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
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 Medicine Only	18th February 1998
00019/0156	Warner Lambert (UK) Limited	Diclomax SR	Diclofenac Sodium 75.000 mg	(See PL 00019/0155.) Prescription Medicine Only	18th February 1998
00019/0167	Warner Lambert (UK) Limited	Halls Mentholyptus Original	Eucalyptus Oil .080 ww L-Menthol .185 ww	For the symptomatic relief of discomforts caused by head colds, nasal congestion, sore throats and chestiness. General Sales List	7th November 1997
00019/0168	Warner Lambert (UK) Limited	Halls Mentholyptus Extra Strong	Eucalyptus Oil .260 ww L-Menthol .520 ww	For the symptomatic relief of discomforts caused by head colds, nasal congestion, sore throats and chestiness. General Sales List	7th November 1997
00019/0175	Warner Lambert (UK) Limited	Ponstan Paediatric Suspension	Mefenamic acid BP 50.00 mg	Mefenamic acid is a non-steroidal anti-inflammatory agent with analgesic properties, and a demonstrable antipyretic effect. It has been shown to inhibit prostaglandin acitivity. 1. As an anti-inflammatory analgesic for the symptomatic relief of rheumatoid arthritis (including Still’s Disease), osteoarthritis, and pain including muscular, traumatic and dental pain, headaches of most aetiology, post-operative and post-partum pain; pyrexia in children. 2. Primary dysmenorrhoea. 3. Menorrhagia due to dysfunctional causes and presence of an IUD when other pelvic pathology has been ruled out. Prescription Only Medicine	28th November 1997
00030/0120	Novartis Consumer Health UK Limited	Lypsyl Cold Sore Gel	Lignocaine Hydrochloride BP 2.00 w/w Zinc Sulphate BP 1.00 w/w Cetrimide BP 0.50 w/w	For the symptomatic relief of cold sores. Pharmacy Medicine	1st November 1997
00030/0122	Novartis Consumer Health UK Limited	Savlon Antiseptic Savlon Antiseptic Healing Cream Savlon Antiseptic Cream Savlon Antiseptic First Aid Cream	Chlorhexidine Gluconate Solution .500 vw Strong Cetrimide Solution 40% 1.250 vw	The cleansing and prevention of infection in all types of lesions, ranging from minor skin disorders or blisters, to minor burns and small wounds. General Sales List	1st November 1997
00030/0123	Novartis Consumer Health UK Limited	Baby Savlon Healing Cream Baby Savlon Cream	Demethicone 1000 10.000 ww Strong Cetrimide Solution .750 vw	Useful whenever the skin needs to be protected from water-soluble irritants. Specific indications are: (i)  Chronic dermatitis—especially useful to doctors, nurses and veterinary surgeons whose skins are sensitive to antibiotics, local anaesthetics, and other sensitising agents. (ii)  Colostomies, ileostomies, haemorrhoidectomies and other forms of surgery where skin requires protection from body fluids and discharges. (iii) Pruritus ani due to persistent diarrhoea; napkin rash and the effects of incontinence in geriatric patients. (iv) Eczematous and neurodermatitic lesions, and for protecting the intact skin surrounding varicose ulcers. General Sales List	1st November 1997
00030/0125	Novartis Consumer Health UK Limited	Savlon Babycare Baby Cream	Strong Cetrimide Solution 40% 1.250 vw	For the treatment and prevention of nappy rash. General Sales List	1st November 1997
00031/0505	Roche Products Ltd.	Biovital Liquid	Thiamine Hydrochloride EP 0.15 mg Riboflavin Sodium Phosphate BP 0.89 mg Equivalent to Riboflavin 0.65 mg Pyridoxine Hydrochloride EP 0.25 mg Nicotinamide EP 2.5 mg Cyanocobalamin EP 0.5 Mg Ascorbic Acid EP 5.0 mg Ferric Sodium Citrate 16.65 mg Equivalent to Iron 3.0 mg Manganese Citrate Soluble 0.1 mg Equivalent to Manganese 0.015 mg	As a supplement for the prevention of Vitamin and Iron Deficiency. Pharmacy Medicine	30th November 1997
00031/0506	Roche Products Ltd.	Biovital Tablets	Thiamine Mononitrate EP 0.6 mg, Riboflavin EP 0.6 mg, Pyridoxine Hydrochloride EP 1.0 mg, Nicotinamide EP 10.0 mg, Cyanocobalamin EP 0.002 mg, Ascorbic Acid (Coated) HSE 20.0 mg, Ferric Sodium Citrate HSE 50.0 mg, Equivalent to Iron III 16.5 mg, Ferrous Sulphate Dried BP 50.0 mg, Equivalent to Iron II 16.0 mg, Manganese Citrate Soluble HSE 1.0 mg, Equivalent to Manganese 0.15 mg	(See PL00031/0505) Pharmacy Medicine	30th November 1997
00032/0225	Pharmacia & Upjohn Limited	Depo-Provera Oncology	Medroxyprogresterone Acetate 150.0 mg/ml	Progestogen. As adjunctive therapy in certain classes of malignant tumours exhibiting a degree of hormone sensitivity. Prescription Only Medicine	25th November 1997
00043/0204	Leo Laboratories Ltd.	Innohep Syringe 10,000 IU/ml	Tinzaparin Sodium 10,000.0 A-XAU	For the prevention of thromboembolic events, including deep vein thrombosis in patients undergoing general and orthopaedic surgery. Prescription Only Medicine	20th November 1997
00079/0341	Beecham Group PLC	Day Nurse Liquicaps	Dextromethorphan Hydrobromide 7.5 mg, Paracetamol 325.0 mg, Phenylpropanolamine Hydrochloride 12.5 mg	For the relief of symptoms associated with colds and influenza, including shivers, aches and pains, sore throat pain, headache, blocked nose and dry non-productive cough. Pharmacy Medicine	6th November 1997
