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
00017/0402	Astra Pharmaceuticals Limited	Unimax 2.5 mg	Felodipine 2.500 mg Ramipril 2.500 mg	Treatment of essential hypertension in patients whose blood pressure is normalised with individual components in the same doses as the proposed fixed combination. Prescription Only Medicine.	25th August 1998
00017/0403	Astra Pharmaceuticals Limited	Unimax 5mg	Felodipine 5.000 mg Ramipril 5.000 mg	See PL 00017/0402 Prescription Only Medicine.	25th August 1998
00017/0407	Astra Pharmaceuticals Limited	Solvent for Losec IV Injection 40 mg	No Actives Present	To be used as a Solvent for i.v. injection with 1 vial of powder for injection which contains Omeprazole sodium Ph. Eur., equivalent to Omeprazole 40mg. Prescription Only Medicine.	17th November 1998
00019/0176	Warner Lambert (UK) Limited	Nipent	Pentostatin 10.000 mg	Treatment of adult patients with hairy cell leukaemia. Prescription Only Medicine.	20th November 1998
00025/0373	Merck Sharp & Dohme Limited	Cosopt	Dorzolamide Hydrochloride 22.260 mg/ml Timolol Maleate 6.830 mg/ml	Treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, or pseudoexfoliative glaucoma when beta-blocker monotherapy is not sufficient. Prescription Only Medicine.	4th August 1998
00116/0315	Baxter Healthcare Limited	Physioneal Glucose 1.36% w/v/13.6 mg/ml	Calcium Chloride Dihydrate .184 gm/l Glucose Monohydrate 15.000 gm/l Magnesium Chloride Hexahydrate .051 gm/l Sodium Bicarbonate 2.100 gm/l Sodium Chloride 5.380 gm/l Sodium Lactate Solution 1.680 gm/l	For whenever peritoneal dialysis is employed, including:—Acute and chronic renal failure;—Severe water retention;—Severe electrolyte imbalance;—Drug intoxication with dialysable substances, when a more adequate therapeutic alternative is not available. Bicarbonate/lacate-based Physioneal peritoneal dialysis solutions with a physiological pH are particularly indicated in patients in whom solutions based on lactate buffer only, with a low pH, cause abdominal pain or discomfort. Prescription Only Medicine.	25th August 1998
00116/0316	Baxter Healthcare Limited	Physioneal Glucose 2.27% w/v/22.7 mg/ml	Calcium Chloride Dihydrate .184 gm/l Glucose Monohydrate 25.000 gm/l Magnesium Chloride Hexahydrate .051 gm/l Sodium Bicarbonate 2.100 gm/l Sodium Chloride 5.380 gm/l Sodium Lactate Solution 1.680 gm/l	See PL 0116/0315 Prescription Only Medicine.	25th August 1998
00116/0317	Baxter Healthcare Limited	Physioneal Glucose 3.86% w/v/38.6 mg/ml	Calcium Chloride Dihydrate .184 gm/l Glucose Monohydrate 42.450 gm/l Magnesium Chloride Hexahydrate .051 gm/l Sodium Bicarbonate 2.100 gm/l Sodium Chloride 5.380 gm/l Sodium Lactate Solution 1.680 gm/l	See PL 0116/0315 Prescription Only Medicine.	25th August 1998
00173/0169	Diomed Developments Limited	Ibumousse	Ibuprofen 5.000% w/w	For backache, Rheumatic and muscular pain, and neuralgia. Also for symptomatic relief of pain due to non-serious arthritic conditions. Pharmacy Medicine.	26th August 1998
00458/0071	Lundbeck Ltd.	Cipramil Drops 40 mg/ml	Citalopram Hydrochloride 44.480 mg/ml	Treatment of depressive illness in the initial phase and as maintenance against potential relapse/recurrence. Also treatment of panic disorder with or without agoraphobia. Prescription Only Medicine.	4th August 1998
00512/0155	Solvay Healthcare Limited	Colofac MR	Mebeverine Hydrochloride 200 mg	For the symptomatic relief of irritable bowel syndrome. Prescription Only Medicine	14th August 1998
