MEDICINES CONTROL AGENCY

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

Product Licences Authorised

Product Licence Number	Company Name	Product Name	Active Ingredients	Indications	Date of Authorisation
00014/0564	The Boots Company Plc	Sensitive F Formula Mouthwash	Cetylpyridinium Chloride .050 wv Potassium Citrate 2.000 wv Sodium Fluoride .050 wv	For the treatment of dentine hypersensitivity, reduction of plaque accumulation and protection against decay. General Sales List	13th March 1998
00014/0604	The Boots Company Plc	Nirolex Decongestant Syrup	Guaiphenesin 100.000 mg Pseudoephedrine Hydrochloride 30.000 mg	An expectorant for the relief of chesty coughs, nasal congestion and catarrh without causing drowsiness. Pharmacy Medicine	4th March 1998
00022/0119	Pharmacia Laboratories Limited	Water for Injections	None	To be used to reconstitute Gammonative. Prescription Only Medicine	27th May 1998
00030/0100	Novartis Consumer Health UK Limited	Proflex Sustained Relief Capsules	Ibuprofen BP 300 mg	For the relief of mild and moderate pain for the symptomatic relief of sprains, strains, rheumatic pain, lumbago, fibrositis, backache and muscular aches and pains. For the relief of headache, migraine, neuralgia, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. Pharmacy Medicine	1st March 1998
00030/0103	Novartis Consumer Health UK Limited	Bradosol Plus	Domiphen Bromide BP 0.5 mg Lignocaine Hydrochloride BP 5.0 mg	The symptomatic relief of sore throats. Pharmacy Medicine	1st March 1998
00030/0104	Novartis Consumer Health UK Limited	Bradosol Sugar-Free Original Citrus	Benzalkonium Chloride Solution .040 vw	For the relief of sore throats. General Sales List	1st March 1998
00030/0105	Novartis Consumer Health UK Limited	Bradosol Sugar-Free Cherry Menthol	Benzalkonium Chloride Solution .040 vw	The lozenges are intended for the relief of sore throats. General Sales List	1st March 1998
00030/0133	Novartis Consumer Health UK Limited	Aller-Eze	Clemastine Fumarate HSE 1.34 mg	1. Allergic rhinitis including hay fever and perennial rhinitis, vasomotor rhinitis. 2. Dermatoses including pruritus, atopic eczema, contact dermatitis and other allergic dermatoses. 3. Urticaria. 4. Angioneurotic Oedema. 5. Drug Allergy. Pharmacy Medicine	1st March 1998
00030/0134	Novartis Consumer Health UK Limited	Aller-Eze Plus	Clemastine Hydrogen Fumarate USP 670.0 mcg Phenylpropanolamine Hydrochloride BP 25.0 mg	Relief of nasal and sinus congestion, hayfever and other allergy symptoms. Pharmacy Medicine	1st March 1998
00030/0135	Novartis Consumer Health UK Limited	Aller.eze Cream	Diphenhydramine Hydrochloride 2.000 ww	Symptomatic treatment of allergic conditions e.g., urticaria, pruritus, allergic rashes, stings and insect bites. Pharmacy Medicine	1st March 1998
00031/0507	Roche Products Limited	Cal-D-Vita Effervescent Tablets	Calcium Carbonate 1500.000 mg Cholecalciferol Concentrate (Powder Form) 8.000 mg	Correction of combined vitamin D and calcium deficiencies in the elderly. Vitamin D and calcium supplementation as an adjunct to specific treatment for osteoporosis in patients, where combined vitamin D and calcium deficiencies have been diagnosed or at a high risk of such deficiencies. Pharmacy Medicine	2nd March 1998
00041/0070	Bioglan Laboratories Limited	Selegiline Tablets 5 mg	Selegiline Hydrochloride 5.000 mg	For the treatment of Parkinson’s disease or symptomatic Parkinsonism. May be used alone, in early Parkinson’s disease to delay the need for levodopa (with or without a decarboxylase inhibitor), or as an adjunct with levodopa (with or without a decarboxylase inhibitor). Prescription Only Medicine	29th May 1998
00041/0071	Bioglan Laboratories Limited	Selegiline Tablets 10 mg	Selegiline Hydrochloride 10.000 mg	(See PL 00041/0070) Prescription Only Medicine	29th May 1998
00041/0077	Bioglan Laboratories Ltd	Benzamycin Gel	Benzoyl Peroxide EP 5.0 ww Erythromycin EP 3.0 ww	For the topical treatment of acne vulgaris. Prescription Only Medicine	1st March 1998
00049/0042	Colgate-Palmolive (UK) Limited	Duraphat	Soduim Fluoride 5.000 wv	For the prevention of caries in high risk adults and children. When used as part of a comprehensive caries control programme, and is effective in reducing fissure caries, decalcification around orthodontic appliances and the progression of caries lesions. For the desensitisation of hypersensitive teeth as part of a treatment regimen which includes the daily use of a suitable toothpaste. Prescription Only Medicine	6th March 1998
00101/0484	Novartis Pharmaceuticals UK Limited	Lamisil DermGel	Terbinafine 1.000 ww	Fungal infections of the skin caused by dermatophytes. Pityriasis (tinea) versicolor. Prescription Only Medicine	31st March 1998
00173/0168	Diomed Developments Limited	Ibuleve Mousse	Ibuprofen 5.000 ww	For fast local relief of pain and inflammation in musculoskeletal conditions including backache, rheumatic and musculoskeletal conditions including backache, rheumatic and muscular pain, sprains, strains, lumbago and fibrositis, and neuralgia. Also for the symptomatic relief of pain due to non-serious arthritic conditions. Pharmacy Medicine	11th March 1998
