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
00002/0236	Smithkline & French Laboratories Limited	Isotonic Saline Solution 0.9% w/v	No actives present	For reconstitution of lyophilised vaccines. Prescription Only Medicine	15th May 1998
00019/0155	Warner Lambert (UK) Limited	Diclomax Retard	Diclofenac Sodium 100.000 mg	Adults: For rheumatoid arthritis; osteoarthritis, low back pain; acute musculoskeletal 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 in pain and inflammation in orthopaedic, dental and other minor surgery. Prescription Only Medicine	18th February 1998
00019/0156	Warner Lambert (UK) Limited	Diclomax SR	Diclofenac Sodium 75.000 mg	(See PL00019/0155) Prescription Only Medicine	18th February 1998
00019/0157	Warner Lambert (UK) Limited	Pro-Epanutin	Fosphenytoin Disodium 75.000 mg/ml	For the control of status epilepticus of the tonic-clonic (grand mal) type and prevention and treatment of seizures occurring during or following neurosurgery and/or following head trauma. It can also be substituted for oral phenytoin. Prescription Only Medicine	4th February 1998
00019/0189	Warner Lambert (UK) Limited	Benafed	Diphenhydramine Hydrochloride EP 12.5 mg Dextromethorphan Hydrobromide EP 15.0 mg Pseudoephedrine Hydrochloride BP 30.0 mg L-Menthol EP 1.0 mg	For the relief of cough and its congestive symptoms and in treatment of hayfever and other allergic conditions affecting the upper respiratory tract. Prescription Only Medicine	13th February 1998
00022/0197	Pharmacia Laboratories Limited	Fragmin 10,000 IU	Dalteparin Sodium 10000.000 IU	Treatment of acute deep venous thrombosis (DVT). Prescription Only Medicine	11th February 1998
00022/0198	Pharmacia Laboratories Limited	Fragmin 12,500 IU	Dalteparin Sodium 12500.000 IU	Prescription Only Medicine (See PL00022/0197)	11th February 1998
00022/0199	Pharmacia Laboratories Limited	Fragmin 15,000 IU	Dalteparin Sodium 15000.000 IU	Prescription Only Medicine (See PL00022/0197)	11th February 1998
00022/0200	Pharmacia Laboratories Limited	Fragmin 18,000 IU	Dalteparin Sodium 18000.000 IU	Prescription Only Medicine (See PL00022/0197)	11th February 1998
00030/0085	Novartis Consumer Health UK Limited	Triogesic Tablets	Phenylpropanolamine Hydrochloride BP 12.5 mg Paracetamol EP 500.00 mg	For nasal and sinus decongestion and relief from pain. Pharmacy Medicine	16th February 1998
00030/0086	Novartis Consumer Health UK Limited	Triogesic Elixir	Phenoylpropanolamine Hydrochloride BP 3.0 mg Paracetamol EP 125.0 mg	(See PL00030/0085.) Pharmacy Medicine	16th February 1998
00030/0087	Novartis Consumer Health UK Limited	Triominic Tablets	Phenylpropanolamine Hydrochloride BP 25.0 mg Pheniramine Maleate BP 25.0 mg	Relieves nasal congestion and allergic rhinitis including hayfever. Pharmacy Medicine	16th February 1998
00030/0088	Novartis Consumer Health UK Limited	Triominic Syrup	Phenylpropanolamine HC1 BP 12.50 mg Pheniramine Maleate BP 12.50 mg	For symptomatic relief of all forms of rhinitis, especially hayfever. Pharmacy Medicine	16th February 1998
00030/0097	Novartis Consumer Health UK Limited	Do-Do Chesteze Do-Do	Caffeine 30.000 mg Ephedrine Hydrochloride 18.310 mg Theophylline 100.000 mg	To relieve bronchial cough, wheezing, breathlessness and other symptoms of asthmatic bronchitis, also to clear the chest of mucus following upper respiratory tract infection. Route of administration: For oral use. Pharmacy Medicine	1st February 1998
00030/0136	Novartis Consumer Health UK Limited	Otrivine Metered Dose Sinusitis Spray, Adult Formula	Xylometazoline Hydrochloride 1.000 mg	For the symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis. General Sales List	12th February 1998
00032/0222	Pharmacia & Upjohn Limited	Detrusitol 1 mg	Tolterodine L-Tartrate 1.000 mg	For the treatment of unstable bladder with symptoms of urgency, frequency or urge incontinence. Prescription Only Medicine	3rd February 1998
00032/0223	Pharmacia & Upjohn Limited	Detrusitol 2 mg	Tolterodine L-Tartrate 2.000 mg	(See PL00032/0222.) Prescription Only Medicine	3rd February 1998
00037/0282	Abbott Laboratories Limited	Levophed	Noradrenaline Acid Tartrate EP 0.20 wv	For use as an emergency measure in the restoration of blood pressure in cases of acute hypotension. Prescription Only Medicine	9th February 1998
00037/0283	Abbott Laboratories Limited	Levophed Special	Nordrenaline Acid Tartrate EP 0.02 wv	See PL 00037/0282. Prescription Only Medicine	9th February 1998
00101/0356	Novartis Pharmaceuticals UK Limited	Sandoglobulin 12 G	Human Normal Immunoglobulin 12.000 gm	4.1.1 Replacement therapy. Primary immunodeficiency syndromes:— congenital agammaglobulinaemia and hypogammaglobulinaemia—common variable immunodeficiency—severe combined immunodeficiencies. Secondary hypogammaglobulinaemia in patients with chronic lymphocytic leukaemia and multiple myeloma with recurrent bacterial infections. Children with congenital AIDS who have repeated bacterial infections. 4.1.2 Immunomodulatory effect: Idiopathic thrombocytopenic purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count. Allogeneic bone marrow transplantation. Kawasaki disease. Prescription Only Medicine	12th February 1998