00576/0135	Global Pharmaceuticals Ltd	Arthrotec 50 mg Tablets	Diclofenac Sodium 50 mg Misoprostol 200 mcg	Treatment of osteoarthritis and rheumatoid arthritis for patients with a need for the prophylaxis of NSAID-induced gastric and duodenal ulceration. Prescription Only Medicine	26th October 1998
00576/0138	Global Pharmaceuticals Ltd	Pulmicort Turbohaler 200	Budesonide 200 mcg	Bronchial asthma Prescription Only Medicine	6th November 1998
00637/0035	Nycomed Imaging AS	Omnipaque Injection 300 mg I/ml	Iohexol INN 647 mg	Intravenous injection for urography, phlebography, DSA and CT intra-arterial injection for arteriography and DSA subarachnoid use for myelography. Body cavity uses: Arthrography, Hysterosal pingography and Sialography. Prescription Only Medicine	23rd November 1998
00637/0036	Nycomed Imaging AS	Omnipaque Injection 350 mg I/ml	Iohexol INN 755 mg	Intravenous injection for urography, DSA, CT intra-arterial injection for arteriography, cardioangiography. Body cavity, use in G-I Tract. Prescription Only Medicine	23rd November 1998
03132/0125	Novo Nordisk Pharmaceuticals Limited	Kliovance	Estradiol Hemihydrate 1.030 mg Norethisterone Acetate .500 mg	Hormone Replacement Therapy (HRT) for estrogen deficiency symptoms in women who are more than one year past the menopause. Prescription Only Medicine	20th August 1998
03243/0329	Munro Wholesale Medical Supplies Ltd	Flixotide Inhaler 250 micrograms	Fluticasone Propionate 250 mcg	Anti-asthmatic Prescription Only Medicine	18th November 1998
03551/0042	B Braun Melsungen AG	Gelofusine	Succinylated Gelatin WT.AV.MOL.WT. 40 wv 22600 (formed in-situ from Gelatin and Succinic anhydride) Sodium ions (from NaC1 and NaOH) 154 MMOL/Litre 0.35 wv Chloride (from NaC1 and HCL 6M) 125 MMOL/Litre 0.44 wv	As a plasma volume substitute in the initial management of hypovolaemic shock due to, for example, haemorrhage, acute trauma or surgery, burns, sepsis, peritonitis, pancreatitis or crush injury. Gelofusine may be used in the initial treatment of blood loss during pregnancy where plasma volume replacement is needed. Prescription Only Medicine	1st November 1998
03787/0478	Swingward Limited (t/a Medihealth)	Augmentin 625 mg Tablets	Amoxycillin 500 mg Clavulanic Acid 125 mg	Broad spectrum antibiotic Prescription Only Medicine	30th October 1998
03787/0483	Swingward Limited (t/a Medihealth)	Diflucan 150 mg Capsule Fluconazole 150 mg Capsule	Fluconazole 150 mg	The treatment of candidiasis Prescription Only Medicine	4th November 1998
03787/0514	Swingward Limited (t/a Medihealth)	Efexor 37.5 mg Tablets	Venlafaxine Hydrochloride 42.420 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	20th November 1998
03787/0542	Swingward Limited (t/a Medihealth)	Doxazosin 4 mg Tablets	Doxazosin Mesylate 4.850 mg	Hypertension Prescription Only Medicine	3rd November 1998
03787/0545	Swingward Limited t/a Medihealth	Lisinopril 5 mg Tablets Zestril 5 mg Tablets	Lisinopril Dihydrate 5.45 mg	Hypertension. Prescription Only Medicine	30th October 1998
03787/0559	Swingward Limited t/a Medihealth	Oruvail 200 Capsules	Ketoprofen 200 mg	The reduction of joint pain and inflammation. Prescription Only Medicine	30th October 1998
03787/0574	Swingward Limited t/a Medihealth	Serevent Inhaler	Salmeterol 25 mcg	Reversible airways obstruction. Prescription Only Medicine	3rd November 1998
