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
00022/0202	Pharmacia Laboratories Limited	Fragmin Graduated Syringe	Dalteparin Sodium 10000.000 iu	Unstable coronary artery disease, defined as newly developed or increased angina or ongoing chest pain, with the electrocardiogram changes of non Q-wave myocardial infarction. Prescription Only Medicine	24th April 1998
00030/0124	Novartis Consumer Health UK Limited	Savlon Dry Savlon Dry Antiseptic	Povidone-Iodine 1.140 ww	A broad spectrum antiseptic for topical application in the treatment and prevention of infection in wounds, including burns, varicose ulcers and bed sores. General Sales List	15th April 1998
00031/0498	Roche Products Limited	Neupogen Syringe 10 mu	Filgrastim 10.000 mu	For the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation in patients considered to be at increased risk of prolonged severe neutropenia. Neupogen is indicated for the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy in order to accelerate haematopoietic recovery by infusion of such cells after myelosuppressive or myeloablative therapy. The safety and efficacy of it are similar in adults and children receiving cytotoxic chemotherapy. In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an ANC of *0.5 × 109/L, and a history of severe or recurrent infections, long-term administration is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Prescription Only Medicine	21st April 1998
00031/0499	Roche Products Limited	Neupogen Syringe 30 mu	Filgrastim 30.000 mu	See PL00031/0498 Prescription Only Medicine	21st April 1998
00031/0500	Roche Products Limited	Neupogen Syringe 48 mu	Filgrastim 48.000 mu	See PL00031/0498 Prescription Only Medicine	21st April 1998
00041/0075	Bioglan Laboratories Ltd	Xepin	Doxepin Hydrochloride 5.000 ww	For the relief of pruritus associated with eczema. Prescription Only Medicine	27th April 1998
00079/0344	Beecham Group PLC	Hexylresorcinol and Benzalkonium Chloride Lozenges	Benzalkonium Chloride Solution 1.200 mg Hexylresorcinol 2.500 mg	(1) For the symptomatic relief of sore throat, and its associated pain. (2) For the symptomatic relief of pharyngitis. General Sales List	6th July 1998
00101/0483	Novartis Pharmaceuticals UK Limited	Neoral Soft Gelatin Capsules 10 mg	Cyclosporin 10.000 mg	Transplantation indications Organ transplantation: Prevention of graft rejection following kidney, liver, heart, combined heart-lung, lung or pancreas transplants. Treatment of transplant rejection in patients previously receiving other immunosuppresive agents. Bone marrow transplantation: Prevention of graft rejection following bone marrow transplanation and prophylaxis of graft-versus-host disease (GVHD). Treatment of established graft-versus-host disease (GVHD). Non-transplantation indications Psoriasis in patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate. Atopic dermatitis: for the short term treatment (8 weeks) of patients with severe atopic dermatitis in whom conventional therapy is ineffective or inappropriate. Rheumatoid arthritis for the treatment of severe, active rheumatoid arthritis in patients in whom classical, slow-acting anti-rheumatic agents are inappropriate or ineffective. Nephrotic syndrome: for the treatment of steriod dependent or steroid resistant nephrotic syndrome (associated with adverse prognostic features) due to minimal change glomerulonephritis, focal segmental glomerulosclerosis or membranous glomerulonephritis in both adults and children. Prescription Only Medicine	3rd April 1998
00101/0511	Novartis Pharmaceuticals UK Limited	Sandostatin LAR 10 mg	Octreotide Acetate 11.200 mg	Treatment of patients with acromegaly who are adequately controlled on s.c. treatment with Sandostatin, in whom surgery, radiotherapy or dopamine agonist therapy is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective. Prescription Only Medicine	29th April 1998
00101/0512	Novartis Pharmaceuticals UK Limited	Sandostatin LAR 20 mg	Octreotide Acetate 22.400 mg	(See PL/00101/0511) Prescripton Only Medicine	29th April 1998
00101/0513	Novartis Pharmaceuticals UK Limited	Sandostatin LAR 30 mg	Octreotide Acetate 30.000 mg	(See PL/00101/0511) Prescription Only Medicine	29th April 1998
