MEDICINES CONTROL AGENCY

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

Product Licences Granted

Product Licence Number	Company Name	Product Name	Active Ingredients	Indications	Date of Authorisation
00011/0240	John Wyeth & Brother Limited	HeliClear	Amoxycillin Trihydrate 500.000 mg Clarithromycin 500.000 mg Lansoprazole 30.000 mg	Eradication of Helicobacter pylori (H. pylori) from the upper gastrointestinal tract in patients with duodenal ulcer leading to the healing and prevention of relapse of the ulcer. Prescription Only Medicine	4th January 1999
00015/0240	Boehringer Ingelheim Limited	Dulco-lax Tablets 5 mg	Bisacodyl 5.000 mg	Short term relief of constipation. General Sales List	1st April 1999
00015/0241	Boehringer Ingelheim Limited	Dulco-lax Tablets 5 mg	Bisacodyl 5.000 mg	Constipation, either chronic or of recent onset, whenever a stimulant laxative is required. Bowel clearance before surgery or radiological investigation. Replacement of the evacuant enema in all its indications. Pharmacy Medicine	1st April 1999
00015/0242	Boehringer Ingelheim Limited	Dulco-lax Suppositories for Children 5 mg	Bisacodyl 5.000 mg	Constipation, either chronic or of recent onset, whenever a stimulant laxative is required. Bowel clearance before surgery or radiological investigation. Replacement of the evacuant enema in all its indications. Pharmacy Medicine	1st April 1999
00015/0243	Boehringer Ingelheim Limited	Dulco-lax Suppositories 10 mg	Bisacodyl 10.000 mg	See PL 00015/0242 Pharmacy Medicine	1st April 1999
00015/0249	Boehringer Ingelheim Limited	Dulco-lax Liquid Laxoberal Liquid	Sodium Picosulphate 5.000 mg	Constipation of any aetiology and bowel clearance before surgery, childbirth or radiological investigations. General Sales List Pharmacy Medicine	1st April 1999
00031/0519	Roche Products Limited	Cal-D-Vita Chewable Tablets	Calcium Carbonate 1500.00 mg Cholecalciferol Concentrate 8.000 mg Water-dispersible powder form	Correction of combined vitamin D and calcium deficiencies in the elderly. Vitamin D and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients, where combined vitamin D and calcium deficiencies have been diagnosed or at a high risk of such deficiencies. Pharmacy Medicine	8 January 1999
00031/0523	Roche Products Limited	Bezalip	Bezafibrate 200.000 mg	For use in hyperlipidaemias of Type IIa, IIb, III, IV and V (Fredrickson classification). It should be employed only in patients with a fully defined and diagnosed lipid abnormality which is inadequately controlled by dietary means, or by other changes in life-style such as physical exercise and weight reduction, and in whom the long-term risks associated with the condition warrant treatment. The rationale for the use is to control abnormalities of serum lipids and lipoproteins to reduce or prevent the long term effects which have been shown by many epidemiological studies to be positively and strongly correlated with such hyperlipidaemias. Prescription Only Medicine	1st April 1999
00031/0524	Roche Products Limited	Bezalip Mono	Bezafibrate 400.000 mg	See PL 00031/0523 Prescription Only Medicine	1st April 1999
00031/0526	Roche Products Limited	Ismo 10	Isosorbide Mononitrate 10.000 mg	Ismo products are indicated for use in the treatment and prophylaxis of angina pectoris and as adjunctive therapy in congestive heart failure which does not respond adequately to cardiac glycosides and/or diuretics. Pharmacy Medicine	1st April 1999
00031/0528	Roche Products Limited	Ismo 40	Isosorbide Mononitrate 40.000 mg	For use in the treatment and prophylaxis of angina pectoris and as adjunctive therapy in congestive heart failure which does not respond adequately to cardiac glycosides and/or diuretics. Pharmacy Medicine	1st April 1999
00031/0529	Roche Products Limited	Ismo Retard	Isosorbide Mononitrate HSE 40.00 mg	Indicated for the prophylaxis of angina pectoris. Pharmacy Medicine	1st April 1999
00031/0550	Roche Products Limited	Eucardic 3.125	Carvedilol 3.125 mg	For the treatment of symptomatic CHF (New York Heart Association (NYHA) Classes II and III) as adjunct to standard therapies e.g. diuretics, digoxin, ACE inhibitors. In these patients, addition of it has been shown to delay the progresion of disease. Patients with NYHA class II CHF are characterised by slight limitation of physical activity. They are comfortable at rest but ordinary physical activity results in fatigue, palpitation or dyspnoea. Patients with NYHA class III CHF are characterised by marked limitation of physical activity. They are comfortable at rest but even less than ordinary activity causes fatigue, palpitation or dyspnoea. Due to lack of experience, it should not be initiated in patients with severe (NYHA class IV) CHF (see contraindications). For the treatment of hypertension. For the prophylactic treatment of stable angina. Prescription Only Medicine	1st April 1999
00031/0551	Roche Products Limited	Eucardic 6.25	Carvedilol 6.250 mg	See PL 00031/0550 Prescription Only Medicine	1st April 1999
00031/0552	Roche Products Limited	Eucardic 12.5	Carvedilol 12.500 mg	Symptomatic chronic heart failure (CHF). For the treatment of symptomatic CHF (New York Heart Association (NYHA) Classes II and III) as adjunct to standard therapies e.g. diuretics, digoxin, ACE inhibitors. In these patients, addition of this has been shown to delay the progression of disease. Patients with NYHA Class II CHF are characterised by slight limitation of physical activity. They are comfortable at rest but ordinary physical activity results in fatigue, palpitation or dyspnoea. Patients with NYHA Class III CHF are characterised by marked limitation of physical activity. They are comfortable at rest but even less than ordinary activity causes fatigue, palpitation or dyspnoea. Due to lack of experience, it should not be initiated in patients with severe (NYHA Class IV) CHF (see contra-indications). For the treatment of hypertension. For the prophylactic treatment of stable angina. Prescription Only Medicine	1st April 1999