03787/0580	Swingward Limited t/a Medihealth	Enalapril Maleate 20 mg Tablets	Enalapril Maleate 20 mg	Hypertension. Prescription Only Medicine	29th October 1998
03787/0586	Swingward Limited t/a Medihealth	Ikorel 10 mg Tablets	Nicorandil 10 mg	Angina pectoris. Prescription Only Medicine	18th November 1998
04423/0295	Doncaster Pharmaceuticals Group Limited	Ventide Inhaler ventaide Inhaler	Beclomethasone Dipropionate 50 mcg Salbutamol 100 mcg	Reversible airways obstruction. Prescription Only Medicine	27th October 1998
04543/0398	CP Pharmaceuticals Limited	Amoxicillin Sodium for Injection BP 250 mg	Amoxicillin 250 mg	Treatment of bacterial infections such as actinomycosis, biliary-tract infections, bone and joint infections, acute exacerbations of chronic bronchitis, gastroenteritis, (including Escherichia coli enteritis and Salmonella enteritis, but not shigellosis), gonorrhoea, mouth infections, sinusitis, otitis media, pneumonia (except where Mycoplasma suspected), typhoid and paratyphoid fever, urinary-tract infections, bacterial meningitis and the prophylaxis of endocarditis. Treatment of Lyme disease. Prescription Only Medicine	30th October 1998
04543/0399	CP Pharmaceuticals Limited	Amoxicillin Sodium for Injection BP 500 mg	Amoxicillin 500 mg	See PL 04543/0398. Prescription Only Medicine	30th October 1998
04543/0400	CP Pharmaceuticals Limited	Amoxicillin Sodium for Injection BP 1 g	Amoxicillin 1 gm	See PL 04543/0398. Prescription Only Medicine	30th October 1998
04543/0401	CP Pharmaceuticals Limited	Flucloxacillin Sodium for Injection BP 250 mg	Flucloxacillin 250 mg	Treatment of infections due to *-lactamase-producing staphylococci. These infections include bone and joint infections, endocarditis, peritonitis (associated with continuous ambulatory peritoneal dialysis), pneumonia and other respiratory tract infections, skin and soft tissue infections (including cellulitis, impetigo and otitis externa), prophylaxis of infection in major surgical procedures, urinary tract infections, meningitis, septicaemia and toxic shock syndrome. Prescription Only Medicine	30th October 1998
04543/0402	CP Pharmaceuticals Limited	Flucloxacillin Sodium for Injection BP 500 mg	Flucloxacillin 500 mg	See PL 04543/0401. Prescription Only Medicine	30th October 1998
04543/0403	CP Pharmaceuticals Limited	Flucloxacillin Sodium for Injection BP 1 g	Flucloxacillin 1.000 gm	(See PL/04543/0401) Prescription Only Medicine	30th October 1998
05322/0003	Pharbita BV	Forabec 100 micrograms	Beclomethasone Dipropionate .115 mg	For the prophylactic management of asthma, in the following types of patients. Adults Mild asthma: Patients requiring symptomatic bronchodilator asthma medication on a regular basis. Moderate asthma: Patients with unstable or worsening asthma despite prophylactic therapy or bronchodilator alone. Severe asthma: Patients with severe chronic asthma and those who are dependent on systemic corticosteroids for adequate control of symptoms. On transfer to high dose inhaled beclomethasone dipropionate, many patients who are dependent on systemic corticosteroids for adequate control of symptoms may be able to reduce significantly, or eliminate, their requirement for oral corticosteroids. Children: Any child who requires prophylactic asthma medication. Prescription Only Medicine	12th August 1998
05322/0004	Pharbita BV	Forabec 200 micrograms	Beclomethasone Dipropionate .230 mg	(See PL 05322/0003) Prescription Only Medicine	12th August 1998