00327/0085	Crookes Healthcare Ltd	Nurofen For Children	Ibuprofen 2.000 wv	Prescription only: For symptomatic treatment of juvenile rheumatoid arthritis. Prescription and OTC: For the fast and effective reduction of fever, including post immunisation pyrexia and the fast and effective relief of mild to moderate pain, such as sore throat, teething pain, toothache, earache, headache, minor aches and sprains. Prescription Only Medicine Pharmacy Medicine	11th March 1998
00427/0113	Rosemont Pharmaceuticals Limited	Methadone Oral Solution 1 mg/1 ml Sugar Free	Methadone Hydrochloride 5.000 mg	For use in the treatment of opioid drug addictions (as a narcotic abstinence syndrome suppressant). For use as an analgesic for moderate to severe pain. Prescription Only Medicine	3rd June 1998
00512/0156	Solvay Healthcare Limited	Influvac Sub-unit	A/Singapore/6/86 (H1N1)—Like 15.000 mg A/Wuhan/359/95 (H3N2)—Like 15.000 mg B/Beijing/184/93—Like 15.000 mg	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 the basis of national immunisation policies. Prescription Only Medicine	16th March 1998
00530/0546	Norton Healthcare Limited	Calcicard XL 300 mg Capsules	Diltiazem Hydrochloride 300.000 mg	Mild to moderate hypertension.	27th March 1998
00551/0006	Typharm Ltd	Docusol Adult Solution	Docusate Sodium 50.000 mg	(a) To prevent and treat chronic constipation. (b) As an adjunct in abdominal radiological procedures. Pharmacy Medicine	9th March 1998
00551/0007	Typharm Ltd	Docusol Paediatric Solution	Docusate Sodium 12.500 mg	(See 00551/0006) Pharmacy Medicine	9th March 1998
PI 03243/0337	Munro Wholesale Medical Supplies Ltd	Zoton 30 mg Capsules	Lansoprazole 30.000 mg	For the treatment of acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	19th June 1998
01932/0033	Seven Seas Limited	Bioral Gel	Carbenoxolone Sodium 2.000 WW	For the treatment of mouth ulcers. Prescription Only Medicine	31st March 1998
03473/0034	Common Services Agency	Human Hepatitis B Immunoglobulin 500IU	Human Hepatitis B Immunoglobulin 500.000 IU	For the post exposure prophylaxis of Hepatitis B infection in individuals who have not been immunised with Hepatitis B vaccine and who has been inoculated with blood or secretions containing Hepatitis B Surface Antigen (HBsAg). HBsAg positive material is presumed to contain Hepatitis B virus. This product should be used in conjunction with Hepatitis B vaccine to confer both passive and active immunity after exposure. Where used together, these products should be administered with separate syringes into separate sites. For known non-responders to vaccine, a booster dose of vaccine can be considered for simultaneous administration with hepatitis B Immunoglobulin. Indications for the use of this product are as follows: (i) Parenteral exposures: Any subcutaneous or other injections, needleprick or blood transfusion. Other indications are skin breaking bites by infective people and cases where there is clear evidence of contamination of a wound or of the conjunctiva. Simultaneous administration of the first dose of a licensed Hepatitis B vaccine may be considered for administration into a separate site. (ii) Sexual Exposure. It may be administered to recent sexual contracts of diagnosed Hepatitis B cases. (iii) Newborns: It is indicated for a neonate where the mother has had acute Hepatitis B in the last trimester of pregnancy, or who is an HBeAg positive carrier or who is an HBsAg—Positive carrier without HBe markers (or where the HBeAg status has not been determined). A single dose of immunoglobulin is given within 4 hours of birth combined with vaccine into a separate site. The vaccine course is then completed according to the Manufacturer’s instructions. Prescription Only Medicine	11th June 1998
04416/0284	Lagap Pharmaceuticals Limited	Modisal 60 XL	Isosorbide 5-Mononitrate 60.000 mg	Prophylactic treatment of angina pectoris. Pharmacy Medicine.	5th March 1998
04416/0299	Lagap Pharmaceuticals Limited	Sulphasalazine Tablets 500 mg	Sulphasalazine 500.000 mg	Recommended Clinical Indications: 1. Ulcerative colitis. 2. Crohn’s disease. Route of Administration Oral. Prescription Only Medicine	16th June 1998
04423/0238	Doncaster Pharmaceuticals Group Limited	Naprosyn 250 mg Tablets/ Naproxen 250 mg Tablets	Naproxen 250.000 mg	Rheumatoid arthritis and dysmenorrhoea. Prescription Only Medicine	1st June 1998
04423/0239	Doncaster Pharmaceuticals Group Limited	Naprosyn LE 500 mg Tablets/ Naproxen 500 mg Tablets	Naproxen 500.000 mg	Rheumatoid arthritis and dysmenorrhoea. Prescription Only Medicine	1st June 1998
04423/0248	Doncaster Pharmaceuticals Limited	Fluanxol 0.5 mg Tablets/ Flupenthixol Tablets 500 microgram	Flupenthixol dihydrochloride 0.583 mg	For treatment of depression. Prescription Only Medicine	22nd June 1998
04423/0249	Doncaster Pharmaceuticals Group Limited	Fluanxol 1 mg Tablets/ Flupenthixol 1 mg Tablets	Flupenthixol 1.168 mg	For the treatment of depression. Prescription Only Medicine	19th June 1998