00142/0434	A H Cox & Company Limited	Zopiclone 7.5 mg Tablets	Zopiclone 7.500 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	24th April 1998
00142/0460	A H Cox & Company Limited	Ranitidine Tablets BP 150 mg	Ranitidine Hydrochloride 170.000 mg	(1) For the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. (2) For the prevention of NSAID associated duodenal ulcers. (3) For the treatment of post-operative ulcer, Zollinger-Ellison syndrome and oesophageal reflux disease including the long term management of healed oesophagitis. Other patients with chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but is not associated with the preceding conditions may benefit from Ranitidine treatment. (4) Ranitidine Tablets are indicated for the following conditions where reduction of gastric secretion and acid output is desirable: the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients; the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson’s syndrome), particularly obstetric patients during labour. Prescription Only Medicine	18th May 1998
00142/0461	A H Cox Company Limited	Ranitidine Tablets BP 300 mg	Ranitidine Hydrochloride 340.000 mg	See PL 00142/0460. Prescription Only Medicine	18th March 1998
00156/0087	Martindale Pharmaceuticals Ltd	Strong Sterile Dopamine Hydrochloride Solution 200 mg/5 ml	Dopamine Hydrochloride 40.000 mg	Is used for the correction of poor perfusion, low cardiac output, impending renal failure and shock associated with myocardial infarction, trauma, endotoxic septicaemia, open heart surgery, heart failure. Prescription Only Medicine	2nd May 1998
00156/0088	Martindale Pharmaceuticals Ltd	Strong Sterile Dopamine Hydrochloride Solution 800 mg/5 ml	Dopamine Hydrochloride 160.000 mg	See PL 00156/087. Prescription Only Medicine	2nd May 1998
00156/0089	Martindale Pharmaceuticals Ltd.	Fluphenazine Decanoate Injection BP 25 mg/ml	Fluphenazine Decanoate 25.000 mg	For the treatment and maintenance of schizophrenic patients and those with paranoid psychoses. While it has been shown to be effective in acute states, it is particularly useful in the maintenance treatment of chronic patients who are unreliable in taking their oral medicines and also for those who do not absorb oral phenothiazines in adequate amounts. Prescription Only Medicine	2nd May 1998
00156/0090	Martindale Pharmaceuticals Ltd.	Fluphenazine Decanoate Injection BP 100 mg/ml	Fluphenazine Decanoate 100.000 mg	See PL0156/0089. Prescription Only Medicine	2nd May 1998
00174/0201	Stiefel Laboratories (UK) Ltd.	Isotrex Cream	Isotretinoin .050 ww	For the topical treatment of mild to moderate acne vulgaris and is effective in treating both inflammatory and non-inflammatory lesions. The cream is particularly suitable for patients with sensitive or dry skin. Prescription Only Medicine	12th February 1998
00174/0202	Stiefel Laboratories (UK) Ltd.	Isotrex Cream	Isotretinoin .100 ww	See PL 00174/0201. Prescription Only Medicine	12th February 1998
00242/0338	Janssen-Cilag Limited	Leustat Injection 1 mg/ml	Cladribine 10.000 mg	For the primary or secondary treatment of patients with Hairy Cell Leukaemia (HCL). Also for the treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) who have not responded to, or whose disease has progressed during or after, treatment with at least one standard alkylating-agent-containing regimen. Prescription Only Medicine	9th February 1998
00289/0324	Approved Prescription Services Limited	Sodium Valproate Enteric Coated Tablets 200 mg	Sodium Valproate 200.000 mg	For the treatment of generalised, partial or other epilepsy. In women of child bearing age, sodium valproate should only be used in severe cases or in cases where alternative treatments have not been successful. Prescription Only Medicine	28th April 1998
00289/0325	Approved Prescription Services Limited	Sodium Valproate Enteric Coated Tablets 500 mg	Sodium Valproate 500.000 mg	See PL 00289/0324. Prescription Only Medicine	28th April 1998
00440/0100	Galen Limited	Tramadol Hydrochloride Liquid 50 mg/5 ml Tramake Liquid	Tramadol Hydrochloride 50.000 mg	Prevention and treatment of moderate to severe pain. Tramadol has been found to be of benefit in relieving both acute and chronic pain. Prescription Only Medicine	28th April 1998
00493/0174	E Merck Limited	Feminova	Estradiol 1.500 mg	Hormone replacement therapy for the symptomatic relief of menopausal symptoms including: Vasomotor symptoms such as sweating and flushing: Associated disorders of the menopause, eg, vaginal atrophy, psychological symptoms; insomnia and irritability, mood swings, urinary incontinence and urethal atrophy. Hormone replacement therapy is also indicated for the: Prevention and management of osteoporosis in women considered at risk of developing fractures. Epidemiological studies have suggested that there are a number of risk factors associated with post menopausal osteoporosis such as early menopause, a family history of osteoporosis, prolonged exposure to corticosteroid therapy, small and thin skeletal frame and excessive cigarette smoking. Prescription Only Medicine	6th February 1998