0101/0353	Novartis Pharmaceuticals UK Ltd., t/a Sandoz Pharmaceuticals	Sandoglobulin 1g	Human normal immunoglobulin for intravenous infusion (Max. 1gA content 40 mg)	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. 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 Medicines	10th February 1998
0101/0354	Novartis Pharmaceuticals UK Ltd., t/a Sandoz Pharmaceuticals	Sandoglobulin 3g	Human normal immunoglobulin for intravenous infusion (Max. 1gA content 120 mg)	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. 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 Medicines	10th February 1998
0101/0355	Novartis Pharmaceuticals UK Ltd., t/a Sandoz Pharmaceuticals	Sandoglobulin 6g	Human normal immunoglobulin for intravenous infusion (Max. 1gA content 240 mg)	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. 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 Medicines	10th February 1998
00101/0481	Novartis Pharmaceuticals UK Limited	Voltarol Rapid Tablets 25 mg	Diclofenac Potassium 25.000 mg	Rheumatoid arthritis, Osteoarthrosis, low back pain, acute musculo-skeletal disorders and trauma such as periarthritis (especially frozen shoulder), tendinitis, tenosynovitis, bursitis, sprains, strains and dislocations; relief of pain in fractures, Ankylosing spondylitis, acute gout control of pain and inflammation in orthopaedic, dental and other minor surgery. Pyrophosphate arthropathy and associated disorders. Prescription Only Medicine	17th February 1998
00101/0482	Novartis Pharmaceuticals UK Limited	Voltarol Rapid Tablets 50 mg	Diclofenac Potassium 50.000 mg	(See PL0010/0481) Prescription Only Medicine	17th February 1998
00101/0528	Novartis Pharmaceuticals UK Limited	Lentaron I.M. Depot 250 mg	CGP 32349 (Formestane) Microcrystalline HSE 250.0 mg	Treatment of advanced breast cancer in women with natural or artificially induced post-menopausal status. Prescription Only Medicine	17th November 1997
00101/0531	Novartis Pharmaceuticals UK Limited	Orimeten Tablets 250 mg	Aminoglutethimide 250.000 mg	Advanced carcinoma of the breast in post-menopausal or oophorectomised women (especially where the tumours are oestrogen-sensitive), including in particular patients who have previously responded to endocrine therapy or have painful bony metastases. Advanced carcinoma of the prostate as palliative treatment. Subjective improvement and pain relief have been noted in up to 50 per cent of patients. Cushing’s syndrome due to malignant disease, e.g. adrenocortical carcinoma or ectopic ACTH syndrome, in place of or in conjunction with surgery. Prescription Only Medicine	17th November 1997
00101/0533	Novartis Pharmaceuticals UK Limited	Prescal Concentrate For Infusion 1 mg/10 ml	Isradipine HSE 1.0 mg	Treatment of hypertension following coronary surgery. Prescription Only Medicine	17th November 1997
00101/0534	Novartis Pharmaceuticals UK Limited	Prescal LS 1.25 mg	Isradipine HSE 1.25 mg	Treatment of essential hypertension. Prescription Only Medicine	17th November 1997
00101/0535	Novartis Pharmaceuticals UK Limited	Prescal Retard Capsules 2.5 mg	Isradipine 2.500 mg	For the treatment of essential hypertension. Prescription Only Medicine	17th November 1997
00101/0536	Novartis Pharmaceuticals UK Limited	Prescal Retard Capsules 5 mg	Isradipine 5.000 mg	For the treatment of essential hypertension. Prescription Only Medicine	17th November 1997
00101/0537	Novartis Pharmaceuticals UK Limited	Prescal Tablets 2.5 mg	Isradipine HSE 2.5 mg	(See PL/00101/0534) Prescription Only Medicine	17th November 1997
00101/0538	Novartis Pharmaceuticals UK Limited	Prescal Tablets 5 mg	Isradipine HSE 5.0 mg	(See PL/00101/0534) Prescription Only Medicine	17th November 1997
00101/0541	Novartis Pharmaceuticals UK Limited	Scopoderm TTS	Drug Reservoir: Scopolamine (Hyoscine) USP 1.31 mg. Adhesive (to skin): Scopolamine (Hyoscine) USP 0.23 mg.	For the prevention of symptoms of motion sickness such as nausea, vomiting and vertigo. Prescription Only Medicine.	17th November 1997
00101/0542	Novartis Pharmaceuticals UK Limited	Slow-K Tablets 600 mg	Potassium Chloride BP 600 mg	For the correction and/or prevention of Hypokalaemia in those patients who cannot tolerate and/or refuse to take liquid or effervescent Potassium Chloride, or when there is a problem of compliance with these preparations. Pharmacy Medicine.	17th November 1997
00101/0543	Novartis Pharmaceuticals UK Limited	Synacthen Ampoules 250 mcg	Tetracosactrin (as acetate) BP 0.25 mg	As a diagnostic test for the investigation of adrenocortical insufficiency. Prescription Only Medicine.	17th November 1997
00101/0544	Novartis Pharmaceuticals UK Limited	Synacthen Depot Ampoules 1 mg/1 ml	Tetracosactrin (as acetate) BP 1 mg	Should normally only be used for short-term therapy in conditions for which Glucocorticoids are indicated in principal, for example, in Ulcerative Colitis and Crohn’s Disease, Juvenile Rheumatoid Arthritis, or as adjunct therapy in patients with Rheumatoid Arthritis and Osteoarthrosis. Synacthen Depot may be particularly useful in patients unable to tolerate oral glucocorticoid therapy in patients where normal therapeutic doses of Glucocorticoids have been ineffective. Prescription Only Medicine.	17th November 1997
