Medicines

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
00022/0186	Pharmacia Laboratories Limited	Genotropin MiniQuick 0.6IU (0.2 mg)	Somatropin (rbe) .200 mg	Growth disturbance due to insufficient secretion of growth hormone or associated with gonadal dysgenesis (Turner syndrome). Growth disturbance in prepubertal children with chronic renal insufficiency. Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed in two different dynamic tests for growth hormone deficiency. Patients must also fulful the following criteria: Childhood onset: Patients, who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with the product is started. Adult onset: Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin. Prescription Only Medicine	14th September 1998
00022/0187	Pharmacia Laboratories Limited	Genotropin MiniQuick 1.2IU (0.4 mg)	Somatropin (rbe) .400 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0188	Pharmacia Laboratories Limited	Genotropin MiniQuick 1.8IU (0.6 mg)	Somatropin (rbe) .600 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0189	Pharmacia Laboratories Limited	Genotropin MiniQuick 2.4IU (0.8 mg)	Somatropin (rbe) .800 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0190	Pharmacia Laboratories Limited	Genotropin MiniQuick 3IU (1 mg)	Somatropin (rbe) 1.000 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0191	Pharmacia Laboratories Limited	Genotropin MiniQuick 3.6IU (1.2 mg)	Somatropin (rbe) 1.200 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0192	Pharmacia Laboratories Limited	Genotropin MiniQuick 4.2IU (1.4 mg)	Somatropin (rbe) 1.400 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0193	Pharmacia Laboratories Limited	Genotropin MiniQuick 4.8IU (1.6 mg)	Somatropin (rbe) 1.600 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0194	Pharmacia Laboratories Limited	Genotropin MiniQuick 5.4IU (1.8 mg)	Somatropin (rbe) 1.800 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00022/0195	Pharmacia Laboratories Limited	Genotropin MiniQuick 6IU (2 mg)	Somatropin (rbe) 2.000 mg	(See PL 00022/0186). Prescription Only Medicine	14th September 1998
00043/0205	Leo Laboratories Ltd.	Innohep 10,000 IU/ml	Tinzaparin Sodium 10000.000 IU	For the prevention of thromboembolic events including deep vein thrombosis in patients undergoing general and orthopaedic surgery. For the prevention of clotting in the extracorporeal circuit during haemodialysis in patients with chronic renal insufficiency. Prescription Only Medicine.	30th September 1998
00108/0117	Pharmax Limited	Syscor MR 10	Nisoldipine 10.000 mg	For the first-line treatment of mild to moderate arterial essential hypertension and the prophylaxis of chronic stable angina pectoris. Prescription Only Medicine.	7th December 1998
00108/0118	Pharmax Limited	Syscor MR 20	Nisoldipine 20.000 mg	(See PL 00108/0117). Prescription Only Medicine.	7th December 1998
00108/0119	Pharmax Limited	Syscor MR 30	Nisoldipine 30.000 mg	(See PL 00108/0117). Prescription Only Medicine.	7th December 1998
00142/0432	A H Cox & Compnay Limited	Captopril/Hydrochlorothiazide Tables 25/12.5 mg	Captopril 25.000 mg Hydrochlorothiazide 12.500 mg	Treatment of mild to moderate hypertension in patients previously stabilised on the individual components given in the same proportions. Prescription Only Medicine.	27th November 1998
00142/0433	A H Cox & Compnay Limited	Captopril/Hydrochlorothiazide Tables 50/25 mg	Captopril 50.000 mg Hydrochlorothiazide 25.000 mg	(See PL 00142/0432). Prescription Only Medicine.	27th November 1998