00530/0545	Norton Healthcare Limited	Fluoxetine Capsules 20 mg	Fluoxetine Hydrochloride 22.400 mg	For the symptoms of depressive (with or without associated anxiety symptoms, and where sedation is not required). Prescription Only Medicine	1st May 1998
00649/0134	Alcon Laboratories (UK) Limited	Timolol Eye Drops 0.25%	Timilol Maleate .340 wv	For the treatment of open-angle glaucoma, aphakic glaucoma, some patients with secondary glaucoma, and other patients with elevated intraocular pressure who are at sufficient risk to require lowering of their ocular pressure. Prescription Only Medicine	21st May 1998
00649/0135	Alcon Laboratories (UK) Limited	Timolol Eye Drops 0.5%	Timolol Maleate .680 wv	(See PL00649/0134) Prescription Only Medicine	21st May 1998
03105/0058	Bell, Sons & Co (Druggists) Limited	Benzyl Benzoate Application BP	Benzyl Benzoate 25.000 wv	For the treatment of scabies. Pharmacy Medicine	21st May 1998
03105/0061	Bell, Sons & Co (Druggists) Limited	Aqueous Cream	Emulsifying Wax BP 9.0% w/w White Paraffin BP 15.0% w/w Liquid Paraffin BP 6.0% w/w	Suitable for dry scaling disorders. General Sale List	30th April 1998
03105/0062	Bell, Sons & Co (Druggists) Limited	Hydrous Ointment BP	Hard Paraffin 12.000 ww Liquid Paraffin 30.000 ww White Soft Paraffin 5.000 ww Wool Alcohols 3.000 ww	Suitable for chronic, dry, scaling, irritant conditions (e.g. ichthyosis, eczematous disorders and psoriasis). General Sales List	30th April 1998
03105/0063	Bell, Sons & Co (Druggists) Limited	Codeine Linctus BP	Codeine Phosphate BP 0.3 wv	Dry or painful cough. Pharmacy Medicine	21st May 1998
03243/0354	Munro Wholesale Medical Supplies Limited	Zocor 20 mg Tablets	Simvastatin 20.000 mg	For use in patients with hypercholesterolaemia. Prescription Only Medicine	12th May 1998
03787/0458	Swingward Ltd t/a Medihealth	Pergolide 50 Micrograms	Pergolide 50.000 mcg	Parkinson’s disease. Prescription Only Medicine	27th April 1998
03787/0479	Swingward Limited t/a Medihealth	Adalat LA 30 tablets	Nifedipine 30.000 mg	Hypertension and angina pectoris. Prescription Only Medicine	29th April 1998
03787/0480	Swingward Limited t/a Medihealth	Adalat LA 60 tablets	Nifedipine 60.000 mg	Hypertension and angina pectoris. Prescription Only Medicine	29th April 1998
03787/0527	Swingward Limited t/a Medihealth	Gopten 0.5 mg capsules	Trandolapril 0.500 mg	Mild to moderate hypertension. Prescription Only Medicine	27th April 1998
04382/0043	Scotia Pharmaceuticals Limited	Efamast 80 Capsules	Gamolenic Acid 80.000 mg	For the symptomatic relief of pre-menstrual breast pain (cyclical mastalgia) and non-cyclical mastalgia. Prescription Only Medicine	19th February 1998
04416/0294	Lagap Pharmaceuticals Limited	Haloperidol Tablets BP 0.5 mg	Haloperidol .005 mg	It is a neuroleptic butyrophenone drug indicated for the following conditions: Adults: 1. Schizophrenia; treatment of symptoms and prevention of relapse. 2. Other psychoses, especially paranoid. 3. Mania and hypomania. 4. Mental or behavioural problems such as aggression, hyperactivity and sulf-mutilation in the mentally retarded and in patients with organic brain damage. 5. As an adjunct to short-term management of moderate to severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour. 6. Intractable hiccup. 7. Restlessness and agitation in the elderly. 8. Gilles De La Tourette syndrome and severe tics. Children: 1. Childhood behavioural disorders especially when associated with hyperactivity and aggression. 2. Gilles De La Tourette syndrome. 3. Childhood schizophrenia. Prescription Only Medicine	27th April 1998
04416/0295	Lagap Pharmaceuticals Limited	Haloperidol Tablets BP 1.5 mg	Haloperidol 1.005 mg	(See PL/04416/0294)	27th April 1998
04416/0296	Lagap Pharmaceuticals Limited	Haloperidol Tablets BP 5 mg	Haloperidol 5.000 mg	(See PL/04416/0294)	27th April 1998
04416/0297	Lagap Pharmaceuticals Limited	Haloperidol Tablets BP 10 mg	Haloperidol 10.000 mg	(See PL/04416/0294)	27th April 1998
04416/0298	Lagap Pharmaceuticals Limited	Haloperidol Tablets BP 20 mg	Haloperidol 20.000 mg	(See PL/04416/0294)	27th April 1998
04423/0234	Doncaster Pharmaceuticals Group Limited	Adalat Retard 20 mg tablets	Nifedipine 20.000 mg	Angina pectoris Prescription only medicine	23rd April 1998
04423/0235	Doncaster Pharmaceutical Group Limited	Becotide 50 Inhaler/Beclomethasone Dipropionate 50 micrograms Inhaler	Beclomethasone Dipropionate 50.000 mcg	Treatment of mild to moderate asthma. Prescription only Medicine	8th May 1998
04569/0281	Generics (UK) Limited	Naproxen Enteric Coated Tablets 250 mg	Naproxen 250.000 mg	For the management of various arthritides, such as rheumatoid arthritis, osteoarthrosis, spondylitis, gout, etc., and of musculo-skeletal disorders. For the management of rheumatoid arthritis in children over the age of five years. In the management of dysmenorrhoea. Prescription Only Medicine	15th May 1998
04569/0282	Generics (UK) Limited	Naproxen Enteric Coated Tablets 375 mg	Naproxen 375.000 mg	(See PL/04569/0281) Prescription Only Medicine	15th May 1998
04569/0283	Generics (UK) Limited	Naproxen Enteric Coated Tablets 500 mg	Naproxen 500.000 mg	(See PL/04569/0281) Prescription Only Medicine	15th May 1998
05662/0374	Dowelhurst Limited	Elantan LA Capsules.	Isosorbide Mononitrate 50.000 mg.	Angina Pectoris. Prescription Only Medicine	8th May 1998