04423/0258	Doncaster Pharmaceuticals Group Limited	Triludan Suspension	Terfenadine 30.000 mg	Allergic conditions responsive to antihistamines. Prescription Only Medicine	1st June 1998
04423/0276	Doncaster Pharmaceuticals Group Limited	Glucobay 50 mg Tablets/ Acarbose 50 mg Tablets (Spain)	Acarbose 50.00 mg	Non-insulin dependent diabetes mellitus. Prescription Only Medicine	3rd June 1998
04423/0290	Doncaster Pharmaceuticals Group Limited	Risperdal 1 mg Tablets/ Risperidone 1 mg Tablets	Risperidone 1.000 mg	For the treatment of acute and chronic schizophrenic psychoses. Prescription Only Medicine	1st June 1998
04515/0084	Faulding Pharmaceuticals Plc	Bleomycin for Injection	Bleomycin Sulphate 15000.000 iu	1. Squamous cell carcinoma affecting the mouth nasopharynx and paranasal sinuses, larynx, oesophagus, external genitalia, cervix or skin. Well-differentiated tumours usually respond better than anaplastic ones. 2. Hodgkin’s disease and other malignant lymphomas including mycosis fungoides. 3. Testicular teratoma. 4. Malignant effusions of serous cavities. 5. Secondary indications in which bleomycin has been shown to be of some value (alone or in combination with other drugs) include metastatic malignant melanoma, carcinoma of the thyroid, lung and bladder. Prescription Only Medicine	29th May 1998
04543/0396	CP Pharmaceuticals Limited	Monoparin 1,000 iu/ml	Heparin Sodium 1000.000 iu/ml	Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion. In extracorporeal circulation and haemodialysis. Prescription Only Medicine	6th March 1998
04543/0397	CD Pharmaceuticals Limited	Monoparin 5,000 iu/ml	Heparin Sodium 5000.000 iu/ml	Prophylaxis of deep vein thrombosis and pulmonary embolism. Treatment of deep vein thrombosis, pulmonary embolism, unstable angina pectoris and acute peripheral arterial occlusion. Prophylaxis of mural thrombosis following myocardial infarction. In extracorporeal circulation and haemodialysis. Prescription Only Medicine	6th March 1998
04569/0341	Generics (UK) Limited	Aciclovir Sodium for Infusion BP 250 mg	Aciclovir 250.000 mg	Severe primary genital herpes infections in immunologically normal patients. Herpes simplex encephalitis. Herpes simplex infections in the neonate and the infant up to 3 months of age. Severe recurrent infections caused by Varicella zoster virus in immunologically normal patients. Prophylaxis of Herpes simplex virus infections in immunocompromised patients. Herpes simplex virus infections in immunocompromised patients. Primary and recurrent infections caused by Varicella zoster virus in immunocompromised patients. Prescription Only Medicine	11th June 1998
04569/0342	Generics (UK) Limited	Aciclovir Sodium for Intravenous Infusion BP 500 mg	Aciclovir 500.000 mg	(See PL 04569/0341) Prescription Only Medicine	11th June 1998
04917/0021	Pinewood Laboratories Limited	Acidex Liquid	Calcium Carbonate 80.000 mg, Sodium Alginate 250.000 mg, Sodium Bicarbonate 133.500 mg.	Alleviates the painful conditions resulting from the reflux of gastric acid and bile into the oesophagus by suppressing the reflux itself. It is indicated in heartburn, including heartburn of pregnancy, dyspepsia associated with gastric reflux, hiatus hernia, reflux oesophagitis, regurgitation and all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux. General Sales List	25th March 1998
04917/0022	Pinewood Laboratories Limited	Pinadone Methadone Mixture DTF Sugar Free 1 mg/ml	Methadone Hydrochloride 5.000 mg	Used as part of the treatment of dependence on opioid drugs. It is administered in doses sufficient to suppress withdrawal symptoms. Prescription Only Medicine	30th March 1998
05036/0147	M. K. Shah, t/a M. K. Shah Pharmaceuticals	Losec 20 mg Capsules	Omeprazole 20.000 mg	Oesophageal reflux disease. Prescription Only Medicine	16th June 1998
05662/0435	Dowelhurst Limited	Prozac 20 mg Capsules/ Fluoxetine Capsules 20 mg	Fluoxetine Hydrochloride 22.360 mg	For treatment of depressive illness. Prescription Only Medicine	19th June 1998
05662/0453	Dowelhurst Limited	Lamisil cream/Terbinafine Hydrochloride 1% cream	Terbinafine Hydrochloride 1.000% ww	Fungal infections of the skin. Prescription Only Medicine	11th June 1998
05662/0456	Dowelhurst Limited	Augmentine 625 mg Tablets/Co-Amoxiclav 500/125 mg Tablets	Amoxycillin 500.000 mg, Clavulanic Acid 125.000 mg	The short term treatment of bacterial infections. Prescription Only Medicine	9th June 1998
05662/0467	Dowelhurst Limited	Mobic 7.5 mg tablets/ Meloxicam 7.5 mg tablets/ Movalis 7.5 mg tablets	Meloxicam 7.500 mg	Symptomatic treatment of ankylosing spondylitis, rheumatoid arthritis, osteoarthrosis. Prescription Only Medicine	5th June 1998
05662/0488	Dowelhurst Limited	Seroxat 20 mg tablets/ Paroxetine tablets 20 mg	Paroxetine 20.000 mg	Treatment of the symptoms of depressive illness. Prescription Only Medicine	16th June 1998
PI/05662/0507	Dowelhurst Limited	Zoladex LA 10.8 mg Injection/Zoladex 10.8 mg Injection	Goserelin 10.800 mg	Prostate cancer. Prescription Only Medicine	27th May 1998
PI/06464/0332	Waymade Plc	Duovent Inhaler	Fenoterol Hydrobromide 100.000 mcg Ipratropium Bromide 40.000 mcg	Reversible airways obstruction. Prescription Only Medicine	8th June 1998