00142/0446	A H Cox & Compnay Limited	Pizotifen Tablets BP 0.5 mg	Pizotifen Hydrogen Malate .725 mg	Prophylactic treatment of recurrent vascular headaches, including classical migraine, common migraine and cluster headache (periodic migrainous neuralgia. Prescription Only Medicine.	1st December 1998
00142/0447	A H Cox & Compnay Limited	Pizotifen Tablets BP 1.5 mg	Pizotifen Hydrogen Malate 2.175 mg	(See PL 00142/0446). Prescription Only Medicine.	1st December 1998
00156/0091	Martindale Pharmaceuticals Ltd.	DF118 Injection 50 mg/ml	Dihydrocodeine Tartrate 5.000 %w/w	Relief of severe pain. Prescription Only Medicine.	14th December 1998
00156/0093	Martindale Pharmaceuticals Ltd.	DF118 Forte 40 mg	Dihydrocodeine Tartrate 40.000 mg	Relief of severe pain and chronic severe pain. Prescription Only Medicine.	14th December 1998
00169/0110	Knoll Limited	Zoleptil 25	Zotepine 25.000 mg	For the treatment of schizophrenia. Prescription Only Medicine	21st September 1998
00169/0111	Knoll Limited	Zoleptil 50	Zotepine 50.000 mg	(See PL 00169/0110.) Prescription Only Medicine21st September 1998
00169/0112	Knoll Limited	Zoleptil 100	Zotepine 100.000 mg	(See PL 00169/0110). Prescription Only Medicine 21st September 1998
00221/0137	Nycomed Amersham Plc	[123-I]-Ortho-Iodohippurate Injection	Sodium Ortho-Iodohippurate I-123 37.000 mbq, Sodium Ortho-Iodohippurate I-123 166.500 mbq, Sodium Ortho-Iodohippurate I-123 185.000 mbq, Sodium Ortho-Iodohippurate I-123 18.500 mbq, Sodium Ortho-Iodohippurate I-123 55.500 mbq, Sodium Ortho-Iodohippurate I-123 148.000 mbq, Sodium Ortho-Iodohippurate I-123 74.000 mbq, Sodium Ortho-Iodohippurate I-123 92.500 mbq, Sodium Ortho-Iodohippurate I-123 111.000 mbq Sodium Ortho-Iodohippurate I-123 129.500 mbq	Investigation of renal function: Measurement of effective renal plasma flow—Split and regional renal function (i.e. duplicated kidneys)—Localisation of intact renal parenchyma Dynamic renal scintigraphy for perfusion, function and urinary tract studies. Prescription Only Medicine	1st December 1998
00221/0138	Nycomed Amersham Plc	[123-I] Sodium Iodide Injection	Sodium Iodide I 123 37.000 mbq, Sodium Iodide I 123 55.500 mbq, Sodium Iodide I 123 74.000 mbq, Sodium Iodide I 123 18.500 mbq, Sodium Iodide I 123 95.500 mbq, Sodium Iodide I 123 185.000 mbq, Sodium Iodide I 123 111.000 mbq, Sodium Iodide I 123 129.500 mbq, Sodium Iodide I 123 148.000 mbq and Sodium Iodide I 123 166.500 mbq	A diagnostic agent in the functional or morphological study of the thyroid gland by means of: Scintigraphy—Radioactive iodine uptake test. The 24 hours uptake data are generally used in calculating the therapeutic dose. Prescription Only Medicine	1st December 1998
00221/0139	Nycomed Amersham Plc	[81 Rb/81m Kr]—Generator for Elution with Air	Krypton—81m .000 none and Rubidium—81 222.000 mbq	Investigation of pulmonary ventilation. According to the low radiation dose, this product can be especially recommended for paediatric examination.—Combined with a pulmonary perfusion: scintigraphy for diagnosis of pulmonary embolism. Pulmonary ventilation (81 m-Kr)/perfusion (99m-Tc-macroaggregate) studies are possible because of the different spectrometric windows of 81m-Kr and 99m-Tc. Prescription Only Medicine	1st December 1998
00221/0140	Nycomed Amersham Plc	Iobenguane (123 I) Solution for Injection	Metaiodobenzylguanidine (I-123) 370.000 mbq	Diagnostic scintigraphic localisation of tumours originating in tissue that embryologically stems from the neural crest. These are pheochromocytomas, paragangliomas, chemodectomas and ganglioneuromas. Detection staging and follow-up on therapy of neuroblastomas. Evaluation of the uptake of lobenguane. The sensitivity to diagnostic visualisation is different for the listed pathological entities. Pheochromocytomas and neuroblastomas are sensitive in approximately 90% of patients, carcinoids in 70% and MCT in only 35%. Functional studies of the adrenal medulla (hyperplasia) and the myocardium (sympathetic innervation). Prescription Only Medicine	1st December 1998