05662/0474	Dowelhurst Limited	Ikorel 20 mg tabets/Nicorandil 20 mg tablets.	Nicorandil 20 mg.	Prevention and treatment of chronic stable angina pectoris. Prescription Only Medicine	30th April 1998
05662/0493	Dowelhurst Ltd	Combivent Inhaler/Combivent metered Aerosol.	Ipratropium Bromide Monohydrate 0.021 mg. Salbutamol Sulphate 0.120 mg.	For the treatment of bronchospasm. Prescription Only Medicine	8th May 1998
06453/0002	Athlone Laboratories Limited	Cholordiazepoxide Capsules 5 mg	Chlordiazepoxide 5.000 mg	For the short-term (2-4 weeks) symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic organic or psychotic illness. Symptomatic relief of acute alcohol withdrawal. Muscle spasm of varied aetiology. Prescription Only Medicine	22nd May 1998
06453/0003	Athlone Laboratories Limited	Cholordiazepoxide Capsules 10 mg	Chlordiazepoxide 10.000 mg	(See 06453/0002) Prescription Only Medicine	22nd May 1998
06464/0421	Waymade PLC	Adalat Retard 10 mg tablets	Nifedipine 10.000 mg	Hypertension. Prescription Only Medicine	12th May 1998
06464/0470	Waymade PLC	Renitec 20 mg tablets/Enalapril Maleate 20 mg tablets	Enalapril Maleate 20.000 mg	Hypertension. Prescription Only Medicine	7th May 1998
PI/06464/0482	Waymade PLC	Pantorc 40 mg Tablets/ Pantoprazole Sodium Enteric Coated Tablets 40 mg	Pantoprazole 40.000 mg	For duodenal ulcer, gastric ulcer and reflux esophagitis. Prescription Only Medicine	21st May 1998
PI/06464/0502	Waymade PLC	Enapren 20 mg Tablets/ Enalapril Maleate 20 mg Tablets	Enalapril Maleate 20.000 mg	Hypertension. Prescription Only Medicine	30th April 1998
PI/06679/0226	Polyfarma Limited	Flixotide 250 Inhaler	Fluticasone Propionate 250.000 mcg	Mild to moderate asthma. Prescription Only Medicine	27th April 1998
PI/06792/0346	Europharm of Worthing Limited	Amlodipine 10 mg Tablets	Amlodipine 10.000 mg	Hypertension of chronic stable angina. Prescription Only Medicine	28th April 1998
PI/06792/0362	Europharm of Worthing Limited	Fucibet Cream	Fusidic acid 2.000% ww, Betamethasone Valerate 0.100% ww	Eczematous Dermatoses. Prescription Only Medicine	15th May 1998
PI/06792/0366	Europharm of Worthing Limited	Lisinopril 10 mg Tablets	Lisinopril 10.000 mg	Essential hypertension and renovascular hypertension. Prescription Only Medicine	30th April 1998
06832/0132	Ashbourne Pharmaceutical (Holdings) Limited	Isotard 25XL, Isib 25XL	Isosorbide 5-Mononitrate 25.000 mg	Prophylactic treatment of angina pectoris. Pharmacy Medicine	25th February 1998
06832/0133	Ashbourne Pharmaceutical (Holdings) Limited	Isotard 30XL, Isib 30XL	Isosorbide 5-Mononitrate 30.000 mg	(See PL/06832/0132.) Pharmacy Medicine	25th February 1998
06832/0134	Ashbourne Pharmaceutical (Holdings) Limited	Isotard 40XL, Isib 40XL	Isosorbide 5-Mononitrate 40.000 mg	(See PL/06832/0132.) Pharmacy Medicine	25th February 1998
06832/0135	Ashbourne Pharmaceutical (Holdings) Limited	Isotard 50XL, Isib 50XL	Isosorbide 5-Mononitrate 50.000 mg	(See PL/06832/0132.) Pharmacy Medicine	25th February 1998
06934/0015	Laboratoires Ethypharm	Diacardyne-XL Capsules 240 mg	Diltiazem Hydrochloride 240.000 mg	For the management of angina pectoris. For the management of mild to moderate hypertension. Prescription Only Medicine	25th February 1998
08747/0211	Chemilines Limited	Zocor 10 mg Tablets/ Simvastatin 10 mg Tablets	Simvastatin 10.000 mg	Hypercholesterolaemia. Prescription Only Medicine	18th May 1998
08747/0212	Chemilines Limited	Imdur 60 mg Tablets	Isosorbide Mononitrate 60.000 mg	Prophylactic treatment of angina pectoris. Prescription Only Medicine	27th April 1998
08821/0006	Monsanto Plc	Arthrotec 50 Tablets	Diclofenac HSE 50.0 mg, Misoprostol HSE 200.0 ug	For Patients who require a non-steroidal anti-inflammatory drug (diclofenac) together with misoprostol. The diclofenac component is indicated for the symptomatic treatment of osteo-arthritis and rheumatoid arthritis. The misoprostol component is indicated for patients with a special need for the prophylaxis of NSAid-induced gastric and duodenal ulceration. Prescription Only Medicine	27th February 1998
08821/0012	Monsanto Plc	Aldactide 50 Tablets	Spironolactone BP 50.0 mg Hydroflumethiazide BP 50.0 mg	For the control of oedema in congestive cardiac failure. Prescription Only Medicine	27th February 1998
08821/0018	Monsanto Plc	Diatensec Tablets	Spironolactone BP 50.0 mg	Congestive Cardiac failure, Hepatic cirrohosis with ascites and oedema, malignant ascites, nephrotic syndrome, and diagnosis and treatment of primary aldosteronism. Prescription Only Medicine	27th February 1998
10256/0320	Stephar (UK) Limited	Pergolide 250 microgram Tablets	Pergolide mesylate 250 mcg	Parkinson’s Disease. Prescription Only Medicine	21st April 1998
10256/0321	Stephar (UK) Limited	Pergolide 50 microgram Tablets	Pergolide 50.000 mcg	Parkinson’s Disease. Prescription Only Medicine	23rd April 1998
10256/0322	Stephar (UK) Limited	Pergolide 1 mg Tablets	Pergolide mesylate 1.000 mg	Parkinson’s Disease. Prescription Only Medicine	21st April 1998
10256/0336	Stephar (UK) Limited	Zestoretic 20	Lisinopril 20.000 mg Hydrochlorothiazide 12.500 mg	Hypertension. Prescription Only Medicine	7th May 1998
