treatment of mild to moderate hypertension. Prescription Only Medicine	13th March 2000
PI05513/0787	Eurochem Limited	Xatral SR Tablets	Alfuzosin Hydrochloride 5.000 mg	The functional symptoms associated with benign prostatic hypertrophy. Prescription Only Medicine	24th March 2000
PI05513/0791	Eurochem Limited	Omeprazole 10 mg Capsules	Omeprazole 10.000 mg	Treatment of oesophageal reflux disease. Treatment of benign gastric ulcers, duodenal ulcers. In combination with antibiotics for eradication of helicobacter pylori. Prescription Only Medicine	16th March 2000
PI05513/0826	Eurochem Limited	Lamictal 25 mg Dispersible Tablets	Lamotrigine 25.000 mg	Epilepsy. Prescription Only Medicine	21st March 2000
PI05513/0827	Eurochem Limited	Atorvastatin 10mg Tablets	Atorvastatin 10.000 mg	Hypercholesterolaemia. Prescription Only Medicine	16th March 2000
PI05513/0828	Eurochem Limited	Atorvastatin 40 mg Tablets	Atorvastatin 40.000 mg	Hypercholesterolaemia. Prescription Only Medicine	16th March 2000
PI05662/0459	Dowelhurst Limited	Estracomb TTS Estracombi TTS	Norethisterone Acetate 250.000 mcg Oestradiol 50.000 mcg Oestradiol 50.000 mcg	1. Hormone replacement therapy for patients with an intact uterus. 2. Prevention of post-menopausal osteoporosis. Prescription Only Medicine	6th March 2000
PI05662/0522	Dowelhurst Limited	Neoral Oral Solution 100 mg/ml	Cyclosporin 100.000 mg/ml	Prevention of graft rejection following organ and bone marrow transplantation. The treatment of severe psoriasis and atopic dermatitis. The treatment of severe active rheumatoid arthritis. The treatment of steroid resistent or steroid dependent nephrotic syndrome. Prescription Only Medicine	3rd March 2000
PI05662/0629	Dowelhurst Limited	Blopress 8 mg Tablets Candesartan Cilexetil Tablets 8 mg	Candesartan Cilexetil 8.000 mg	Essential hypertension. Prescription Only Medicine	22nd February 2000
PI05662/0633	Dowelhurst Limited	Efexor 37.5 mg Tablets Venlafaxine Tablets 37.5 mg	Venlafaxine Hydrochloride 42.420 mg	Treatment of depressive illness, including depression accompanied by anxiety. Prescription Only Medicine	6th March 2000
05815/0016	Les Laboratoires Servier	Indapamide 1.5 mg SR Tablets	Indapamide 1.500 mg	Essential hypertension. Prescription Only Medicine	21st March 2000
06043/0024	Orion Corporation	Beclomet Easyhaler 200 micrograms/dose inhalation powder	Beclomethasone Dipropionate 2.625 % w/w	Indicated in the prophylactic management of mild, moderate, or severe asthma in adults. Mild asthma: Patients requiring symptomatic broncholdilator asthma medication on a regular basis. Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilater alone. Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. Many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly, or eliminate their requirement for oral corticosteroids when they are transferred to high dose inhaled beclomethasone dipropionate. Prescription Only Medicine	21st December 1999
PI06464/0540	Waymade Plc	Clarityne Liquid Loratadine Liquid 5 mg/5 ml	Loratadine 1.000 mg/ml	Rhinitis and allegic skin condition. Prescription Only Medicine	22nd February 2000
PI06464/0595	Waymade Plc	Lipemol 10 mg Tablets	Pravastatin Sodium 10 mg Tablets Pravastatin Sodium 10.000 mg	Coronary Artery disease and hypercholesteroleamia. Prescription Only Medicine	22nd February 2000
PI06464/0598	Waymade Plc	Ciproxin 250 mg Tablets	Ciprofloxacin 250.000 mg	Infections caused by sensitive bacteria. Prescription Only Medicine	14th February 2000
PI06464/0612	Waymade Plc	Dantrium 25 mg Capsules	Dantrolene Sodium 25.000 mg	Treatment of chronic, severe spasticity of skeletal muscle in adults. Prescription Only Medicine	22nd February 2000
PI06464/0613	Waymade Plc	Dantrium 100 mg Capsules	Dantrolene Sodium 100.00 mg	Treatment of chronic, spasticity of skeletal muscle in adults. Prescription Only Medicine	22nd February 2000
PI06464/0627	Waymade Plc	Zomig 2.5 mg Tablets	Zolmitriptan 2.500 mg	Migraine. Prescription Only Medicine	22nd February 2000
PI06464/0642	Waymade Plc	Zineryt Topical Solution	Erythromycin 40.000 mg/ml Zinc Acetate 12.000 mg/ml	Topical treatment of acne vulgans. Prescription Only Medicine	29th February 2000
PI06464/0664	Waymade Plc	Kytril 1 mg Tablets	Granisetron 1.000 mg	Prevention of nausea and vomiting induced by cytostatic therapy. Prescription Only Medicine	18th February 2000
PI06464/0685	Waymade Plc	Azelastine Nasal Spray	Azelastine Hydrochloride 0.140 mg	Rhinitis. Prescription Only Medicine	21st February 2000
PI06464/0735	Waymade Plc	Betaxol 0.5 % Eye Drops Betoptic 0.5 % Eye Drops	Betaxolol Hydrochloride 0.560 % w/v	The reduction of elevated intraculur pressure. Prescription Only Medicine	17th March 2000
PI06464/0736	Waymade Plc	Simvastatin 40 mg Tablets Zocor 40 mg Tablets	Simvastatin 40.000 mg	1. Coronary heart disease with a plasma cholesterol level of 5.5 mm 01/100 greater. 2. Hyperlipidaemia. Prescription Only Medicine	6th March 2000
PI06464/0737	Waymade PLC	Diflucan 150 mg Capsules	Fluconazole 150.000 mg	The treatment of genital and vaginal candidiasis and candidal balanitis. Prescription Only Medicine	13th March 2000
PI06464/0738	Waymade PLC	Sinemet CR Tablets	Carbidopa Monohydrate 54.000 mg Levodopa 200.000 mg	Parkinson’s disease. Prescription Only Medicine	21st February 2000