05322/0005	Pharbita BV	Forabec 400 micrograms	Beclomethasone Dipropionate .460 mg	(See PL 05322/0003) Prescription Only Medicine	12th August 1998
105513/0543	Eurochem Limited	Oruvail 200 mg Capsules	Ketoprofen 200.000 mg	The management of joint pain and inflamation. Prescription Only Medicine	20th November 1998
05544/0091	Sussex Pharmaceutical Ltd	Flu Strength Hot Lemon Powder	Paracetamol 1000.000 mg	For the relief of cold and flu symptoms. General Sales List	13th November 1998
105662/0442	Dowelhurst Limited	Pantoprazole Enteric Coated Tablets 40 mg	Pantoprazole Sodium Sesquihydrate 45.100 mg	Gastrointestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	27th October 1998
105662/0433	Dowelhurst Limited	Clarithromycin 500 mg Tablets Klaricid 500 mg Tablets Zeclar 500 mg Tablets	Clarithromycin 500.000 mg	The treatment of infections caused by susceptible organisms. Prescription Only Medicine	4th November 1998
105662/0457	Dowelhurst Limited	Pulmicort Turbuhaler 100 Budesonide 100 Microgram Turbuhaler Pulmicort Turbohaler 100 Budesonide 100 Microgram Turbohaler	Budesonide 100.000 mcg	Bronchial asthma. Prescription Only Medicine	11th November 1998
105662/0468	Dowelhurst Limited	Enalapril Maleate 20 mg Tablets Renitec 20 mg Tablets	Enalapril Maleate 20.000 mg	Hypertension. Prescription Only Medicine	16th November 1998
105662/0571	Dowelhurst Limited	Carduran 2 mg Tablets Doxazosin Tablets 2 mg	Doxazosin Mesylate 2.430 mg	Hypertension. Prescription Only Medicine	5th November 1998
106464/0510	Waymade Plc	Nizoral Shampoo	Ketoconazole 20.000 mg/ml	Treatment of dandruff, seborrhoeic dermatitis and pityriasis versicolor. Prescription Only Medicine	18th November 1998
106464/0511	Waymade Plc	Fucibet Cream	Betamethasone Valerate .100% ww Fusidic Acid 2.000% ww	The treatment of eczematous dermatoses. Prescription Only Medicine	20th November 1998
06464/0528	Waymade Plc	Daonil 5 mg Tablets	Glibenclamide 5.000 mg	Diabetes. Prescription Only Medicine	28th October 1998
06464/0539	Waymade Plc	Loratadine 10 mg Tablets Clarityne 10 mg Tablets	Loratadine 10.000 mg	Rhinitis. Prescription Only Medicine	18th November 1998
08265/0002	Sankyo Pharma UK Limited	Dermacort Hydrocortisone Cream	Hydrocortisone .100% ww	Treatment of skin irritations, contact dermatitis, allergic contact dermatitis and rashes due to reactions to plants, insect bite, jewellery, toiletries, deodorants, soaps and detergents. Treatment of mild to moderate eczema. Pharmacy Medicine	12th November 1998
08265/0013	Panpharma Limited	Prareduct 10 mg tablets	Pravastatin Sodium 10.000 mg	Hypercholesterolaemia: The reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolaemia who have not responded adequately to dietary measures Coronary Heart Disease: As an adjunct to diet to slow the progressive course of coronary atherosclerosis and reduce the incidence of clinical cardiac events in patients with hypercholesterolaemia and documented atherosclerotic coronary artery disease. Prevention of Coronary Heart Disease: As an adjunct to diet in hypercholesterolaemic patients without clinically evident coronary heart disease to: * reduce the risk of fatal and non-fatal myocardial infarction * reduce the need to undergo myocardial revascularisation procedures * improve survival by reducing cardiovascular deaths. Prescription Only Medicine	20th August 1998