PI/10256/0338	Stephar (UK) Limited	Fosamax	Alendronic Acid 10.000 mg	Treatment of Oestroporosis in post-menopausal women. Prescription Only Medicine	13th May 1998
PI/10256/0346	Stephar (UK) Limited	Priadel 400 mg tablets	Lithium Carbonate 400.00 mg	Depressive disorders. Prescription Only Medicine	8th May 1998
PI/10256/0351	Stephar (UK) Limited	Lescol 20 mg	Fluvastatin Sodium 21.060 mg	Primary hypercholesterolaemia Prescription Only Medicine	18th May 1998
PI/10380/0212	Swinghope Limited	Paludrine Tablets/Proguanil Hydrochloride 100 mg Tablets	Proguanil Hydrochloride 100.000 mg	Anti malarial agent. Pharmacy Medicine	20th May 1998
PI/10383/0402	Primecrown Limited	Tegretol CR 200 mg tablets	Carbamazepine 200.000 mg	Epilepsy Prescription Only Medicine	8th May 1998
PI/10383/0511	Primecrown Ltd.	Flixotide 50 Microgram Inhaler/Fluticasone Propionate 50 Microgram Inhaler	Fluticasone Propionate 50.000 mcg	Asthma. Prescription Only Medicine	15th May 1998
PI/10383/0520	Primecrown Limited	Metrodin HP 75/Metrodin High Purity 75	Urofollitrophin 75.000 iu	Stimulation of follicular development and ovulation in women with hypothalmic-pituitary dysfunction. Prescription Only Medicine	18th May 1998
PI/10383/0521	Primecrown Limited	Sodium Chloride Injection 0.9% w/v	Sodium Chloride 0.900 w/v	Reconstruction of any parenteral product requiring 0.9% sodium chloride solution as diluent. Prescription Only Medicine	18th May 1998
PI/10383/0524	Primecrown Ltd.	Pharken 50 Microgram Tablets/Celance 50 Microgram Tablets/Pergolide Tablets 50 Microgram	Pergolide 50.000 mcg	Parkinson’s disease. Prescription Only Medicine	8th May 1998
PI/10383/0535	Primecrown Limited	Ikorel 10 mg tablets/Nicorandil 10 mg tablets	Nicorandil 10.000 mg	For the prevention and long-term treatment of chronic stable angina pectoris Prescription Only Medicine	21st April 1998
PI/10383/0560	Primecrown Limited	Renitec 20 mg Tablets/Enalapril Maleate 20 mg Tablets/Enapren 20 Tablets	Enalapril Maleate 20.000 mg	Hypertension. Prescription Only Medicine	30th April 1998
10590/0035	Galderma (UK) Ltd	Metrogel	Metronidazole 0.750 ww	For the treatment of acute inflammatory exacerbation of rosacea. For the deoderisation of the smell associated with malodorous fungating tumours. Prescription Only Medicine	27th February 1998
10592/0036	Smithkline Beecham PLC	Seroxat Tablets 20 mg	Paroxetine Hydrochloride 22.800 mg	Treatment of symptoms of depressive illness of all types including depression accompanied by anxiety. Following an initial satisfactory response, continuation with “Seroxat” therapy is effective in preventing relapse. Treatment of symptoms and prevention of relapse of obsessive compulsive disorder (OCD). Treatment of symptoms and prevention of relapse of panic disorder with or without agoraphobia. Prescription Only Medicine	6th February 1998
10592/0118	Smithkline Beecham PLC	Fluarix	A/Singapore/6/86 (H1N1)—Like 15.000 mcg A/Wuhan/359/95 (H3N2)—Like 15.000 mcg B/Beijing/184/93—Like 15.000 mcg	Prophylaxis of influenza, especially in those who run an increased risk of associated complications. The specific categories of subjects to be immunised are to be determined on basis of national immunisation policies. Prescription Only Medicine	27th February 1998
10949/0311	Glaxo Wellcome UK Limited	Wellcome Glycine Buffer Diluent	None	Wellcome Glycine Buffer Diluent is used to reconstitute Flolan. Prescription Only Medicine	18th May 1998
11382/0030	Eastern Pharmaceuticals Limited	Nupercainal Ointment	Cinchocaine hydrochloride BP 1.10 w/w	Anaesthetic analgesic for symptomatic relief of various conditions for example, pain of the skin and mucocutaneous junctions. Relief of pain caused by haemorrhoids. Anal and nipple fissures. Pharmacy Medicine	27th February 1998
12406/0013	Link Pharmaceuticals Limited	Piriton Injection	Chlorpheniramine Maleate BP 1.00 wv	For the acute urticaria control of allergic reaction to insects bites and stings, angioneurotic oedema, drug and serum reactions, desensitisation reactions, hayfever, vasomotor rhinitis, severe pruritus of non-specific origin. Prescription Only Medicine	23rd February 1998
12064/0032	Aurum Pharmaceuticals Limited	Ephedrine Hydrochloride Injection 3 mg per ml	Ephedrine Hydrochloride .300 wv	Reversal of hypotension from spinal or epidural anaesthesia. Prescription Only Medicine	15th May 1998
12064/0043	Aurum Pharmaceuticals Limited	Ephedrine Hydrochloride Injection 3 mg per ml	Ephedrine Hydrochloride .300 wv	(See PL12064/0032) Prescription Only Medicine	15th May 1998
12762/0021	Goldshield Pharmaceutical Limited	Rheumox Capsules	Azapropazone Dihydrate HSE 300 mg	(See PL12762/0022) Prescription Only Medicine	1st February 1998
12762/0022	Goldshield Pharmaceutical Limited	Rheumox 600	Azapropazone Dihydrate HSE 600.0 mg	A non-steroidal anti-flammatory analgestic agent indicated in the treatment of rheumatoid arthritis, ankylosing spondylitis and attacks of acute gouty arthritis in patients for whom other therapy has been ineffective. Prescription Only Medicine	1st February 1998
13402/0058	Hoechst Marion Rousell Limited	Euglucon Tablets 2.5 mg	Glibenclamide BP 2.5 mg	For the treatment of maturity-onset diabetes which is not adequately controlled by dietary measures alone. Prescription Only Medicine	13th February 1998