00440/0109	Galen Limited	Kapake Insts 30/500	Codeine Phosphate Hemihydrate 30.000 mg and Paracetamol DC 96% PVP 4% 520.830 mg	Relief of severe pain. Prescription Only Medicine	15th September 1998
00440/0110	Galen Limited	Kapake Insts 60/1000	Codeine Phosphate Hemihydrate 60.000 mg and Paracetamol DC 96% PVP 4% 1041.660 mg	Relief of severe pain. Prescription Only Medicine	15th September 1998
00576/0141	Global Pharmaceuticals Ltd	Zoladex 3.6 mg Injection	Goserelin 3.600 mg	Prostate cancer suitable for hormonal manipulation; advanced breast cancer; the management of endometriosis. Prescription Only Medicine	27th November 1998
03787/0451	Swingward Limited (t/a Medihealth)	Efexor 37.5 mg Tablets	Venlafaxine Hydrochloride 42.420 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	11th December 1998
03787/0452	Swingward Limited1 (t/a Medihealth)	Efexor 75 mg Tablets	Venlafaxine Hydrochloride 84.840 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	11th December 1998
03787/0465	Swingward Limited t/a Medihealth	Estraderm MX 25	Oestradiol .750 mg	Estrogen replacement therapy. Prescription Only Medicine.	24th November 1998
03787/0488	Swingward Limited t/a Medihealth	Metrodine HP 75	Urofollitrophin 75 IU	1. The stimulation of multifollicular development in women. 2. The stimulation of spermatogenesis in men. Prescription Only Medicine.	8th December 1998
03787/0489	Swingward Limited t/a Medihealth	Sodium Chloride Injection 0.9% w/v	Sodium Chloride .900% w/v	For reconstitution of any paremteral product requiring 0.9% sodium chloride solution as a diluent. Prescription Only Medicine.	8th December 1998
03787/0496	Swingward Limited t/a Medihealth	Amlodipine 5 mg Tablets	Amlodipine 5 mg	Hypertension. Prescription Only Medicine.	7th December 1998
03787/0497	Swingward Limited t/a Medihealth	Amlodipine 10 mg Tablets	Amlodipine 10 mg	Hypertension. Prescription Only Medicine.	7th December 1998
03787/0499	Swingward Limited t/a Medihealth	Zestril 20 mg Tablets. Lisinopril 20 mg Tablets	Lisinopril 20 mg	The treatment of hypertension and congestive heart failure. Prescription Only Medicine.	1st December 1998
03787/0515	Swingward Limited t/a Medihealth	Efexor 75 mg Tablets	Venlafaxine Hydrochloride 84.840 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine.	11th December 1998
03787/0533	Swingward Limited t/a Medihealth	Cytotec	Misoprostol 20 mg	The treatment of duodenal and gastric ulcers. Prescription Only Medicine.	7th December 1998
03787/0576	Swingward Limited t/a Medihealth	Simvastatin 10 mg Tablets	Simvastatin 10 mg	The reduction of elevated cholesterol. Prescription Only Medicine.	1st December 1998
03787/0577	Swingward Limited t/a Medihealth	Simvastatin 20 mg Tablets	Simvastatin 20 mg	Primary hypercholesterolaemia. Prescription Only Medicine.	11th December 1998
04423/0277	Doncaster Pharmaceuticals Group Limited	Sodium Cromoglycate 5 mg Inhaler	Sodium Cromoglycate 5 mg	Bronchial asthma. Prescription Only Medicine.	25th November 1998
04515/0105	Faulding Pharmaceuticals PLC	Astrix XL	Aspirin 100 mg	Aspirin has an anti-thrombotic action which has been shown to be useful in a number of thromboembolic indications such as the prevention of graft occlusion folloiwng aorto-coronary bypass surgery, prophylaxis in unstable coronary artery disease, e.g. following myocardial infarction or in unstable angina, and prophylaxis in patients with a history of stroke or transient ischaemic attacks. Prescription Only Medicine. Pharmacy Medicine	21st September 1998