08313/0038	Deproco UK Ltd	Septanest 1:200,000	Articaine Hydrochloride 68.000 mg Epinephrine Bitartrate 15.470 mcg	For Use in Dental Anaesthesia Only. For local or regional dental anaesthesia in patients of at least 12 years who are to undergo the following procedures: Classic operations: single extractions with no complications, multiple extractions, extractions of impacted teeth, trephinement, apical resections, removal of cysts, alveolectomies, preparation of cavity, biopulpectomies, maxillo-facial surgery, crown and bridge procedures. Muco-gingival operations. Prescription Only Medicine	19th August 1998
08313/0039	Deproco UK Ltd	Septanest 1:100,000	Articaine Hydrochloride 68.000 mg Epinephrine Bitartrate 30.940 mcg	For Use in Dental Anaesthesia Only. For local or regional dental anaesthesia in patients of at least 12 years who are to undergo the following procedures: Classic operations: single extractions with no complications, multiple extractions, extractions of impacted teeth, trephinement, apical resections, removal of cysts, alveolectomies, preparation of cavity, biopulpectomies, maxillo-facial surgery, crown and bridge procedures. Muco-gingival operations. Dental surgical procedures where bone removal is necessary. Prescription Only Medicine	19th August 1998
08747/0204	Chemilines Limited	Lansoprazole 15 mg capsules Zoton 15 capsules Lansox 15 Capsules	Lansoprazole 15.000 mg	Acid related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	29th October 1998
08747/0234	Chemilines Limited	Co-Triamterzide Tablets 50/25 Dyazide Tablets	Hydrochlorothiazide 25.000 mg Triamterene 50.000 mg	Hypertension. Prescription Only Medicine	6th November 1998
08747/0251	Chemilines Limited	Lipostat 10 mg Tablets Pravasin 10 mg Tablets Pravastatin Sodium 10 mg Tablets	Pravastatin Sodium 10.000 mg	Hypercholesterolaemia. Prescription Only Medicine	30th October 1998
10256/0263	Stephar (UK) Limited	Premarin 0.625 mg	Conjugated Oestrogens .625 mg	Oestrogen therapy in women without a uterus. Prescription Only Medicine	10th November 1998
10256/0301	Stephar (UK) Limited	Premarin 1.25 mg	Conjugated Oestrogens 1.250 mg	Oestrogen therapy. Prescription Only Medicine	6th November 1998
10256/0361	Stephar (UK) Limited	Azithromycin 250 mg Capsules	Azithromycin Dihydrate 262.050 mg	Infections caused by susceptible organisms. Prescription Only Medicine	28th October 1998
10256/0407	Stephar (UK) Limited	Prothiaden 75 mg Tablets	Dothiepin Hydrochloride 75.000 mg	Symptoms of depressive illness. Prescription Only Medicine	11th November 1998
10380/0178	Swinghope Limited	Cisapride 10 mg Tablets Prepulsid Tablets	Cisapride 10.000 mg	Gastro-oesophagial reflux. Prescription Only Medicine	30th October 1998
10380/0231	Swinghope Limited	Fluoxetine Liquid 20 mg/5 ml Prozac 20 mg/5 ml Liquid	Fluoxetine Hydrochloride 22.360 mg	Depressive illness. Prescription Only Medicine	30th October 1998
10380/0234	Swinghope Limited	Lamotrigine 100 mg Tablets Lamictal 100 mg Tablets	Lamotrigine 100.000 mg	Epilepsy. Prescription Only Medicine	29th October 1998
10380/0237	Swinghope Limited	Sertraline Tablets 100 mg Besitran 100 mg Tablets	Sertraline Hydrochloride 111.900 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	20th November 1998
10380/0241	Swinghope Limited	Cisapride 10 mg Tablets Prepulsid Tablets	Cisapride 10.000 mg	Gastro-oesophagial reflux. Prescription Only Medicine	10th November 1998