13402/0059	Hoechst Marion Roussel Limited	Euglucon Tablets 5 mg	Glibenclamide BP 5.00 mg	(See PL13402/0058) Prescription Only Medicine	13th February 1998
13402/0061	Hoechst Marion Roussel Limited	Cefrom 250 mg IV Injection	Cefpirome Sulphate 298.000 mg	(See PL13402/0064) Prescription Only Medicine	13th February 1998
13402/0062	Hoechst Marion Roussel Limited	Cefrom 500 mg IV Injection	Cefpirome Sulphate 596.000 mg	(See PL13402/0064) Prescription Only Medicine	13th February 1998
13402/0063	Hoechst Marion Roussel Limited	Cefrom 1 g IV Injection	Cefpirome Sulphate 1.191 gm	(See PL13402/0064) Prescription Only Medicine	13th February 1998
13402/0064	Hoechst Marion Roussel Limited	Cefrom 2 g IV Injection	Cefpirome Sulphate 2.382 gm	For the treatment of infections, either before the infecting organism has been identified or when caused by bacteria of established sensitivity, as follows: Lower respiratory tract infections (bronchopneumonia and lobar pneumonia). Complicated upper (pyelonephritis) and lower urinary tract infections. Skin and soft tissue infections (cellulitis, skin abscess and wound infections). Infections in neutropenic patients. Bacteraemia/septicaemia. Severe infections, as listed above. Prescription Only Medicine	13th February 1998
13402/0065	Hoechst Marion Roussel Limited	Cefrom 1 g IV Infusion	Cefpirome Sulphate 1.191 gm	(See PL13402/0064) Prescription Only Medicine	13th February 1998
13402/0066	Hoechst Marion Roussel Limited	Cefrom 2 g IV Infusion	Cefpirome Sulphate 2.382 gm	(See PL13402/0064) Prescription Only Medicine	13th February 1998
13402/0067	Hoechst Marion Roussel Limited	Orelox Tablets 100 mg	Cefpodoxime Proxetil HSE 130.45 mg (Equivalent to 100 mg Cefpodoxime)	Orelox is a bactericidal cephalosporin antibiotic active against a wide range of gram-negative and gram-positive organisms. It is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity. Upper respiratory tract infections caused by organisms sensitive to cefpodoxime, including sinusitis. In tonsillitis and pharyngitis, orelox should be reserved for recurrent or chronic infections, or for infections where the causative organism is known or suspected to be resistant to commonly used antibiotics. Lower respiratory tract infections caused by organisms sensitive to cefpodoxime, including acute bronchitis, relapses or exacerbations of chronic bronchitis and bacterial pneumonia. Upper and lower urinary tract infections caused by organisms sensitive to cefpodoxime including cystitis and acute pyelonephritis. Skin and soft tissue infections caused by organisms sensitive to cefpodoxime such as abscesses, cellulitis, infected wounds, furuncles, folliculitis, paronychia, carbuncles and ulcers. Gonorrhoea—uncomplicated gonococcal urethritis. Prescription Only Medicine	13th February 1998
13402/0068	Hoechst Marion Roussel Limited	Orelox Paediatric Suspension	Cefpodoxime Proxetil HSA 52.18 mg (Equivalent to 40 mg Cefpodoxime)	Orelox is a bactericidal cephalosporin antibiotic active against a wide range of gram-negative and gram-positive organisms. It is indicated for the treatment of the following infections either before the infecting organism has been identified or when caused by bacteria of established sensitivity. Indications include: Upper respiratory tract infections caused by organisms sensitive to cefpodoxime, including acute otitis media, sinusitis, tonsillitis and pharyngitis. Orelox should be reserved for recurrent or chronic infections, or for infections where the causative organism is known or suspected to be resistant to commonly used antibiotics. Lower respiratory tract infections caused by organisms sensitive to cefpodoxime, including pneumonia, acute bronchitis and when bacterial super-infection complicates bronchiolitis. Upper and lower urinary tract infections caused by organisms sensitive to cefpodoxime including cystitis and acute pyelonephritis. Skin and soft tissue infections caused by organisms sensitive to cefpodoxime such as abscesses, cellulitis, infected wounds, furuncles, folliculitis, paronychia, carbuncles and ulcers. Prescription Only Medicine	13th February 1998
13402/0069	Hoechst Marion Roussel Limited	Anandron Tablets 50 mg	Nilutamide 50.000 mg	Treatment of metastatic prostate cancer, in combination with surgical or medical castration, in patients not previously treated. Prescription Only Medicine	13th February 1998
13402/0070	Hoechst Marion Roussel Limited	Anandron Tablets 150 mg	Nilutamide 150.000 mg	(See PL13402/0069) Prescription Only Medicine	13th February 1998
PI/13826/0083	Caseview (PL) Limited	Imigran 50 mg Tablets/Sumatriptan 50 mg Tablets	Sumatriptan 50.000 mg	Acute relief of migraine attack with or without aura. Prescription Only Medicine	13th May 1998
PI/13826/0085	Caseview (PL) Limited	Lamictal 100 mg Tablets/Lamotrigine 100 mg Tablets	Lamotrigine 100.000 mg	Epilepsy. Prescription Only Medicine	18th May 1998
PI/13826/0095	Caseview (PL) Limited	Adalat LA 60 mg Tablets	Nifedipine 60.000 mg	Hypertension. Prescription Only Medicine	14th May 1998
PI/13826/0098	Caseview (PL) Limited	Brufen Retard 800 mg Tablets	Ibuprofen 800.000 mg	Anti-inflammatory agent. Prescription Only Medicine	23rd April 1998