04569/0382	Generics (UK) Limited	Zopiclone Tablets 7.5 mg	Zopiclone 7.500 mg	For the short-term treatment of insomnia. Prescription Only Medicine.	9th December 1998
05036/0148	Shah M K MPS t/a M. K. Shah Pharmaceuticals	Renitec 5 mg	Enalapril Maleate 5.00 mg	Hypertension and congestive heart failure. Prescription Only Medicine.	27th November 1998
05513/0500	Eurochem Limited	Sertraline Hydrochloride 50 mg Tablets	Sertraline Hydrochloride 55.950 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine.	25th November 1998
05513/0555	Eurochem Limited	Perindopril Tert Butylamine salt 4 mg Tablets. Coversyl 4 mg Tablets	Perindopril Tert-Butylamine Salt 4.00 mg	Hypertension and heart failure. Prescription Only Medicine.	27th November 1998
05662/0461	Dowelhurst Limited	Mupirocin 2% Nasal Ointment. Bactroban Nasal Ointment	Mupirocin 2.000% w/w	The elimination of nasal carriage of staphylococci. Prescription Only Medicine.	27th November 1998
05662/0490	Dowelhurst Limited	Anastrozole 1 mg Tablets. Arimidex Tablets	Anastrozole 1.000 mg	Treatment of advanced breast cancer in post-menopausal women. Prescription Only Medicine.	7th December 1998
05662/0528	Dowelhurst Limited	Relifex 500 mg Tablets. Nabumetone 500 mg Tablets	Nabumetone 500.000 mg	Treatment of osteoarthritis and rheumatoid arthritis. Prescription Only Medicine.	11th December 1998
05562/0558	Dowelhurst Limited	Zestril 10 mg Tablets. Lisinopril Tablets 10 mg	Lisinopril Dihydrate 10.890 mg	Hypertension. Prescription Only Medicine.	8th December 1998
05815/0014	Les Laboratoires Servier	Preterax 4/1.25	Indapamide 1.250 mg Perindopriltert-Butylancine Salt 4.000 mg	Treatment of essential hypertension, in patients whose blood pressure is not adequately controlled on perindopril alone. Prescription Only Medicine.	23rd September 1998
06453/0052	Athlone Laboratories Limited	Phenoxymethylpenicillin Oral Solution BP 125 mg/5 ml	Phenoxymethylpenicillin Potassium 137.500 mg	In the treatment of mild to moderately severe infections associated with micro-organisms whose susceptibility to penicillin is within the range of serum levels attained with the dosage form. Note: Severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with Penicillin V during the acute phase. The following infections will usually respond to adequate doses: Streptococcal infections (without bacteraemia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. Pneumococcal infections: mild to moderately severe infections of the respiratory tract. Staphylococcal infections sensitive to penicillin: mild infections of the skin and soft tissues. Fusospirochaetosis (Vincent’s gingivitis and pharyngitis); mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. Prophylactic use: prophylaxis with oral penicillin has proved effective in preventing the recurrence of rheumatic fever and chorea. Patients with a past history of rheumatic fever receiving continuous prophylaxis may harbour penicillin-resistant organisms. In these patients, the use of another prophylactic agent should be considered. Note: oral penicillin should not be used as adjunctive prophylaxis for genito-urinary instrumentation or surgery, lower intestinal tract surgery, sigmoidoscopy and child birth. Prescription Only Medicine.	1st December 1998
06453/0053	Athlone Laboratories Limited	Phenoxymethylpenicillin Oral Solution BP 250 mg/5 ml	Phenoxymethylpenicillin Potassium 275.000 mg	(See PL 06453/0052.) Prescription Only Medicine.	1st December 1998