10383/0572	Primecrown Limited	Terbutaline Sulphate 500 Microgram Turbohaler Bricanyl Turbohaler	Terbutaline Sulfate .500 mg	Relief and prevention of bronchospasms. Prescription Only Medicine	18th November 1998
10383/0583	Primecrown Limited	Tibolone 2.5 mg Tablets	Tibolone 2.500 mg	Oestrogen deficiency. Prescription Only Medicine	28th October 1998
10383/0614	Primecrown Limited	Bactroban Ointment Mupirocin 2% Ointment	Mupirocin 20.000 mg	The treatment of skin infections. Prescription Only Medicine	18th November 1998
10383/0617	Primecrown Limited	Perindopril Tert-Butylamine salt 4 mg Tablets Coversyl 4 mg Tablets	Perindopril Tert-Butylamine Salt 4.000 mg	Hypertension and heart failure. Prescription Only Medicine	30th October 1998
10592/0126	Smithkline Beecham Plc	Typherix	Salmonella Typhi VI Polysaccharide 25.000 mcg	Active immunisation against typhoid fever for adults and children older than two years of age. Prescription Only Medicine	5th August 1998
11314/0120	Seton Products Ltd.	Compound W Gel	Salicylic Acid 17.000% ww	For the treatment of common warts and verrucae. Pharmacy Medicine	30th October 1998
11723/0246	Sanofi Winthrop Limited	Ticlid	Ticlopidine Hydrochloride 250.000 mg	Reduction of risk of first and recurrent stroke for patients who have experienced at least one of the following events: complete thromboembolic stroke, minor stroke, reversible ischaemic neurological deficit (RIND), or transient ischaemic attach (TIA) including transient monocular blindness (TMB). Reduction of risk of major ischaemic accidents, particularly coronary, in patients presenting with chronic arterial disease of the lower limbs at the stage of intermittent claudication. In view of the risk of serious haematological side effects, the initiation of theraphy should be carried out by a clinician in hopsital. The prescriber needs to carefully consider the risks and benefits of ticlopidine versus aspirin as the benefit/risk ratio is greater in patients for whom aspirin is not suitable. Prescription Only Medicine	21st August 1998
11972.0004	Nexstar Pharmaceuticals Limited	AmBisome Injection (liposomal amphotericin)	Amphotericin 50.000 mg	The treatment of severe systemic and/or deep mycoses where toxicity (particularly nephrotoxicity) precludes the use of conventional systemic amphotericin B in effective dosages. The treatment of visceral leishmaniasis in immunocompetent patients including both adults and children. The empirical treatment of presumed fungal infections in febrile neutropenic patients, where the fever has failed to respond to broad spectrum antibiotics and appropriate investigations have failed to define a bacterial or viral cause. Infections successfully treated with AmBisome include: disseminated candidiasis, aspergillosis, mucormycosis, chronic mycetoma, cryptococcal meningitis and visceral leishmaniasis. This drug should not be used to treat the common clinically in apparent forms of fungal disease which show only positive skin or serologic tests. Prescription Only Medicine	13th August 1998
13606/0045	Co-Pharma Limited	Loperamide Hydrochloride Capsules 2mg	Loperamide Hydrochloride 2.000 mg	Treatment of acute diarrhoea of any aetiology including acute exacerbation of chronic diarrhoea for periods of up to 5 days, in adults and children over 4 years, and chronic diarrhoea in adults. Since persistent diarrhoea can be an indicator of potentially more serious conditions, it should not be used for prolonged periods until the underlying cause of the diarrhoea has been investigated. Treatment of acute diarrhoea. Prescription Only Medicine Pharmacy Medicine	4th November 1998
