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
00010/0255	Bayer PLC	Canestan Oasis	Citric Acid Anhydrous 1063.000 mg Sodium Bicarbonate 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	23rd June 1999
00012/0333	May & Baker Limited	Zopiclone 3.75 mg	Zopiclone 3.750 mg	Short term treatment of insomnia, including difficulties in falling asleep, nocturnal awakening and early awakening, transient, situational or chronic insomnia, and insomnia secondary to psychiatric disturbances, in situations where the insomnia is debilitating or is causing severe distress for the patient. Long term continuous use is not recommended. A course of treatment should employ the lowest effective dose. Prescription Only Medicine	1st September 1999
00012/0334	May & Baker Limited	Zopiclone 7.5 mg	Zopiclone 7.500 mg	See PL 00012/0333. Prescription Only Medicine	1st September 1999
00025/0383	Merck Sharp & Dohme Limited	Vioxx 12.5 mg Tablets	Rofecoxib 12.500 mg	Symptomatic relief in the treatment of osteoarthritis. Prescription Only Medicine	4th June 1999
00025/0384	Merck Sharp & Dohme Limited	Vioxx 25 mg Tablets	Rofecoxib 25.000 mg	See PL 00025/0383. Prescription Only Medicine	4th June 1999
00025/0385	Merck Sharp & Dohme Limited	Vioxx 12.5 mg/5 ml Oral Suspension	Rofecoxib 2.500 mg/ml	See PL 30025/0380. Prescription Only Medicine	4th June 1999
00025/0386	Merck Sharp & Dohme Limited	Vioxx 25 mg/5 ml Oral Suspension	Rofecoxib 5.000 mg/ml	See PL 00025/0383. Prescription Only Medicine	4th June 1999
00025/0387	Merck Sharp & Dohme Limited	Coxxid 12.5 mg Tablets	Rofecoxib 12.500 mg	Symptomatic relief in the treatment of osteoarthritis. Prescription Only Medicine	16th September 1999
00025/0388	Merck Sharp & Dohme Limited	Coxxid 25 mg Tablets	Rofecoxib 25.000 mg	Symptomatic relief in the treatment of osteoarthritis. Prescription Only Medicine	16th September 1999
00025/0389	Merck Sharp & Dohme Limited	Coxxid 12.5 mg/5 ml Oral Suspension	Rofecoxib 2.500 mg/ml	Symptomatic relief in the treatment of osteoarthritis. Prescription Only Medicine	9th June 1999
00025/0390	Merck Sharp & Dohme Limited	Coxxid 25 mg/5 ml Oral Suspension	Rofecoxib 5.000 mg/ml	Symptomatic relief in the treatment of osteoarthritis. Prescription Only Medicine	9th June 1999
00030/0154	Novartis Consumer Health UK Limited	Boots Nicotine Chewing Gum 2 mg	Nicotine 2.000 mg	Boots Nicotine Chewing Gum treatment is indicated for the relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. General Sales List	16th September 1999
00030/0155	Novartis Consumer Health UK Limited	Boots Nicotine Chewing Gum 4 mg	Nicotine 4.000 mg	Boots Nicotine Chewing Gum treatment is indicated for the relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. Boots Nicotine Chewing Gum 4 mg is for use when severe withdrawal symptoms are experienced. Pharmacy Medicine	16th September 1999
00032/0245	Pharmacia & Upjohn Limited	Aromasin	Exemestane 25.000 mg	For the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Also indicated for the third-line hormonal treatment of advanced breast cancer (ABC) in women with natural or induced postmenopausal status whose disease progressed following treatment with anti-oestrogens and either non-steroidal aromatase inhibitors or progestins. Prescription Only Medicine	4th June 1999
00032/0255	Pharmacia & Upjohn Limited	Nicorette Nasal Spray 10 mg/ml	Nicotine 10.000 mg/ml	For the rapid relief of nicotine withdrawal symptoms in the treatment of nicotine dependent persons as part of a supervised smoking cessation programme. It may be of particular use in the most heavily dependent smokers. Prescription Only Medicine	30th August 1999
00036/0072	Stafford-Miller Limited	EarCalm Spray	Glacial Acetic Acid 2.000 % w/w	For the treatment of superficial infections of the external auditory canal. Pharmacy Medicine	8th June 1999
00065/0161	Organon Laboratories Limited	Implanon	Etonogestrel 68.000 mg	Contraception. Prescription Only Medicine	9th June 1999
00065/0165	Organon Laboratories Limited	Pregnyl 1500 I.U.	Chorionic Gonadotrophin 1500.000 IU	In the male: Hypogonadotrophic hypogonadism. Delayed puberty associated with insufficient gonadotrophic pituitary function. Sterility in selected cases of deficient spermatogenesis. In the female: Sterility due to the absence of follicle-ripening or ovulation. In conjunction with HMG, in the promotion of controlled superovulation in medically assisted reproduction programs. Prescription Only Medicine	24th June 1999
00221/0118	Nycomed Amersham PLC	Gallium [67Ga] Citrate Injection	Gallium (67Ga) Citrate HSE 37. MBC	Non-specific tumour imaging and/or localising agent. Localisation of inflammatory lesions. Prescription Only Medicine	14th September 1999
00242/0357	Janssen-Cilag Limited	Erypo 40,000 IU/ML Solution for Injection Eprex 40,000 IU/ML Solution for Injection	Epoetinum Alpha 40000.000 IU/ML	Can be used to increase the yield of autologous blood from patients in a predonation program. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency) if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). Can be used to reduce exposure to allogeneic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml). Good blood management practices shold always be used in the perisurgical setting. Prescription Only Medicine	11th June 1999
00530/0592	Norton Healthcare Limited	Fluoxetine 20 mg Capsules	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. Bulimia Nervosa: For the reduction of binge-eating and purging activity. Obsessive Compulsive Disorder. Prescription Only Medicine	2nd September 1999
PI 03243/0364	Munro Wholesale Medical Supplies Ltd	Neoral 25 mg Capsules	Ciclosporin 25.00 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	1st September 1999
PI 03243/0365	Munro Wholesale Medical Supplies Ltd	Neoral 50 mg Capsules	Cyclosporin 50.000 MG	See PLPI/03243/0364. Prescription Only Medicine	3rd September 1999
PI 03243/0366	Munro Wholesale Medical Supplies Ltd	Neoral 100 mg Capsules	Cyclosporin 100.000 MG	See PLPI/03243/0364. Prescription Only Medicine	26th August 1999
PI 03243/0378	Munro Wholesale Medical Supplies Ltd	Risperdal 1 mg Tablets	Risperidone 1.000 MG	Treatment of schizophrenic psychoses. Prescription Only Medicine	17th September 1999
PI 03243/0379	Munro Wholesale Medical Supplies Ltd	Risperdal 2 mg Tablets	Risperidone 2.000 MG	See PLPI/03243/0378. Prescription Only Medicine	17th September 1999
PI 03787/0646	Swingward Limited (t/a Medihealth)	Lamictal 5 mg dispersible/chewable tablets	Lamotrigine 5.000 MG	Epilepsy. Prescription Only Medicine	24th August 1999