PI/13826/0099	Caseview (PL) Limited	Glucobay 50 mg Tablets	Acarbose 50.000 mg	Treatment of non-insulin dependent diabetes mellitus. Prescription Only Medicine	28th April 1998
PI/13826/0100	Caseview (PL) Limited	Lescol 20 mg Capsules	Fluvastatin 21.100 mg	For use in the treatment of primary hypercholesterolaemia, and patients with coronary heart disease who do not adequately respond to dietary control. Prescription Only Medicine	8th May 1998
13826/0101	Caseview (PL) Limited	Sabril 500 mg tablets/Vigabatrin 500 mg tablets	Vigabatrin 500.00 mg	The treatment of epilepsy. Prescription Only Medicine	21st April 1998
13826/0105	Caseview (PL) Limited	Pergolide 1 mg tablets/Pharken 1 mg tablets/Celance 1 mg tablets	Pergolide 1.000 mg	Parkinson’s Disease. Prescription Only Medicine	21st May 1998
13826/0106	Caseview (PL) Limited	Pergolide 250 microgram tablets/Pharken 250 microgram tablets/Celance 250 microgram tablets	Pergolide 250.000 mcg	Parkinson’s Disease. Prescription Only Medicine	18th May 1998
13826/0107	Caseview (PL) Limited	Pergolide 50 microgram tablets/Pharken 50 microgram tablets/Celance 50 microgram tablets	Pergolide 50.000 mcg	Parkinson’s Disease. Prescription Only Medicine	15th May 1998
13826/0110	Caseview (PL) Ltd	Ventide Inhaler/Ventaide Inhaler	Salbutamol 100.00 mcg Beclomethasone Dipropionate 50.000 mcg	Reversible airways obstruction. Prescription Only Medicine	8th May 1998
13826/0112	Caseview (PL) Limited	Hytrin 2 mg tabets	Terazosin 2.000 mg	Hypertension. Prescription Only Medicine	15th May 1998
13826/0113	Caseview (PL) Ltd	Inderal LA 160 mg Capsules	Propranolol Hydrochloride 160.000 mg	Cardiac dysrythmias and thyrotoxic crisis. Prescription Only Medicine	18th May 1998
13826/0115	Caseview (PL) Ltd	Prepulsid 10 mg tablets/Cisapride 10 mg tablets	Cisapride 10.000 mg	Treatment of symptoms associated with gastro-oesophageal reflux. Prescription Only Medicine	8th May 1998
14038/0006	Smith & Nephew Healthcare Limited	Sprilon Spray	Zinc Oxide EP 12.5% w/w Dimethicone 350 EP 1.04% w/w	To be sprayed as a topical application for the prophylaxis and treatment of pressure sores, skin maceration due to faeces or urine, or around fistulae and ileostomies. For the protection and treatment of fissures, leg ulcers, moist eczemas.For the protection of skin beneath plaster casts. General Sales List	1st June 1998
14038/0008	Smith & Nephew Healthcare Limited	Iodosorb Ointment	Cadexomer Iodine HSE 50.0% w/w	Treatment of chronic leg ulcers. When applied to the wound, it absorbs pus and exudate and cleans the wound surface and reduces bacterial count. In chronic ulcers it stimulates granulation reduces pain and accelerates healing. The ointment formulation improves the ease of application on awkward wound sites. Pharmacy Medicine	1st June 1998
14040/0010	Desitin Arzneimittel GMBH	Asympan 200 SR	Carbamazepine 200.000 mg	Epilepsy: simple partial seizures—complex partial seizures—generalised tonic-clonic seizures, in particular of focal aetiology (sleep grand mal, diffuse grand mal)—mixed forms of epilepsy Trigeminal neuralgia Prophylaxis of manic-depressive disorder. As carbamazepine is ineffective in, and may cause or exacerate absence seizures, it is contra-indicated in this condition. Prescription Only Medicine	25th February 1998
14040/0011	Desitin Arzneimittel GMBH	Asympan 400 SR	Carbamazepine 400.000 mg	(See PL14040/0011) Prescription Only Medicine	25th February 1998
14068/0002	Oxford Pharmaceuticals Limited	Liqui-Char	Activated Charcoal 50.000 gm	Poisoning, including drug overdose. Pharmacy Medicine	19th February 1998
14069/0024	Denfleet International Limited	Risperdal 4 mg Tablets/Risperidone 4 mg Tablets	Risperidone 4.000 mg	For treatment of acute and chronic schizophrenic psychoses. Prescription Only Medicine	30th April 1998
14069/0032	Denfleet International Limited	Risperdal 1 mg Tablets/Risperidone 1 mg Tablets	Risperidone 1.000 mg	(See PL14069/0024) Prescription Only Medicine	29th April 1998
14069/0033	Denfleet International Limited	Risperdal 2 mg Tablets/Risperidone 2 mg Tablets	Risperidone 2.000 mg	(See PL14069/0024) Prescription Only Medicine	29th April 1998
14069/0034	Denfleet International Limited	Risperdal 3 mg Tablets/Risperidone 3 mg Tablets	Risperidone 3.000 mg	(See PL14069/0024) Prescription Only Medicine	29th April 1998
14207/0004	Du Pont Pharma S.A.	Nephroscint	Dimercaptosuccinic Acid 1.000 mg	After reconstitution with sodium pertechnetate (Tc-99 m) solution the agent may be used for: static (planar or tomographic) renal imaging—morphological studies of renal cortex—individual kidney function—location of ectopic kidney. Prescription Only Medicine	6th February 1998
14447/0003	Bracco International B.V.	LumenHance	Manganese Chloride Tetrahydrate 43.200 mg	LumenHance is indicated for contrast enhancement in magnetic resonance imaging (MRI) of the abdomen and pelvis to rule out or facilitate the detection and the assessment of the extent of lesions of the gastrointestinal tract or adjacent organs and structures. Prescription Only Medicine	12th February 1998
PI/15361/0016	P.I.E. Pharma Ltd.	Ikorel 10 mg Tablets/ Nicorandil 10 mg Tablets	Nicorandil 10.000 mg	Chronic stable angina pectoris. Prescription Only Medicine	28th April 1998