PI06464/0755	Waymade PLC	Celiprolol Hydrochloride 200 mg Tablets	Celiprolol Hydrochloride 200.000 mg	Management of mild to moderate hypertension. Prescription Only Medicine	6th March 2000
PI06464/0760	Waymade PLC	Lipobay 100 microgram Tablets	Cerivastatin Sodium 100.000 mcg	Primary hypercholesterolaemia. Prescription Only Medicine	14th February 2000
06464/0769	Waymade PLC	Dosulepin/Dothiepin Capsules 25 mg	Dosulepin Hydrochloride 25.000 mg	Treatment of symptons of depressive illness, especially where an anti-anxiety effect is required. Prescription Only Medicine	24th March 2000
06464/0770	Waymade PLC	Dosulepin/Dothiepin Tablets 75 mg	Dosulepin Hydrochloride 75.000 mg	(See PL 06464/0769). Prescription Only Medicine	24th March 2000
06464/0771	Waymade PLC	Ibuprofen Tablets 200 mg	Ibuprofen 200.000 mg	Indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic conditions. Indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendinitis, tenosynovitis and low back pain; Ibuprofen can also be used in soft tissue injuries such as sprains and strains. Also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for symptomatic relief of headache, including migraine headache. Prescription Only Medicine	21st March 2000
06464/0772	Waymade PLC	Ibuprofen Tablets 400 mg	Ibuprofen 400.000 mg	(See PL 06464/0771). Prescription Only Medicine	21st March 2000
06464/0773	Waymade PLC	Ibuprofen Tablets 600 mg	Ibuprofen 600.000 mg	(See PL 06464/0771). Prescription Only Medicine	21st March 2000
PI06464/0808	Waymade PLC	Arthrotec 75 Tablets	Diclofenac Sodium 75.000 mg Misoprostol 200.000 mcg	Osteoarthritis and rheumatoid arthritis, for the prophylexis of NSAID—induced gastric and duodenal ulceration. Prescription Only Medicine	28th February 2000
PI06464/0809	Waymade PLC	Telfast 180 mg Tablets	Fexofenadine Hydrochloride 180.000 mg	Urticaria. Prescription Only Medicine	22nd February 2000
PI06464/0843	Waymade Plc	Curatoderm Ointment	Tacalcitol Monohydrate 4.170 mcg	Psoriasis Prescription Only Medicine	24th March 2000
PI06464/0882	Waymeade Plc	Detrusitol 2 mg Tablets	Tolterodine L-Tartrate 2.000 mg	The treatment of unstable bladder. Prescription Only Medicine	22nd February 2000
08387/0001	Hogens Limited	Clophene 50 mg Tablets	Clomiphene Citrate 50.000 mg	The treatment of anovulatory infertility in women Prescription Only Medicine	3rd December 1999
08685/0024	Dispersa (UK) Limited	Miochol-E	Acetylcholine Chloride 20.000 mg	To obtain rapid and complete miosis after delivery of the lens in cataract surgery as well as in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid complete miosis is required. Prescription Only Medicine	22nd December 1999
PI08747/0299	Chemilines Limited	Estraderm MX 25	Estradiol .750 mg	1. Estrogen replacement therapy for patients with disorders due to natural or surgically induced menopause. 2. Prevention of post-menopausal osteoporosis in women considered at risk of developing fractures. Prescription Only Medicine	9th March 2000
PI08747/0300	Chemilines Limited	Estraderm MX 50	Estradiol 1.500 mg	See PL PI08747/0299	9th March 2000
PI08747/0301	Chemilines Limited	Estraderm MX 100	Estradiol 3.000 mg	See PL PI08747/0299	10th March 2000
PI08747/0317	Chemilines Limited	Creon Capsules 25000	Amylase 18000.000 U Lipase 25000.000 U Protease 1000.000 U	Treatment of pancreatic exocrine insufficiency. Prescription Only Medicine	2nd March 2000
PI08829/0114	Trinity Pharmaceuticals Limited	Nifeslow SR Capsules 20 mg	Nifedipine 20.000 mg	Prophylaxis of chronic stable angina pectoris and treatment of hypertension. Prescription Only Medicine	2nd March 2000
PI0256/0528	Stephar (UK) Limited	Pantoprazole EC 40 mg Tablets	Pantoprazole Sodium Sesquihydrate 45.100 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	21st February 2000
PI10256/0541	Stephar (UK) Limited	Disipal 50 mg Tablets	Orphenadrine Hydrochloride 50.000 mg	Treatment of all forms of Parkinsonism. Prescription Only Medicine	13th March 2000
PI10256/0555	Stephar (UK) Limited	Candesartan Cilexetil 4 mg Tablets	Candesartan Cilexetil 4.000 mg	Essential hypertension. Prescription Only Medicine	28th February 2000
PI10256/0560	Stephar (UK) Limited	Lodine Retard Tablets	Etodolac 600.000 mg	Rheumatoid arthritis and osteoarthritis. Prescription Only Medicine	22nd February 2000
PI10256/0564	Stephar (UK) Limited	Aricept 5 mg Tablets	Donepezil Hydrochloride 5.000 mg	Prescription Only Medicine.	28th January 2000
PI10256/0565	Stephar (UK) Limited	Aricept 10 mg Tablets	Donepezil Hydrochloride 10.000 mg	Prescription Only Medicine.	28th January 2000
PI10256/0567	Stephar (UK) Limited	Dutonin 100 mg Tablets	Nefazodone Hydrochloride 100.000 mg	Depressive illness. Prescription Only Medicine	22nd February 2000
PI10380/0363	Swinghope Limited	Omeprazole 20 mg Capsules	Omeprazole 20.000 mg	Prescription Only Medicine.	3rd February 2000
PI10380/0374	Swinghope Limited	Paroxetine Tablets 20 mg Seroxat 20 mg Tablets	Paroxetine Hydrochloride 22.800 mg	Treatment of depressive illness. Prescription Only Medicine	13th March 2000
PI10380/0386	Swinghope Limited	Fluvastatin Capsules 40 mg Lescol 40 Capsules	Fluvastatin Sodium 42.120 mg	Primary hypercholesterolaemia and patients with coronary heart disease with a plasma cholesterol level of 6.5 mmol/L or greater. Prescription Only Medicine	17th March 2000