00031/0553	Roche Products Limited	Eucardic 25	Carvedilol 25.000 mg	See PL 00031/0552 Prescription Only Medicine	1st April 1999
00031/0554	Roche Products Limited	Eucardic 50	Carvedilol 50.000 mg	Treatment of hypertension. Prescription Only Medicine	1st April 1999
00032/0240	Pharmacia & Upjohn Limited	Structolipid	Purified Structured Triglycerides 100.000 gm	To supply energy and essential fatty acids to adult paitents, as part of a parenteral nutrition regimen. Prescription Only Medicine	29th January 1999
00032/0248	Pharmacia & Upjohn Limited	Nicorette 2 mg Chewing Gum	Nicotine-Resin Complex 2.000 mg	To help smokers who want to give up smoking, but who experience difficulty in doing so owing to their dependence on nicotine. Pharmacy Medicine	26th April 1999
00032/0249	Pharmacia & Upjohn Limited	Nicorette Plus	Nicotine-Resin Complex 20.000 mg	See PL 00032/0248 Pharmacy Medicine	26th April 1999
00032/0250	Pharmacia & Upjohn Limited	Nicorette Mint Chewing Gum Boots Nicotine Gum 2 mg	Nicotine 2.000 mg Nicotine-Resin Complex 10.000 mg	See PL 00032/0248 Pharmacy Medicine	26th April 1999
00032/0251	Pharmacia & Upjohn Limited	Nicorette Mint Plus Chewing Gum Boots Nicotine Gum 4 mg	Nicotine 4.000 mg Nicotine-Resin Complex 20.000 mg	See PL 00032/0249 Pharmacy Medicine	26th April 1999
00053/0263	Schering Health Care Ltd	Nuvelle Continuous	Estradiol Hemihydrate 2.000 mg Norethisterone Acetate 1.000 mg	Hormone replacement therapy for the treatment of menopausal symptoms such as night sweats and hot flushes in women who are at least 1 year past their menopause and who have an intact uterus. Prophylaxis and treatment of the postmenopausal sequelae of oestrogen withdrawal, including atrophic vaginitis and atrophic urethritis. Although for maximum prophylactic benefit, hormone replacement therapy should commence as soon as possible, in the case of this product this should be at least one year past the menopause. If given in the earlier postmenopausal phase the incidence of bleeding is unacceptably high. Administration is continued without a break in therapy. The presence of continuous progestogen is designed to result in the absence of menstrual bleeding whilst also protecting against the development of endometrial hyperplasia. It does not consistently inhibit ovulation and is, therefore, unsuitable for contraception. Combined preparations containing an oestrogen and progestogen are only necessary in patients with an intact uterus. Prescription Only Medicine	12th January 1999
00068/0180	3M Health Care Limited	Benzydamine Throat Spray	Benzydamine Hydrochloride .150% w/v	For the relief of pain in traumatic conditions such as following tonsillectomy or the use of a naso-gastric tube; dental surgery. Pharmacy Medicine	31st March 1999
00068/0181	3M Health Care Limited	Benzydamine Spray 3M	Benzydamine Hydrochloride .150 % W/V	See 00068/0180. Pharmacy Medicine	31st March 1999
00101/0561	Novartis Pharmaceuticals UK Limited	Voltarol Rapid Tablets 25 mg	Diclofenac Potassium 25.000 mg	Rheumatoid arthritis Osteoarthrosis Low back pain migraine attacks Acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures Ankylosing spondylitis Acute gout Control of pain and inflammation in orthopaedic, dental and other minor surgery Pyrophosphate arthropathy and associated disorders. Prescription Only Medicine	4th January 1999
00174/0210	Stiefel Laboratories (UK) Limited	Warticon Cream	Podophyllotoxin .150% W/W	For the topical treatment of condylomata acuminata affecting the penis and the external female genitalia. Prescription Only Medicine	26th April 1999
00221/0099	Nycomed Amersham PLC	Thallous [201T1] Chloride Injection	Thallous [201T1] Chloride 37.MBq EP (The finished dosage form is the subject of a ph. eur. monograph)	Prescription Only Medicine	8th April 1999
00221/0101	Nycomed Amersham PLC	Amerscan Stannous Agent	Stannous Fluoride USP 4.0 mg	Diagnostic imaging of blood pools by scintigraphy following intravenous administration. Prescription Only Medicine	12th April 1999
PI00576/0136	Global Pharmaceuticals Ltd	Flixotide 250 Inhaler	Fluticasone Propionate 250.000 mcg	Asthma. Prescription Only Medicine	19th April 1999
02748/0010	Pharma-Global (UK) Limited	Artelac Single Dose Unit	Hypromellose 3.200 mg	Acts as a lubricant and artificial tear in the symptomatic treatment of dehydration of the cornea and conjunctiva due to impaired lacrimal secretion and functional disorders as a result of topical or systematic diseases, or caused by deficient or incomplete eyelid closure. Pharmacy Medicine	8th January 1999
03194/0075	Ferring Pharmaceuticals Limited	Quintasa Sachet	Mesalazine 1000.000 mg	Mild to moderate ulcerative colitis. Prescription Only Medicine	6th January 1999
PI03243/0318	Munro Wholesale Medical Supplies Ltd	Enalapril Maleate 5mg Tablets	Enalapril Maleate 5.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	13th April 1999
PI03243/0359	Munro Wholesale Medical Supplies Ltd	Paroxetine 20 mg Tablets	Paroxetine 20.000 mg	The treatment of the symptoms of depressive illness. Prescription Only Medicine	29th March 1999
PI03787/0538	Swingward Limited t/a Medihealth	Pravastatin Sodium 10 mg Tablets	Pravastatin Sodium 10.000 mg	Primary hypercholesterolaemia. Prescription Only Medicine	26th March 1999