PI 03787/0647	Swingward Limited (t/a Medihealth)	Lamictal 25 mg dispersible/chewable tablets	Lamotrigine 25.000 MG	Epilepsy. Prescription Only Medicine	24th August 1999
PI 03787/0662	Swingward Limited (t/a Medihealth)	Requip 2 mg Tablets	Ropinirole Hydrochloride 2.280 MG	Parkinson’s disease. Prescription Only Medicine	3rd September 1999
PI03787/0663	Swingward Limited (t/a Medihealth)	Tenif Capsules	Atenolol 50.000 mg Nifedipine 20.000 mg	Hypertension and Angina pictoris. Prescription Only Medicine	3rd September 1999
PI03787/0681	Swingward Limited (t/a Medihealth)	Flixonase Aqueous Nasal Spray	Fluticasone Propionate 50.000 mcg	The treatment of rhinitus. Prescription Only Medicine	3rd September 1999
PI03787/0683	Swingward Limited (t/a Medihealth)	Trusopt	Dorzolamide Hydrochloride 22.260 mg	The treatment of elevated intra-ocular pressure. Prescription Only Medicine	10th September 1999
PI03787/0708	Swingward Limited (t/a Medihealth)	Ikorel 20 mg Tablets	Nicorandil 20.000 mg	Angina pectoris. Prescription Only Medicine	14th September 1999
PI03787/0721	Swingward Limited (t/a Medihealth)	Zoladex LA 10.8 mg Injection	Goserelin Acetate 10.800 mg	Prostate cancer suitable for hormonal manipulation. Prescription Only Medicine	16th September 1999
PI04012/0046	A/S GEA Farmaceutisk Fabrik	Virovir Dispersible 200. Aciclovir Dispersible Tablets 200 mg	Aciclovir 200.000 mg	Treatment of herpes simplex infections of the skin and mucous membranes including initial and recurrent genital herpes. Suppression of recurrent herpes simplex infections. Prevention of herpes simplex infections in immunocompromised patients. Treatment of herpes zoster infections. Treatment of varicella (chickenpox) infections. Prescription Only Medicine	14th September 1999
PI04012/0047	A/S GEA Farmaceutisk Fabrik	Virovir Dispersible 400. Aciclovir Dispersible Tablets 400 mg	Aciclovir 200.000 mg	(See 04012/0046) Prescription Only Medicine	14th September 1999
PI04012/0048	A/S GEA Farmaceutisk Fabrik	Virovir Dispersible 800. Aciclovir Dispersible Tablets 800 mg	Aciclovir 800.000 mg	Treatment of herpes zoster infections. Treatment of varicella (chickenpox) infections. Prescription Only Medicine	14th September 1999
PI04423/0320	Doncaster Pharmaceuticals Group Limited	Pantoprazole EC Tablets 40 mg	Pantoprazole Sodium Sesquihydrate 45.100 mg	Gastintestinal diseases which require a reduction in acid secretion; the eradication of helicobaster pylori in combination with antibiotics. Prescription Only Medicine	8th September 1999
PI04423/0322	Doncaster Pharmaceuticals Group Limited	Glucobay 100 Tablets	Acarbose 100.000 mg	Non-insulin dependent diabetes. Prescription Only Medicine	14th September 1999
PI04423/0330	Doncaster Pharmaceuticals Group Limited	Renitec 5 mg Tablets Enalapril Maleate 5 mg Tablets	Enalapril Maleate 5.000 mg	Hypertension, congestive heart failure. Prescription Only Medicine	6th September 1999
04515/0108	Faulding Pharmaceuticals Plc	Midazolam Injection BP 1 mg/ml	Midazolam 1.000 mg	Midazolam Injection BP is a short acting sedative and anaesthetic agent indicated for intravenous sedative cover before and during minor medical, dental and surgical procedures such as gastroscopy, endoscopy, cystoscopy, bronchoscopy and cardiac catheterisation. Midazolam Injection BP may also be used for sedation by intravenous injection (either continuous infusion or intermittent bolus injection) in critically ill patients in intensive care. Midazolam Injection BP may also be used as an intramuscular premedication before surgery for patients with the physical status ASA I-IV who are to undergo surgical procedures. Midazolam Injection BP may also be used as an alternative intravenous agent for the induction of anaesthesia in elderly or high risk patients, especially where cardiovascular stability is of particular importance. Induction is more reliable when heavy opiate premedication has been administered or when Midazolam Injection BP is given with a narcotic analgesic such as fentanyl. Prescription Only Medicine	10th September 1999
04515/0110	Faulding Pharmaceuticals Plc	Midazolam Injection BP 5 mg/ml	Midazolam 5.000 mg	See PL 04515/0108. Prescription Only Medicine	10th September 1999
04543/0389	CP Pharmaceuticals Limited	Midazolam Injection BP 2 mg/ml	Midazolam 2.000 mg/ml	Midazolam may be used as an intravenous sedative before and during minor medical, dental and surgical procedures. As an intravenous sedative (either by continuous infusion or intermittent bolus injection) in critically ill patients in intensive care. As an alternative intravenous agent for the induction of anaesthesia in high risk and elderly patients where cardiovascular stability is of particular importance. Induction is more reliable when heavy opiate medication has been administered or when midazolam injection is given with a narcotic analgesic such as fentanyl. Prescription Only Medicine	25th August 1999
04543/0390	CP Pharmaceuticals Limited	Midazolam Injection BP 5 mg/ml	Midazolam 5.000 mg/ml	See PL 04543/0389. Prescription Only Medicine	25th August 1999
04569/0386	Generics (UK) Limited	Sulpiride Tablets 200 mg	Sulpiride 200.000 mg	Acute and chronic schizophrenia. Prescription Only Medicine	15th September 1999
PLPI05513/0488	Eurochem Limited	Trusopt 2 % Ophthalmic Solution	Dorzolamide Hydrochloride 2.226 % w/v	Treatment of elevated intra-ocular pressure. Prescription Only Medicine	15th September 1999
PI05513/0489	Eurochem Limited	Trusopt 2 % Ophthalmic Solution	Dorzolamide Hydrochloride 2.226 % w/v	See PLPI05513/0488. Prescription Only Medicine	15th September 1999
PI05513/0490	Eurochem Limited	Mometasone Furoate 0.1 % Cream Elocom Cream	Mometasone Furoate .100 % w/w	Psoriasis and atopic dermatitis. Prescription Only Medicine	26th August 1999
PI05513/0510	Eurochem Limited	Fosinopril Sodium 20 mg Tablets	Fosinopril Sodium 20.000 mg	Hypertension; heart failure. Prescription Only Medicine	8th September 1999
PI05513/0511	Eurochem Limited	Nitrolingual Pump Spray	Glyceryl Trinitrate 400.000 MCG	Angina pectoris and variant angina. Pharmacy Medicine	8th September 1999
PI05513/0524	Eurochem Limited	Pergolide 1 mg Tablets	Pergolide 1.000 MG	Parkinson’s disease. Prescription Only Medicine	15th September 1999
PI05513/0550	Eurochem Limited	2% Eye Drops	Dorzolamide Hydrochloride 22.300 MG	The treatment of elevated intra-ocular pressure. Prescription Only Medicine	10th September 1999
PI05513/0559	Eurochem Limited	Lamictal 25 mg Tablets (Dispersible/Chewable)	Lamotrigine 25.000 MG	Epilepsy. Prescription Only Medicine	8th September 1999