14069/0057	Denfleet International Limited	Propofol 1% Injection	Propofol 1.000% wv	Intravenous anaesthetic agent. Prescription Only Medicine	2nd November 1998
14894/0016	Ranbaxy (UK) Limited	Co-amoxiclav Tablets 250/125 mg	Amoxycillin Trihydrate 297.956 mg Potassium Clavulanate 162.498 mg	An antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics. For short-term treatment of bacterial infections when amoxycillin resistant beta-lactamase producing strains are suspected to be the cause, at the following sites: Upper respiratory tract infections (including otorhinolaryngeal) e.g. tonsillitis, sinusitis, otitis media and lower respiratory tract infections e.g. acute and chronic bronchitis, lobar and bronchopneumonia, where the infections are often caused by Streptococcus pneumoniac, Haemophilus influenzae, and (upper repiratory tract) Streptococcus pyogenes. Genito-urinary tract infections e.g. cystitis (especially when recurrent or complicated, but excluding prostatitis), urethritis, pyelonephritis. Skin and soft tissue infections. Bone and joint infections e.g. osteomyelitis. Other infections e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis. Prescription Only Medicine	19th November 1998
14784/0017	Ranbaxy (UK) Limited	Co-amoxiclav Tablets 500/125 mg	Amoxycillin Trihydrate 595.912 mg Potassium Clavulanate 162.498 mg	(See PL 14894/0016) Prescription Only Medicine	19th November 1998
14919/0005	Genthon GMBH	Aciclovir Cream BP 5% ww Zuvogen Cream	Aciclovir 50.000 mg	For treatment of herpes labialis (cold sore) in non-immunocompromised patients. Treatment of initial herpes genitalis. Prescription Only Medicine	3rd November 1998
15281/0002	Alza Limited	Actisite Tetracycline Fibre	Tetracycline Hydrochloride 12.700 mg	Adjunct to conventional scaling theraphy of chronic periodontal disease with pocketing in adults. Prescription Only Medicine	11th November 1998
15361/0031	P.I.E. Pharma Limited	Trusopt Ophthalmic solution 2% Dorzolamide Ophthalmic solution 2%	Dorzolamide Hydrochloride 22.260 mg	The treatment of elevated intra-ocular pressure. Prescription Only Medicine	20th November 1998
15361/0087	P.I.E. Pharma Limited	Ropinirole 1 mg Tablets Requip 1 mg Tablets	Ropinirole 1.000 mg	Parkinsons disease. Prescription Only Medicine	30th October 1998
15361/0088	P.I.E. Pharma Limited	Requip 2 mg Tablets Ropinirole 2 mg Tablets	Ropinirole 2.000 mg	Parkinsons disease. Prescription Only Medicine	29th October 1998
15361/0089	P.I.E. Pharma Limited	Requip 5 mg Tablets Ropinirole 5 mg Tablets	Ropinirole 5.000 mg	Parkinsons Disease. Prescription Only Medicine	30th October 1998
15361/0098	P.I.E. Pharma Limited	Budesonide Suspension for Nebulisation 0.5 mg Pulmicort Respules 0.5 mg	Budesonide .500 mg	Bronchial asthma. Prescription Only Medicine	10th November 1998
15814/0068	OPD Laboratories Limited	Bricanyl Turbohaler Terbutaline Sulphate 500 Microgram Turbohaler	Terbutaline Sulphate .500 mg	Relief and prevention of bronchospasms. Prescription Only Medicine	18th November 1998
15814/0105	OPD Laboratories Limited	Efexor 50 mg Tablets Venlafaxine Tablets 50 mg	Venlafaxine Hydrochloride 56.560 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	20th November 1998