00101/0514	Novartis Pharmaceuticals UK Limited	Diluent for Sandostatin LAR	None	Prescription Only Medicine	29th April 1998
00101/0515	Novartis Pharmaceuticals UK Limited	Anturan	Sulphinpyrazone 100.000 mg	Chronic, including tophaceous gout, recurrent gouty arthritis. Hyperuricaemia. Prescription Only Medicine	10th April 1998
00101/0516	Novartis Pharmaceuticals UK Limited	Anturan Tablets 200 mg	Sulphinpyrazone BP 200.0 mg	Chronic, including tophaceous gout, recurrent gouty arthritis. Hyperuricaemia. Prescription Only Medicine	10th April 1998
00101/0527	Novartis Pharmaceuticals UK Limited	Lamprene Capsules 100 mg	Clofazimine BP 100.00 mg	Given in combinatoin with dapsone and rifampicin, can be used to treat the multibacillary forms of leprosy. These include lepromatous, borderline lepromatous and mid-borderline leprosy. In addition, this combination of drugs may be used to treat the lepra reaction, erythema nodosum leprosum. Combined chemotherapy should be employed to prevent the emergence of resistant strains of M. Leprae. Prescription Only Medicine	10th April 1998
00142/0445	A H Cox & Company Limited	Bumetanide Tablets 1 mg	Bumetanide 1.000 mg	For use when diuretic therapy is required in the treatment of oedema, for example: oedema associated with heart failure; oedema associated with cirrhosis; oedema associated with renal disease, including the nephrotic syndrome. Prescription Only Medicine	24th July 1998
00189/0027	The Mentholatum Company Limited	Deep Relief	Ibuprofen 5.000 ww Levomentol 3.000 ww	Relief of rheumatic pain, muscular aches, pains and swellings such as strains, sprains and sports injuries. [Also for the relief of the pain associated with non-serious arthritic conditions.]* *[ ] represents P text only. Pharmacy Medicine	2nd April 1998
00211/0038	The Wallis Laboratory Limited	Full Strength Hot Lemon Powder	Paracetamol 1000.000 mg Phenylephrine Hydrochloride 10.000 mg	For the relief of sinus pain and congestion and the symptoms of cold and influenza including headache, sore throat and feverishness”. General Sales List	14th July 1998
00211/0039	The Wallis Laboratory Limited	Hot Lemon Plus	Paracetamol 650.000 mg Phenylephrine Hydrochloride 10.000 mg	See PL0211/0038. General Sales List	14th July 1998
00211/0040	The Wallis Laboratory Limited	Hot Blackcurrant Plus	Paracetamol 650.000 mg Phenylephrine Hydrochloride 10.000 mg	See PL00211/0038. General Sales List	14th July 1998
00427/0117	Rosemont Pharmaceuticals Limited	Metoclopramide Hydrochloride Oral Solution	Metoclopramide Hydrochloride 5.000 mg	1. Symptomatic relief of gastro-duodenal dysfunction, including: dyspepsia, flatulence, heartburn, pain, regurgitation of bile and sickness. 2. Nausea and vomiting. 3. Migraine. 4. Restoration of normal gastric emptying and motility in post operative conditions. 5. In diagnostic procedures such as radiology and duodenal intubation. Speeds up passage of a barium meal by decrease of gastric emptying time, dilation of duodenal bulb and co-ordination of peristalsis. 6. In young adults and children, must be restricted to the following uses: severe, intractable vomiting, of which the cause is known; vomiting caused by radiotherapy and/or intolerance to cytotoxic agents; aid to gastro-intestinal intubation; pre-medication prior to surgical procedures. Prescription Only Medicine	1st July 1998
00427/0118	Rosemont Pharmaceuticals Limited	Trifluoperazine Hydrochloride Oral Solution 5 mg/5 ml	Trifluoperazine (as HCI) 5 mg/5 ml	Low Dosage: As an adjunct in the short term management of anxiety states, depressive symptoms secondary to anxiety, and agitation. Also indicated in the symptomatic treatment of nausea and vomiting. High Dosage: For the treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses. May also be used as an adjunct in the short term management of severe psychomotor agitation and of dangerously impulsive behaviour, for example, mental subnormality. Prescription Only Medicine	1st July 1998
00790/0123	Clonmel Healthcare Limited	Tramadol Hydrochloride Capsules 50 mg	Tramadol Hydrochloride 50.000 mg	Management (treatment and prevention) of moderate to severe pain. Prescription Only Medicine	7th July 1998
01932/0032	Seven Seas Limited	Mil-Par	Magnesium Hydroxide Mixture 3.750 ml Paraffin Liquid 1.250 ml	For the temporary relief of constipation. Pharmacy Medicine.	30th April 1998