PI03787/0553	Swingward Limited t/a Medihealth	Neurontin 400 mg Capsules	Gabapentin 400.000 mg	Anti-epileptic. Prescription Only Medicine	22nd April 1999
PI03787/0555	Swingward Limited t/a Medihealth	Cisapride 10 mg Tablets	Cisapride Monohydrate 10.387 mg	Symptoms associated with gastro-oesophageal reflux. Prescription Only Medicine	20th April 1999
PI03787/0568	Swingward Limited t/a Medihealth	Bezalip Mono 400 mg Tablets	Bezafibrate 400.000 mg	Hyperlipidaemia. Prescription Only Medicine	26th April 1999
PI03787/0571	Swingward Limited t/a Medihealth	Tegretol Retard 200 mg Tablets	Carbamazepine 200.000 mg	Epilepsy. Prescription Only Medicine	30th March 1999
PI03787/0585	Swingward Limited t/a Medihealth	Zocor 40 mg Tablets	Simvastatin 40.000 mg	Coronary heart disease and hypercholesterolaemia. Prescription Only Medicine	22nd April 1999
PI03787/0572	Swingward Limited t/a Medihealth	Dovonex Cream	Calcipotriol 50.000 mcg	Treatment is plaque psoriasis. Prescription Only Medicine	22nd April 1999
PI03787/0588	Swingward Limited t/a Medihealth	Xatral 2.5 mg Tablets	Alfuzosin Hydrochloride 2.500 mg	Functional symptoms of benign prostatic hypertrophy. Prescription Only Medicine	7th April 1999
PI03787/0590	Swingward Limited t/a Medihealth	Lansoprazole 30 mg Capsules	Lansoprazole 30.000 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	29th March 1999
PI03787/0594	Swingward Limited t/a Medihealth	Adalat LA 60 Tablets	Nifedipine 60.000 mg	Hypertension and angina pectoris. Prescription Only Medicine	22nd April 1999
PI03787/0613	Swingward Limited t/a Medihealth	Pulmicort Turbohaler 100	Budesonide 100.000 mcg	Bronchial asthma. Prescription Only Medicine	13th April 1999
PI03787/0633	Swingward Limited t/a Medihealth	Lamictal 100 mg Tablets	Lamotrigine 100.000 mg	Epilepsy. Prescription Only Medicine	22nd April 1999
PI03787/0645	Swingward Limited t/a Medihealth	Loratadine 10 mg Tablets Clarityne Tablets	Loratadine 10.000 mg	Rhinitis and chronic urticaria. Prescription Only Medicine	22nd April 1999
PI03787/0661	Swingward Limited t/a Medihealth	Requip 1 mg Tablet	Ropinirole Hydrochloride 1.140 mg	Parkinson’s disease. Prescription Only Medicine	24th March 1999
PI03787/0665	Swingward Limited t/a Medihealth	Carteolol Hycrochloride 2% Eye Drops	Carteolol Hydrochloride 2.000 %w/v	The reduction of intra-ocular pressure. Prescription Only Medicine	9th April 1999
PI04423/0335	Doncaster Pharmaceuticals Group Limited	Bezalip 200 mg Tablets Bezafibrate 200 mg Tablets	Bezafibrate 200.000 mg	Hyperlipidaemia. Prescription Only Medicine	7th April 1999
04569/0399	Generics (UK) Limited	Cyproterone Acetate Tablets 100 mg	Cyproterone Acetate 100.000 mg	For the management of patients with prostatic cancer (1) to suppress “Flare” with initial LHRH analogue therapy, (2) in long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred, and (3) in the treatment of hot flushes in patients under treatment with LHRH analogues or who have had an orchidectomy. Prescription Only Medicine	12th April 1999
04889/0018	BYK Gulden Lomberg Chemische Fabrik GMBH	Protium 20 mg	Pantoprazole Sodium Sesquihydrate 22.600 mg	Treatment of endoscopically proven mild reflux oesophagitis and associated symptoms (e.g. heartburn, acid regurgitation, pain on swallowing). For long-term management and prevention of relapse in reflux oesophagitis. Prescription Only Medicine	7th January 1999
PI05513/0470	Eurochem Limited	Cipramil 20 mg Tablets. Citalopram 20 mg Tablets.	Citalopram Hydrobromide 24.980 mg	Depressive illness. Prescription Only Medicine	22nd April 1999
PI05513/0473	Eurochem Limited	Renitec 5 mg Tablets	Enalapril Maleate 5.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	20th April 1999
PI05513/0532	Eurochem Limited	Bezalip 200 mg Tablets	Bezafibrate 200.000 mg	Hyperlipidaemia. Prescription Only Medicine	26th March 1999
PI05513/0535	Eurochem Limited	Bezalip Mono 400 mg Tablets	Bezafibrate 400.000 mg	Hyperlipidaemia. Prescription Only Medicine	22nd April 1999
PI05513/0581	Eurochem Limited	Losec 20 mg Capsules	Omeprazole 20.000 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	31st March 1999
PI03787/0582	Swingward Limited t/a Medihealth	Klaricid 500 mg Tablets	Clarithromycin 500.000 mg	Infections caused by susceptible organisms. Prescription Only Medicine	20th April 1999
PI05513/0582	Eurochem Limited	Voltaren Retard	Diclofenac Sodium 100.000 mg	Conditions requiring analgesic and anti-inflammatory treatment. Prescription Only Medicine	31st March 1999
PI05513/0611	Eurochem Limited	Beconase Aqueous Nasal Spray	Beclomethasone Dipropionate .050 % w/w	Allergic rhinitis. Prescription Only Medicine	31st March 1999
PI05513/0644	Eurochem Limited	Imigran 100 Tablets Sumatriptan 100 Tablets	Sumatriptan 100.000 mg	The treatment of migraine. Prescription Only Medicine	31st March 1999
PI05513/0689	Eurochem Limited	Lansoprazole 15 Capsules Zoton 15 Capsules	Lansoprazole 15.000 mg	Acid related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	31st March 1999
PI05662/0376	Dowelhurst Limited	Celance 1 mg Tablets Pergolide Tablets 1 mg Permax 1 mg Tablets	Pergolide 1.000 mg	Parkinsons disease. Prescription Only Medicine	25th March 1999
PI05662/0377	Dowelhurst Limited	Pergolide 250 Microgram Tablets Celance 250 Microgram Tablets Permax 250 Microgram Tablets	Pergolide 250.000 mcg	Parkinsons disease. Prescription Only Medicine	25th March 1999
PI05662/0466	Dowelhurst Limited	Misoprostol Tablets 200 Microgram Cytotec Tablets	Misoprostol 200.000 mcg	Duodenal and gastric ulcer. Prescription Only Medicine	13th April 1999
PI05662/0492	Dowelhurst Limited	Lacidipine 4 mg Tablets Motens 4 mg Tablets	Lacidipine 4.000 mg	Hypertension. Prescription Only Medicine	24th March 1999