06464/0512	Waymade plc	Dorzolamide 2% Ophthalamic Solution	Dorzolamide Hydrochloride 22.260 mg	The treatment of elevated intra-ocular pressure. Prescription Only Medicine	8th December 1998
06464/0545	Waymade plc	Losartan Potassium 50 mg Tablets Cozaar 50 mg Tablets	Losartan Potassium 50.000 mg	Hypertension. Prescription Only Medicine	1st December 1998
06745/0100	Pasteur Merieux MSD Ltd	Tetravac	Diphtheria Toxoid Purified 30.000 iu. Inactivated Poliovirus Type 1 40.000 u. Inactivated Poliovirus Type 2 8.000 u. Inactivated Poliovirus Type 3 32.000 u. Pertussis Purified Filamentous Haemagglutinin 25.000 mcg. Pertussis Toxoid Purified 25.000 mcg. Tetanus Toxoid Purified 40.000 iu.	Active immunisation against diphtheria, tetanus, pertussis and poliomyelitis—for primary vaccination in infants,—for booster in children who have previously received a primary vaccination with a diphtheria-tetanus-whole-cell or acellular pertussis-poliomyelitis vaccine. Prescription Only Medicine	16th September 1998
06745/0101	Pasteur Merieux MSD Ltd	Pentavac	Diphtheria Toxoid Purified 30.000 iu. Haemophilus Influenzae B 10.000 mcg. Polysaccharide-Tetanus Conjugate. Inactivated Poliovirus Type 1 40.000 u. Inactivated Poliovirus Type 2 8.000 u. Inactivated Poliovirus Type 3 32.000 u. Pertussis Purified Filamentous Haemagglutinin 25.000 mcg. Pertussis Toxoid Purified 25.000 mcg. Tetanus Toxoid Purified 40.000 iu.	Active immunisation against diphtheria, tetanus, pertussis and poliomyelitis and invasive infections caused by Haemophilus influenzae type b (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc)—for primary vaccination in infants,—for booster in children who have previously received a primary vaccination with this vaccine or a diphtheria-tetanus-whole-cell or acellular pertussis-poliomyelitis vaccine, whether mixed or not with freeze-dried conjugate Haemophilus influenzae type b vaccine. Prescription Only Medicine	16th September 1998
08829/0072	Trinity Pharmaceuticals Limited	Makrobac 250	Erythromycin Stearate 346.700 mg	For the prophylaxis and treatment of infection caused by erythromycin sensitive organisms. Effective in the treatment of a great variety of clinical infections. 1. Upper respiratory tract infections: Tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in colds and influenza. 2. Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis, pneumonia, bronchiectasis. 3. Oral infections: Gingivitis, Vincent’s angina. 4. Eye infections: Blepharitis. 5. Ear infections: Otitis media and otitis externa, mastoiditis. 6. Skin and soft tissue infections: Boils and carbuncles, paronychia, abscesses, acne, impetigo, cellulitis, erysipelas. 7. Prophylaxis: Pre- and post-operative, trauma, burns, rheumatic fever. 8. Genito-urinary infections: Urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, prostatitis. 9. Other infections: Osteomyelitis, diphtheria, scarlet fever. Microbiological indications: Active against a wide range of gram-positive Staphylococci, Pneumococci and Streptococi, Meningococci, Mycoplasma, L-forms, Haemophilus influenzae, agents causing trachoma and lymphogranuloma venureum, Chlamydia, Clostridia, Corynebacteria neisseria, Treponema pallidum and Bordetella. Prescription Only Medicine	8th September 1998
08829/0073	Trinity Pharmaceuticals Limited	Makrobac 500	Erythromycin Stearate 693.500 mg	See PL 08829/0072. Prescription Only Medicine	8th September 1998
10256/0404	Stephar (UK) Limited	Gopten 2 mg Capsules	Trandolapril 2.000 mg	Hypertension. Prescription Only Medicine	11th December 1998