00101/0545	Novartis Pharmaceuticals UK Limited	Tofranil Syrup	Tofranil Resin Compound*. Imipramine Hydrochloride BP 25.00 mg. *Prepared from: Imipramine base (Pharma grade) 22.12 mg. Purolite C108 (Purified). (=66.36 mg dried weight.)	Symptoms of depressive illness. Relief of nocturnal enuresis in children. Prescription Only Medicine.	17th November 1997
00101/0546	Novartis Pharmaceuticals UK Limited	Tofranil Tablets 10 mg	Imipramine Hydrochloride BP 10.00 mg	Symptoms of depressive illness. Relief of nocturnal enuresis in children. Prescription Only Medicine.	17th November 1997
00101/0547	Novartis Pharmaceuticals UK Limited	Tofranil Tablets 25 mg	Imipramine Hydrochloride BP 25.00 mg	(See PL00101/0546.) Prescription Only Medicine.	17th November 1997
00116/0274	Baxter Healthcare Limited	Ivelip 10%	Soybean Oil 10.000 wv	(See PL0116/0275.) Prescription Only Medicine.	1st November 1997
00116/0275	Baxter Healthcare Limited	Ivelip 20%	Soybean Oil 20.000 wv	As a source of calories and essential fatty acids for patients requiring parenteral nutrition. Prescription Only Medicine	1st November 1997
00116/0283	Baxter Healthcare Limited	Primene 10%	L-Isoleucine HSE 0.670 g L-Leucine HSE 1.000 g L-Valine HSE 0.760 g L-Lysine HSE 1.100 g L-Methionine HSE 0.240 g L-Phenylalanine HSE 0.420 g L-Threonine HSE 0.370 g L-Tryptophan HSE 0.200 g L-Arginine HSE 0.840 g L-Histidine HSE 0.380 g L-Alanine HSE 0.800 g L-Aspartic Acid HSE 0.600 g L-Cysteine HSE 0.189 g L-Glutamic Acid HSE 1.000 g Glycine (VIIIth Ed) FP 0.400 g L-Proline HSE 0.300 g L-Serine HSE 0.400 g L-Tyrosine HSE 0.045 g L-Ornithine Hydrochloride HSE 0.318 g Taurine HSE 0.060 g	(See PL00116/0284) Prescription Only Medicine	1st November 1997
00116/0284	Baxter Healthcare Limited	Primene 5%	L-Isoleucine HSE 0.335 g L-Leucine HSE 0.500 g L-Valine HSE 0.380 g L-Lysine HSE 0.550 g L-Methionine HSE 0.120 g L-Phenylalanine HSE 0.210 g L-Threonine HSE 0.185 g L-Tryptophan HSE 0.100 g L-Arginine HSE 0.420 g L-Histidine HSE 0.190 g L-Alanine HSE 0.400 g L-Aspartic Acid HSE 0.300 g L-Cysteine HSE 0.095 g L-Glutamic Acid HSE 0.500 g Glycine (VIIIth Ed) FP 0.200 g L-Proline HSE 0.150 g L-Serine HSE 0.200 g L-Tyrosine HSE 0.045 g L-Ornithine Hydrochloride HSE 0.144 g Taurine HSE 0.030 g	(1) Children and infants (2) Neonates, at term or premature, of normal or low birth-weight when oral or enteral nutrition is impossible, insufficient or contraindicated. Prescription Only Medicine	1st November 1997
00116/0305	Baxter Healthcare Limited	Cernevit	Retinol Palmitate HSE 3500 IU Colecalciferol HSE 220 IU DL A Tocopherol HSE 10.20 mg Ascorbic Acid HSE 125 mg Cocarboxylase Tetrahydrate HSE 5.80 mg Riboflavin Dihydrated Sodium Phosphate HSE 5.67 mg Pyridoxine Hydrochloride HSE 5.50 mg Cyanocobalamin HSE 6 ug Folic Acid HSE 414 ug Dexpanthenol HSE 16.15 mg D-Biotin HSE 69 ug Nicotinamide HSE 46 mg	Supply of vitamins corresponding to the daily needs of the adult and the child aged over 11 years requiring multi-vitamin supplementation by parenteral route since oral route is contraindicated, impossible or insufficient (e.g. due to malnutrition, gastrointestinal malabsorption, parenteral nutrition etc.). Prescription Only Medicine	1st November 1997
00211/0041	The Wallis Laboratory Limited	Aspirin Tablets 75 mg. Enteric Coated	Aspirin 75.000 mg	For the secondary prevention of myocardial infarction in patients with previous myocardial infarction, angina or stroke and for secondary prevention of stroke in patients with cerebrovascular disease. Prescription Only Medicine Pharmacy Medicine	19th February 1998
00242/0324	Janssen-Cilag Limited	Daktarin Dual Action Cream	Miconazole Nitrate 2.000 ww	For the treatment of mycotic infections of the skin and nails and super-infections due to gram-positive bacteria Pharmacy Medicine	17th November 1997
00337/0270	Napp Laboratories Limited	Zytram XL Tablets 150 mg	Tramadol Hydrochloride 150.000 mg	For the management (treatment and prevention) of moderate to severe pain. Prescription Only Medicine	28th November 1997
00337/0271	Napp Laboratories Limited	Zytram XL Tablets 200 mg	Tramadol Hydrochloride 200.000 mg	For the management (treatment and prevention) of moderate to severe pain. Prescription Only Medicine	28th November 1997
00337/0272	Napp Laboratories Limited	Zytram XL Tablets 300 mg	Tramadol Hydrochloride 300.000 mg	(See PL00337/0271) Prescription Only Medicine	28th November 1997
00337/0273	Napp Laboratories Limited	Zytram XL Tablets 400 mg	Tramadol Hydrochloride 400.000 mg	(See PL00337/0271) Prescription Only Medicine	28th November 1997