PI10380/0388	Swinghope Limited	Nizatidine 150 mg Capsules Nizax 150 mg Capsules	Nizatidine 150.000 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	21st March 2000
PI10380/0389	Swinghope Limited	Nizatidine 300 mg Capsules Nizax 300 mg Capsules	Nizatidine 300.00 mg	(See PLPI10380/0388). Prescription Only Medicine	21st March 2000
PI10380/0396	Swinghope Limited	Lamisil Cream Terbinafine Hydrochloride 1% Cream	Terbinafine Hydrochloride 1.000 % w/w	Fungal infections of the skin. Prescription Only Medicine	22nd February 2000
PI10380/0404	Swinghope Limited	Diprosalic Ointment	Betamethasone Dipropionate 0.064 % w/w Salicylic Acid 3.000 % w/w	The treatment of hyperkeratotic and dry dermatoses. Prescription Only Medicine	20th March 2000
PI10380/0420	Swinghope Limited	Didronel 200 mg Tablets	Etidronate Disodium 200.000 mg	Pagets disease. Prescription Only Medicine	15th March 2000
PI10380/0422	Swinghope Limited	Risperdal 1 mg Tablets Risperidone 1 mg Tablets	Risperidone 1.000 mg	The treatment of schizophrenic psychoses. Prescription Only Medicine	15th March 2000
PI10380/0430	Swinghope Limited	Alendronate Sodium Tablets 10 mg Fosamax Tablets	Alendronate Sodium 13.050 mg	Osteoporosis. Prescription Only Medicine	22nd February 2000
PI10380/0441	Swinghope Limited	Xatral Retard 5 mg Tablets	Alfuzosin Hydrochloride 5.000 mg	The functional symptoms associated with benign prostatic hypertrophy. Prescription Only Medicine	17th March 2000
PI10380/0449	Swinghope Limited	Accolate 20 mg Tablets Zafirlukast 20 mg Tablets	Zafirlukast 20.000 mg	Asthma. Prescription Only Medicine	22nd February 2000
PI10383/0618	Primecrown Limited	Flixonase Aqueous Nasal Spray	Fluticasone Propionate 50.000 mcg	Treatment of seasonal allergic rhinitis and pevenimal rhinitis. Prescription Only Medicine	29th February 2000
PI10383/0660	Primecrown Limited	Pradif MR 400 micrograms Capsules	Tamsulosin Hydrochloride 400.000 mcg	Treatment of functional systems of benign hyperplasia. Prescription Only Medicine	3rd March 2000
PI10383/0702	Primecrown Limited	Fosinopril Sodium 10 mg Tablets	Fosinopril Sodium 10.000 mg	Hypertension. Prescription Only Medicine	21st March 2000
PI10383/0718	Primecrown Limited	Lamotrigine 25 mg Tablets	Lamotrigine 25.000 mg	Epilepsy. Prescription Only Medicine	28th February 2000
PI10383/0719	Primecrown Limited	Lamotrigine 50 mg Tablets	Lamotrigine 50.000 mg	Epilepsy. Prescription Only Medicine	29th February 2000
PI10383/0720	Primecrown Limited	Lamotrigine 100 mg Tablets	Lamotrigine 100.000 mg	Epilepsy. Prescription Only Medicine	28th February 2000
PI10383/0735	Primecrown Limited	Pulmicort Turbuhaler 100	Budesonide 100.000 mcg	Treatment of bronchial asthma. Prescription Only Medicine	29th February 2000
PI10383/0748	Primecrown Limited	Omeprazole 10 mg Capsules	Omeprazole 10.000 mg	Treatment of oesophageal reflux disease. Treatment of benign gastric ulcers, duodenal ulcers. In combination with antibiotics for eradication of helicobacter pyliri. Prescription Only Medicine	29th February 2000
PI10383/0753	Primecrown Limited	Lipitor 10 mg Tablets	Atorvastatin Calcium Trihydrate 10.850 mg	Indicated as an adjunct to diet for reduction of elevated lipids. Prescription Only Medicine	3rd March 2000
PI10383/0754	Primecrown Limited	Atorvastatin 10 mg Tablets	Atorvastatin Calcium Trihydrate 10.850 mg	Indicated as an adjunct to diet for reduction of elevated total cholesterol. Prescription Only Medicine	22nd February 2000
PI10383/0755	Primecrown Limited	Atorvastatin 20 mg Tablets	Atorvastatin Calcium Trihydrate 21.690 mg	Primary hypercholesterolaemia. Prescription Only Medicine	22nd February 2000
11184/0076	Bristol-Myers Squibb Pharmaceuticals Limited	Videx 200 mg chewable/dispersible tablets	Didanosine 200.000 mg	Videx is indicated as part of a combination therapy for antiviral treatment of HIV infected patients. Prescription Only Medicine	10th December 1999
11382/0036	Eastern Pharmaceuticals Limited	Chlorpheniramine/ Chlorphenamine Tablets 4 mg	Chlorpheniramine Maleate 4.000 mg	The symptomatic control of allergic conditions responsive to antihistamines e.g. hayfever, vasomotor rhinitis, urticaria, angioneurotic oedema, food allergies, drug and serum reactions and insect bites. Pharmacy Medicine	9th March 2000
11382/0037	Eastern Pharmaceuticals Limited	Naproxen Tablets BP 250 mg	Naproxen 250.000 mg	For the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout and acute musculoskeletal disorders (such as sprains and strains direct trauma, lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis). Prescription Only Medicine	13th March 2000
11382/0038	Eastern Pharmaceuticals Limited	Naproxen Tablets BP 500 mg	Naproxen 500.000 mg	See PL 11382/0037	13th March 2000
11382/0068	Eastern Pharmaceuticals Limited	Nericur Gel 5%	Benzoyl Peroxide USP 5.00 % w/w	All stages of acne vulgaris. Pharmacy Medicine	13th March 2000
11382/0069	Eastern Pharmaceuticals Limited	Nericur Gel 10%	Benzoyl Peroxide USP 10.00 % w/w	All stages of acne vulgaris. Pharmacy Medicine	13th March 2000
12308/0020	Guerbet	Hexabrix 200 Injection	Ioxaglic acid HSE 33.31 % w/v	For phlebography of the leg by injection into a vein in the foot. Prescription Only Medicine	24th February 2000