PI/06464/0459	Waymade Plc	Fosamax Tablets	Alendronate Sodium 13.050 mg	Treatment of Osteoporosis in post-menopausal women. Prescription Only Medicine	5th June 1998
PI/06464/0484	Waymade Plc	Plendil 5 mg Tablets	Felodipine 5.000 mg	Hypertension; Angina Pectoris. Prescription Only Medicine	19th June 1998
PI/06464/0501	Waymade Plc	Serevent 50 microgram Accuhaler	Salmeterol Xinafoate 72.500 mcg	Reversible airways obstruction. Prescription Only Medicine	3rd June 1998
06464/0505	Waymade Plc	Rheumatac Retard 75	Diclofenac Sodium 75.000 mg	Rheumatoid arthritis, osteoarthritis, acute gout, low back pain, relief of pain in fractures, acute musculo-skeletal disorders and trauma including periarthritis (particularly frozen shoulder), bursitis, tendinitis, tenosynovitis, dislocations, sprains and strains, ankylosing spondylitis, and the control of pain and inflammation in orthopaedic, dental and other minor surgery. Prescription Only Medicine	27th March 1998
06464/0506	Waymade Plc	Chemydur 60XL	Isosorbide 5-Mononitrate 60.000 mg	Prophylactic treatment of angina pectoris. Prescription Only Medicine	12th March 1998
PI/06679/0218	Polyfarma Limited	Plaquenil 200 mg Tablets	Hydroxychloroquine Sulphate 200.000 mg	Rheumatoid Arthritis. Prescription Only Medicine	1st June 1998
PI/06792/0368	Europharm of Worthing Limited	Lansoprazole 15 mg Capsules	Lansoprazole 15.000 mg	For the treatment of acid related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	22nd May 1998
PI/06792/0384	Europharm of Worthing Limited	Beta-Adalat Capsules	Atenolol 50.000 mg Nifedipine 20.000 mg	Management of hypertension and chronic stable angina pectoris. Prescription Only Medicine	1st June 1998
106792/0394	Europharm of Worthing Limited	Didronel 200 mg Tablets	Etidronate Disodium 200.000 mg	Osteitis Deformans. Prescription Only Medicine	27th May 1998
06831/0055	Ethical Generics Limited	Aciclovir 250 mg for IV Infusion	Aciclovir Sodium 274.400 mg	Aciclovir for intravenous infusion is indicated for the following: the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised; the prophylaxis of Herpes simplex infections in immunocompromised patients; the treatment of Varicella zoster infections; the treatment of herpes encephalitis; the treatment of Herpes simplex infections in the neonate and infant up to 3 months of age. Prescription Only Medicine	15th June 1998
08747/0216	Chemilines Limited	Budesonide Turbohaler 400 microgram	Budesonide 400.000 mcg	Bronchial Asthma. Prescription Only Medicine	3rd June 1998
08747/0222	Chemilines Limited	Paludrine Tablets/Proguanil Hydrochloride 100 mg Tablets	Proguanil Hydrochloride 100.000 mg	Anti-malarial agent. Pharmacy Medicine	29th May 1998
08821/0015	Monsanto Plc	Femulen	Ethynodiol Diacetate BP 0.50 mg	Oral contraception. Prescription Only Medicine	19th March 1998
08821/0036	Monsanto Plc	Noriday	Norethisterone .350 mg	A progestogen oral contraceptive, it is particularly useful for women for whom oestrogens may not be appropriate. Prescription Only Medicine	24th March 1998
08821/0037	Monsanto Plc	Brevinor	Ethinyloestradiol .036 mg and Norethisterone .500 mg	For oral contraception, with the benefit of a low intake of oestrogen. Prescription Only Medicine	24th March 1998
08821/0039	Monsanto Plc	Norinyl-l	Mestranol .050 mg and Norethisterone 1.000 mg	Norinyl-l is indicated for oral contraception, with the benefit of a low intake of oestrogen. Prescription Only Medicine	11th March 1998
08821/0040	Monsanto Plc	Norimin	Ethinyloestradiol .036 mg and Norethisterone 1.000 mg	Norimin is indicated for oral contraception, with the benefit of a low intake of oestrogen. Prescription Only Medicine	11th March 1998
08821/0041	Monsanto Plc	Synphase	Blue Tablets: Ethinyloestradiol .035 mg and Norethisterone .500 mg White Tablets: Norethisterone 1.000 mg and Ethinyloestradiol .035 mg	Synphase is indicated for oral contraception, with the benefit of a low intake of oestrogen. Prescription Only Medicine	11th March 1998
08821/0044	Monsanto Plc	Anthrotec 75	Diclofenac Sodium 75.000 mg Misoprostol 200.000 mcg	For patients who require the non-steroidal anti-inflammatory drug diclofenac together with misoprostol. The diclofenac component is indicated for the symptomatic treatment of osteoarthritis and rheumatoid arthritis. The misoprostal component is indicated for patients with a special need for the prophylaxis of NSAID-induced gastric and duodenal ulceration. Prescription Only Medicine	31st March 1998
08821/0051	Monsanto Plc	Condrotec	Misoprostol 200.000 mcg Naproxen 500.000 mg	For patients who require naproxen 500 mg twice daily together with misoprostol 200 micrograms twice daily. The naproxen component is indicated for the treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis) and ankylosing spondylitis. The misoprostal component is indicated for the prophylaxis of NSAID-induced gastroduodenal ulceration. Prescription Only Medicine	31st March 1998
10038/0031	Elan Pharma Limited	Nifensar XL 20 mg	Nifedipine 20.000 mg	In the management of mild to moderate hypertension (supine diastolic blood pressure of 95-119 mmHg) either as a monotherapy or in conjunction with B-blockers or diuretics. Prophylaxis of chronic stable angina pectoris. Prescription Only Medicine