00364/0062	Proctor & Gamble Pharmaceuticals UK Limited	Alora 50	Oestradiol Hemihydrate 1.500 mg	Hormone replacement therapy for the symptomatic relief of natural or surgically induced menopausal symptoms (e.g. hot flushes and nocturnal sweating, urogenital conditions such as atrophic vaginitis/vulvitis, urinary incontinence and urethral atrophy, psychological symptoms, insomnia, irritability and mood swings). Prescription Only Medicine	10th November 1997
00364/0063	Proctor & Gamble Pharmaceuticals UK Limited	Alora 75	Oestradiol Hemihydrate 2.300 mg	(See PL00364/0062) Prescription Only Medicine	10th November 1997
00364/0064	Proctor & Gamble Pharmaceuticals UK Limited	Alora 100	Oestradiol Hemihydrate 3.000 mg	(See 00364/0062) Prescription Only Medicine	10th November 1997
00530/0514	Norton Healthcare Limited	Gliclazide Tablets BP 80 mg	Gliclazide 80.000 mg	Maturity onset diabetes mellitus. Prescription Only Medicine	18th February 1998
01618/0061	Rusco Ltd	Bronchial Mixture	Ammonium Bicarbonate 117.500 mg, Ipecacuanha Tincture .075 ml, Squill Liquid Extract 47.500 mcl	A traditional remedy for the temporary relief of symptoms of catarrh and irritating cough. General Sales List	31st January 1998
03105/0059	Bell, Sons & Co. (Druggists) Limited	Pholcodine Linctus BP	Pholcodine .100 wv	It is a cough suppressant with mild sedative but little analgesic effect. It is used for the relief of unproductive cough. Pharmacy Medicine	16th February 1998
03105/0060	Bell, Sons & Co. (Druggists) Limited	Strong Pholcodine Linctus BP	Pholcodine .200 wv	It is a cough-suppressant with mild sedative but little analgesic effect. It is used for the relief of unproductive cough. Prescription Only Medicine	16th February 1998
03132/0117	Novo Nordisk Pharmaceuticals Limited	Gabitril 5 mg	Tiagabine Hydrochloride Monohydrate 5.730 mg	An antiepileptic drug indicated as add-on therapy for partial seizures with or without secondary generalisation where control is not achieved by optimal doses of at least one other antiepileptic drug Prescription Only Medicine	11th November 1997
03132/0118	Novo Nordisk Pharmaceuticals Limited	Gabitril 10 mg	Tiagabine Hydrochloride Monohydrate 11.460 mg	(See PL 03132/0117) Prescription Only Medicine	11th November 1997
03132/0119	Novo Nordisk Pharmaceuticals Limited	Gabitril 15 mg	Tiagabine Hydrochloride Monohydrate 17.190 mg	(See PL 03132/0117) Prescription Only Medicine	11th November 1997
3243/0330	Munro Wholesale Medical Supplies Limited	Serc 8 mg Tablets	Betahistine Dihydrochloride 8.000 mg	Vertigo, Tinnitus and hearing loss associated with Meniere’s disease. Prescription Only Medicine	29th January 1998
3787/0462	Swingward Limited, t/a Medihealth	Lamictal 50 mg Tablets	Lamotrigine 50.000 mg	Epilepsy. Prescription Only Medicine	30th January 1998
4423/0250	Doncaster Pharmaceuticals Group Limited	Locoid Cream 0.1 %	Hydrocortisone 17-Butyrate 0.100 % w/w	Conditions responsive to topical corticosteroids. Prescription Only Medicine	9th February 1998
4423/0256	Doncaster Pharmaceuticals Group Ltd.	Stugeron Forte 75 mg Capsules/Cinnarizine 75 mg Capsules	Cinnarizine 75.000 mg	Peripheral arterial disease. Pharmacy Medicine Only	27th January 1998
4423/0271	Doncaster Pharmaceuticals Group Limited	Flixotide 250 Inhaler/ Fluticasone Propionate 250 microgram Inhaler	Fluticasone Propionate 250.000 mcg	For mild, moderate and severe asthma. Prescription Only Medicine	9th February 1998
4423/0279	Doncaster Pharmaceuticals Group Limited	Amlodipine Tablets 10 mg	Amlodipine 10.000 mg	Hypertension and prophylaxis of chronic stable angina pectoris. Prescription Only Medicine	17th February 1998
04423/0281	Doncaster Pharmaceuticals Group Limited	Manidon SR 240 mg tablets/ Securon SR 240 mg tablets. Manidon 240 mg/Manidon 240 mg Retard tablets	Verapamil Hydrochloride 240.0 mg	Treatment of hypertension and angina pectoris. Prescription Only Medicine	17th February 1998
04569/0289	Generics (UK) Limited	Ranitidine Tablets BP 150 mg	Ranitidine Hydrochloride 168.000 mg	For the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. In addition, for the prevention of NSAID-associated duodenal ulcers. Ranitidine Tablets BP are indicated for the treatment of duodenal ulcers associated with Helicobacter Pylori. Also for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux disease including 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. 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	6th February 1998
04569/0290	Generics (UK) Limited	Ranitidine Tablets BP 300 mg	Ranitidine Hydrochloride 336.000 mg	(See PL 04569/0289) Prescription Only Medicine	6th February 1998
04986/0018	Tad Pharmazeutisches Werk GMBH	Ranipep	Ranitidine Hydrochloride 84.000 mg	For the short term symptomatic relief of heartburn, dyspepsia, indigestion, acid indigestion and hyperacidity. Pharmacy Medicine	27th November 1997
04986/0019	Tad Pharmazeutisches Werk GMBH	Virasorb Cold Sore Cream	Aciclovir 5.000 ww	For the treatment of recurrent herpes labialis. Pharmacy Medicine	6th November 1997
5662/0362	Dowelhurst Limited	Aerolin CR 4 mg Tablets	Salbutamol Sulphate 4.820 mg	Reversible airways obstruction due to asthma. Prescription Only Medicine	19th February 1998