12308/0021	Guerbet	Hexabrix 320 Injection	Ioxaglic acid HSE 53.30 % w/v	Low Osmolar X-Ray contrast medium for the opacification of the vascular system, urinary tract and joints and female genital tract. Prescription Only Medicine	24th February 2000
12930/0007	Instituto Grifols S.A.	Flebogamma 5%	Human Normal Immunoglobulin 0.500 gm	Used as substitution/replacement therapy in primary and secondary antibody deficiency disorders and for the prevention and treatment of infections associated with these conditions. Also been used to modify or control the individual’s immune response in idiopathic thrombocytopenic purpura. (1) Replacement therapy for congenital agammaglobulinaemia and hypoganimaglobulinaemia and other primary immunodeficiency syndromes including common variable immunodeficiency, severe combined immunodeficiency and Wiskott-Aldrich syndrome. (2) Replacement therapy for secondary immunodeficiency disorders. (3) Idiopathic thrombocytopenic purpura (ITP) in adults or children at high risk of bleeding or prior to surgery to correct the platelet count. (4) Prophylactic use in children with symptomatic HIV infection who have recurrent bacterial infections. Prescription Only Medicine	23rd March 2000
13767/0013	Chiron S.P.A.	Menjugate (Meningococcal C-CRM197 Conjugate Vaccine)	CRM197 30.000 mcg Meningococcal Group C Oligosaccharide 12.000 mcg	Active immunisation of children of 12 months of age and older, adolescents and adults, for the prevention of invasive disease caused by Neisseria meningitidis serogroup C. Prescription Only Medicine	1st March 2000
13767/0014	Chiron S.P.A.	Aluminium Hydroxide solvent (Single-dose)	Aluminium Hydroxide 1.600 mg	Prescription Only Medicine	1st March 2000
13767/0015	Chiron S.P.A.	Aluminium Hydroxide solvent (Multidose)	Aluminium Hydroxide 15.000 mg	Prescription Only Medicine	1st March 2000
PI13826/0179	Caseview (PL) Limited	Paroxetine 20 mg Tablets Seroxat 20 mg Tablets	Paroxetine Hydrochloride 22.880 mg	The treatment of the symptoms of depressive illness. Prescription Only Medicine	15th March 2000
PI13975/0007	Community Pharmacy Supplies Limited	Zocor 10 mg Tablets	Simvastatin 10.000 mg	1. Coronary heart disease with a plasma cholesterol level of 5.5 mm 01/1 or greater. 2. Hyperlipidaemia. Prescription Only Medicine	2nd March 2000
PI13975/0009	Community Pharmacy Supplies Limited	Zestril 5 mg Tablets	Lisinopril Dihydrate 5.450 mg	All grades of essential hypertension and renovascular hypertension. Prescription Only Medicine	22nd February 2000
PI13975/0010	Community Pharmacy Supplies Limited	Zestril 10 mg Tablets	Lisinopril Dihydrate 10.890 mg	All grades of essential hypertension and renovascular hypertension. Prescription Only Medicine	22nd February 2000
PI13975/0011	Community Pharmacy Supplies Limited	Zestril 20 mg Tablets	Lisinopril Dihydrate 21.780 mg	Parkinson’s Disease. Prescription Only Medicine	22nd February 2000
PI13975/0015	Community Pharmacy Supplies Limited	Zocor 20 mg Tablets	Simvastatin 20.000 mg	1. Coronary heart disease with a plasma cholesterol level of 5.5 mm 01/1 or greater. 2. Hyperlipidaemia. Pescription Only Medicine	2nd March 2000
PI14069/0074	Denfleet International Limited	Oxytocin 10 I.U. Injection Syntocinon 10 I.U. Injection	Oxytocin 10.000 IU	Induction of labour for medical reasons, stimulation of labour in hypotonic uterine inertia, during caesarean section. following delivery of the child, prevention and treatment of postpastum uterine atony and haemorrhage. Early stages of pregnancy as an adjunctive therapy for the management of incomplete, inevitable or missed abortion. Prescription Only Medicine	3rd March 2000
PI14069/0098	Denfleet International Limited	Finasteride 5 mg Tablets Proscar 5 mg Tablets	Finasteride 5.000 mg	Treatment and control of benign prostatic hyperplasia. Prescription Only Medicine	22nd February 2000
PI14069/0118	Denfleet International Limited	Imdur 60 mg Tablets Isosorbide Mononitrate 60 mg M.R. Tablets	Isosorbide Mononitrate 60.000 mg	Angina Pectoris. Pharmacy Medicine	20th March 2000
PI14069/0131	Denfleet International Limited	Cerivastatin Sodium 100 Micrograms Tablets Lipobay 100 Micrograms Tablets	Cerivastatin Sodium 100.000 mcg	Primary hypercholesterolaemia. Prescription Only Medicine	21st March 2000
14894/0018	Ranbaxy (UK) Limited	Etodolac Capsules 200 mg	Etodolac 200.000 mg	For acute or long term use in: (i) Osteoarthritis (ii) Rheumatoid arthritis. Prescription Only Medicine	23rd February 2000
14894/0019	Ranbaxy (UK) Limited	Etodolac Capsules 300 mg	Etodolac 300.000 mg	See PL14894/0018	23rd February 2000
15281/0004	Alza Limited	Amphocil 50 mg	Amphotericin B 50.000 mg	Prescription Only Medicine Amphocil is indicated for the treatment of severe systemic and/or deep mycoses in cases where toxicity or renal failure precludes the use of conventional amphotericin B in effective doses, and in cases where prior systemic antifungal therapy has failed. Fungal infections successfully treated with Amphocil include disseminated candidiasis and aspergillosis. Amphocil has been used successfully in severely neutropenic patients. Amphocil is not intended for use in common, clinically in apparent fungal diseases diagnosed only by skin tests or serological determinations.	17th March 2000
15281/0005	Alza Limited	Amphocil 100 mg	Amphotericin 100.000 mg	Prescription Only Medicine (See PL15281/0004).	17th March 2000