PI05513/0567	Eurochem Limited	Tenoxicam 20 mg Tablets Mobiflex 20 mg Tablets	Tenoxicam 20.000 MG	Rheumatoid arthritis, osteoarthritis and acute musculoskeletal disorders. Prescription Only Medicine	9th September 1999
PI05513/0573	Eurochem Limited	Famciclovir 250 mg Tablets Famvir 250 mg Tablets	Famciclovir 250.000 MG	Herpes zoster infections. Prescription Only Medicine	14th September 1999
PI05513/0574	Eurochem Limited	Zestril 20 mg Tablets	Lisinopril Dihydrate 21.780 MG	Hypertension and congestive heart failure. Prescription Only Medicine	7th September 1999
PI05513/0743	Eurochem Limited	Claritine Syrup 5 mg/5 ml Loratadine Syrup 5 mg/5 ml	Loratadine 5.000 MG	Allergic rhinitus, urticaria. Prescription Only Medicine	17th September 1999
PI05513/0744	Eurochem Limited	Fluvastatin 40 mg Capsules Lescol 40 mg Capsules	Fluvastatin Sodium 42.120 MG	Coronary heart disease and hypercholesterolaemia. Prescription Only Medicine	15th September 1999
PI05513/0745	Eurochem 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	24th August 1999
PI05513/0760	Eurochem Limited	Provera 10 mg Tablets	Medroxyprogesterone Acetate 10.000 mg	The treatment of dysfunctional uterine bleeding secondary amenorrhoea and endometriosis. Prescription Only Medicine	24th August 1999
PI05513/0784	Eurochem Limited	Plendil 5 mg Tablets	Felodipine 5.000 mg	Hypertension; angina pectoris. Prescription Only Medicine	16th September 1999
PI05662/0494	Dowelhurst Limited	Oestradiol Valerate 2 mg Progynova 2 mg Tablets	Oestradiol Valerate 2.000 mg	Hormone replacement therapy. Prescription Only Medicine	24th August 1999
PI05662/0536	Dowelhurst Limited	Transiderm-Nitro 5	Glyceryl Trinitrate 25.000 mg	Treatment of attacks of angina pectoris. Treatment of phlebitis and extravasation secondary to venous cannulation for intravenous fluid and drug administration. Pharmacy Medicine.	3rd September 1999
PI05662/0537	Dowelhurst Limited	Transiderm-Nitro 10	Glyceryl Trinitrate 50.000 mg	Angina Pectoris. Pharmacy Medicine.	1st September 1999
PI05662/0594	Dowelhurst Limited	Topiramate Tablets 50 mg Epitomax 50 mg Tablets	Topiramate 50.000 mg	Epilepsy. Prescription Only Medicine	6th September 1999
PI05662/0595	Dowelhurst Limited	Epitomax 100 mg Tablets Topiramate Tablets 100 mg	Topiramate 100.000 mg	Epilepsy. Prescription Only Medicine	26th August 1999
PI05662/0596	Dowelhurst Limited	Topiramate Tablets 200 mg Epitomax 200 mg Tablets	Topiramate 200.000 mg	Epilepsy. Prescription Only Medicine	3rd September 1999
PI05662/0598	Dowelhurst Limited	Donepezil Hydrochloride Tablets 10 mg Aricept Tablets 10 mg	Donepezil Hydrochloride 10.000 mg	Symptomatic treatment of alzheimers dementia. Prescription Only Medicine	25th August 1999
PI06464/0563	Waymade plc	Lisinopril 5 mg Tablets Zestril 5 mg Tablets	Lisinopril Dihydrate 5.450 mg	Hypertension; congestive heartfailure; acute myocardial infarction; renal complications of diabetes mellitus. Prescription Only Medicine	17th September 1999
PI06464/0604	Waymade Plc	Omeprazole 10 mg Capsules Mopral 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	26th August 1999
PI06464/0607	Waymade Plc	Requip 1 mg Tablets	Ropinirole Hydrochloride 1.140 mg	Parkinson’s disease. Prescription Only Medicine	1st September 1999
PI06464/0608	Waymade Plc	Requip 2 mg Tablets	Ropinirole Hydrochloride 2.280 mg	Parkinson’s disease. Prescription Only Medicine	1st September 1999
PI06464/0623	Waymade Plc	Lisinopril 5 mg Tablets Zestril 5 mg Tablets	Lisinopril Dihydrate 5.450 mg	Hypertension and congestive heart failure. Prescription Only Medicine	3rd September 1999
PI06464/0624	Waymade Plc	Fucithalmic Viscous Eye Drops	Fusidic Acid 1.000% w/w	Bacterial conjunctivitis. Prescription Only Medicine	24th August 1999
08215/0007	Kent Pharmaceuticals Limited	Tolbutamide Tablets BP 500 mg	Tolbutamide 500.000 mg	Tolbutamide is indicated for the oral treatment of patients with non-insulin dependent diabetes (maturity-onset or type II diabetes) who respond inadequately to dietary treatment alone. Prescription Only Medicine	17th September 1999
PI08747/0256	Chemilines Limited	Pantoprazole Enteric Coated Tablets 40 mg Protium 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 September 1999
PI08747/0258	Chemilines Limited	Losartan Potassium Tablets 50 mg Cozaar Tablets 50 mg	Losartan Potassium 50.000 mg	Hypertension. Prescription Only Medicine	10th September 1999
PI08747/0260	Chemilines Limited	Simvastatin 10 mg Tablets 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	3rd September 1999
PI08747/0261	Chemilines Limited	Simvastatin 20 mg Tablets Zocor 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	3rd September 1999
PI08747/0269	Chemilines Limited	Lisinopril 5 mg Tablets Zestril 5 mg Tablets	Lisinopril 5.000 mg	Hypertension; congestive heart failure. Prescription Only Medicine	8th September 1999
PI08747/0270	Chemilines Limited	Lisinopril 10 mg Tablets Zestril 10 mg Tablets	Lisinopril 10.000 mg	See PLPI08747/0269. Prescription Only Medicine	7th September 1999
PI08747/0271	Chemilines Limited	Lisinopril 20 mg Tablets Zestril 20 mg Tablets	Lisinopril 20.000 mg	Hypertension; congestive heart failure. Prescription Only Medicine	7th September 1999
PI08747/0272	Chemilines Limited	Lisinopril 20 mg Tablets Zestril 20 mg Tablets	Lisinopril Dihydrate 21.780 mg	See PLPI08747/0271. Prescription Only Medicine	7th September 1999
PI08747/0275	Chemilines Limited	Relifex Tablets 500 mg Nabumetone Tablets 500 mg	Nabumetone 500.000 mg	Rheumatoid arthritis and osteoarthritis requiring anti-inflammatory and analgesic treatment. Prescription Only Medicine	9th September 1999
PI08747/0276	Chemilines Limited	Prozac Liquid Fluoxetine Liquid 20 mg/5 ml	Fluoxetine Hydrochloride 20.000 mg	Treatment of depressive illness. Prescription Only Medicine	6th September 1999
PI08747/0278	Chemilines Limited	Serc Tablets 8 mg Betayhistine Dihydrochloride Tablets 8 mg	Betahistine Dihydrochloride 8.000 mg	Vertigo, tinnitus and hearing loss associated with Menieres syndrome. Prescription Only Medicine	14th September 1999
PI08747/0294	Chemilines Limited	Gopten Capsules 0.5 mg Trandolapril Capsules 0.5 mg	Trandolapril 0.500 mg	Mild or moderate hypertension. Left ventricular dysfunction after myocardial infarction. Prescription Only Medicine	26th August 1999
PI08747/0295	Chemilines Limited	Gopten Capsules 2 mg Trandolapril Capsules 2 mg	Trandolapril 2.000 mg	See PLPI08747/0294. Prescription Only Medicine	26th August 1999