PI05662/0499	Dowelhurst Limited	Lamotrigine Tablets 50 mg Labileno 50 mg Tablets	Lamotrigine 50.000 mg	Epilepsy. Prescription Only Medicine	9th April 1999
PI05662/0500	Dowelhurst Limited	Lamotrigine Tablets 100 mg Labileno 100 mg Tablets	Lamotrigine 100.000 mg	Epilepsy. Prescription Only Medicine	6th April 1999
PI05662/0506	Dowelhurst Limited	Simvastatin 10 mg Tablets Sivastin 10 Tablets	Simvastatin 10.000 mg	Coronary heart disease and hypercholesterolaemia. Prescription Only Medicine	29th March 1999
PI05662/0508	Dowelhurst Limited	Lamotrigine Tablets 200 mg Lamictal 200 mg Tablets	Lamotrigine 200.000 mg	Epilepsy. Prescription Only Medicine	22nd April 1999
PI05662/0510	Dowelhurst Limited	Fluticasone Propionate 50 Microgram Inhaler Flixotide 50 Microgram Inhaler	Fluticasone Propionate 6.000 mg	Management of asthma. Prescription Only Medicine	26th March 1999
PI05662/0569	Dowelhurst Limited	Arthrotec 50	Diclofenac Sodium 50.000 mg Misoprostol 200.000 mcg	Osteoarthritis and rheumatoid arthritis, and the prophylaxsis of NSAID-induced gastric and duodenal ulceration. Prescription Only Medicine	13th April 1999
PI05662/0580	Dowelhurst Limited	Cerivastatin Sodium Tablets 200 Microgram Lipobay 200 microgram Tablets	Cerivastatin Sodium 200.000 mcg	Primary hypercholesterolaemia. Prescription Only Medicine	13th April 1999
PI05662/0581	Dowelhurst Limited	Trandolapril Capsules 2 mg Gopten 2 mg Capsules	Trandolapril 2.000 mg	Hypertension. Prescription Only Medicine	22nd April 1999
PI05662/0583	Dowelhurst Limited	Cardura 1 Tablets Doxazosin Tablets 1 mg Cardura 1 mg Tablets	Doxazosin Mesilate 1.213 mg	The treatment of hypertension and symptoms associated with benign prostatic hyperplasia. Prescription Only Medicine	23rd April 1999
PI05662/0584	Dowelhurst Limited	Zirtek Tablets 10 mg Cetirizine Dihydrochloride Tablets 10 mg	Cetirizine Dihydrochloride 10.000 mg	Rhinitus and urtiearia. Prescription Only Medicine	19th April 1999
PI06464/0504	Waymade Plc	Beta Adalat Capsules	Atenolol 50.000 mg Nifedipine 20.000 mg	The management of hypertension and angina pectoris. Prescription Only Medicine	25th March 1999
PI06464/0527	Waymade Plc	Canesten Cream 1%	Clotrimazole 1.000 %w/w	Broad spectrum anti-fungal. Pharmacy Medicine	7th April 1999
PI06464/0530	Waymade Plc	Estracomb TTS Patches	Norethisterone Acetate 30.000 mg Oestradiol 10.000 mg Oestradiol 4.000 mg	Hormone replacement therapy. Prescription Only Medicine	23rd April 1999
PI06464/0531	Waymade Plc	Inderal LA 80 Capsules	Propranolol Hydrochloride 80.000 mg	Cardiac dysrhythmias and thyrotoric crisis. Prescription Only Medicine	19th April 1999
PI06464/0543	Waymade Plc	Sumatriptan 50 mg Tablets Imigran 50 mg Tablets	Sumatriptan Succinate 70.000 mg	Migraine attacks. Prescription Only Medicine	13th April 1999
PI06464/0547	Waymade Plc	Trusopt 2% Ophthalmic Solution	Dorzolamide Hydrochloride 22.280 mg	The reduction of elevate intra ocular pressure. Prescription Only Medicine	22nd April 1999
PI06464/0555	Waymade Plc	Klaricid 250 mg Tablets	Clarithromycin 250.000 mg	The treatment of infections caused by susceptible organisms. Prescription Only Medicine	22nd April 1999
PI06464/0560	Waymade Plc	Klaricid 500 mg Tablets	Clarithromycin 500.000 mg	The treatment of infections caused by susceptible organisms. Prescription Only Medicine	7th April 1999
PI06464/0603	Waymade plc	Pentasa 500 mg Slow Release Tablets	Mesalazine 500.000 mg	Mild to moderate exacerbations of ulcerative colitis. Prescription Only Medicine	19th April 1999
06831/0062	Ethical Generics Limited	Oxybutynin Hydrochloride 2.5 mg Tablets	Oxybutynin Hydrochloride 2.500 mg	(1) For urinary incontinence, urgency and frequency in unstable bladder conditions due either to idiopathic detrusor instability or neurogenic bladder disorders (detrusor hyperreflexia) in conditions such as spina bifida and multiple sclerosis. (2) Children over 5 years of age: In addition to neurogenic bladder disorders oxybutynin may be used in nocturnal enuresis in conjunction with other non-drug therapy where this alone, or in conjunction with other drug treatment, has failed. Prescription Only Medicine	30th March 1999
08637/0002	Dr Falk Pharma GMBH	Budenofalk 3 mg	Budesonide 3.000 mg	Induction of remission in patients with mild to moderate Crohn’s disease affecting the ileum and/or the ascending colon. Please note: Treatment with it does not appear useful in patients with Crohn’s disease affecting the upper gastro-intestinal tract. Extraintestinal symptoms, e.g. involving the skin, eyes or joints, are unlikely to respond to treatment because of its local action. Prescription Only Medicine	4th January 1999
PI08747/0228	Chemilines Limited	Bezafibrate Tablets 200 mg Bezalip Tablets 200 mg	Bezafibrate 200.000 mg	Hyperlipidaemia. Prescription Only Medicine	19th April 1999
PI08747/0231	Chemilines Limited	Mopral 20 mg Capsules Omeprazole 20 mg Capsules Losec 20 mg Capsules	Omeprazole 20.000 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	30th March 1999
PI08747/0235	Chemilines Limited	Fucibet Cream	Betamethasone .100 %w/w Fusidic Acid 2.000 %w/w	Eczamatous Dermatoses. Prescription Only Medicine	26th March 1999
PI08747/0239	Chemilines Limited	Fluvastatin 20 mg Capsules Lescol 20 mg Capsules	Fluvastatin 20.000 mg	Primary hypercholesterolaemia. Prescription Only Medicine	13th April 1999
PI08747/0246	Chemilines Limited	Neurontin 100 Capsules Gabapentin 100 mg Capsules	Gabapentin 100.000 mg	Epilepsy. Prescription Only Medicine	8th April 1999
PI08747/0247	Chemilines Limited	Gabapentin 300 mg Capsules Neurontin 300 Capsules	Gabapentin 300.000 mg	Epilepsy. Prescription Only Medicine	29th March 1999