PI15361/0148	P. I. E. Pharma Limited	Zoladex LA 10.8 mg	Goserelin Acetate 10.800 mg	Prescription Only Medicine Indicated for prostate cancer suitable for hormonal manipulation.	7th March 2000
PI15361/0169	P. I. E. Pharma Limited	Pulmicort Turbohaler 100 micrograms	Budesonide 100.000 mcg	Prescription Only Medicine Bronchial Asthma	7th March 2000
PI15361/0188	P. I. E. Pharma Limited	Hytrin 2 mg Tablets	Terazosin Hydrochloride 2.000 mg	Prescription Only Medicine Mild to moderate hypertension.	29th February 2000
PI15361/0189	P. I. E. Pharma Limited	Hytrin 5 mg Tablets	Terazosin Hydrochloride 5.000 mg	Prescription Only Medicine Hypertension.	22nd February 2000
PI15361/0194	P. I. E. Pharma Limited	Pulmicort Turbohaler 400 micrograms	Budesonide 400.000 mcg	Prescription Only Medicine Bronchial Asthma	6th March 2000
PI15361/0195	P. I. E. Pharma Limited	Celectol 200 mg Tablets	Celiprolol Hydrochloride 200.000 mg	Prescription Only Medicine Treatment of mild to moderate hypertension	2nd March 2000
PI15361/0196	P. I. E. Pharma Limited	Lacidipine 2 mg Tablets	Lacidipine 2.000 mg	Prescription Only Medicine Hypertension.	10th March 2000
PI15361/0199	P. I. E. Pharma Limited	Accupro 5 mg Tablets	Quinapril 5.000 mg	Prescription Only Medicine Hypertension; congestive heart failure.	21st February 2000
PI15361/0200	P. I. E. Pharma Limited	Accupro 10 mg Tablets	Quinapril 10.000 mg	Prescription Only Medicine Hypertension.	22nd February 2000
PI15361/0230	P. I. E. Pharma Limited	Tildiem LA 200	Diltiazem Hydrochloride 200.000 mg	Hypertension; angina pectoris. Prescription Only Medicine	14th March 2000
PI15361/0231	P. I. E. Pharma Limited	Tildiem LA 300	Diltiazem Hydrochloride 300.000 mg	Hypertension; angina pectoris. Prescription Only Medicine	14th March 2000
PI15361/0240	P. I. E. Pharma Limited	Zocor 10 mg Tablets	Simvastatin 10.000 mg	1. Coronary heart disease with a plasma cholesterol level of 5.5 mm 01/1 or greater. 2. Hyperlipidaemia. Prescription Only Medicine	28th February 2000
PI15361/0247	P. I. E. Pharma Limited	Dorzalamide Ophthalmic Solution 2% Trusopt Ophthalmic Solution 2%	Dorzolamide Hydrochloride 22.260 mg	Ocular hypertension, open-angle glaucoma Pseudo-exfoliative glaucoma. Prescription Only Medicine	11th February 2000
PI15361/0250	P. I. E. Pharma Limited	Neoral 100 mg Capsules	Cyclosporin 100.000 mg	Prevention of graft rejection following organ and bone marrow transplantation. The treatment of severe psoriasis and atopic dermatitis. The treatment of severe active rheumatoid arthritis. The treatment of steroid resistant or steroid dependent nephrotic syndrome. Prescription Only Medicine	21st February 2000
15747/0003	Istituto Sieroterapico Berna S. R. L.	Epaxal Berna	Hepatitis A Virus Strain RG-SB 500.000	Active immunisation against hepatitis A. Prescription Only Medicine	14th December 1999
PI15814/0155	OPD Laboratories Limited	Pergolide Tablets 50 Microgram Pharken 50 Microgram Tablets	Pergolide 50.000 mcg	Parkinson’s disease. Prescription Only Medicine	18th February 2000
PI15814/0158	OPD Laboratories Limited	Trisequens Tablets	Norethisterone Acetate 1.000 mg Oestradiol 2.000 mg Oestradiol 1.000 mg Oestradiol 2.000 mg	The symptons of oestrogen deficiency. Prescription Only Medicine	21st March 2000
PI15814/0186	OPD Laboratories Limited	Fluticasone Propionate 125 microgram Inhaler	Fluticasone Propionate 125.000 mcg	Treatment of mild, moderate or severe asthma. Prescription Only Medicine	29th February 2000
PI15814/0187	OPD Laboratories Limited	Salmeterol Inhaler 25 micrograms Serevent Inhaler	Salmeterol 25.000 mcg	Reversible airways obstruction. Prescription Only Medicine	14th March 2000
PI15814/0246	OPD Laboratories Limited	Amlodipine Tablets 5 mg	Amlodipine 5.000 mg	Hypertension; angina pectoris. Prescription Only Medicine	21st March 2000
16075/0079	Special Concept Development BV	Paracetamol Tablets BP 500 mg	Paracetamol 500.000 mg	For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pain, aches and pains. Symptomatic relief of rheumatic aches and pains. Symptomatic relief of influenza, feverishness, feverish colds. General Sales List Pharmacy Medicine	6th March 2000
16363/0003	Milpharm Limited	Monomil XL Tablets Carmil XL Tablets	Isosorbide 5-Mononitrate 60.000 mg	For the prophylaxis of angina pectoris. Pharmacy Medicine	10th December 1999
PI16369/0001	G-Pharma Limited	Aceclofenac 100 mg Tablets	Aceclofenac 100.000 mg	Conditions requiring analgisic and anti-inflammatory treatment. Prescription Only Medicine	10th March 2000
PI16369/0041	G-Pharma Limited	Didronel PMO	Calcium Carbonate 1250.000 mg Disodium Etidronate 400.000 mg	Osteoporosis. Prescription Only Medicine	13th March 2000
PI16369/0098	G-Pharma Limited	Livial 2.5 mg Tablets	Tibolone 2.500 mg	Oestrogen deficiency states. Prescription Only Medicine	21st March 2000
PI16369/0101	G-Pharma Limited	Loratadine 10 mg Tablets	Loratadine 10.000 mg	Rhinitis and urticaria. Prescription Only Medicine	21st February 2000
PI16369/0180	G-Pharma Limited	Zneryt Topical Application	Erythromycin 40.000 mg/ml Ethanol 68.000 % w/w Zinc Acetate 12.000 mg/ml	Acne vulgaris. Prescription Only Medicine	24th March 2000