01932/0034	Seven Seas Limited	Paracetamol Tablets	Paracetamol 500.000 mg	For the treatment of most painful and febrile conditions, for example, headache including migraine, toothache, neuralgia, cold and influenza, sore throat, rheumatic pain and dysmenorrhoea. General Sales List Prescription Only Medicine Pharmacy Medicine	24th June 1998
02848/0205	Antigen International Ltd	Atracurium Besylate 10 mg/ml Injection	Atracurium Besylate 10.000 mg	As an adjunct to general anaesthesia, to relax the skeletal muscles during a wide range of surgical procedures and to facilitate controlled ventilation of the lungs; for administration by continuous infusion to maintain neuromuscular blockade during prolonged surgical procedures; to facilitate endotracheal intubation where subsequent maintenance of neuromuscular relaxation is required; to maintain muscular relaxation during Caesarean section. Prescription Only Medicine	1st July 1998
03105/0066	Bell, Sons & Co (Druggists) Limited	Glycerin, Blackcurrant and Honey	Citric Acid Anhydrous 45.700 mg Glycerin .750 gm	For the symptomatic relief of tickly coughs and sore throats. General Sales List	22nd July 1998
PI03243/0332	Munro Wholesale Medical Supplies Limited	Imdur Tablets 60 mg	Isosorbide Mononitrate 60.000 mg	Prophylactic treatment of Angina Pectoris. Prescription Only Medicine	26th June 1998
PI03243/0350	Munro Wholesale Medical Supplies Limited	Vagifem 25 microgrammes Vaginal Tablets	Estradiol 25.000 mcg	Atrophic vaginitis due to oestrogen deficiency. Prescription Only Medicine	23rd July 1998
03524/0027	Organon Teknika Limited	OncoTICE	BCG TICE Strain 12.500 mg	For treatment of primary or concurrent carcinoma-in-situ of the urinary bladder and for the prevention of recurrence of high grade and/or relapsing superficial papillary transitional cell carcinoma of the urinary bladder (Stage Ta or T1) after transurethral resection. Prescription Only Medicine	28th April 1998
03551/0017	B Braun Melsungen AG	Streptokinase Braun 100 000	Streptokinase 100000.000 iu	It may be used for the intravascular dissolution of thrombi and emboli in: pulmonary embolism acute or sub-acute occlusion of peripheral arteries extensive deep vein thrombosis central retinal venous or arterial thrombosis. Prescription Only Medicine	25th June 1998
03551/0018	B Braun Melsungen AG	Streptokinase Braun 250 000	Streptokinase 250000.000 iu	(See PL03551/0017) Prescription Only Medicine	25th June 1998
03551/0019	B Braun Melsungen AG	Streptokinase Braun 750 000	Streptokinase 750000.000 iu	(See PL03551/0017) Prescription Only Medicine	25th June 1998
03551/0020	B Braun Melsungen AG	Streptokinase Braun 1500 000	Streptokinase 1500000.000 iu	Acute myocardial infarction. Prescription Only Medicine	25th June 1998
PI03787/0463	Swingward Limited, t/a Medihealth	Estraderm TTS 100	Oestradiol 8.000 mg	Estrogen replacement therapy. Prescription Only Medicine	24th July 1998
PI03787/0464	Swingward Limited, t/a Medihealth	Estraderm TTS 50	Oestradiol 4.000 mg	Estrogen replacement therapy. Prescription Only Medicine	20th July 1998
PI03787/0466	Swingward Limited, t/a Medihealth	Flixotide 125 Inhaler	Fluticasone Dipropionate 125.000 mcg	Asthma. Prescription Only Medicine	29th June 1998
PI03787/0482	Swingward Limited (t/a Medihealth)	Clarityne Tablets	Loratadine 10.000 mg	Allergic rhinitis, Idiopathic chronic urticaria. Prescription Only Medicine	26th June 1998
PI/03787/0486	Swingward Limited (t/a Medihealth)	Risperdal 3 mg Tablets	Risperidone 3.000 mg	Acute and chronic schizophrenic psychoses. Prescription Only Medicine	15th July 1998
PI03787/0498	Swingward Limited (t/a Medihealth)	Bricanyl Turbohaler 500	Terbutaline Sulphate 500.000 mcg	The relief and prevention of bronchospasms. Prescription Only Medicine	15th July 1998
PI03787/0501	Swingward Limited (t/a Medihealth)	Zoladex LA 10.8 mg Injection	Goserelin Acetate 10.800 mg	Prostate Cancer. Prescription Only Medicine	9th July 1998
PI03787/0508	Swingward Limited (t/a Medihealth)	Meloxicam 7.5 mg Tablets	Meloxicam 7.500 mg	Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis. Prescription Only Medicine	26th June 1998