5662/0385	Dowelhurst Limited	Prepulsid 10 mg Tablets/ Cisparide Tablets 10 mg/ Prepulsid 10 mg Tablets	Cisapride Monohydrate 10.387 mg	Gastro-oesophageal reflux. Prescription Only Medicine	13th February 1998
5662/0398	Dowelhurst Limited	Plendil 5 Tablets/Plendil 5 mg Tablets	Felodipine 5.000 mg	Hypertension and angina pectoris. Prescription Only Medicine	9th February 1998
05662/0424	Dowelhurst Limited	Paludrine Tablets/Proguanil Hydrochloride 100 mg Tablets	Proguanil Hydrochloride 100.000 mg	Antimalarial agent. Pharmacy Medicines Only	13th February 1998
5662/0425	Dowelhurst Limited	Zocor 10 mg Tablets/Simvastatin 10 mg Tablets	Simvastatin 10.000 mg	Primary hypercholesterolaemia. Prescription Only Medicine	19th February 1998
5662/0430	Dowelhurst Limited	Feldene 0.5% Gel/Piroxicam 0.5% Gel	Piroxicam 5.000 mg	For a variety of conditions characterised by pain and inflammation, or stiffness. Prescription Only Medicine	10th February 1998
5662/0446	Dowelhurst Limited	Lipantil 100 mg Capsules Lipanthyl 100 Capsules Fenofibrate 100 mg Capsules	Fenofibrate 100.000 mg	Treatment of severe hyperlipidaemia. Prescription Only Medicine	27th January 1998
6464/0441	Waymade Plc	Gopten 0.5 mg Capsules	Trandolapril 0.500 mg	Mild or moderate hypertension. Prescription Only Medicine	29th January 1998
6464/0454	Waymade Plc	Gopten 2 mg Capsules	Trandolapril 2.000 mg	Mild or moderate hypertension. Prescription Only Medicine	30th January 1998
08081/0030	Shire Pharmaceutical Contracts Limited	Elleste Duet Conti	Norethisterone Acetate 1.000 mg Oestradiol Hemihydrate 2.000 mg	Hormone replacement therapy for the treatment of menopausal symptoms such as night sweats and hot flushes in women who are at least 1 year past their menopause and who have an intact uterus. Treatment of the postmenopausal sequelae of oestrogen withdrawal, including atrophic vaginitis and atrophic urethritis. It should only be used in women who are at least 1 year past their menopause. If given in the earlier post-menopausal phase the incidence of bleeding is unacceptably high. Administration is continued without a break in therapy. The presence of continuous progestogen is designed to result in the absence of menopausal bleeding whilst also protecting against the production of endometrial hyperplasia. Prescription Only Medicine	27th November 1997
08336/0066	Asta Medica Limited	Zamadol Injection	Tramadol Hydrochloride 100.000 mg	For the treatment and prevention of moderate to severe pain. Prescription Only Medicine	28th November 1997
08336/0075	Asta Medica Limited	Optilast	Azelastine Hydrochloride .050 wv	Symptomatic treatment and prevention of seasonal allergic conjunctivitis. Prescription Only Medicine	18th February 1998
08336/0083	Asta Medica Limited	Azelastine Eye Drops	Azelastine Hydrochloride .050 wv	Symptomatic treatment and prevention of allergic conjunctivitis. Prescription Only Medicine	18th February 1998
8747/0169	Chemilines Limited	Sodium Cromoglycate 5 mg Inhaler Intal 5 mg Inhaler	Sodium Cromoglycate 5.000 mg	Bronchial asthma. Prescription Only Medicine	27th January 1998
8747/0177	Chemilines Limited	Floxyfral 50 mg Tablets Fluvoxamine Maleate 50 mg Tablets	Fluvoxamin Maleate 50.000 mg	Treatment of symptoms of depressive illness. Prescription Only Medicine	27th January 1998
8747/0189	Chemilines Limited	Lamictal 50 mg Tablets Lamotrigine 50 mg Tablets	Lamotrigine 50.000 mg	Epilepsy. Prescription Only Medicine	12th February 1998
8747/0220	Chemilines Limited	Destolit Tablets	Ursodeoxychloic Acid 150.000 mg	For the dissolution of radiolucent (i.e. non-radio opaque) cholesterol gallstones in patients with a functioning gallbladder. Prescription Only Medicine	9th February 1998
08821/0023	Monsanto plc	Diclofenac 50 mg Tablets	Diclofenac Sodium 50.0 mg	For the treatment of pain and inflammation of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and in other musculo-skeletal disorders including periarthritis, bursitis, tendinitis, tenosynovitis, sprains, strains and dislocations. The control of pain and inflammation in minor surgery. The control of pain and inflammation in acute gout. The treatment of pain and inflammation of chronic juvenile arthritis. Prescription Only Medicine	29th January 1998
08821/0032	Monsanto plc	Rehidrat Orange	Sodium Chloride EP 3.12 gm/Potassium Chloride EP 2.68 gm/Sodium Bicarbonate EP 3.02 gm	For the prevention and correction of mild and moderate dehydration. In the management of diarrhoea in infants, children and adults. Maintenance and replacement of fluid and electrolytes following corrective parenteral therapy for dehydration and as a supplement to corrective parenteral therapy for dehydration. Pharmacy Medicine	29th January 1998
08829/0066	Trinity Pharmaceuticals Limited	Rineral LA, Redupress LA	Propranolol Hydrochloride 160.000 mg	Propranolol Hydrochloride is a competitive blocking agent of B-adrenergic receptor sites. It is used for the treatment of hypertension and angina. Prescription Only Medicine	7th November 1997
08829/0067	Trinity Pharmaceuticals Limited	Zileze 3.75, Zopiclone Tablets 3.75 mg	Zopiclone 3.750 mg	For the short-term treatment of insomnia. Prescription Only Medicine	30th January 1998