PI16369/0183	G-Pharma Limited	Zocor 10 mg Tablets	Simvastatin 10.000 mg	1. Coronary heart disease in patients with a plasma cholesterol level of 5.5 mmol/l or greater. 2. Hyperlipidaemia. Prescription Only Medicine	24th March 2000
PI16369/0184	G-Pharma Limited	Zocor 20 mg Tablets	Simvastatin 20.000 mg	1. Coronary heart disease with a plasma cholesterol level of 5.5 mmol/l or greater. 2. Hyperlipidaemia. Prescription Only Medicine	6th March 2000
PI16369/0209	G-Pharma Limited	Motens 4 mg Tablets	Lacidipine 4.000 mg	Hypertension. Prescription Only Medicne	22nd February 2000
PI16369/0235	G-Pharma Limited	Celiprolol Hydrochloride 200 mg Tablets	Celiprolol Hydrochloride 200.000 mg	Management of mild to moderate hypertension. Prescription Only Medicne	7th March 2000
PI16369/0236	G-Pharma Limited	Celiprolol Hydrochloride 400 mg Tablets	Celiprolol Hydrochloride 400.000 mg	Treatment of mild to moderate hypertension. Prescription Only Medicne	2nd March 2000
PI16369/0252	G-Pharma Limited	Lipantil Micro 200 Capsules	Fenofibrate Micronised 200.00 mg	Hyperlipidaemia. Prescription Only Medicine	21st March 2000
PI16369/0259	G-Pharma Limited	Fluconazole 50 mg capsules	Fluconazole 50.00 mg	Treatment of genital candidiasis, vaginal candidiasis, mucosal candidiasis, Tinea pedis, systemic candidiasis, cryptocococcosis and prevention of fungal infections following cytoxic chemotherapy or radiotherapy, including bone marrow transplant patients. Prescription Only Medicine	23rd February 2000
PI16369/0264	G-Pharma Limited	Amlodipine 5 mg Tablets	Amlodipine 5.000 mg	Hypertension. Prescription Only Medicine	24th March 2000
PI16369/0266	G-Pharma Limited	Enalapril Maleate 20 mg Tablets	Enalapril Maleate 20.000 mg	Treatment of hypertension. Prescription Only Medicine	3rd March 2000
PI16369/0268	G-Pharma Limited	Lacidipine 2 mg Tablets	Lacidipine 2.000 mg	Hypertension. Prescription Only Medicine	22nd February 2000
PI16369/0293	G-Pharma Limited	Tegretol CR 200 mg Tablets	Carbamazepine 200.000 mg	Epilepsy. Prescription Only Medicine	24th March 2000
PI16369/0311	G-Pharma Limited	Fosamax 10 mg Tablets	Alendronate Sodium 13.050 mg	Osteoporosis. Prescription Only Medicine	21st March 2000
PI16369/0316	G-Pharma Limited	Adalat LA 60 mg Tablets	Nifedipine 60.000 mg	Treatment of mild to moderate hypertension. Prescription Only Medicine	28th February 2000
PI16369/0342	G-Pharma Limited	Celance 1 mg Tablets	Pergolide Mesylate 1.310 mg	Parkinson’s disease. Prescription Only Medicine	11th February 2000
PI16369/0345	G-Pharma Limited	Aricept 10 mg Tablets	Donepezil Hydrochloride 10.000 mg	Mild to moderately severe Alzheimer’s dementia. Prescription Only Medicine	29th February 2000
PI16369/0350	G-Pharma Limited	Zolpidem Hemitartrate 10 mg Tablets	Zolpidem Hemitartrate 10.000 mg	Insomnia. Prescription Only Medicine	15th March 2000
PI16369/0385	G-Pharma Limited	Acamprosate 333 mg EC Tablets	Acamprosate 333.000 mg	Alcohol dependence. Prescription Only Medicine	21st March 2000
PI16369/0393	G-Pharma Limited	Pentasa Slow Release Tablets 500 mg	Mesalazine 500.000 mg	Treatment of mild to moderate exacerbations of ulcerative colitis. For the maintenance of remission of ulcerative colitis. Prescription Only Medicine	7th March 2000
PI16369/0394	G-Pharma Limited	Fucibet Cream	Betamethasone Valerate .100% w/w Fusidic Acid 2.000% w/w	Treatment of eczematous dermatoses. Prescription Only Medicine	24th March 2000
PI16369/0397	G-Pharma Limited	Creon 10000 Capsules	Amylase 8000.000 EPU Lipase 10000.000 EPU Protease 600.000 EPU	Treatment of pancreatic exocrine insufficiency. Pharmacy Medicine	3rd March 2000
PI16369/0415	G-Pharma Limited	Aricept 5 mg Tablets	Donepezil Hydrochloride 5.000 mg	Alzheimer’s dementia. Prescription Only Medicine	22nd February 2000
PI16369/0436	G-Pharma Limited	Detrusitol 1 mg Tablets	Tolterodine L-Tartrate 1.000 mg	Treatment of unstable bladder with symptoms of urgency, frequency or urge incontinence. Prescription Only Medicine	3rd March 2000
PI16369/0437	G-Pharma Limited	Prothiaden 75 mg Tablets	Dothiepin Hydrochloride 75.000 mg	Depressive illness. Prescription Only Medicine	21st February 2000
PI16369/0443	G-Pharma Limited	Gopten 2 mg Capsules	Trandolapril 2.000 mg	Mild to moderate hypertension. Prescription Only Medicine	9th March 2000
PI16369/0509	G-Pharma Limited	Amlodipine 10 mg Tablets	Amlodipine 10.000 mg	Hypertension, prophylaxis of chronic stable angina pectoris. Prescription Only Medicine	2nd March 2000
PI16369/0510	G-Pharma Limited	Amlodipine 5 mg Tablets	Amlodipine Besylate 6.944 mg	Hypertension. Proplylaxis of chronic stable angina pectoris. Prescription Only Medicine	2nd March 2000
PI16378/0059	Beachcourse Limited	Zoladex 3.6 Depot Injection	Goserelin 3.600 mg	Prostate cancer suitable for hormonal manipulation; advanced breast cancer; the management of endometriosis. Prescription Only Medicine	10th March 2000
16520/0005	Tanabe Europe N.V.	Herleed 2.5 mg Tablets	Imidapril Hydrochloride 2.500 mg	Treatment of essential hypertension. Prescription Only Medicine	22nd December 1999
16520/0006	Tanabe Europe N.V.	Herleed 5 mg Tablets	Imidapril Hydrochloride 5.000 mg	(See PL16520/0005). Prescription Only Medicine	22nd December 1999
16520/0007	Tanabe Europe N.V.	Herleed 10 mg Tablets	Imidapril Hydrochloride 10.000 mg	(See PL16520/0005). Prescription Only Medicine	22nd December 1999