10038/0032	Elan Pharma Limited	Nifensar XL 50 mg	Nifedipine 50.000 mg	See PL 10038/0031. Prescription Only Medicine	31st March 1998
10038/0033	Elan Pharma Limited	Univer Capsules 120 mg	Verapamil Hydrochloride BP 120.0 mg	Mild to moderate hypertension. Angina pectoris. Prescription Only Medicine	23rd March 1998
10038/0034	Elan Pharma Limited	Univer Capsules 180 mg	Verapamil Hydrochloride BP 180.0 mg	See PL 10038/0033. Prescription Only Medicine	23rd March 1998
10038/0035	Elan Pharma Limited	Univer Capsules 240 mg	Verapamil Hydrochloride BP 240.0 mg	See PL 10038/0033. Prescription Only Medicine	23rd March 1998
10256/0345	Stephar (UK) Limited	Zyrtec 10 mg Tablets	Cetirizine Hydrochloride 10.000 mg	For the treatment of perennial rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria. Prescription Only Medicine	18th June 1998
10256/0350	Stephar (UK) Limited	Budesonide Turbohaler 400.000 microgram	Budesonide 400.000 mcg	Bronchial asthma. Prescription Only Medicine	11th June 1998
10256/0355	Stephar (UK) Limited	Imdur 60 mg Tablets	Isosorbide mononitrate 60.000 mg	Prophylactic treatment of angina pectoris. Prescription Only Medicine	3rd June 1998
10380/0205	Swinghope Limited	Lansox 30 capsules/Zoton 30 capsules/Lansoprazole 30 mg capsules	Lansoprazole 30.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	16th June 1998
10380/0206	Swinghope Limited	Lansox 15 capsules/Zoton 15 capsules/Lansoprazole 15 mg capsules	Lansoprazole 15.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	17th June 1998
10380/0209	Swinghope Limited	Renitec 20 mg tablets/Enalapril Maleate 20 mg tablets	Enalapril Maleate 20.000 mg	Hypertension. Prescription Only Medicine	22nd May 1998
10380/0211	Swinghope Limited	Brufen Retard 800 tablets/Brufen Retard tablets	Ibuprofen 800.000 mg	Anti-inflammatory. Prescription Only Medicine	2nd June 1998
10380/0239	Swinghope Limited	Zoton 15 Capsules/Lansoprazole 15 mg Capsules	Lansoprazole 15.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	22nd May 1998
10380/0240	Swinghope Limited	Zoton 30 Capsules/Lansoprazole 30 mg Capsules	Lansoprazole 30.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	22nd May 1998
10383/0567	Primecrown Limited	Casodex 50 mg Tablets/Bicalutamide 50 mg Tablets	Bicalutamide 50.000 mg	Advanced prostate cancer. Prescription Only Medicine	22nd May 1998
10673/0009	Octapharma Ltd.	Octaplas 200 ml	Human plasma protein solution 4.500 wv	Indications are identical to those for fresh frozen plasma (FFP): Complex deficiencies of coagulation factors such as consumption coagulopathy, e.g. disseminated intravascular coagulation (DIC), or coagulopathy due to severe hepatic failure or massive transfusion. Isolated coagulation factor deficiency, e.g. Factor V or Factor XI, where no specific coagulation factor concentrate is available. Substitution therapy in coagulation factor deficiencies, when emergency situations, e.g. haemorrhage do not allow a precise laboratory diagnosis, or when a specific coagulation factor concentrate is not available. Rapid reversal of effects of oral anticoagulants (coumarin or indanedione type), when vitamin K is insufficient due to impaired liver function or in emergency situations. Thrombotic thrombocytopenic purpura (TTP), usually in conjunction with plasma exchange. In intensive plasma exchange procedures, it should only be used to correct the coagulation abnormality when abnormal haemorrhage occurs. Prescription Only Medicine	5th March 1998
10949/0302	Glaxo Wellcome UK Limited	Permethrin Creme Rinse	Permethrin Medical Grade 1.000 ww	The treatment of infections with the head louse, Pediculus Humanus Capitis. Pharmacy Medicine	23rd June 1998
11159/0001	Istituto Luso Farmaco d’Italia SPA	Retalzem 60	Diltiazem Hydrochloride 60.000 mg	Prophylaxis and treatment of angina pectoris. Prescription Only Medicine	5th March 1998
11314/0085	Seton Products Ltd.	Uriflex G	Citric Acid Monohydrate 3.230 wv Magnesium Oxide Light 0.380 wv Sodium Hydrogen Carbonate 0.700 wv	Used in catheter care to prevent or minimise catheter encrustation and crystallisation and so to reduce the risk of trauma during removal. It is administered by irrigation. Pharmacy Medicine	6th March 1998
11314/0086	Seton Products Ltd.	Uriflex R	Citric Acid Monohydrate 6.000 wv Gluconolactone 0.600 wv Light Magnesium Carbonate 2.800 wv	To be used in catheter care to prevent or minimise catheter encrustation and crystallisation, to aid in the dissolution of tenacious crystallisaton and so to reduce the risk of trauma during removal of catheters. Pharmacy Medicine	6th March 1998
11314/0102	Seton Products Ltd.	Full Marks Mousse	Phenothrin 0.500 ww	For treatment of head lice infestations. Pharmacy Medicine	31st March 1998
11382/0027	Eastern Pharmaceuticals Ltd.	Konsyl-Orange Sugar Free	Ispaghula Husk 60.300 ww	For treatment of constipation. General Sales List	30th March 1998
11723/0254	Sanofi Winthrop Limited	Gabitril 5mg	Tiagabine Hydrochloride Monohydrate 5.730 mg	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.	1st March 1998