PI/15361/0021	P.I.E. Pharma Ltd.	Mobic 7.5 mg Tablets/ Meloxicam 7.5 mg Tablets	Meloxicam 7.500 mg	Acute exacerbations of osteoarthrosis and long term treatment of rheumatoid arthritis. Prescription Only Medicine	28th April 1998
PI/15361/0022	P.I.E. Pharma Ltd.	Zoladex LA 10.8 mg	Goserelin 10.800 mg	Prostate cancer suitable for hormonal manipulation. Prescription Only Medicine	6th May 1998
15513/0062	Warner-Lambert Consumer Healthcare	Caladryl Cream	Diphenhydramine Hydrochloride EP 1.0 ww Zinc Oxide EP 8.0 ww Racemic Camphor EP 0.1 ww	For the relief of irritation associated with urticaria, herpes zoster and other minor skin affections and to alleviate the discomforts of sunburn, prickly heat, insect bites and nettle stings. In infants it may be used for hives. Pharmacy Medicine	13th February 1998
15638/0007	Concord Pharmaceuticals Limited	Pro-banthine Tablets 15 mg	Propantheline Bromide 15.000 mg	Adjunctive in GI disorders characterised by smooth muscle spasm. Hyperhydrosis. Adult enuresis. Prescription Only Medicine	28th February 1998
15722/0018	Boehringer Mannheim UK Limited	Recormon	Epoetin Beta (rch) 8.300 mcg Epoetin Beta (rch) 16.600 mcg	For use in the treatment of anaemia associated with chronic renal failure (renal anaemia) in patients on dialysis. Also for use in the treatment of symptomatic renal anaemia in patients not yet undergoing dialysis. Also for use in the prevention of anaemias of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks. For the treatment of anaemia in adult patients with ovarian carcinoma and treated with platinum-based chemotherapy prone to induce anaemia (cisplatin: 75 mg/m2/cycle or more; carboplatin: 350 mg/m2/cycle or more). It can be used to increase the yield of autologous blood from patients in a predonation programme initiated to avoid the use of homologous blood. Treatment is only indicated in patients with moderate, non-iron deficient anaemia (haemoglobin approximately 11 g to 13 g per 100 ml) when blood conserving procedures are insufficient or unavailable (i.e. a large volume of blood is required or when there is only a short time period for collection of blood). Prescription Only Medicine	13th February 1998
PI/15814/0054	O.P.D. Laboratories Limited	Deroxat 20 mg Tablets/ Seroxat 20 mg Tablets/ Paroxetine Tablets 20 mg	Paroxetine 20.000 mg	Treatment of symptoms of depressive illness. Prescription Only Medicine	18th May 1998
15819/0004	Lorex Synthelabo UK & Ireland Limited	Migramax	DL-Lysine Acetylsalicylate 1620.000 mg Metoclopramide Hydrochloride 10.540 mg	For the treatment of migraine-associated symptoms such as headache, nausea and vomiting. Prescription Only Medicine	5th February 1998
15819/0033	Lorex Synthelabo UK & Ireland Limited	Dolmatil 200 mg Tablets	Sulpiride 200.00 mg	Acute and chronic schizophrenia. Prescription Only Medicine	30th June 1998
15819/0034	Lorex Synthelabo UK & Ireland Limited	Dolmatil 400 mg Tablets	Sulpiride 400.000 mg	(See PL 15819/0033). Prescription Only Medicine	30th June 1998
15819/0036	Lorex Synthelabo UK & Ireland Limited	Dolmatil Injection 100 mg	Sulpiride 100.000 mg	(See PL 15819/0033). Prescription Only Medicine	30th June 1998
15929/0008	Linde Gas UK Limited	Equanox	Nitrous Oxide 50.000 ww, Oxygen 50.000 ww	As an analgesic where rapid-onset powerful short-term relief of pain is required. Pharmacy Medicine	4th February 1998
16028/0027	Galpharm Healthcare Ltd	Ibuprofen Caplets, Ibuprofen Tablets BP 200 mg, Galprofen Ibuprofen Easy to Swallow Tablets	Ibuprofen 200.000 mg	Pharmacy Packs: For relief of pain of non-serious arthritic conditions, rheumatic and muscular pain, backache, neuralgia, headache, migraine, dental pain and period pain and for relief of the symptoms of colds and influenza. GSL Packs: For the relief of mild to moderate pain in rheumatic and muscular pain, backache, neuralgia, headache, migraine, dental pain, dysmenorrhoea and for relief of the symptoms of colds and influenza. General Sales List Pharmacy Medicine	20th May 1998
16028/0028	Galpharm Healthcare Ltd	Ibuprofen Cold and Flu, Galprofen Ibuprofen Cold and Flu	Ibuprofen 200.000 mg	The tablets may be used as an analgesic and anti-inflammatory for the relief of mild to moderate pain in headache, toothache, migraine, neuralgia, period pain, backache and rheumatic and muscular pain. For the relief of the symptoms of cold and flu. General Sales List Pharmacy Medicine	20th May 1998
16075/0001	Special Concept Development BV	Metronidazole Suspension 125 mg/5 ml	Benzoyl Metronidazole 201.000 mg	Metronidazole suspension is used in the prophylaxis and treatment of intestinal and hepatic amoebiasis, giardiasis and anaerobic infections. Prescription Only Medicine	27th April 1998
16457/0004	Futuna Limited	Betamethasone Valerate Ointment BP 0.1%	Betamethasone Valerate=Betamethasone BP 0.1 ww	Severe inflammatory skin disorders such as eczema in patients unresponsive to less potent corticosteroids. Prescription Only Medicine	18th May 1998
16457/0005	Futuna Limited	Betamethasone Valerate Cream BP 0.1%	(See PL 16457/0004)	(See PL 16457/0004). Prescription Only Medicine	18th May 1998

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