16520/0008	Tanabe Europe N.V.	Herleed 20 mg Tablets	Imidapril Hydrochloride 20.000 mg	(See PL16520/0005). Prescription Only Medicine	22nd December 1999
16950/0003	Napp Pharmaceuticals Limited	Oxynorm Liquid 5 mg/5 ml	Oxycodone Hydrochloride 5.000 mg	For the treatment of moderate to severe pain in patients with cancer and post-operative pain. Prescription Only Medicine	9th December 1999
16950/0004	Napp Pharmaceuticals Limited	Oxynorm Concentrate 10 mg/ml	Oxycodone Hydrochloride 10.000 mg	(See PL16950/6003). Prescription Only Medicine	9th December 1999
16950/0014	Napp Pharmaceuticals Limited	Codafen Continus Tablets	Codeine Phosphate 20.000 mg Ibuprofen 300.000 mg	Relief of pain in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and sero-negative arthropathies; inflammatory disorders such as bursitis, capsulitis of the shoulder, tendinitis, tenosynovitis; relief of severe pain in such clinical conditions as post-episiotomy pain, dental extraction pain, post-operative pain, dysmenorrhoea, migraine, sprains strains and low back pain. Prescription Only Medicine	15th March 2000
16950/0111	Napp Pharmaceuticals Limited	Dromadol SR Tablets 75 mg	Tramadol Hydrochloride 75.000 mg	Treatment of moderate to severe pain. Prescription Only Medicine	21st December 1999
16950/0113	Napp Pharmaceuticals Limited	Dromadol SR Tablets 150 mg	Tramadol Hydrochloride 150.000 mg	Treatment of moderate to severe pain. Prescription Only Medicine	21st December 1999
16950/0114	Napp Pharmaceuticals Limited	Dromadol SR Tablets 200 mg	Tramadol Hydrochloride 200.000 mg	Treatment of moderate to severe pain. Prescription Only Medicine	21st December 1999
17092/0002	Pathogenesis Limited	Tobi 300 mg/5 ml Nebuliser Solution	Tobramycin 300.000 mg	Long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients aged 6 years and older. Prescription Only Medicine	10th December 1999
17154/0001	Xyrofin (UK) Limited	Lactitol Monohydrdate Sachets	Lactitol Monohydrate 10.000 gm	Constipation. Portal systemic encephalopathy. Pharmacy Medicine	24th March 2000
PI17211/0067	Polyfarma Limited	Timoptol 0.5% Eyedrops	Timolol Maleate 0.500 % w/v	Reduction of elevated intraocular pressure. Prescription Only Medicine	31st March 2000
PI17211/0226	Polyfarma Limited	Flixotide 250 Inhaler	Fluticasone Propionate 250.000 mcg	Asthma. Prescription Only Medicine	31st March 2000
PI17211/0245	Polyfarma Limited	Zestril 20 mg Tablets	Lisinopril Dihydrate 21.780 mg	Hypertension, congestive heart failure, acute myocardial infarction. Prescription Only Medicine	22nd February 2000
PI17211/0247	Polyfarma Limited	Imdur 60 mg Tablets	Isosorbide Mononitrate 60.000 mg	Treatment of angina pectoris. Prescription Only Medicine	10th March 2000
PI17211/0286	Polyfarma Limited	Pravastatin Sodium 10 mg Tablets	Pravastatin Sodium 10.000 mg	Coronary artery disease and hypercholesterolaemia. Prescription Only Medicine	22nd February 2000
17246/0010	Dr. Regenold GmbH	Oxybutynin 5 mg Tablets	Oxybutynin Hydrochloride 5.000 mg	Urinary incontinence, urgency and frequency in the unstable bladder, whether due to neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as multiple sclerosis and spina bifida, or to idiopathic detrusor instability (motor urge incontinence). Children over 5 years of age: In addition to neurogenic bladder disorders. Oxybutynin may also be used in nocturnal enuresis in conjunction with non-drug therapy where this alone, or in conjunction with other drug therapy, has failed. Prescription Only Medicine	23rd February 2000
17284/0001	Pan European Pharmaceuticals Limited	Junior Ibuprofen Suspension 100 mg/5 ml	Ibuprofen 100.000 mg	For reduction of fever (including post immunisation fever); and relief of mild to moderate pain such as headache, sore throat, earache, teething pain and toothache, cold and flu symptoms, minor aches and sprains. Pharmacy Medicine	13th March 2000
17284/0002	Pan European Pharmaceuticals Limited	Junior Ibuprofen Suspension 100 mg/5 ml	Ibuprofen 100.000 mg	(See PL 17284/0001.) Pharmacy Medicine	13th March 2000
PI17367/0008	Concept Medical Limited	Atacand 16 mg Tablets Candesartan Cilexetil Tablets 16 mg	Candesartan Cilexetil 16.000 mg	Hypertension. Prescription Only Medicine	14th March 2000
PI17367/0010	Concept Medical Limited	Requip 1 mg Tablets Ropinirole Tablets 1 mg	Ropinirole Hydrochloride 1.140 mg	Parkinson’s disease. Prescription Only Medicine	28th February 2000
PI17367/0011	Concept Medical Limited	Requip 2 mg Tablets Ropinirole Tablets 2 mg	Ropinirole Hydrochloride 2.280 mg	Parkinson’s disease. Prescription Only Medicine	29th February 2000
PI17367/0012	Concept Medical Limited	Requip 5 mg Tablets Ropinirole Tablets 5 mg	Ropinirole Hydrochloride 5.700 mg	Parkinson’s disease. Prescription Only Medicine	28th February 2000
PI17367/0019	Concept Medical Limited	Zoladex LA 10.8 mg Injection	Goserelin 10.800 mg	Prostate cancer suitable for hormonal manipulation. Prescription Only Medicine	2nd March 2000
PI17367/0024	Concept Medical Limited	Serevent Accuhaler 50 micrograms	Salmeterol Xinafoate 72.500 mcg	Reversible airways obstruction. Prescription Only Medicine	18th February 2000
PI17367/0025	Concept Medical Limited	Anagastra 40 mg Tablets Pantoprazole Enteric Coated Tablets 40 mg	Pantoprazole Sodium Sesquihydrate 45.100 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	14th March 2000