PI08747/0304	Chemilines Limited	Augmentin Tablets 625 mg Co-Amoxiclav Tablets 625 mg	Amoxycillin 500.000 mg Clavulanic Acid 125.000 mg	The treatment of infections caused by susceptible organisms. Prescription Only Medicine	3rd September 1999
PI08747/0309	Chemilines Limited	Cisapride Tablets 10 mg Prepulsid Tablets 10 mg	Cisapride 10.000 mg	Treatment of symptoms associated with gastro-oesophageal reflux; relief or impaired gastric motility secondary to disturbed and delayed gastric emptying associated with diabetes, systemic sclerosis and autonomic neuropathy. Prescription Only Medicine	10th September 1999
PI08747/0316	Chemilines Limited	Anastrozole Tablets 1 mg Arimidex Tablets 1 mg	Anastrozole 1.000 mg	Treatment of advanced breast cancer. Prescription Only Medicine	1st September 1999
PI08747/0320	Chemilines Limited	Risperdal Tablets 3 mg Risperidone Tablets 3 mg	Risperidone 3.000 mg	The treatment of schizophrenic psychoses. Prescription Only Medicine	10th September 1999
PI08747/0321	Chemilines Limited	Risperidone Tablets 4 mg Risperdal Tablets 4 mg	Risperidone 4.000 mg	See PLPI08747/0320. Prescription Only Medicine	10th September 1999
PI08747/0329	Chemilines Limited	Serevent Diskhaler	Salmeterol 50.000 mcg	Reversible airways obstruction. Prescription Only Medicine	6th September 1999
08828/0133	Fresenius Kabi Limited	HAES-steril 6%	Hydroxyethyl Starch 6.000 %W/V	Therapy and prophylaxis of hypovolaemia and shock in association with: surgery (haemorrhagic shock) injury (traumatic shock) infections (septic shock) burns (burns shock). Prescription Only Medicine	10th September 1999
08828/0134	Fresenius Kabi Limited	HAES-steril 10%	Hydroxyethyl Starch 10.000 %W/V	Therapy and prophylaxis of hypovolaemia and shock in association with: surgery (haemorrhagic shock) injury (traumatic shock) infections (septic shock) burns (burns shock). Prescription Only Medicine	10th September 1999
08829/0022	Trinity Pharmaceuticals Limited	Vasogard SR 90	Diltiazem Hydrochloride 90.000 mg	For the management of angina pectoris. For the management of mild to moderate hypertension. Prescription Only Medicine	21st June 1999
08829/0023	Trinity Pharmaceuticals Limited	Vasogard SR 120	Diltiazem Hydrochloride 120.000 mg	See (PL08829/0022) Prescription Only Medicine	21st June 1999
08829/0024	Trinity Pharmaceuticals Limited	Vasogard SR 180	Diltiazem Hydrochloride 180.000 mg	(See PL08829/0022) Prescription Only Medicine	21st June 1999
08829/0025	Trinity Pharmaceuticals Limited	Vasogard XL 300	Diltiazem Hydrochloride 300.000 mg	(see 8829/0022) Prescription Only Medicine	21st June 1999
08829/0096	Trinity Pharmaceuticals Limited	Vasogard XL 240	Diltiazem Hydrochloride 240.000 mg	(see 8829/0022) Prescription Only Medicine	21st June 1999
PI10256/0362	Stephar (UK) Limited	Imigran Injection	Sumatriptan Succinate 8.400 mg	Migraine. Prescription Only Medicine	27th August 1999
PI10256/0416	Stephar (UK) Limited	Cacit 500 mg Effervescent Tablets	Calcium Carbonate 1.250 gm	Calcium deficiency states; osteoporosis; bone demineralisation. Pharmacy Medicine	2nd September 1999
PI10256/0428	Stephar (UK) Limited	Duovent Inhaler	Fenoterol Hydrobromide 99.900 mcg Ipratropium Bromide 39.900 mcg	Reversible airways obstruction. Prescription Only Medicine	1st September 1999
PI10256/0442	Stephar (UK) Limited	Motival Tablets	Fluphenazine Hydrochloride 0.500 mg Nortriptyline 10.000 mg	Anxiety depressive states. Prescription Only Medicine	10th September 1999
PI10256/0498	Stephar (UK) Limited	Zomig 2.5 mg Tablets	Zolmitriptan 2.500 mg	Migraine. Prescription Only Medicine	1st September 1999
PI10256/0499	Stephar (UK) Limited	Hivid 0.375 mg Tablets	Zalcitabine 0.375 mg	HIV infected adults in combination with other antiretroviral drugs. Prescription Only Medicine	25th August 1999
PI10256/0500	Stephar (UK) Limited	Hivid 0.75 mg Tablets	Zalcitabine 0.750 mg	HIV infected adults in combination with other antiretroviral drugs. Prescription Only Medicine	24th August 1999
PI10256/0505	Stephar (UK) Limited	Tildiem Retard 90 mg Tablets	Diltiazem 90.000 mg	Angina pectoris. Prescription Only Medicine	26th August 1999
PI10256/0506	Stephar UK Limited	Tildiem Retard 120 mg Tablets	Diltiazem 120.000 mg	Angina pectoris. Prescription Only Medicine	26th August 1999
PI10256/0531	Stephar UK Limited	Naramig 2.5 mg Tablets	Naratriptan Hydrochloride 2.780 mg	Migraine. Prescription Only Medicine	14th September 1999
PI10256/0534	Stephar UK Limited	Oxis 6 Turbohaler	Formoterol Fumarate Dihydrate 4.500 mcg	Asthma. Prescription Only Medicine	8th September 1999
PI10256/0535	Stephar UK Limited	Oxis 12 Turbohaler	Formoterol Fumarate Dihydrate 9.000 mcg	Asthma. Prescription Only Medicine	24th August 1999
PI10256/0540	Stephar UK Limited	Imigran Nasal Spray	Sumatriptan 20.000 mg	Migraine. Prescription Only Medicine	14th September 1999
PI10380/0325	Swinghope Limited	Atorvastatin Tablets 10 mg Lipitor 10 mg Tablets	Atorvastatin Calcium Trihydrate 10.850 mg	Hypercholesterolaemia and as an adjunct to diet in reducing elevated total cholesterol. Prescription Only Medicine	24th August 1999
PI10380/0370	Swinghope Limited	Arthrotec 50 Tablets	Diclofenac Sodium 50.000 mg Misoprostol 200.000 mcg	Osteoarthritis and rheumatoid arthritis. NSAID induced gastric and duodenal ulceration. Prescription Only Medicine	17th September 1999
PI10380/0418	Swinghope Limited	Buspar 10 mg Tablets	Buspirone Hydrochloride 10.000 mg	Management of anxiety disorders. Prescription Only Medicine	20th September 1999
PI10383/0619	Primecrown Limited	Adalat LA 60 Tablets	Nifedipine 60.000 mg	Hypertension; angina pectoris. Prescription Only Medicine	26th August 1999
PI10383/0620	Primecrown Limited	Adalat LA 30 Tablets	Nifedipine 30.000 mg	(See PI10383/0619.) Prescription Only Medicine	26th August 1999
PI10383/0623	Primecrown Limited	Zomig 2.5 mg Tablets	Zolmitriptan 2.500 mg	Migraine. Prescription Only Medicine	1st September 1999
PI10383/0638	Primecrown Limited	Trisequens Tablets	Estradiol 2.000 mg Norethisterone Acetate 1.000 mg Oestradiol 1.000 mg Oestradiol 2.000 mg	The treatment of symptoms due to eostrogen deficiency. The prophylaxis of postmenopausal osteoporisis. Prescription Only Medicine	9th September 1999
PI10383/0643	Primecrown Limited	Lipanthyl Micro 67	Fenofibrate Micronised 67.000 mg	The treatment of severe dyslipidaemia. Prescription Only Medicine	10th September 1999
PI10383/0652	Primecrown Limited	Zoladex LA 10.8 mg Injection	Goserelin Acetate 10.800 mg	Prostate cancer suitable for hormonal manipulation. Prescription Only Medicine	16th September 1999
PI10383/0654	Primecrown Limited	Omnic MR 400 micrograms Capsules	Tamsulosin Hydrochloride 400.000 mcg	Benign prostatic hyperplasia. Prescription Only Medicine	10th September 1999