08829/0068	Trinity Pharmaceuticals Limited	Zileze 5, Zopiclone Tablets 5 mg	Zopiclone 5.000 mg	For the short-term treatment of insomnia. Prescription Only Medicine	30th January 1998
08829/0069	Trinity Pharmaceuticals Limited	Zileze 7.5, Zopiclone Tablets 7.5 mg	Zopiclone 7.500 mg	For the short-term treatment of insomnia. Prescription Only Medicine	30th January 1998
10256/0313	Stephar (UK) Limited	Fucibet Cream	Betamethasone valerate 0.100% ww, Fusidic acid 2.000% ww	Eczematous dermatoses. Prescription Only Medicine	11th February 1998
10256/0314	Stephar (UK) Limited	Tenormin 25 mg Tablets	Atenolol 25.000 mg	1. Control of hypertension 2. Management of angina pectoris 3. Control of cardiac dysrhythmias 4. Treatment of myocardial infarction: early intervention of the acute phase. Prescription Only Medicine	12th February 1998
10256/0325	Stephar (UK) Limited	Requip 1 mg	Ropinirole Hydrochloride 1.140 mg	Parkinson’s disease. Prescription Only Medicine	29th January 1998
10256/0326	Stephar (UK) Limited	Requip 2 mg	Ropinirole Hydrochloride 2.280 mg	Parkinson’s disease. Prescription Only Medicine	29th January 1998
10256/0327	Stephar (UK) Limited	Requip 5 mg	Ropinirole Hydrochloride 5.700 mg	Parkinson’s disease. Prescription Only Medicine	29th January 1998
10256/0354	Stephar UK Limited	Zoladex 3.6 mg Injection	Goserelin 3.600 mg	1. Prostate cancer suitable for hormonal manipulation. 2. Advanced breast cancer in pre- and peri-menopausal women suitable for hormonal manipulation. 3. Endometriosis. Prescription Only Medicine	9th February 1998
10380/0195	Swinghope Limited	Relif 500 mg Tablets Relifex Tablets Nabumetone 500 mg Tablets	Nabumetone 500.000 mg	Anti-inflammatory and analgesic treatment. Prescription Only Medicine	3rd February 1998
10383/0401	Primecrown Limited	Ditropan 5 mg tablets Oxybutynin Hydrochloride 5 mg tablets	Oxybutynin Hydrochloride 5.000 mg	Urinary incontinence. Prescription Only Medicine	17th February 1998
10383/0507	Primecrown Limited	Clarityn Syrup Loratadine 5 mg/5 ml Syrup	Loratadine 5.000 mg	Seasonal and perennial allergic rhinitis. Pharmacy Medicine Only	5th February 1998
10383/0509	Primecrown Limited	Metrodin HP 75 Metrodin High Purity 75	Urofollitrophin 75.000 IU	For stimulation of follicular development and ovulation. Prescription Only Medicine	12th February 1998
10383/0510	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	12th February 1998
10383/0531	Primecrown Limited	Zithromax 250 mg Capsules/ Azithromycin 250 mg Capsules	Azithromycin 250.000 mg	For infections caused by susceptible organisms, in respiratory tract infections, skin and soft tissue infections, otitis media and sexually transmitted diseases. Prescription Only Medicine	13th February 1998
10592/0112	Smithkline Beecham PLC	Famvir 500 mg Tablets	Famciclovir 500.000 mg	Treatment of herpes zoster infections and treatment and suppression of herpes simplex infections in immunocompromised patients. Prescription Only Medicine	17th February 1998
10949/0293	Glaxo Wellcome UK Limited	Paracetamol Infant Suspension	Paracetamol 120.000 mg	For the treatment of mild to moderate (including teething pain), and as an antipyretic. Pharmacy Medicine	9th February 1998
10949/0294	Glaxo Wellcome UK Limited	Paracetamol SF Infant Suspension	Paracetamol 120.000 mg	(See PL 10949/0293) Pharmacy Medicine	9th February 1998
11314/0084	Seton Products Ltd	Uriflex C Chlorhexidine Irrigation Solution 0.02%	Chlorhexidine Gluconate .020 wv	Sterile chlorhexidine solution 0.02% for irrigation is recommended for disinfection and wound cleansing. The 100 ml presentation is for use as a bladder irrigation; aqueous chlorhexidine is effective against a wide range of urinary tract tract pathogens Pharmacy Medicine	21st November 1997
11314/0087	Seton Products Ltd	Uriflex S Uriflex SP	Sodium Chloride .900 wv	For the cleaning of external wounds and the irrigation of open wounds during surgical procedures Pharmacy Medicine	21st November 1997
11314/0088	Seton Products Ltd	Uriflex W Sterile Water for Irrigation	Water for Irrigation 100.000 vv	Recommended for use when sterile pyrogen-free water is required. For the irrigation of wounds and cavities. As a diluent for antiseptic solutions Pharmacy Medicine	21st November 1997
11314/0112	Seton Products Ltd	Woodward’s Colic Drops	Simethicone Emulsion 23.500 ww	An antiflatulent for the relief of symptoms of griping pain, colic or wind due to swallowed air Pharmacy Medicine	17 February 1998
11648/0026	Merck Ltd	Tanatril 5 mg Tablets	Imidapril Hydrochloride 5.000 mg	Treatment of essential hypertension Prescription Only Medicine	12th November 1997
11648/0027	Merck Ltd	Tanatril 10 mg Tablets	Imidapril Hydrochloride 10.000 mg	Treatment of essential hypertension Prescription Only Medicine	12th November 1997
11648/0028	Merck Ltd	Tanatril 20 mg Tablets	Imidapril Hydrochloride 20.000 mg	Treatment of essential hypertension Presctiption Only Medicine	12th November 1997