11723/0255	Sanofi Winthrop Limited	Gabitril 10 mg	Tiagabine Hydrochloride Monohydrate 11.460 mg	(See PL 11723/0254). Prescription Only Medicine.	1st March 1998
11723/0256	Sanofi Winthrop Limited	Gabitril 15 mg	Tiagabine Hydrochloride Monohydrate 17.190 mg	(See PL 11723/0254). Prescription Only Medicine	1st March 1998
12724/0219	Regent-GM Laboratories Ltd.	Aspirin Tablets BP 300mg	Aspirin 300.00 mg	For the relief of mild to moderate pain and reduction of fever associated with upper respiratory tract infections, headaches, migraine, rheumatic pains, myalgias, neuritis and toothache. Pharmacy Medicine General Sales List	31st May 1998
12724/0220	Regent-GM Laboratories Limited	Childrens Cough Balsam Linctus	Ipecacuanha Liquid Extract 0.005 ml Liquorice Liquid Extract 0.125 ml	For the symptomatic treatment of productive cough in children. Pharmacy Medicine	31st May 1998
12724/0221	Regent-GM Laboratories Limited	Codeine Linctus BP	Codeine Phosphate 15.000 mg	For the relief of dry and painful cough. Pharmacy Medicine	31st May 1998
12724/0224	Regent-GM Laboratories Limited	Junior Expectorant Elixir	Guaiphenesin 50.000 mg Pseudoephedrine Hydrochloride 15.000 mg	For the symptomatic relief of upper respiratory tract infections Pharmacy Medicine	31st May 1998
12724/0225	Regent-GM Laboratories Limited	Kaolin and Morphine Mixture BP	Light Kaolin (Sterilised) 1.00 gm Chloroform and Morphine Tincture 0.20 ml	For the symptomatic treatment of chronic diarrhoea Pharmacy Medicine	31st May 1998
12724/0226	Regent-GM Laboratories Limited	Menthol and Wintergreen Cream	Eucalyptus Oil 1.30% ww Menthol 0.23% ww Methyl Salicylate 11.22% ww Thymol 0.75% ww Camphor 0.38% ww Volatile Oil of Mustard 1949 0.07% ww	For the symptomatic relief of rheumatic pains, stiff neck, chilblains and sprains General Sales List	31st May 1998
12724/0227	Regent-GM Laboratories Limited	Mentholated Balsam Linctus	Capsicum Oleoresin 0.080 mg Liquorice Liquid Extract 0.640 ml Menthol 0.250 mg	For the symptomatic relief of coughs and colds Pharmacy Medicine	31st May 1998
12724/0228	Regent-GM Laboratories Limited	Paracetamol Tablets BP 500 mg	Paracetamol Powder 500.00 mg	For the relief of headaches, migraine, neuralgia, rheumatic aches and pains. Relief of colds and influenza Pharmacy Medicine General Sales List	31st May 1998
12724/0230	Regent-GM Laboratories Limited	Vitamin A, D and C Tablets (Chewable-Orange)	Ascorbic Acid 30.000 mg Vitamin A 4500.000 iu Vitamin D 400.000 iu	For the prevention of vitamin A, D and C deficiency Pharmacy Medicine	31st May 1998
12762/0023	Goldshield Pharmaceuticals Ltd.	Amsidine	Amsacrine HSE 50 mg	For the induction and maintenance of remission in acute leukaemia of adults. It is effective in patients refractory to the anthracycline antibiotics used singly or in combination with other chemotherapeutic agents, and in patients who were formerly treated with maximum cumulative doses of these antibiotics Prescription Only Medicine	3rd March 1998
13079/0001	South Devon Healthcare NHS Trust	Morphine Sulphate Injection 1 mg/ml	Morphine Sulphate 0.100 wv	Morphine Sulphate Injection is indicated for the relief of moderate to severe pain. Morphine is used especially in pain associated with cancer, myocardial infarction and surgery. Morphine also helps to relieve the anxiety and insomnia which may be associated with severe pain Prescription Only Medicine	16th June 1998
13402/0088	Hoechst Marion Roussel Limited	Norplant	Levonorgestrel 38.000 mg	Contraception. A long term (up to five years) reversible contraceptive system. The efficacy in preventing pregnancy is comparable to or greater than that of other hormonally based and non-hormonally based reversible methods of contraception. The efficacy does not depend on patient compliance but may be reduced in heavier women Prescription Only Medicine	18th March 1998
13402/0089	Hoechst Marion Roussel Limited	Altacite Plus Suspension	Hydrotalcite Light HSE 500.00 mg Dimethicone (Activated) HSE 125.00 mg	For the symptomatic relief of: Dyspepsia: flatulence and abdominal distention, hyperacidity; Gastritis: peptic ulceration, heartburn especially when associated with oesophagitis or hiatus hernia and heartburn and pregnancy Pharmacy Medicine General Sale List	15th March 1998
13606/0070	Co-Pharma Limited	Oxybutynin Hydrochloride Tablets 2.5 mg	Oxybutynin Chloride 2.500 mg	Urinary incontinence, urgency and frequency in unstable bladder conditions. This may be due to idiopathic detrusor instability or due to neurogenic bladder disorders in spina bifida, multiple sclerosis and other such conditions. In children over the age of 5 years, it may be used not only to treat neurogenic bladder disorders but may also be used in nocturnal enuresis with drug therapy or non drug therapy, where previously these alone have failed. Prescription Only Medicine	3rd June 1998
13606/0071	Co-Pharma Limited	Oxybutynin Hydrochloride Tablets 5 mg	Oxybutynin Chloride 5.000 mg	See PL 13606/0070. Prescription Only Medicine	3rd June 1998