PI10383/0658	Primecrown Limited	Pulmicort Turbuhaler 100	Budesonide 100.000 mcg	Bronchial asthma. Prescription Only Medicine	24th August 1999
PI10383/0659	Primecrown Limited	Bezalip 200 mg Tablets Bezafibrate 200 mg Tablets	Bezafibrate 200.000 mg	Hyperlipidaemia. Prescription Only Medicine	20th September 1999
PI10383/0676	Primecrown Limited	Serevent Inhaler	Salmeterol Xinafoate 36.300 mcg	Reversible airways obstruction. Prescription Only Medicine	20th September 1999
PI10383/0684	Primecrown Limited	Cytotec 200 microgram Tablets	Misoprostol 200.000 mcg	Duodenal and gastric ulcers. Prescription Only Medicine	7th September 1999
10592/0136	Smithkline Beecham Plc	Hepatyrix	Hepatitis A Virus Antigen HM 175 Strain 1440.00 eu Salmonella Typhi VI Polysaccharide 25.000 mcg	Active immunisation against hepatitis. A virus infection and typhoid fever for adults and adolescents 15 years of age and older. Prescription Only Medicine	22nd June 1999
10622/0051	Dominion Pharma Limited	Neo-Cortef Eye/Ear Drops	Hydrocortisone Acetate 15.000 mg Neomycin Sulphate 5.000 mg	Eye: Short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease. Eyelid: Blepharitis. Ear: Otitis externa caused by susceptible organisms. Prescription Only Medicine	16th September 1999
10622/0052	Dominion Pharma Limited	Neo-Cortef Eye/Ear Ointment	Hydrocortisone Acetate 15.000 mg Neomycin Sulphate 5.000 mg	See PL 10622/0051. Prescription Only Medicine	16th September 1999
10943/0001	Laboratorios Grifols SA	Soyacal 10 %	Soybean Oil Purified 10.000 % w/v	(i) As a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time. (ii) As a source of essential fatty acids when a deficiency occurs. Prescription Only Medicine	13th September 1999
10943/0002	Laboratorios Grifols SA	Soyacal 20 %	Soybean Oil Purified 20.000 % w/v	See PL 10943/0001. Prescription Only Medicine	13th September 1999
10949/0327	Glaxo Wellcome UK Limited	Relenza	Zanamivir 5.000 mg	Relenza is indicated for treatment of both influenza A and B in adults and adolescents (*12 years) who present with symptoms typical of influenza when influenza is circulating in the community. Prescription Only Medicine	24th June 1999
11184/0072	Bristol-Myers Squibb Pharmaceuticals Limited	Lipostat Tablets 40 mg	Pravastatin Sodium 40.000 mg	Coronary Artery Disease: In patients with a history of either a myocardial infarction or unstable angina pectoris and a total serum cholesterol level in excess of 4.8 mmol/L or a LDL-cholesterol in excess of 3.2 mmol/L, Lipostat is indicated to reduce the risk of total mortality—reduce the risk of CHD death—reduce the risk of recurrent coronary events (including MI)—reduce the need for myocardial revascularisation procedure—reduce the risk of stroke Coronary Atherosclerotic Disease. As an adjunct to diet to slow the progressive course of coronary atherosclerosis and reduce the incidence of clinical cardiac events in patients with hypercholesterolaemia and documented atherosclerotic coronary artery disease. Prevention of Coronary Heart Disease. As an adjunct to diet in hypercholesterolaemic patients without clinically evident coronary heart disease to: reduce the risk of fatal and non-fatal myocardial infarction; reduce the need to undergo myocardial revascularisation procedures; improve survival by reducing cardiovascular deaths. Hypercholesterolaemia. The reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolaemia who have not responded adequately to dietary measures. Prescription Only Medicine	3rd June 1999
11204/0064	Stada Arzneimittel AG	Flutamid Stada	Flutamide 250.000 mg	Treatment of advanced prostatic carcinoma in which suppression of testosterone effects is indicated. Flutamid Stada may be used as initial treatment in combination with LHRH agonists as adjunctive therapy in patients, already receiving LHRH agonist therapy. Flutamid Stada may also be used in surgically castrated patients. Prescription Only Medicine	26th August 1999
11204/0072	Stada Arzneimittel AG	Metformin 500 mg Tablets	Metformin Hydrochloride 500.000 mg	Non-insulin-dependent diabetes (NIDDM, type II) and, in particular, in obese patients, when adequate dietary treatment has failed. Metformin 500 mg Tablets can be given alone as initial therapy, or can be administered in combination with sulphonylureas after careful assessment of the contra-indications. Prescription Only Medicine	27th August 1999
11204/0073	Stada Arzneimittal AG	Metformin 850 mg Tablets	Metformin Hydrochloride 850.000 mg	See PL 11204/0072. Prescription Only Medicine	27th August 1999
11314/0128	Seton Products Limited	Paracetamol and Dihydrocodeine Tablets	Dihydrocodeine Tartrate 7.460 mg Paracetamol DC (PVP) 521.000 mg	For the treatment of mild to moderate pain and as an antipyretic. Pharmacy Medicine	16th September 1999
11723/0262	Sanofi Winthrop Limited	Domperidone Tablets 10 mg	Domperidone Maleate 12.720 mg	Adults (including the elderly) 1. For the acute treatment of nausea and vomiting of any aetiology in adults. The drug is not recommended for chronic use or for the routine prophylaxis of post-operative vomiting. 2. For up to 12 weeks treatment of nausea and vomiting caused by L-dopa and bromocriptine. 3. For the treatment of the symptoms of functional dyspepsia. Children: the drug is not recommended for use in children unless indicated for the management of nausea and vomiting following cancer chemotherapy or irradiation. Prescription Only Medicine	8th September 1999
12064/0025	Aurum Pharmaceuticals Limited	Sodium Chloride Injection BP 0.9% w/v	Sodium Chloride 0.900% w/v	Diluent for the administration of other drugs given intravenously, intramuscularly or subcutaneously. Prescription Only Medicine	14th September 1999
12070/0022	Cambridge Selfcare Diagnostics Limited	Antizol	Fomepizole 100.000% w/v	An antidote for ethylene glycol (antifreeze) poisoning in patients who have ingested, or are suspected of having ingested, ethylene glycol. Treatment of Antizol should be continued until ethylene glycol levels falls below 200 mg/L (3.2 millimol/L). Prescription Only Medicine	18th June 1999
12297/0009	Laboratoires Arkopharma	Phytorelax Arkocaps	Valerian Root Powdered 270.000 mg	For the temporary symptomatic relief of mild forms of stresses and strains and to promote natural sleep. Pharmacy Medicine	16th September 1999
12557/0043	BCM Limited	Sensitive Teeth Tooth Gel	Sodium Monofluorophosphate 0.800% w/w Tripotassium Citrate Monohydrate 5.350% w/w	For the relief of dentine hypersensitivity and protection against decay. For topical application to the teeth. General Sales List	31st August 1999