11648/0030	Merck Ltd	Tanatril 2.5 mg Tablets	Imidapril Hydrochloride 2.500 mg	Treatment of essential hypertension Prescription Only Medicine	12th November 1997
12063/0027	Wrafton Laboratories Limited	Paracetamol, Caffeine, Codeine Phosphate Capsules Dual Action Pain Relief Capsule Power Plus Pain Relief Capsule Double Action Pain Relief Capsule	Caffeine 30.000 mg Codeine Phosphate Hemihydrate 8.000 mg Paracetamol 500.000 mg	For the relief of moderate to strong pain. Suitable for migraine, headache, rheumatic pain, period pain, toothache, neuralgia, sore throat and feverishness, and the symptomatic relief of colds and influenza. Pharmacy Medicine	12th February 1998
13298/0003	Syner-Med (Pharmaceutical Products) Ltd	Sustamycin Capsules	Tetracycline Hydrochloride BP 250 mg	For use in the treatment of infections due to organisms susceptible to Tetracycline, for example in chronic bronchitis, acute exacerbation of chronic bronchitis, severe acne, lymphogranuloma venereum, chancroid, non-specific urethritis, granuloma inguinale, chlamydial infections (psittacosis, trachoma and inclusion conjunctivitis) myocoplasma (respiratory and genital), rickettsial infection (Q fever, typhus, rocky mountain spotted fever) and brucellosis. Sustamycin is also for use as second or third line therapy in gonorrhoea and syphilis and in other infections due to sensitive organisms after bacteriological confirmation of sensitivity. Prescription Only Medicine	12th November 1997
13402/0018	Hoechst Marion Roussel Limited	Arelix Capsules	Piretanide HSE 6.0 mg	For the treatment of mild to moderate hypertension. Prescription Only Medicine	1st November 1997
13402/0019	Hoechst Marion Roussel Limited	Lasix Liquid 10 mg/ml	Frusemide* BP 50.00 mg Equivalent to frusemide sodium 53.32 mg/ml *Furosemide INN	All indications when a prompt and effective diuresis is required in patients who are unable to take solid dosage form. It includes cardiac, pulmonary, hepatic and renal oedema, peripheral oedema due to mechanical obstruction or venous insufficiency or hypertension. Prescription Only Medicine	1st November 1997
13402/0020	Hoechst Marion Roussel Limited	Oestrogel Pump-Pack	Oestradiol Hemihydrate .062 ww	As oestrogen replacement therapy for the relief of symptoms due to natural or surgically induced menopause such as vasomotor symptoms (hot flushes and sweating), atrophic vaginitis and atrophic urethritis. Prescription Only Medicine	1st November 1997
13402/0021	Hoechst Marion Roussel Limited	Tritace 1.25 mg	Ramipril HSE 1.25 mg	For the treatment of mild to moderate hypertension. Congestive heart failure as adjunctive therapy to diuretics with or without cardiac glycosides. It has been shown to reduce mortality when given to patients surviving acute myocardial infarction with clinical evidence of heart failure. Prescription Only Medicine	1st November 1997
13402/0022	Hoechst Marion Roussel Limited	Tritace 2.5 mg	Ramipril HSE 2.5 mg	(See PL13402/0021). Prescription Only Medicine	1st November 1997
13402/0023	Hoechst Marion Roussel Limited	Tritace 5.0 mg	Ramipril HSE 5.0 mg	(See PL13402/0021). Prescription Only Medicine	1st November 1997
13402/0024	Hoechst Marion Roussel Limited	Tritace 10.0 mg	Ramipril HSE 10.0 mg	(See PL13402/0021). Prescription Only Medicine	1st November 1997
13402/0025	Hoechst Marion Roussel Limited	Tritazide 2.5/12.5 mg	Ramipril HSE 2.5 mg Hydrochlorothiazide EP 12.5 mg	Treatment of mild to moderate hypertension in patients (in whom combination therapy is appropriate) who have been stabilised on the individual components given in the same proportion. Prescription Only Medicine	1st November 1997
13402/0026	Hoechst Marion Roussel Limited	Tritazide 5/25 mg	Ramipril HSE 5.0 mg Hydrochlorothiazide EP 25.0 mg	(See PL 13402/0025) Prescription Only Medicine	1st November 1997
13402/0060	Hoechst Marion Roussel Limited	Loprazolam Tablets (Dormonoct)	Loprazolam Mesylate HSE 1.245 mg (equivalent to Loprazolam 1 mg)	For the short term treatment including difficulty in falling asleep and/or frequent nocturnal awakenings. Prescription Only Medicine	13th February 1998
13606/0058	Co-Pharma Limited	Quinine Bisulphate Tablets BP 300 mg	Quinine Bisulphate 300.000 mg	For the treatment of falciparum malaria. For the treatment of nocturnal leg cramps. Prescription Only Medicine	18th February 1998
13606/0059	Co-Pharma Limited	Quinine Sulphate Tablets BP 300 mg	Quinine Sulphate 300.000 mg	(See PL 13606/0058) Prescription Only Medicine	18th February 1998
14160/0003	Beiersdorf UK Ltd	Eucerin 10% Urea Cream	Urea 10.000 ww	For the treatment of ichthyosis, xeroderma (especially in the elderly), hyperkeratosis and other chronic dry skin conditions such as atopic eczema (dermatitis). General Sales List	9th February 1998