PI17367/0031	Concept Medical Limited	Isodur Tablets 60 mg Pertil Retard Tablets 60 mg	Isosorbide 5-Mononitrate 60.000 mg	Prophylactic treatment of angina pectoris. Pharmacy Medicine	11th February 2000
PI17367/0038	Concept Medical Limited	Ursofalk 250 mg Capsules	Ursodeoxycholic Acid 250.000 mg	Treatment of primary biliary cirrhosis and for the dissolution of radiolucent gallstones. Prescription Only Medicine	29th February 2000
PI17367/0046	Concept Medical Limited	Xalatan 0.005% Eye Drops	Latanoprost .005 W/V	The reduction of elevated intraocular pressure. Prescription Only Medicine	10th March 2000
PI17367/0049	Concept Medical Limited	Flixotide 100 Accuhaler	Fluticasone Propionate 100.000 MCG	Asthma. Prescription Only Medicine	22nd February 2000
PI17367/0050	Concept Medical Limited	Flixotide 250 Accuhaler	Fluticasone Propionate 250.000 MCG	Asthma. Prescription Only Medicine	2nd March 2000
PI17367/0051	Concept Medical Limited	Flixotide 500 Accuhaler	Fluticasone Propionate 500.000 MCG	Asthma. Prescription Only Medicine	29th February 2000
PI17367/0052	Concept Medical Limited	Risperdal 3 mg Tablets Risperidone Tablets 3 mg	Risperidone 3.000 MG	The treatment of schizophrenic psychoses. Prescription Only Medicine	15th March 2000
PI17367/0053	Concept Medical Limited	Risperdal 4 mg Tablets Risperidone Tablets 4 mg	Risperidone 4.000 MG	The treatment of schizophrenic psychoses. Prescription Only Medicine	15th March 2000
PI17367/0055	Concept Medical Limited	Casodex 50 mg Tablets	Bicalutamide 50.000 mg	Treatment of advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. Prescription Only Medicine	13th March 2000
PI17367/0059	Concept Medical Limited	Imigran 20 Nasal Spray	Sumatriptan 200.000 mg/ml	Prescription Only Medicine	15th February 2000
PI17367/0062	Concept Medical Limited	Atorvastatin Tablets 40 mg Lipitor 40 mg Tablets Tahor 40 mg Tablets	Atorvastatin Calcium Trihydrate 43.330 mg	Indicated as an adjunct to diet for reduction of elevated total lipids. Prescription Only Medicine	6th March 2000
PI17367/0063	Concept Medical Limited	Amlodipine Tablets 5 mg	Amlodipine Besylate 6.994 mg	Hypertension. Prescription Only Medicine	3rd March 2000
PI17367/0077	Concept Medical Limited	Famciclovir Tablets 750 mg Famvir 750 mg Tablets	Famciclovir 750.000 mg	Herpes infections. Prescription Only Medicine	18th February 2000
PI17367/0089	Concept Medical Limited	Lipitor 10 mg Tablets	Atorvastatin Calcium Trihydrate 10.850 mg	Is indicated as an adjunct to diet for reduction of elevated total lipids. Prescription Only Medicine	10th March 2000
PI17367/0090	Concept Medical Limited	Lipitor 20 mg Tablets	Atorvastatin Calcium Trihydrate 21.690 mg	Is indicated as an adjunct to diet for reduction of elevated total lipids. Prescription Only Medicine	10th March 2000
17496/0002	Dalkeith Laboratories Limited	Vitamin B Compound Tablets BPC	Nicotinamide 15.000 mg Riboflavin 1.000 mg Thiamine Hydrochloride 1.000 mg	For the prophylaxis of Vitamin B deficiencies; as a nutritional supplement in the elderly; and as an aid to convalescence after illness or surgery. Pharmacy Medicine	23rd March 2000
17521/0007	Metwest Pharmaceuticals Limited	Erythromycin Tablets 250 mg	Erythromycin 274.000 mg	For the prophylaxis and treatment of infections caused by Erythromycin-sensitive organisms: 1. Upper and lower respiratory tract infections 2. Soft tissue and skin infections 3. Bone infections 4. Oral and dental infection 5. Gastro-intestinal infections 6. Eye infections 7. Sexually transmitted diseases 8. Prophylaxis 9. Microbiological indications. Prescription Only Medicine	6th March 2000
17521/0013	Metwest Pharmaceuticals Limited	Prochlorperazine Tablets 5 mg	Prochlorperazine Maleate 5.000 mg	Vertigo due to Meniere’s syndrome, labyrinthine and other causes. Nausea and vomiting from whatever cause. Migraine. Schizophrenia and other psychotic disorders. Short-term management of anxiety. Prescription Only Medicine	13th March 2000
17637/0002	Alston Gerrard and Company	Collins Elixir	Ethylmorphine Hydrochloride 1.500 mg	For relieving coughs caused by colds, sore throat and congestion of the upper respiratory tract. For that unpleasant tickling in the throat which causes an incessant cough and deprives one of rest at night. Pharmacy Medicine	14th March 2000
17740/0001	Hermes Arzneimittel GMBH	Calcium 600 mg D3 400IU/Hermes	Calcium Carbonate 1500.000 mg Cholecalciferol 100000 IU/G .010 mg	Correction of combined vitamin D3 and calcium deficiencies. Vitamin D3 and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients where combined calcium and vitamin D deficiencies have been disagnosed or at high risk of such deficiencies. Pharmacy Medicine	22nd March 2000
17740/0002	Hermes Arzneimittel GMBH	Calcium 600 mg Vitamin D3 400IU/Hermes	Calcium Carbonate 1500.000 mg Cholecalciferol 100000 IU/G .010 mg	(See PL 17740/0001.) Pharmacy Medicine	22nd March 2000
17740/0003	Hermes Arzneimittel GMBH	Calcium 600 mg Vitamin D3 400IU/Hermes	Calcium Carbonate 1500.000 mg Cholecalciferol 100000 IU/G .010 mg	(See PL 17740/0001.) Pharmacy Medicine	22nd March 2000
17740/0004	Hermes Arzneimittel GMBH	Calcium 600 mg plus D3 400IU/Hermes	Calcium Carbonate 1500.000 mg Cholecalciferol 100000 IU/G .010 mg	(See PL 17740/0001.) Pharmacy Medicine	22nd March 2000