12619/0120	Zeneca Limited	Casodex 150 mg	Bicalutamide 150.000 mg	The management of patients with locally advanced, non-metastatic prostrate cancer for whom surgical castration or other medical intervention is not considered appropriate or acceptable. Prescription Only Medicine	17th June 1999
12627/0008	Health Matters Pharmacies Ltd.	Gastroseals 300 mg EC Tablets	Aspirin 300.00 mg	Gastroseals is an antipyretic, anti-inflammatory and analgesic agent designed to reduce the gastric side-effects of aspirin in rheumatoid arthritis and in conditions requiring continued management with aspirin. Gastroseals may also be used to reduce the risk of myocardial infarction in patients with unstable angina or in patients with a previous history of myocardial infarction. Prescription Only Medicine Pharmacy Medicine	1st September 1999
12627/0009	Health Matters Pharmacies Ltd.	Capotace 12.5 mg Captopril Tablets 12.5 mg	Captopril 12.500 mg	Treatment of mild to moderate hypertension and severe hypertension where standard therapy is ineffective or inappropriate. Congestive heart failure with concomitant use of diuretics and, where appropriate, digitalis. Captopril is indicated following myocardial infarction in clinically stable patients with asymptomatic and symptomatic left ventricular dysfunction to improve survival, delay the onset of asymptomatic heart failure, reduce hospitalisations for heart failure and reduce recurrent myocardial infarction and coronary revascularisation procedures. Determination of cardiac function by radionuclide ventriculography or echocardiography should be undertaken prior to initiation of preventative treatment with captopril in post-myocardial infarction patients. Prescription Only Medicine	1st September 1999
12627/0010	Health Matters Pharmacies Ltd.	Capotace 25 mg Captopril Tablets 25 mg	Captopril 25.000 mg	(See PL/12627/0009) Prescription Only Medicine	1st September 1999
12627/0011	Health Matters Pharmacies Ltd.	Captopril Tablets 50 mg Capotace 50 mg	Captopril 50.000 mg	(See PL/12627/0009) Prescription Only Medicine	1st September 1999
12627/0012	Health Matters Pharmacies Ltd	Cholestyramine Oral Powder 4 g	Cholestyramine 4.000 gm	Reduction of plasma cholesterol in hypercholesterolaemia, particularly in those patients who have been diagnosed as Frederickson’s Type II (high plasma cholesterol with normal or slightly elevated triglycerides). Relief of diarrhoea associated with ileal resection, Crohn’s disease, vagotomy and diabetic vagal neuropathy. Relief of pruritis associated with partial biliary obstruction. Management of radiation-induced diarrhoea. Prescription Only Medicine	1st September 1999
12627/0013	Health Matters Pharmacies Ltd	Zemtard MR 120 Angiozem MR 120	Diltiazem Hydrochloride 120.000 mg	Treatment of mild to moderate hypertension. Prophylaxis and treatment of angina pectoris. Prescription Only Medicine	1st September 1999
12627/0014	Health Matters Pharmacies Ltd	Graviday Preconcept Tablets	Ferrous Fumarate 305.000 mg Folic Acid 0.400 mg	Prevention of iron and folic acid deficiencies in pregnancy and as a supplement to reduce the risk of neural tube defects. Prescription Only Medicine	1st September 1999
12627/0015	Health Matters Pharmacies Ltd	Graviday Preconcept Forte Tablets	Ferrous Gluconate 250.000 mg Folic Acid 4.000 mg	For the treatment of anaemias associated with iron and folic acid deficiencies. As a supplement to reduce the risk of neural tube defects for those women planning pregnancy and known to be at risk. Prescription Only Medicine	1st September 1999
12627/0018	Health Matters Pharmacies Ltd	Selegiline Hydrochloride 5 mg Tablets	Selegiline Hydrochloride 5.000 mg	Treatment of Parkinson’s disease or symptomatic parkinsonism. May be used either alone in early Parkinson’s disease to delay the need for levodopa (with or without decarboxylase inhibitor). May also be used as an adjunct to levodopa (with or without decarboxylase inhibitor). Prescription Only Medicine	1st September 1999
12627/0019	Health Matters Pharmacies Ltd	Sucralfate 1 g Tablets	Sucralfate 1.000 gm	For the treatment of and promotion of healing duodenal and gastric ulcer, gastritis and for the treatment of reflux oesophagitis. Prescription Only Medicine	1st September 1999
12627/0020	Health Matters Pharmacies Ltd	Sucralfate 1 g Chewable Tablets	Sucralfate 1.000 gm	(See 12627/0019) Prescription Only Medicine	1st September 1999
12627/0021	Health Matters Pharmacies Ltd	Sucralfate 200 mg/ml Mixture	Sucralfate 1.000 gm	(See 12627/0019) Prescription Only Medicine	1st September 1999
12627/0022	Health Matters Pharmacies Ltd	Tamoxifen Tablets BP 10 mg	Tamoxifen Citrate 15.200 mg	1. Treatment for breast cancer. 2. Treatment of anovulatory infertility. Prescription Only Medicine	3rd September 1999
12627/0023	Health Matters Pharmacies Ltd	Tamoxifen Tablets BP 20 mg	Tamoxifen Citrate 30.400 mg	1. Treatment for breast cancer. 2. Treatment of anovulatory infertility. Prescription Only Medicine	3rd September 1999
12627/0024	Health Matters Pharmacies Ltd	Tamoxifen Tablets BP 40 mg	Tamoxifen Citrate 60.800 mg	1. Treatment for breast cancer. 2. Treatment of anovulatory infertility. Prescription Only Medicine	3rd September 1999
12627/0025	Health Matters Pharmacies Ltd	Buspirone 5 mg Tablets	Buspirone Hydrochloride 5.000 mg	Short-term treatment of anxiety disorders (anxiety and phobic neuroses) and symptomatic relief of anxiety with or without accompanying depression. Prescription Only Medicine	31st August 1999
12627/0026	Health Matters Pharmacies Ltd	Buspirone 10 mg Tablets	Buspirone Hydrochloride 10.000 mg	Short-term treatment of anxiety disorders (anxiety and phobic neuroses) and symptomatic relief of anxiety with or without accompanying depression. Prescription Only Medicine	31st August 1999
PI13975/0017	Community Pharmacy Supplies Limited	Xanef 5 mg Tablets Enalapril Maleate 5 mg Tablets	Enalapril Maleate 5.000 mg	Hypertension; congestive heart failure. Prescription Only Medicine	9th September 1999
PI14069/0079	Denfleet International 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 September 1999
PI14069/0080	Denfleet International Limited	Neoral 50 mg Capsules	Cyclosporin 50.000 mg	(See PLPI14069/0079). Prescription Only Medicine	14th September 1999
PI14069/0081	Denfleet International Limited	Neoral 100 mg Capsules	Cyclosporin 100.000 mg	(See PLPI14069/0079). Prescription Only Medicine	14th September 1999