10256/0446	Stephar (UK) Limited	Tarivid 200 mg Tablets	Ofloxacin 200.000 mg	The treatment of infections caused by sensitive organisms. Prescription Only Medicine	7th December 1998
10380/0199	Swinghope Limited	Manerix 150 mg Tablets Moclobemide 150 mg Tablets	Moclobemide 150.000 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	24th November 1998
10380/0222	Swinghope Limited	Citalopram Tablets 20 mg Cipramil 20 mg Tablets Seropram 20 mg Tablets	Citalopram Hydrobromide 24.980 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	1st December 1998
10380/0223	Swinghope Limited	Lacidipine 4 mg Tablets Motens 4 mg Tablets	Lacidipine 4.000 mg	Hypertension. Prescription Only Medicine	8th December 1998
10380/0236	Swinghope Limited	Besitran 50 mg Tablets Sertraline Tablets 50 mg	Sertraline Hydrochloride 55.950 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	24th November 1998
10380/0254	Swinghope Limited	Cipramil 20 mg Tablets Citalopram Tablets 20 mg	Citalopram Hydrobromide 24.980 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	27th November 1998
10380/0273	Swinghope Limited	Buspar 5 mg Tablets	Buspirone Hydrochloride 5.000 mg	Short-term management of anxiety disorders. Prescription Only Medicine	24th November 1998
10383/0563	Primecrown Limited	Venlafaxine Tablets 37.5 mg Efexor 37.5 mg Tablets	Venlafaxine Hydrochloride 42.420 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	1st December 1998
10383/0564	Primecrown Limited	Venlafaxine Tablets 75 mg Efexor 75 mg Tablets	Venlafaxine Hydrochloride 84.840 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	1st December 1998
11204/0030	Stada Arzneimittel AG	Virostad Tablets 400 mg aciclovir Aciclovir Tablets 400 mg	Aciclovir 400.000 mg	The prophylaxis of herpes simplex virus infections in severely immunocompromised patients. The treatment of varicella (chickenpox) and herpes zoster (shingles) infections. Prescription Only Medicine	26th November 1998
11204/0031	Stada Arzneimittel AG	Virostad Tablets 200 mg aciclovir Aciclovir Tablets 200 mg	Aciclovir 200.000 mg	The treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes. The suppression (prevention of recurrences) of frequent and/or severe episodes of recurrent genital herpes or recurrent herpes simplex virus infections at other sites, in immunocompetent patients who cannot be satisfactorily managed by intermittent treatment. The prophylaxis of herpes simplex virus infections in immunocompromised patients. The treatment of varicella (chickenpox) and herpes zoster (shingles) infections. Prescription Only Medicine	26th November 1998
11204/0032	Stada Arzneimittel AG	Virostad Tablets 800 mg aciclovir Aciclovir Tablets 800 mg	Aciclovir 800.000 mg	The treatment of varicella (chickenpox) and herpes zoster (shingles) infections. Prescription Only Medicine	26th November 1998
11204/0033	Stada Arzneimittel AG	Aciclovir Cream 50 mg/g Virostad Cream 50 mg/g aciclovir Viralief Cream 50 mg/g	Aciclovir 5.000 gm	(POM packs): The treatment of herpes simplex virus infections of the skin, including initial genital herpes and herpes labialis. For topical use within 24 hours of onset of prodromal symptoms. Do not use in the eyes. (P packs): The treatment of herpes simplex virus infections of the lips and face. Prescription Only Medicine Pharmacy Medicine	26th November 1998
11314/0115	Seton Products Limited	Anbesol Teething Gel	Cetylpyridinium Chloride .020% w/w. Chlorocresol .100% w/w. Lidocaine Hydrochloride 1.000% w/w.	For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation and teething. Pharmacy Medicine	14th December 1998