14385/0006	King Pharmaceuticals Limited	Capastat Injection	Capreomycin 1.000 gm	Actions: Active against human strains of Mycobacterium tuberculosis. Frequent cross-resistance occurs between capreomycin and viomycin. Varying degrees of cross-resistance between capreomycin and kanamycin and neomycin have been reported. No cross-resistance has been observed between capreomycin and isoniazid, aminosalicylic acid, cycloserine, streptomycin, ethionamide or ethambutol. Indications: It should be used concomitantly with other appropriate antituberculous agents for the treatment of pulmonary infections caused by capreomycin-susceptible strains of Mycobacterium tuberculosis when the primary agents (isoniazid, rifampicin, streptomycin and ethambutol) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli. Prescription Only Medicine	19th November 1997
14641/0005	Dallas Burston Healthcare Limited	Terbutaline Sulphate Inhalation Solution 5.0 mg Terbovent Steripoules 5.0 mg	Terbutaline Sulphate 2.500 mg	For the relief of severe bronchospasm in bronchial asthma and in chronic bronchitis, emphysema and other pulmonary disorders in which bronchospasm is a complicating factor. Prescription Only Medicine	18th February 1998
15513/0037	Warner-Lambert Consumer Healthcare	Agarol	Each 5 ml contains: Phenolphthalein BP 66.0 mg Agar 10.0 mg Liquid Paraffin BP 1.6 ml	Agarol provides balanced cathartic and laxative properties. For the temporary relief of constipation. Agarol may be especially required when straining at stool is a hazard e.g. in patients with hernia, cardiac or hypertensive conditions, during convalescence after surgery, pre and post operatively in the surgical treatment of haemorrhoids and other allied ano-rectal conditions, obstetric patients and patients confined to bed. Pharmacy Medicine	28th November 1997
15513/0038	Warner-Lambert Consumer Healthcare	Alophen	Aloin BP 15.0 mg Phenolphthalein BP 30.0 mg	For the relief of constipation due to torpidity of the lower bowel. Pharmacy Medicine	28th November 1997
15638/0006	Concord Pharmaceuticals Limited	Flaxedil Injection 4%	Gallamine Triethiodide 80.000 mg	Flaxedil is a non-depolarising (competitive-blocking) muscle relaxant having a duration of action of 20-30 minutes. Flaxedil is used as an adjunct to anaesthesia to induce skeletal muscle relaxation and it is also used to manage patients undergoing mechanical ventilation. Prescription Only Medicine	17th November 1997
15679/0002	Mallinckrodt Medical GmbH	INFOSON Injection	Air-filled microspheres of heat Aggregated Human Albumin with diameters from 4.0 to 10.0 Mm 200 million microspheres/ml =20000 million microspheres/100 ml Produced from: Human Albumin Solution 5%(w/v) EP Compressed air DLS (DLS=Danish Drug Standard)	A transpulmonary echocardiographic diagnostic agent for identification or verification of anatomy and function in adults with suspected or established cardiovascular disease. Prescription Only Medicine	24th November 1997
15722/0019	Boehringer Mannheim UK Limited	Water for injections	None	Dissolution of the freeze-dried substance containing a solution for injection. Prescription Only Medicine	13th February 1998
15722/0030	Boehringer Mannheim UK Limited	Recormon 5000	Erythropoietin HSE 5000iu	For use in the treatment of anaemia associated with chronic renal failure (renal anaemia) in patients on dialysis. For use in the treatment of symptomatic renal anaemia in patients not yet undergoing dialysis. For use in the prevention of anaemia of prematurity in infants with a birth weight of 750 to 1500 g and a gestational age of less than 34 weeks. Recormon 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/dl) 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. For use in 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). Prescription Only Medicine	13th February 1998
15722/0031	Boehringer Mannheim UK Limited	Recormon 10000	Erythropoietin HSE 10000iu	(See PL/15722/0030) Prescription Only Medicine	13th February 1998
15814/0018	O.P.D. Laboratories Limited	Losec 20 mg Capsules/Omeprazole 20 mg Capsules	Omeprazole 20.000 mg	Treatment of oesophageal reflux disease. Prescription Only Medicine	19th February 1998
15929/0001	Linde Gas UK Limited	Medical Air	Medical Air 100.000 vv	As replacement for atmospheric air. Carrier gas for volatile anaesthetics. General Sales List	4th February 1998
15929/0002	Linde Gas UK Limited	Medical Carbon Dioxide	Carbon Dioxide 100.000 ww	As an anaesthetic supplement in various clinical circumstances to maintain optimum blood carbon dioxide levels, facilitate blind intubation and rapidly increase depth of anaesthesia with volatile agents. As a respiratory stimulant after apnoea or after relief of chronic respiratory obstruction. To prevent hypocapnia during hyperventilation. Use in clinical and physiological investigations including use as insufflation gas. Pharmacy Medicine	4th February 1998
15929/0004	Linde Gas UK Limited	Medical Nitrous Oxide	Nitrous Oxide 100.000 ww	As an inhalation anaesthetic. As an analgesic where rapid-onset powerful short-term relief of severe pain is required. Pharmacy Medicine	4th February 1998
15929/0005	Linde Gas UK Limited	Medical Oxygen	Oxygen 100.000 vv	Hypoxia of any cause. As diluent for gaseous and volatile anaesthetic agents. General Sales List	4th February 1998

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