PI13826/0108	Caseview (PL) Limited	Lansoprazole 15 mg Capsules/Lansox 15 mg Capsules/Zoton 15 mg Capsules	Lansoprazole 15.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	1st June 1998
PI/13826/0117	Caseview (PL) Limited	Zestoretic 20 Tablets	Lisinopril Dihydrate 21.800 mg Hydrochlorothiazide 12.500 mg	Mild to moderate hypertension. Prescription Only Medicine	27th May 1998
14229/0036	Parkfields Pharmaceuticals Ltd.	Salbutamol Nebuliser Solution 5 mg	Salbutamol Sulphate .240 wv	Salbutamol is a selective beta2-agonist which acts on the beta2-adrenoceptors of bronchial muscle at therapeutic doses to provide bronchodilation. With its fast onset of action (within 5 minutes) it is particularly suitable for the management of attacks in asthma. It is indicated for use in the routine management of chronic bronchospasm unresponsive to conventional therapy and the treatment of acute severe asthma. Prescription Only Medicine	23rd June 1998
14229/0037	Parkfields Pharmaceuticals Ltd.	Salbutamol Nebuliser Solution 2.5 mg	Salbutamol Sulphate .120 wv	See PL 14229/0036. Prescription Only Medicine	23rd June 1998
14385/0001	King Pharmaceuticals Limited	Allegron Tablets 10 mg	Nortriptyline Hydrochloride EP 10.0 mg Equivalent to nortriptyline base	For the relief of symptoms of depression. It may also be used for the treatment of some case of nocturnal eneuresis. Prescription Only Medicine	30th March 1998
14385/0002	King Pharmaceuticals Limited	Allegron Tablets 25 mg	Nortriptyline Hydrochloride EP 25.0 mg Equivalent to nortriptyline base	See PL 14385/0001. Prescription Only Medicine	30th March 1998
14385/0003	King Pharmaceuticals Limited	Nebcin Injection 20 mg/2 ml	Tobramycin EP 1.00% w/v	For the treatment of the following infections caused by susceptible micro-organisms: Central nervous system infections, including meningitis, septicaemia and neonatal sepsis; gastro-intestinal infections, including peritonitis and other significant infections such as: complicated and recurrent urinary tract infections, including pyelonephritis and cystitis; lower respiratory tract infections, including pneumonia, bronchopneumonia and acute bronchitis; skin, bone and soft tissue infections, including burns; Nebcin may be considered in serious staphylococcal infections for which penicillin or other less potentially toxic drugs are contra-indicated and when bacterial susceptibility testing and clinical judgement indicate its use. Prescription Only Medicine	30th March 1998
14385/0004	King Pharmaceuticals Limited	Nebcin Injection 40 mg/1ml	Tobramycin EP 4.00% w/v	(See PL14385/0003) Prescription Only Medicine	30th March 1998
14919/0007	Genthon GMBH	Midazolom 1 mg/ml	Midazolam 1.000 mg	As intravenous sedative cover before and during minor medical, dental and surgical procedures such as gastroscopy, endoscopy, cystoscopy, bronchoscopy and cardiac catheterisation. For sedation by continuous infusion in patients in intensive care. As an intramuscular premedication for patients with physical status ASA I-IV who are to undergo surgical procedures. As an alternative intravenous agent for the induction of anaesthesia in high risk and elderly patients especially where cardiovascular stability is of particular importance. Induction is more reliable when heavy opiate premedication has been administered or when Midazolam is given with a narcotic analgesic such as fentayl. Prescription Only Medicine	11th June 1998
14919/0008	Genthon GMBH	Midazolam 2 mg/ml	Midazolam 2.000 mg	(See PL14919/0007) Prescription Only Medicine	11th June 1998
14919/0009	Genthon GMBH	Midazolam 5 mg/ml	Midazolam 5.000 mg	(See PL14919/0007) Prescription Only Medicine	11th June 1998
15142/0002	I C N Pharmaceuticals Limited	Alcobon	Flucytosine EP 2.5 g	For the treatment of systemic yeast and fungal infections due to sensitive organisms: such infections include cryptococcosis, candidiasis, chromonycosis and infections due to torulopsis glabrata and hansenula. Prescription Only Medicine	1st March 1998
15142/0003	I C N Pharmaceuticals Limited	Efudix Cream	Fluorouracil EP 5.00 ww	For the topical treatment of superficial pre-malignant and malignant skin lesions; keratoses including senile, actinic and arsenical forms; keratoacanthorna; Bowen’s disease; superfical basal-cell carcinoma. Deep, penetrating or nodular basal cell and squamous cell carcinomas do not usually respond to Efudix therapy. It should be used only as a palliative therapy in such cases where no other form of treatment is possible. Prescription Only Medicine	1st March 1998
15142/0004	I C N Pharmaceuticals Limited	Librium Capsules 5 mg	Chlordiazepoxide Hydrochloride 5.000 mg	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. Muscle spasm of varied aetiology. Symptomatic relief of acute alcohol withdrawal. Prescription Only Medicine	1st March 1998
15142/0005	I C N Pharmaceuticals Limited	Librium Capsules 10 mg	Chlordiazepoxide Hydrochloride 10.000 mg	(See PL15142/0004). Prescription Only Medicine	1st March 1998
15142/0006	I C N Pharmaceuticals Limited	Mestinon Tablets 60 mg	Pyridostigmine Bromide 62.500 mg	Myasthenia gravis, paralytic ileus and post-operative urinary retention. Prescription Only Medicine	1st March 1998