11314/0116	Seton Products Limited	Anbesol Adult Strength Gel	Cetylpyridinium Chloride .020% w/w. Chlorocresol .100% w/w. Lidocaine Hydrochloride 2.000% w/w.	For the temporary relief of pain caused by recurrent mouth ulcers, denture irritation. Pharmacy Medicine	14th December 1998
11723/0217	Sanofi Winthrop Limited	Sterwin Cystitis Relief Canesten Oasis	Citric Acid Anhydrous 1063.000 mg. Sodium Bicardonate 1200.000 mg. Sodium Carbonate Anhydrous 130.000 mg. Sodium Citrate Dihydrate 2819.000 mg.	Relief of the symptoms of cystitis in women. General Sales List	18th September 1998
11382/0028	Eastern Pharmaceuticals Limited	Angitak 1.25 mg Spray	Isosorbide Dinitrate 1.250 mg	Treatment and prevention of acute attacks of angina pectoris. Pharmacy Medicine	23rd September 1998
12185/0008	Chugai Pharma UK Limited	Antepsin 1g	Sucralfate 1.000 gm	Treatment of duodenal ulcer, gastric ulcer, chronic gastritis. Prescription Only Medicine	1st December 1998
12185/0009	Chugai Pharma UK Limited	Antepsin 500 mg	Sucralfate 500.000 mg	Treatment of duodenal ulcer, gastric ulcer, chronic gastritis. Prescription Only Medicine	1st December 1998
12185/0010	Chugai Pharma UK Limited	Antepsin Suspension	Sucralfate 1.000 gm	Treatment of duodenal ulcer, gastric ulcer, chronic gastritis, and the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients. Prescription Only Medicine	1st December 1998
12762/0025	Goldshield Pharmaceuticals Limited	Zyomet Gel	Metronidazole .750% ww	Acute inflammatory exacebations of acne rosacea. Prescription Only Medicine	30th September 1998
13402/0111	Hoechst Marion Roussel Limited	Suprefact Depot 9.45 mg	Buserelin Acetate 9.900 mg	For the treatment of advanced hormone-dependent prostatic carcinoma. However, Suprefact Depot 9.45 mg is not indicated after bilateral orchiectomy as there would be no further reduction in testosterone levels. Prescription Only Medicine	3rd September 1998
14069/0055	Denfleet International Limited	Didanosine 100 mg Tablets Videx 100 mg Tablets	Didanosine 100.000 mg	The treatment of HIV infections. Prescription Only Medicine	27th November 1998
14776/0036	Teva Pharma BV	Fluoxetine Capsules 20 mg	Fluoxetine Hydrochloride 22.360 mg	Depression: For the treatment of the symptoms of depressive illness, with or without anxiety symptoms, especially where sedation is not required. Prescription Only Medicine	2nd December 1998
15361/0017	P.I.E. Pharma Limited	Ikorel 20 mg Tablets Nicorandil 20 mg Tablets	Nicorandil 20.000 mg	Angina Pectoris. Prescription Only Medicine	27th November 1998
15361/0025	P.I.E. Pharma Limited	Omnic MR Capsules	Tamsulosin Hydrochloride 400.000 mcg	The treatment of benign prostatic hyperplasia. Prescription Only Medicine	24th November 1998
15361/0046	P.I.E. Pharma Limited	Flixonase Aqueous Nasal Spray Fluticasone propionate 50 microgram aqueous nasal spray	Fluticasone Propionate 50.000 mcg	Rhinitis. Prescription Only Medicine	1st December 1998
15814/0087	OPD Laboratories Limited	Dorzolamide Eye Drops 2% Trusopt 2% Ophthalmic Solution	Dorzolamide Hydrochloride 22.260 mg/ml	The treatment of elevated intra-ocular pressure. Prescription Only Medicine	11th December 1998
15814/0101	OPD Laboratories Limited	Sumatriptan 50 mg Tablets Imigran 50 mg Tablets	Sumatriptan 50.000 mg	Migraine. Prescription Only Medicine	8th December 1998
15814/0116	OPD Laboratories Limited	Pergolide Tablets 250 Microgram Celance 250 Microgram Tablets	Pergolide 250.000 mcg Pergolide Mesilate 326.000 mcg	Parkinson’s Disease. Prescription Only Medicine	1st December 1998