16020/0005	Cusi (UK) Limited	Isopto Carpine 0.5%	Pilocarpine Hydrochloride .500% wv	Treatment of Glaucoma. Chronic Simple Glaucoma:Patients may be maintained on pilocarpine as long as intraocular pressure is controlled and there is no deterioration in the visual fields. Acute (Closed-Angle) Glaucoma: Pilocarpine may be used alone or in conjunction with other agents to decrease intraocular pressure prior to surgical treatment. Miosis: To counter the effects of cycloplegic and mydriatic eye drops. Prescription Only Medicine	20th November 1998
16020/0006	Cusi (UK) Limited	Isopto Carpine 1%	Pilocarpine Hydrochloride 1.000% wv	(See PL 16020/0005) Prescription Only Medicine	20th November 1998
16020/0007	Cusi (UK) Limited	Isopto Carpine 2%	Pilocarpine Hydrochloride 2.000% wv	(See PL 16020/0005) Prescription Only Medicine	20th November 1998
16020/0008	Cusi (UK) Limited	Isopto Carpine 3% Eye Drops	Pilocarpine Hydrochloride 3.000% wv	(See PL 16020/0005) Prescription Only Medicine	20th November 1998
16020/0009	Cusi (UK) Limited	Isopto Carpine 4%	Pilocarpine Hydrochloride 4.000% wv	(See PL 16020/0005) Prescription Only Medicine	20th November 1998
16378/0015	Beachcourse Limited	Losec 20 mg Capsules	Omeprazole 20.000 mg	The treatment of gastro-intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	16th November 1998
16378/0063	Beachcourse Limited	Fluoxetine 20 mg Capsules Prozac 20 mg Capsules	Fluoxetine Hydrochloride 22.360 mg	The treatment of symptoms of depressive illness. Prescription Only Medicine	3rd November 1998
16378/0094	Beachcourse Limited	Risperidone 1 mg Tablets Risperdal 1 mg Tablets	Risperidone 1.000 mg	The treatment of Schizophrenic psychoses. Prescription Only Medicine	18th November 1998
16782/0004	BR Pharma International	Pantoprazole Enteric Coated Tablets 40 mg	Pantoprazole Sodium Sesquihydrate 45.100 mg	The treatment of gastro-intestinal diseases requiring a reduction in acid secretion. Prescription Only Medicine	11th November 1998
16794/0003	Cambridge Healthcare Supplies Limited	Clinitar Cream 1%	Stantar 25% 1.000% ww	Subacute and chronic psoriasis and eczema. For use alone or with UVB irradiation. Pharmacy Medicine	31st October 1998
16794/0004	Cambridge Healthcare Supplies Limited	Clinitar Shampoo 2%	Stantar 25% 2.000% ww	For the treatment of pityriasis simplex capitis (dandruff). Sebhorroeic dermatitis of the scalp, and psoriasis of the scalp. Pharmacy Medicine	31st October 1998
16794/0005	Cambridge Healthcare Supplies Ltd.	Cam Mixture	Ephedrine Hydrochloride EP 4.0 mg	For the symptomatic treatment of bronchospasm in children and adults with bronchitis. Pharmacy Medicine	31st October 1998
16900/0008	Dallas Burston Healthcare Limited	Saline Steripoules 2.5 ml	Sodium Chloride 9.000 mg	For the dilution of solutions for nebulisation. Prescription Only Medicine	13th November 1998
16900/0021	Dallas Burston Healthcare Limited	Beclo-aqua Hayfever Nasal Spray Beclometasone Dipropionate Hayfever Aqueous Nasal Spray Zonivent Hayfever Aquanasal Spray 50 mcg	Beclometasone Dipropionate .385 mg/ml	Prevention and treatment of allergic seasonal or perennial rhinitis and vasomotor rhinitis. Prescription Only Medicine	19th November 1998
17232/0001	Newport Pharmaceuticals Limited	Imunovir	Inosine Pranobex 500.000 mg	In the management of (a) Mucocutaneous infections due to herpes simplex (type I and/or type II) (b) Genital warts as adjunctive therapy to podophyllin or carbon dioxide laser (c) Subacute sclerosing panencephalitis (SSPE). Prescription Only Medicine	15th November 1998