PI08747/0248	Chemilines Limited	Gabapentin 400 mg Capsules Neurontin 400 Capsules	Gabapentin 400.000 mg	Epilepsy. Prescription Only Medicine	13th April 1999
PI08747/0249	Chemilines Limited	Priadel 400 mg Tablets	Lithium Carbonate 400.000 mg	The management of acute manic or hypomanic episodes and recurrent depressive disorders. The prophylaxis against bipolar affective disorders and control of aggressive behaviour or intentional self harm. Prescription Only Medicine	13th April 1999
PI08747/0265	Chemilines Limited	Serevent Accuhaler	Salmeterol Xinafoate 50.000 mcg	Reversible airways obstruction. Prescription Only Medicine	19th March 1999
PI08747/0266	Chemilines Limited	Serevent Accuhaler	Salmeterol Xinafoate 72.500 mcg	See PL PI08747/0265 Prescription Only Medicine	19th March 1999
PI08747/0268	Chemilines Limited	Innovace Tablets 20 mg Renitec Tablets 20 mg Enalapril Maleate Tablets 20 mg	Enalapril Maleate 20.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	13th April 1999
PI08747/0274	Chemilines Limited	Daonil Tablets 5 mg Glibenclamide Tablets 5 mg	Glibenclamide 5.000 mg	Non-insulin dependent diabetes. Prescription Only Medicine	29th March 1999
PI08747/0297	Chemilines Limited	Ikorel Tablets 10 mg	Nicorandil 10.000 mg	Angina pectoris. Prescription Only Medicine	19th April 1999
PI08747/0298	Chemilines Limited	Ikorel Tablets 20 mg	Nicorandil 20.000 mg	Angina pectoris. Prescription Only Medicine	19th April 1999
PI08747/0306	Chemilines Limited	Lamictal Tablets 100 mg Lamotrigine Tablets 100 mg	Lamotrigine 100.000 mg	Epilepsy. Prescription Only Medicine	23rd April 1999
PI10256/0368	Stephar (UK) Limited	Efexor 37.5 Tablets	Venlafaxine Hydrochloride 42.420 mg	The treatment of depressive illness. Prescription Only Medicine	19th April 1999
PI10256/0369	Stephar (UK) Limited	Efexor 75 Tablets	Venlafaxine Hydrochloride 84.840 mg	See PL PI10256/0368 Prescription Only Medicine	19th April 1999
PI10256/0371	Stephar (UK) Limited	Zofron 4 mg Tablets Ondansetron 4 mg Tablets	Ondansetron Hydrochloride Dihydrate 5.000 mg	The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy and the prevention and treatment of post operative nausea and vomiting. Prescription Only Medicine	20th April 1999
PI10256/0372	Stephar (UK) Limited	Zofron 8 mg Tablets Ondansetron 8 mg Tablets	Ondansetron Hydrochloride Dihydrate 10.000 mg	The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy and the prevention and treatment of post operative nausea and vomiting. Prescription Only Medicine	20th April 1999
PI10256/0381	Stephar (UK) Limited	Tenif Capsules	Atenolol 50.000 mg Nifedipine 20.000 mg	Hypertension and chronic stable angina pectoris. Prescription Only Medicine	7th April 1999
PI10256/0387	Stephar (UK) Limited	Serevent Inhaler	Salmeterol Xinafoate 36.300 mcg	Reversible airways obstruction. Prescription Only Medicine	23rd April 1999
PI10256/0398	Stephar (UK) Limited	Manerix 150 mg Tablets	Moclobemide 150.000 mg	Depression and social phobia. Prescription Only Medicine	22nd April 1999
PI10256/0399	Stephar (UK) Limited	Nicardipine Hydrochloride 20 mg Capsules	Nicardipine Hydrochloride 20.000 mg	Chronic stable angina and hypertension. Prescription Only Medicine	6th April 1999
PI10256/0402	Stephar (UK) Limited	Cozaar 50 mg Tablets	Losartan Potassium 50.000 mg	Hypertension. Prescription Only Medicine	8th April 1999
PI10256/0408	Stephar (UK) Limited	Trusopt 2% Ophthalmic Solution	Dorzolamide Hydrochloride 22.300 mg/ml	Treatment of elevated intra-ocular pressure. Prescription Only Medicine	22nd April 1999
PI10256/0419	Stephar (UK) Limited	Manidon SR 240 mg Tablets	Verapamil Hydrochloride 240.000 mg	Hypertension and angina pectoris. Prescription Only Medicine	8th April 1999
PI10256/0420	Stephar (UK) Limited	Indocid Retard 75 mg Capsules	Indomethacin 75.000 mg	Non steroidal anti-inflammatory agent. Prescription Only Medicine	22nd April 1999
PI10256/0426	Stephar (UK) Limited	Rivotril 0.5 mg Tablets	Clonazepam .500 mg	Epilepsy. Prescription Only Medicine	9th April 1999
PI10256/0443	Stephar (UK) Limited	Serevent Inhaler	Salmeterol Xinafoate 36.300 mcg	Reversible airways obstruction. Prescription Only Medicine	26th March 1999
PI10256/0455	Stephar (UK) Limited	Celance 250 Microgram Tablets Pergolide 250 Microgram Tablets	Pergolide Mesilate 326.000 mcg	Parkinson’s disease. Prescription Only Medicine	9th April 1999
PI10256/0456	Stephar (UK) Limited	Pergolide 50 Microgram Tablets Celance 50 Microgram Tablets	Pergolide Mesilate 65.300 mcg	Parkinson’s disease. Prescription Only Medicine	9th April 1999
PI10256/0457	Stephar (UK) Limited	Pergolide 1 mg Tablets Celance 1 mg Tablets	Pergolide Mesilate 1.310 mg	Parkinson’s disease. Prescription Only Medicine	9th April 1999
PI10256/0458	Stephar (UK) Limited	Relifex 500 mg Tablets	Nabumetone 500.000 mg	Osteoarthritis and rheumatoid arthritis requiring anti-inflammatory and analgesic treatment. Prescription Only Medicine	9th April 1999
PI10256/0459	Stephar (UK) Limited	Klaricid 500 Tablets	Clarithromycin 500.000 mg	Infections caused by susceptible organisms. Prescription Only Medicine	20th April 1999
PI10256/0472	Stephar (UK) Limited	Maxepa Capsules	Docosahexaenoic Acid 115.000 mg Eicosapentaenoic Acid 170.000 mg	Severe hypertriglyceridaemia. Prescription Only Medicine	19th April 1999
PI10256/0480	Stephar (UK) Limited	Rifadin 150 mg Capsules	Rifampicin 150.000 mg	Tuberculosis, Leprosy, Brucellosis, Legionnaires disease, and serious staphylococcal infections. Prescription Only Medicine	22nd April 1999
PI10256/0491	Stephar (UK) Limited	Tenormin 25 mg Tablets	Atenolol 25.000 mg	Hypertension, angina pectoris; myocardial infarction; cardiac dysrhythmias. Prescription Only Medicine	23rd April 1999