16002/0003	Pharmafile Limited	Vostar SR 75	Diclofenac Sodium 75.000 mg	Adults: Relief of all grades of pain and inflammation in a wide range of conditions, including: (i) arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout. (ii) acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis. (iii) other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. Prescription Only Medicine	18th September 1998
16239/0009	Menarini International Operations Luxembourg S.A.	Bifril 7.5	Zofenopril Calcium 7.500 mg	For the treatment of mild to moderate essential hypertension.	24th September 1998
16239/0010	Menarini International Operations Luxembourg S.A.	Bifril 15	Zofenopril Calcium 15.000 mg	(See PL 16239/0009). Prescription Only Medicine	24th September 1998
16239/0011	Menarini International Operations Luxembourg S.A.	Bifril 30	Zofenopril Calcium 30.000 mg	(See PL 16239/0009). Prescription Only Medicine	24th September 1998
16239/0012	Menarini International Operations Luxembourg S.A.	Bifril 60	Zofenopril Calcium 60.000 mg	(See PL 16239/0009). Prescription Only Medicine	24th September 1998
16378/0010	Beachcourse Limited	Proscar 5 mg Tablets	Finasteride 5.000 mg	The treatment of benign prostatic hyperplasia. Prescription Only Medicine	24th November 1998
16378/0118	Beachcourse Limited	Uticox 7.5 mg Tablets Meloxicam 7.5 mg Tablets	Meloxicam 7.500 mg	The treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Prescription Only Medicine	24th November 1998
16378/0020	Beachcourse Limited	Manerix 150 mg Tablets	Moclobemide 150.000 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	7th December 1998
16378/0066	Beachcourse Limited	Tarivid 200 mg Tablets Ofloxacin 200 mg Tablets	Ofloxacin 200.000 mg	The treatment of infections caused by sensitive organisms. Prescription Only Medicine	7th December 1998
16378/0096	Beachcourse Limited	Risperidone 3 mg Tablets Risperdal 3 mg Tablets	Risperidone 3.000 mg	The treatment of schizophrenic psychoses. Prescription Only Medicine	7th December 1998
16509/0001	Synthelabo Groupe	Zolim	Mizolastine 10.000 mg	For the symptomatic relief of seasonal allergic rhinoconjunctivitis (hay fever), perennial allergic rhinoconjunctivitis and urticaria. Prescription Only Medicine	24th September 1998
16804/0001	Elan Pharma International Limited	Zelapar 1.25 mg Tablets	Selegiline Hydrochloride 1.250 mg	Adjunctive therapy in combination with levodopa (with or without a peripheral decarboxylase inhibitor or other treatment of Parkinson’s disease) in the treatment of Parkinson’s disease and symptomatic parkinsonism. In combination with maximal levodopa therapy is indicated particularly in patients who experience fluctuations in their condition such as “end-dose” type fluctuations, “on-off” symptoms or other dyskinesias. It may be used alone in early Parkinson’s disease for symptomatic relief and/or to delay the need for levodopa. It is particularly indicated in those patients with Parkinson’s disease who experience difficulties in swallowing. Prescription Only Medicine	18th September 1998
17203/0001	Takeda Europe Research and Development Centre Limited	Blopress Tablets 2 mg	Candesartan Cilexetil 2.000 mg	Essential Hypertension. Prescription Only Medicine	15th December 1998
17203/0002	Takeda Europe Research and Development Centre Limited	Blopress Tablets 4 mg	Candesartan Cilexetil 4.000 mg	Essential Hypertension. Prescription Only Medicine	15th December 1998
17203/0003	Takeda Europe Research and Development Centre Limited	Blopress Tablets 8 mg	Candesartan Cilexetil 8.000 mg	Essential Hypertension. Prescription Only Medicine	15th December 1998
17203/0004	Takeda Europe Research and Development Centre Limited	Blopress Tablets 16 mg	Candesartan Cilexetil 16.000 mg	Essential Hypertension. Prescription Only Medicine	15th December 1998