14308/0001	Transdermal Limited	Grisol	Griseofulvin 1.000 % w/w	The treatment of tinea pedis (athletes foot). Prescription Only Medicine	17th June 1999
14776/0027	Teva Pharma BV	Cefaclor Capsules 500 mg	Cefaclor Monohydrate 500.000 mg	Cefaclor is indicated for the treatment of the following infections due to susceptible micro-organisms: Respiratory tract infections, including pneumonia, bronchitis, exacerbations of chronic bronchitis, pharyngitis and tonsillitis, and as part of the management of sinusitis. Otitis media. Skin and soft tissue infections. Urinary tract infections, including pyelonephritis and cystitis. Cefaclor has been found to be effective in both acute and chronic urinary tract infections. Prescription Only Medicine	15th September 1999
14776/0028	Teva Pharma BV	Cefaclor Suspension 125 mg/5 ml	Cefaclor Monohydrate 125.000 mg	(See PL 14776/0027). Prescription Only Medicine	15th September 1999
14776/0029	Teva Pharma BV	Cefaclor Suspension 250 mg/5 ml	Cefaclor Monohydrate 250.000 mg	(See 14776/0027) Prescription Only Medicine	15th September 1999
14776/0033	Teva Pharma BV	Cefaclor Capsules 250 mg	Cefaclor Monohydrate 250.000 mg	(See 14776/0027) Prescription Only Medicine	15th September 1999
15266/0008	Orphan Europe Sarl	Normosang 25 mg/ml, concentrate for solution for infusion	Hemin 25.000 mg	Treatment of acute attacks of hepatic porphyria (acute intermittent porphyria, porphyria variegata, hereditary coproporphyria). Prescription Only Medicine	24th June 1999
PI15361/0082	P.I.E. Pharma Limited	Diflucan 150 mg Capsule	Fluconazole 150.000 mg	Candidiasis; candidal balanitis. Prescription Only Medicine	7th September 1999
PI15361/0122	P.I.E. Pharma Limited	Serevent Accuhaler 50 micrograms Salmeterol 50 micrograms Accuhaler	Salmeterol 50.000 mcg	Reversible airways obstruction. Prescription Only Medicine	7th September 1999
PI15361/0142	P.I.E. Pharma Limited	Cytotec 200 microgram Tablets	Misoprostol 200.000 mcg	The healing of duodenal and gastric ulcers. Prescription Only Medicine	2nd September 1999
PI15361/0160	P.I.E. Pharma Limited	Detrusitol 1 mg Tablets	Tolterodine L-Tartrate 1.000 mg	The treatment of unstable bladder. Prescription Only Medicine	1st September 1999
PI15361/0161	P.I.E. Pharma Limited	Detrusitol 2 mg Tablet	Tolterodine L-Tartrate 2.000 mg	Treatment of unstable bladder. Prescription Only Medicine	7th September 1999
PI15361/0181	P.I.E. Pharma Limited	Mizollen 10 mg Tablets	Mizolastine 10.000 mg	Rhinoconjunctivitis and urticaria. Prescription Only Medicine	7th September 1999
PI15361/0192	P.I.E. Pharma Limited	Zocor 40 mg Tablets	Simvastatin 40.000 mg	1. Coronary heart disease with a asma cholesterol level of 5.5 mmm 01/1 or greater. 2. Hyperlipidaemia. Prescription Only Medicine	17th September 1999
PI15814/0131	OPD Laboratories Limited	Destolit 150 mg Tablets	Ursodeoxycholic Acid 150.000 mg	The dissolution of radiolucent cholesterol gallstones. Prescription Only Medicine	26th August 1999
PI15814/0138	OPD Laboratories Limited	Simvastatin 40 mg Tablets Zocor 40 mg Tablets	Simvastatin 40.000 mg	1. Coronary heart disease in patients with a plasma cholesterol level of 5.5 mmol/l or greater. 2. Hyperlipidaemia. Prescription Only Medicine	7th September 1999
PI15814/0150	OPD Laboratories Limited	Simvastatin 10 mg Tablets Zocor 10 mg Tablets	Simvastatin 10.000 mg	(See PLPI/15814/0138) Prescription Only Medicine	2nd September 1999
PI15814/0156	OPD Laboratories Limited	Risperdal 4 mg Tablets Risperidone 4 mg Tablets	Risperidone 4..000 mg	Treatment of Schizophrenic psychoses. Prescription Only Medicine	1st September 1999
PI15814/0162	OPD Laboratories Limited	Salmeterol Inhaler 25 micrograms Serevent Inhaler 25 micrograms	Salmeterol Xinafoate 36.300 mcg	Reversible airways obstruction. Prescription Only Medicine	6th September 1999
PI15814/0167	OPD Laboratories Limited	Granisetron 1 mg Tablets Kytril 1 mg Tablets	Granisetron Hydrochloride 1.120 mg	The prevention of nausea and vomiting induced by cytostatic therapy. Prescription Only Medicine	7th September 1999
PI15814/0174	OPD Laboratories Limited	Clarithromycin 500 mg Tablets Klaricid 500 mg Tablets	Clarithromycin 500.000 mg	The treatment of infections caused by susceptible organisms. Prescription Only Medicine	20th September 1999
16363/0006	Milpharm Limited	Glimil Tablets	Gliclazide 80.000 mg	For the treatment of maturity onset diabetes mellitus. Prescription Only Medicine	10th June 1999
PI16378/0007	Beachcourse Limited	Diflucan 150 mg Capsule	Fluconazole 150.000 mg	The treatment of genital and vaginal candidiasis and candidal balanitis. Prescription Only Medicine	20th September 1999
PI16378/0062	Beachcourse Limited	Prevencor 10 mg Tablets Atorvastatin 10 mg Tablets	Atorvastatin 10.000 mg	Hypercholesterolaemia. Prescription Only Medicine	14th September 1999
PI16782/0027	BR Pharma International	Serevent Inhaler	Salmeterol Xinafoate 36.300 mcg	Reversible airways obstruction. Prescription Only Medicine	3rd September 1999
PI6782/0054	BR Pharma International	Meloxicam 7.5 mg Tablets	Meloxicam 7.500 mg	Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Prescription Only Medicine	10th September 1999
16900/0001	Dallas Burston Healthcare Limited	Calcette 500 mg	Calcium Carbonate 1250.000 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	10th June 1999
16950/0009	Napp Pharmaceuticals Limited	Adizem-SR Tablets 120 mg	Diltiazem Hydrochloride 120.000 mg	For the management of angina pectoris. For the treatment of mild to moderate hypertension. Prescription Only Medicine	1st September 1999
16950/0019	Napp Pharmaceuticals Limited	DHC Continus Tablets 60 mg	Dihydrocodeine Tartrate 60.000 mg	For the relief of severe pain in cancer and other chronic conditions. Prescription Only Medicine	1st September 1999
16950/0020	Napp Pharmaceuticals Limited	DHC Continus Tablets 90 mg	Dihydrocodeine Tartrate 90.000 mg	For the relief of severe pain in cancer and other chronic conditions. Prescription Only Medicine	1st September 1999
16950/0021	Napp Pharmaceuticals Limited	DHC Continus Tablets 120 mg	Dihydrocodeine Tartrate 120.000 mg	For the relief of severe pain in cancer and other chronic conditions. Prescription Only Medicine	1st September 1999
16950/0089	Napp Pharmaceuticals Limited	Zydol XL 150 mg Tablets	Tramadol Hydrochloride 150.000 mg	For the management (treatment and prevention) of moderate to severe pain. Prescription Only Medicine	14th June 1999
16950/0090	Napp Pharmaceuticals Limited	Zydol XL 200 mg Tablets	Tramadol Hydrochloride 200.000 mg	(See PL 16950/0089). Prescription Only Medicine	14th June 1999