PI10256/0492	Stephar (UK) Limited	Tenormin 100 mg Tablets	Atenolol 100.000 mg	Angina pectoris; hypertension; cardiac arrhythmias; myocardial infarction. Prescription Only Medicine	23rd April 1999
PI10256/0503	Stephar (UK) Limited	Neoral 50 mg Capsules	Ciclosporin 50.000 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	19th April 1999
PI10256/0504	Stephar (UK) Limited	Neoral 100 mg Capsules	Ciclosporin 100.000 mg	See PL 10256/0503 Prescription Only Medicine	19th April 1999
PI10380/0218	Swinghope Limited	Imdur 60 mg Tablets Imdur 60 mg Durules	Isosorbide 5-Mononitrate 60.000 mg	Angina pectoris. Prescription Only Medicine	26th March 1999
PI10380/0255	Swinghope Limited	Famvir 250 mg Tablets Famciclovir Tablets 250 mg	Famciclovir 250.000 mg	Herpes zoster infections. Prescription Only Medicine	7th April 1999
PI10380/0268	Swinghope Limited	Serevent Diskhaler Salmeterol Diskhaler 50 micrograms	Salmeterol Xinafoate 72.500 mcg	Reversible airways obstruction. Prescription Only Medicine	13th April 1999
PI10380/0274	Swinghope Limited	Becotide Rotacaps 200 micrograms Beclomethasone Dipropionate Rotacaps 200 micrograms	Beclomethasone Dipropionate 200.000 mcg	Bronchial asthma. Prescription Only Medicine	23rd April 1999
PI10380/0283	Swinghope Limited	Amlodipine Tablets 5 mg	Amlodipine 5.000 mg	Hypertension. Prescription Only Medicine	30th March 1999
PI10380/0294	Swinghope Limited	Mopral 20 mg Capsules Omeprazole 20 mg Capsules	Omeprazole 20.000 mg	Oesophageal reflux disease. Prescription Only Medicine	13th April 1999
PI10380/0305	Swinghope Limited	Zyrtec 10 mg Tablets Cetirizine Dihydrochloride 10 mg Tablets	Cetirizine Dihydrochloride 10.000 mg	Rhinitis and urticaria. Prescription Only Medicine	19th April 1999
PI10380/0324	Swinghope Limited	Lansoprazole 15 mg Capsules	Lansoprazole 15.000 mg	The treatment of gastro intestinal disorders requiring a reduction in acid secretion. Prescription Only Medicine	26th April 1999
PI10380/0330	Swinghope Limited	Zocor 10 mg Tablets Simvastatin 10 mg Tablets	Simvastatin 10.000 mg	Coronary heart disease and hypercholesterolaemia. Prescription Only Medicine	22nd April 1999
PI10380/0333	Swinghope Limited	Lansoprazole 30 mg Capsules	Lansoprazole 30.000 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	29th March 1999
PI10383/0539	Primecrown Limited	Zofran 8 mg Tablets	Ondansetron 8.000 mg	The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy and the prevention and treatment of post-operative nausea and vomiting. Prescription Only Medicine	30th March 1999
PI10383/0561	Primecrown Limited	Pantoprazole 40 mg EC Tablets	Pantoprazole Sodium Sesquihydrate 45.100 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	9th April 1999
PI10383/0587	Primecrown Limited	Arimidex Tablets	Anastrozole 1.000 mg	Treatment of advanced breast cancer. Prescription Only Medicine	19th April 1999
PI10383/0606	Primecrown Limited	Betoptic 0.5% Eyedrops Betaxolol Eyedrops 0.5%	Betaxolol Hydrochloride .560% w/v	Ocular hypertension and chronic open angle glaucoma. Prescription Only Medicine	7th April 1999
PI10383/0611	Primecrown Limited	Finasteride 5 mg Tablets	Finasteride 5.000 mg	Benign prostatic hyperplasia. Prescription Only Medicine	23rd April 1999
PI10383/0625	Primecrown Limited	Aricept 5 mg Tablets Donepezil Hydrochloride Tablets 5 mg	Donepezil Hydrochloride 5.000 mg	Mild to moderately severe Alzheimer’s dementia. Prescription Only Medicine	22nd April 1999
PI10383/0626	Primecrown Limited	Aricept 10 mg Tablets Donepezil Hydrochloride 10 mg Tablets	Donepezil Hydrochloride 10.000 mg	Alzheimer’s dementia. Prescription Only Medicine	23rd April 1999
PI10383/0632	Primecrown Limited	Livial 2.5 mg Tablets Tibolone 2.5 mg Tablets	Tibolone 2.500 mg	The treatment of oestrogen deficiency states. Prescription Only Medicine	8th April 1999
PI10383/0633	Primecrown Limited	Zocor 10 mg Tablets Simvastatin 10 mg Tablets	Simvastatin 10.000 mg	Coronary heart disease and hypercholesterolaemia. Prescription Only Medicine	7th April 1999
PI10383/0635	Primecrown Limited	Lamictal 200 mg Tablets	Lamotrigine 200.000 mg	Epilepsy. Prescription Only Medicine	29th March 1999
PI10383/0649	Primecrown Limited	Coversyl 4 mg Tablets	Perindopril Tert-Butylamine Salt 4.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	8th April 1999
10590/0041	Galderma (UK) Limited	Loceryl Cream	Amorolfine Hydrochloride .279% w/w	Dermatomycoses caused by dermatophytes: tinea pedis (athlete’s foot), tinea cruris, tinea inguinalis, tinea corporis, tinea manuum. Pityriasis versicolor. Prescription Only Medicine	19th April 1999
10590/0042	Galderma (UK) Limited	Loceryl Nail Lacquer 5%	Amorolfine Hydrochloride 6.400% w/w	Onychomycoses caused by dermatophytes, yeasts and moulds. Prescription Only Medicine	19th April 1999
10949/0303	Glaxo Wellcome UK Limited	Permethrin Dermal Cream	Permethrin Medical Grade 5.000% w/w	Permethrin Dermal Cream is indicated for the treatment of scabies. Pharmacy Medicine	25th March 1999
10949/0323	Glaxo Wellcome UK Limited	Flixonase Nasule Drops	Fluticasone Propionate Micronised .400 mg	For the regular treatment of nasal polyps and associated symptoms of nasal obstruction. Prescription Only Medicine	27th January 1999
10972/0082	Goldshield Group Plc	Fenbid Forte Gel 10%	Ibuprofen 10.000 mg	Topical analgesic and anti-inflammatory for backache, mild to moderate arthritic pain, rheumatic and muscular pain, sprains, strains, sports injuries and neuralgia. Prescription Only Medicine	5th January 1999