15142/0007	I C N Pharmaceuticals Limited	Prostigmin Ampoules 0.5 mg/ml	Neostigmine Methylsulfate EP 0.5 mg	(See PL15142/0008) Prescription Only Medicine	1st March 1998
15142/0008	I C N Pharmaceutical Limited	Prostigmin Ampoules 2.5 mg/ml	Neostigmine Methylsulphate BP 2.5 mg	Myasthenia gravis; antagonist to non-depolarising neuromuscular blockade; paralytic ileus; post-operative urinary retention. Prescription Only Medicine	1st March 1998
15419/0001	Lafayette Healthcare Limited	Epi-C Barium Dispersion	Barium Sulphate 70.000 ww	X-ray medium for double contrast radiography of the colon. Pharmacy Medicine	27th March 1998
15419/0002	Lafayette Healthcare Limited	Bubble breaker	Liquid Paraffin BP 63.30 % w/w Simethicone BP 7.44 % w/w	To be added to Barium Enema and administered rectally. To be added to Barium meal to be taken by mouth. Pharmacy Medicine	27th March 1998
15513/0063	Warner-Lambert Consumer Healthcare	Caladryl Lotion	Diphenydramine Hydrochloride EP 1.0 wv Zinc Oxide EP 8.0 wv Racemic Camphor EP 0.1 wv	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	16th March 1998
15513/0071	Warner-Lambert Consumer Healthcare	Benylin Four Flu Hot Drink Two	Diphenydramine Hydrochloride 25.000 mg Paracetamol 1000.000 mg Phenylephrine Hydrochloride 12.000 mg	For the relief of symptoms associated with colds and flu; including coughing, fever, headache, muscular aches and pains and congestion. Pharmacy Medicine	5th March 1998
15814/0055	O.P.D. Laboratories Limited	Lamisil Tablets/Terbinafine 250 mg Tablets/Lamisil 250 mg Tablets	Terbinafine Hydrochloride 281.250 mg	Fungal infections of the skin and nails. Prescription Only Medicine	27th May 1998
15814/0083	O.P.D. Laboratories Limited	Augmentine 625 mg tablets/Co-Ammoxiclav 500/125 mg tablets/125 mg tablets	Amoxycillin 500.000 mg Clavulanic Acid 125.000 mg	Short term treatment of bacterial infections. Prescription Only Medicine	9th June 1998
15814/0099	O.P.D. Laboratories Limited	Coversyl 4 mg tablets/Perindopril Tert-Butylamine salt 4 mg tablets	Perindopril Tert-Butylamine salt 4.000 mg	Hypertension. Prescription Only Medicine	22nd June 1998
15922/0001	Apotex Europe (Pty) Limited	Apo-Diclo SR Tablets 75 mg	Diclofenac Sodium 75.000 mg	Relief of all grades of pain and inflammation in a variety of conditions, including:—arthritic conditions: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout; acute musculo-skeletal disorders such as periarthritis, tendinitis, tenosynovitis, bursitis; other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery. Prescription Only Medicine	23rd March 1998
15922/0002	Apotex Europe (Pty) Limited	Apo-Diclo SR Tablets 100 mg	Diclofenac Sodium 100.000 mg	See PL 15922/0001. Prescription Only Medicine	23rd March 1998
16020/0002	Cusi (UK) Ltd.	Timolol Eye Drops 0.25%	Timolol 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. May be used alone or in combination with other glaucoma medications. Prescription Only Medicine	9th June 1998
16020/0003	Cusi (UK) Ltd.	Timolol Eye Drops 0.5%	Timolol Maleate .680 wv	(See PL/16020/0002) Prescription Only Medicine	9th June 1998
16033/0006	Chiron Behring GMBH & Co.	Begrivac 96/97	A/Wuhan/359/95 (H3N2)-Like 15.000 mcg B/Beijing/184/93-Like 15.000 mcg Virus Influenza A/Singapore/6/86 (H1N1)-Like strain 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 the basis of national immunisation policies. Prescription Only Medicine	23rd March 1998
16046/0001	L Molteni & C Dei F.Lli Alitti Societa di Esercizion SPA	Diabrezide	Gliclazide 80.000 mg	Treatment of non-insulin-dependent diabetes mellitus. Prescription Only Medicine	10th March 1998
16189/0001	Takeda UK Limited	Amias Tablets 2 mg	Candesartan Cilexetil 2.000 mg	Essential hypertension. Prescription Only Medicine	26th March 1998
16189/0002	Takeda UK Limited	Amias Tablets 4 mg	Candesartan Cilexetil 4.000 mg	Essential hypertension. Prescription Only Medicine	26th March 1998
16189/0003	Takeda UK Limited	Amias Tablets 8 mg	Candesartan Cilexetil 8.000 mg	Essential hypertension. Prescription Only Medicine	26th March 1998
16189/0004	Takeda UK Limited	Amias Tablets 16 mg	Candesartan Cilexetil 16.000 mg	Essential hypertension. Prescription Only Medicine	26th March 1998
16853/0005	Alliance Pharmaceuticals Ltd.	Calcium Sandoz Syrup	Calcium Glubionate 1.09 gm Calcium Lactobionate 0.727 gm	As an adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis. In the arrest or slowing down of bone demineralisation in osteoporosis where other effective treatment is contraindicated. As a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high. Neonatal hypocalcaemia. Pharmacy Medicine	25th June 1998
16970/0001	CIBA Vision Europe Limited	CIBA Vision Timolol 0.25% Eye Drops	Timolol Maleate 3.400 mg/ml	Reduction of elevated intraocular pressure in conditions such as ocular hypertension; chronic open-angle glaucoma (including aphaki patients); some cases of secondary glaucoma. Prescription Only Medicine	5th June 1998
16970/0002	CIBA Vision Europe Limited	CIBA vision Timolol 0.5% Eye Drops	Timolol Maleate 6.800 mg/ml	(See PL/16970/0001) Prescription Only Medicine	5th June 1998