16950/0091	Napp Pharmaceuticals Limited	Zydol XL 300 mg Tablets	Tramadol Hydrochloride 300.000 mg	(See PL 16950/0089). Prescription Only Medicine	14th June 1999
16950/0092	Napp Pharmaceuticals Limited	Zydol XL 400mg tablets	Tramadol Hydrochloride 400.000 mg	(See 16950/0089) Prescription Only Medicine.	14th June 1999
16973/0002	Almirall Prodesfarma Sa	Benkin Tablets	Flutamide 0.250 gm	Advanced prostatic carcinoma, in which suppression of testosterone effects is indicated. BENKIN” tablets may be used as initial treatment in combination with an LHRH agonist, as adjunctive therapy in patients already on treatment with an LHRH agonist and as therapy for patients who have been surgically castrated and for patients who have not responded to other forms of hormonal manipulation or who have not tolerated them. BENKIN* tablets may be used in combination with LHRH agonists for the management of locally confirmed B2-C2 (T2b-T4) prostate carcinoma as initial therapy; bulky tumours confined to the prostate (stage B2 or T2b) or extending beyond the capsul (stage C or T3-T4), with or without pelvic node involvement. Prescription Only Medicine.	31st August 1999
PI17211/0080	Polyfarma Limited	Becotide 50 Inhaler	Beclomethasone Dipropionate 50.000 mcg	Asthma. Prescription Only Medicine.	31st August 1999
PI17211/0092	Polyfarma Limited	Salazopyrin EN Tablets	Sulphasalazine .500 gm	Ulcerative colitis; Crohn’s disease; rheumatoid arthritis. Prescription Only Medicine.	31st August 1999
PI17211/0098	Polyfarma Limited	Zovirax 800mg Non-Dispersible Tablets	Acyclovir 800.000 mg	Varicella and herpes zoster infections. Prescription Only Medicine.	31st August 1999
PI17211/0113	Polyfarma Limited	Pravastatin Sodium 20mg Tablets	Pravastatin Sodium 20.000 mg	For use in patients with primary hypercholesterolaemia. Prescription Only Medicine.	31st August 1999
PI17211/0153	Polyfarma Limited	Zocor 10mg Tablets	Simvastatin 10.000 mg	For use in patients with primary hypercholesterolaemia resistant to dietary control. Prescription Only Medicine.	31st August 1999
PI17211/0187	Polyfarma Limited	Carteol 2% Eye Drops	Carteolol Hydrochloride 2.000 % w/v	Intra-ocular pressure; Glaucoma. Prescription Only Medicine.	31st August 1999
PI17211/0216	Polyfarma Limited	Prepulsid 10mg Tablets	Cisapride Monohydrate 10.387 mg	Gastro-oesophagial reflux. Prescription Only Medicine.	31st August 1999
PI17211/0223	Polyfarma Limited	Zoton 30mg Capsules	Lansoprazole 30.000 mg	Acid related disorders of the upper gastro-intestinal tract. Prescription Only Medicine.
PI17211/0232	Polyfarma Limited	Citalopram 20 mg Tablets	Citalopram 20.000 mg	Depressive illness and panic disorder. Prescription Only Medicine	7th September 1999
PI17211/0243	Polyfarma 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	3rd September 1999
PI17211/0246	Polyfarma Limited	Proscar 5 mg Tablets	Finasteride 5.000 mg	Benign prostatic hyperplasia. Prescription Only Medicine	1st September 1999
PI17211/0248	Polyfarma Limited	Imigran 50 mg Tablets	Sumatriptan 50.000 mg	Migraine attacks. Prescription Only Medicine	24th August 1999
PI17211/0266	Polyfarma Limited	Diflucan 50 mg Capsules	Fluconazole 50.000 mg	Candidiasis, invasive candidal infections: cryptococcosis. Prescription Only Medicine	8th September 1999
PI17211/0267	Polyfarma Limited	Diflucan 150 mg Capsules	Fluconazole 150.000 mg	Candidiasis: candidal balanitis. Prescription Only Medicine	8th September 1999
PI17211/0268	Polyfarma Limited	Imigran 100 mg Tablets	Sumatriptan Succinate 140.000 mg	Migraine. Prescription Only Medicine	1st September 1999
17225/0010	Schein Pharmaceutical UK Ltd.	Lorazepam Tablets 1.0 mg	Lorazepam 1.000 mg	For the short term treatment of moderate and severe anxiety (i.e. anxiety that is disabling or subjecting the individual to unacceptable distress). Lorazepam is also indicated for the short term treatment of anxiety in psychosomatic, organic and psychotic illness and the short term treatment of insomnia associated with anxiety. Lorazepam may also be used as premedication before operative dentistry and general surgery. Prescription Only Medicine	1st September 1999
17225/0011	Schein Pharmaceutical UK Ltd.	Lorazepam Tablets 2.5 mg	Lorazepam 2.500 mg	(See 17225/0010). Prescription Only Medicine	1st September 1999
The following notice is in substitution for that which appeared on page 9304 of The London Gazette dated 27th August 1999.
15755/0007	OBG Pharmaceuticals Limited	Ibuprofen Tablets BP 200 mg	Ibuprofen 200.000 mg	Ibuprofen is indicated for its analgesic and anti-inflammatory effect in Rheumatoid Arthritis (including juvenile Rheumatoid Arthritis or Still’s Disease) Ankylosing spondylitis, Osteoarthritis and other non-rheumatoid arthropathies. In non-articular rheumatoid conditions, Ibuprofen is indicated in periarticular conditions e.g. Frozen shoulder, Bursitis, Tendinitis, Tenosynovitis and low back pain. Ibuprofen can be used in soft-tissue injuries, e.g. sprains and strains. It is also indicated for the relief of mild to moderate pain, e.g. dental and postoperative pain and dysmenorrhoea. It is also indicated for the relief of migraine. P—for the following indications rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. Pharmacy Medicine Prescription Only Medicine	29th July 1999
The following notice is in substitution for that which appeared on page 9303 of The London Gazette dated 27th August 1999.
PI08747/0289	Chemlines Limited	Clarityn Allergy Syrup Clarityn Syrup Loratadine Syrup 1 mg/ml	Loratadine 1.000 mg/ml	Allergic rhinitis and allergic skin conditions. Prescription Only Medicine Pharmacy Medicine	12th August 1999
The following notice is in substitution for that which appeared on page 9303 of The London Gazette dated 27th August 1999.
PI10380/0341	Swinghope Limited	Doxazosin Tablets 4 mg Cardura 4 mg Tablets	Doxazosin Mesilate 4.850 mg	The treatment of hypertension and symptoms associated with benign prostatic hyperplasia. Prescription Only Medicine	2nd August 1999
The following notice is in substitution for that which appeared on page 9302 of The London Gazette dated 27th August 1999.
PI10256/0468	Stephar (UK) Limited	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	27th July 1999
The following notice is in substitution for that which appeared on page 9301 of The London Gazette dated 27th August 1999.
PI03243/0363	Munro Wholesale Medical Supplies Ltd	Inderal LA 80 mg Capsules	Propranolol Hydrochloride 80.000 mg	Emergency treatment of cardiac dysrhythmias and thyrotoxic crisis. Prescription Only Medicine	2nd August 1999