11173/0050	Du Pont Pharmaceuticals Limited	Cardiolite	L-Cysteine Hydrochloride Monohydrate 1.000 mg Stannous Chloride Dihydrate .075 mg Tetrakis Copper Tetrafluoroborate 1.000 mg	For intravenous injection after reconstitution with Sodium pertechnetate (99m Tc) solution and may be used for: Adjunct for diagnosis of ischaemic heart disease. Adjunct for diagnosis and localisation of myocardial infarction. Assessment of global ventricular function (first pass technique for determination of ejection fraction and/or regional wall motion). A second line diagnostic aid in the investigation of patients with suspected breast cancer when the results of mammography are unsatisfactory or equivocal, particularly in patients with dense breasts. Diagnostic aid in the investigation of patients with recurrent or persistent hyperparathyroidism. Prescription Only Medicine	8th January 1999
11244/0012	ML Laboratories Plc	Dexemel	Icodextrin 40.000 gm	It is recommended as a vehicle for the administration via the peritoneum of drugs compatible with the vehicle and shown to have been used safely and effectively by the intraperitoneal route. Prescription Only Medicine	7th January 1999
11723/0258	Sanofi Winthrop Limited	Fluoxetine Capsules 20 mg	Fluoxetine Hydrochloride 22.360 mg	Depression: for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms, especially where sedation is not required. Obsessive-compulsive disorder. Bulimia nervosa: for the reduction of binge-eating and purging activity. Prescription Only Medicine	26th March 1999
11723/0278	Sanofi Winthrop Limited	Trifyba	Fibrous Extract of Wheat Grain 3.500 gm	Colonic and gastro-intestinal disturbances where a high-fibre regimen is indicated including simple constipation, uncomplicated diverticular disease, irritable colon, haemorrhoidal disorders and fissures and other conditions where straining at stool should be avoided. General Sales List	26th April 1999
12064/0016	Aurum Pharmaceuticals Limited	Cocaine Hydrochloride Solution 10% w/v	Cocaine Hydrochloride 10.000% w/v	To provide local anaesthesia and vasoconstriction of accessible mucous membranes prior to surgery especially in the oral, laryngeal, and nasal cavities. Vasoconstriction prevents excessive blood loss and reduces obstruction/restriction of the operative field. Prescription Only Medicine	14th April 1999
12406/0014	Link Pharmaceuticals Limited	Thiopentone Injection BP 500 mg	Thiopentone Sodium 500.000 mg	1. For the induction of general anaesthesia and it is also used as an adjunct to provide hypnosis during balanced anaesthesia with other anaesthetic agents, including analgesics and muscle relaxants. 2. Also as an adjunct for control of convulsive disorders of various etiology, including those caused by local anaesthetics. 3. It has now been used to reduce the intracranial pressure in patients with increased intracranial pressure, provided controlled ventilation is provided. Prescription Only Medince	5th April 1999
12406/0015	Link Pharmaceuticals Limited	Thiopentone Injection BP 2.5 gm	Thiopentone Sodium 2.500 gm	See PL12406/0014 Prescription Only Medicine	5th April 1999
PI13826/0118	Caseview (PL) Limited	Adalat LA 30 Tablets	Nifedipine 30.000 mg	Hypertension and angina pectoris. Prescription Only Medicine	30th March 1999
PI13826/0149	Caseview (PL) Limited	Itraconazole 100 mg Capsules Sporanox 100 mg Capsules	Itraconazole 100.000 mg	Anti-fungal therapy. Prescription Only Medicine	23rd April 1999
PI15361/0064	P.I.E. Pharma Limited	Prepulsid 10 mg Tablets Cisapride 10 mg Tablets	Cisapride 10.000 mg	Symptoms associated with gastro-oesophageal reflux. Prescription Only Medicine	20th April 1999
PI15361/0078	P.I.E. Pharma Limited	Zyrtec 10 mg Tablets Cetirizine Dihydrochloride 10 mg Tablets	Cetirizine Dihydrochloride 10.000 mg	Rhinitis and urticaria. Prescription Only Medicine	7th April 1999
PI15361/0080	P.I.E. Pharma Limited	Astudal 10 mg Tablets Amlodipine 10 mg Tablets	Amlodipine 10.000 mg	Hypertension and angina pectoris. Prescription Only Medicine	20th April 1999
PI15361/0083	P.I.E. Pharma Limited	Acarbose 50 mg Tablets Glucobay 50	Acarbose 50.000 mg	Non-insulin dependent diabetes mellitus. Prescription Only Medicine	22nd April 1999
PI15361/0084	P.I.E. Pharma Limited	Acarbose 100 mg Tablets Glucobay 100	Acarbose 100.000 mg	Non-insulin dependent diabetes. Prescription Only Medicine	19th April 1999
PI15361/0102	P.I.E. Pharma Limited	Tambocor 100 mg Tablets Flecainide Acetate 100 mg Tablets	Flecainide Acetate 100.000 mg	Tachycardia; arrhythmias. Prescription Only Medicine	9th April 1999
PI15361/0112	P.I.E. Pharma Limited	Motens 4 mg Tablets Lacidipine 4 mg Tablets	Lacidipine 4.000 mg	Hypertension. Prescription Only Medicine	20th April 1999
PI15361/0116	P.I.E. Pharma Limited	Alimix 10 mg Tablets Cisapride 10 mg Tablets Prepulsid 10 mg Tablets	Cisapride 10.000 mg	Treatment of symptoms and mucosal lesions associated with gastro-oesophageal reflux. Prescription Only Medicine	7th April 1999
PI15361/0136	P.I.E. Pharma Limited	Neoral 25 mg Capsules	Cyclosporin 25.000 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	14th April 1999
PI15361/0137	P.I.E. Pharma Limited	Neoral 50 mg Capsules	Cyclosporin 50.000 mg	See PL 15361/0136 Prescription Only Medicine	14th April 1999
PI15361/0138	P.I.E. Pharma Limited	Neoral 100 mg Capsules	Cyclosporin 100.000 mg	See PL 15361/0136 Prescription Only Medicine	14th April 1999
PI15814/0094	OPD Laboratories Limited	Venlafaxine Tablets 75 mg Efexor 75 mg Tablets	Venlafaxine Hydrochloride 84.840 mg	The treatment of depressive illness. Prescription Only Medicine	9th April 1999
PI15814/0095	OPD Laboratories Limited	Venlafaxine Tablets 37.5 mg Efexor 37.5 mg Tablets	Venlafaxine Hydrochloride 42.420 mg	The treatment of depressive illness. Prescription Only Medicine	9th April 1999
PI15814/0106	OPD Laboratories Limited	Alfuzosin Hydrochloride 2.5 mg Tablets Xatral 2.5 mg Tablets	Alfuzosin Hydrochloride 2.500 mg	Functional symptoms of benign prostatic hypertrophy. Prescription Only Medicine	30th March 1999
PI15814/0109	OPD Laboratories Limited	Gabapentin 400 mg Capsules Neurontin 400 Capsules	Gabapentin 400.000 mg	Epilepsy. Prescription Only Medicine	9th April 1999
PI15814/0110	OPD Laboratories Limited	Gabapentin 300 mg Capsules Neurontin 300 Capsules	Gabapentin 300.000 mg	Epilepsy. Prescription Only Medicine	13th April 1999
PI15814/0118	OPD Laboratories Limited	Citalopram Tablets 20 mg Cipramil 20 mg Tablets	Citalopram Hydrobromide 24.980 mg	Treatment of depressive illness. Prescription Only Medicine	30th March 1999
PI15814/0128	OPD Laboratories Limited	Lisinopril Tablets 20 mg Zestril 20 mg Tablets	Lisinopril Dihydrate 21.780 mg	The treatment of hypertension and congestive heart failure. Prescription Only Medicine	7th April 1999
PI15814/0134	OPD Laboratories Limited	Bicalutamide 50 mg Tablets Casodex 50 mg Tablets	Bicalutamide 50.000 mg	Treatment of advanced prostate cancer. Prescription Only Medicine	7th April 1999
PI16378/0008	Beachcourse Limited	Augmentine 500/125 mg Tablets Co-amoxiclav 500/125 mg Tablets	Amoxycillin Trihydrate 500.000 mg Potassium Clavulanate 125.000 mg	Broad spectrum antibiotic. Prescription Only Medicine	13th April 1999
PI16378/0009	Beachcourse Limited	Enalapril Maleate 5 mg Tablets	Enalapril Maleate 5.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	9th April 1999
PI16378/0012	Beachcourse Limited	Glucobay 50 mg Tablets	Acarbose 50.000 mg	The treatment of non-insulin dependent diabetes mellitus. Prescription Only Medicine	13th April 1999
PI16378/0017	Beachcourse Limited	Sertraline 50 mg Tablets Aremis 50 mg Tablets	Sertraline 50.000 mg	Depressive illness. Prescription Only Medicine	19th April 1999
PI16378/0018	Beachcourse Limited	Sertraline 100 mg Tablets Aremis 100 mg Tablets	Sertraline 111.900 mg Sertraline Hydrochloride 100.00 mg	The treatment of the symptoms of depressive illness. Prescription Only Medicine	24th March 1999
PI16378/0035	Beachcourse Limited	Clarityne 10 mg Tablets Loratadine 10 mg Tablets	Loratadine 10.000 mg	1. Rhinitus. 2. Chronic urticaria. Prescription Only Medicine	26th March 1999
PI16378/0046	Beachcourse Limited	Doxazosin 2 mg Tablets	Doxazosin 2.000 mg	The treatment of hypertension and symptoms associated with benign prostatic hyperplasia. Prescription Only Medicine	26th March 1999
PI16378/0047	Beachcourse Limited	Doxazosin 4 mg Tablets	Doxazosin 4.000 mg	Prescription Only Medicine	25th March 1999
PI16378/0051	Beachcourse Limited	Klacid 500 mg Tablets Clarithromycin 500 mg Tablets	Clarithromycin 500.000 mg	The treatment of infections caused by susceptible organisms. Prescription Only Medicine	23rd April 1999
PI16378/0069	Beachcourse Limited	Zestoretic 20 Tablets	Hydrochlorothiazide 12.500 mg Lisinopril Dihydrate 21.800 mg	Hypertension. Prescription Only Medicine	6th April 1999
PI16378/0077	Beachcourse Limited	Imdur 60 mg Tablets	Isosorbide Mononitrate 60.000 mg	Angina pectoris. Prescription Only Medicine	9th April 1999
PI16378/0086	Beachcourse Limited	Adalat Retard 10 mg Tablets	Nifedipine 10.000 mg	Angina pectoris and hypertension. Prescription Only Medicine	6th April 1999
PI16378/0091	Beachcourse Limited	Zocor 10 mg Tablets Simvastatin 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	19th April 1999
PI16378/0092	Beachcourse Limited	Clarithromycin 250 mg Tablets Klacid 250 mg Tablets	Clarithromycin 250.000 mg	Infections caused by susceptible organisms. Prescription Only Medicine	20th April 1999
PI16378/0093	Beachcourse Limited	Renitec 20 mg Tablets Enalapril Maleate 20 mg Tablets	Enalapril Maleate 20.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	20th April 1999
PI16782/0007	BR Pharma International	Nizatidine 150 mg Capsules	Nizatidine 150.000 mg	The treatment of gastro intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	23rd April 1999
PI16782/0008	BR Pharma International	Nizatidine 300 mg Capsules	Nizatidine 300.000 mg	See PL PI16782/0007 Prescription Only Medicine	23rd April 1999
PI16782/0022	BR Pharma International	Diovan 80 mg Capsules	Valsartan 80.000 mg	Hypertension. Prescription Only Medicine	20th April 1999
PI16782/0048	BR Pharma International	Lipobay 100 microgram Tablets	Cerivastatin Sodium 100.000 mcg	Hypercholesterolaemia. Prescription Only Medicine	19th April 1999
PI16782/0049	BR Pharma International	Lipobay 200 micrograms Tablets	Cerivastatin Sodium 200.000 mcg	Hypercholesterolaemia. Prescription Only Medicine	20th April 1999
PI16782/0050	BR Pharma International	Lipobay 300 micrograms Tablets	Cerivastatin Sodium 300.000 mcg	Hypercholesterolaemia. Prescription Only Medicine	20th April 1999
16900/0004	Dallas Burston Healthcare Limited	Isotard 50XL Capsules ISIB 50XL Capsules	Isosorbide 5-Mononitrate 50.000 mg	Prophylactic treatment of angina pectoris. Pharmacy Medicine	15th January 1999
16900/0005	Dallas Burston Healthcare Limited	Isotard 25XL Capsules	Isosorbide 5-Mononitrate 25.000 mg	Prophylactic treatment of angina pectoris. Pharmacy Medicine	15th January 1999
16950/0001	Napp Pharmaceuticals Limited	Imazin XL tablets	Acetylsalicylic Acid 75.000 mg Isosorbide 5-Mononitrate 60.000 mg	Prophylaxis of angina and the prevention of secondary myocardial infarction. Pharmacy Medicine	29th January 1999
16950/0002	Napp Pharmaceuticals Limited	Imazin XL Forte tablets	Acetylsalicylic Acid 150.000 mg Isosorbide 5-Mononitrate 60.000 mg	Prophylaxis of angina and the prevention of secondary myocardial infarction. Pharmacy Medicine	29th January 1999