PI03787/0521	Swingward Limited (t/a Medihealth)	Coversyl 4 mg Tablets	Perindopril Tert-butylamine Salt 4.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	21st July 1998
PI04423/0236	Doncaster Pharmaceuticals Group Limited	Modopar 125 mg Capsules	Levodopa 100.000 mg Benserazide 25.000 mg	For the treatment of Parkinson’s disease. Prescription Only Medicine	27th July 1998
PI04423/0247	Doncaster Pharmaceuticals Group Limited	Clomid 50 mg Tablets	Clomiphene Citrate 50.000 mg	For the treatment of ovulatory failure. Prescription Only Medicine	30th June 1998
PI04423/0257	Doncaster Pharmaceuticals Group Limited	Tagamet 400 mg Tablets Cimetidine 400 mg Tablets	Cimetidine 400.000 mg	For the treatment of duodenal and benign gastric ulceration. Prescription Only Medicine	14th July 1998
PI04423/0261	Doncaster Pharmaceuticals Group Limited	Viskaldix Tablets	Pindolol 10.000 mg Clopamide 5.000 mg	Hypertension. Prescription Only Medicine	21st July 1998
PI/04423/0267	Doncaster Pharmaceuticals Group Limited	Relif 500 mg Tablets/Relifex Tablets/Nabumetone 500 mg Tablets	Nabumetone 500.000 mg	Anti-inflammatory agent. Prescription Only Medicine	8th July 1998
PI/04423/0272	Doncaster Pharmaceuticals Group Limited	Lamictal 50 mg Tablets/Lamotrigine 50 mg Tablets	Lamotrigine 50.000 mg	Epilepsy. Prescription Only Medicine	17th July 1998
PI04423/0286	Doncaster Pharmaceuticals Group Limited	Diprosalic Ointment	Betamethasone Dipropionate 0.064% ww and Salicylic Acid 3.000% ww	For the treatment of hyperkeratotic and dry corticosteroid-responsive dermatoses. Prescription Only Medicine	25th June 1998
PI/04423/0287	Doncaster Pharmaceuticals Group Limited	Inderal LA-80 Capsules	Propranolol Hydrochloride 80.000 mg	Emergency treatment of cardiac dysrhythmias and thyrotoxic crisis. Prescription Only Medicine	17th July 1998
PI/04423/0291	Doncaster Pharmaceuticals Group Limited	Risperdal 2 mg Tablets/Risperidone 2 mg Tablets	Risperidone 2.000 mg	Acute and chronic schizophrenic psychoses. Prescription Only Medicine	23rd June 1998
PI/04423/0292	Doncaster Pharmaceuticals Group Limited	Risperdal 3 mg Tablets/Risperidone 3 mg Tablets	Risperidone 3.000 mg	Treatment of acute and chronic schizophrenic psychoses. Prescription Only Medicine	25th June 1998
PI/04423/0296	Doncaster Pharmaceuticals Group 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	24th June 1998
PI04423/0297	Doncaster Pharmaceuticals Group Limited	Zoton 30 capsules/Lansox 30 capsules/Lansoprazole 30 mg capsules	Lansoprazole 30.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	29th June 1998
04543/0388	CP Pharmaceuticals Limited	Co-codamol Tablets BP 30/500	Codeine Phosphate 30.000 mg and Paracetamol 500.000 mg.	For the relief of severe pain. Prescription Only Medicine	9th July 1998
04569/0383	Generics (UK) Limited	Methex Mixture	Methadone Hydrochloride 5.000 mg	For the treatment of opioid drug addiction. Prescription Only Medicine	1st April 1998
PI/05036/0149	M K Shah t/a M. K. Shah Pharmaceuticals	Zocor 20 mg	Simvastatin 20.000 mg	Primary Hypercholesterolaemia. Prescription Only Medicine	3rd June 1998
PI/05662/0439	Dowelhurst Limited	Pharken 250 microgram Tablets/Celance 250 microgram Tablets/Pergolide 250 microgram Tablets	Pergolide 250.000 mcg	Parkinson’s disease Prescription Only Medicine	10th July 1998
PI/05662/0440	Dowelhurst Limited	Pharken 1 mg Tablets/ Pergolide Tablets 1 mg/ Celance 1 mg Tablets	Pergolide 1.000 mg	Parkinson’s disease Prescription Only Medicine	13th July 1998
PI/005662/0441	Dowelhurst Limited	Pharken 50 microgram Tablets/Celance 50 microgram Tablets/Pergolide 50 microgram Tablets	Pergolide 50.000 mcg	Parkinson’s disease Prescription Only Medicine	15th July 1998
PI/05662/0443	Dowelhurst Limited	Renitec 20 mg Tablets/ Enalapril Maleate 20 mg Tablets	Enalapril Maleate 20.000 mg	Hypertension, Congestive Heart Failure Prescription Only Medicine	3rd July 1998
PI/05662/0463	Dowelhurst Limited	Moclamine 150 mg Tablets/ Manerix 150 mg Tablets/ Moclobemide 150 mg Tablets	Molcobemide 150.000 mg	Major depression. Treatment of social phobia. Prescription Only Medicine	22nd July 1998
PI/05662/0470	Dowelhurst Limited	Risperdal 4 mg Tablets/ Risperidone 4 mg Tablets	Risperidone 4.000 mg	Acute and chronic schizophrenic psychoses. Prescription Only Medicine	20th July 1998
PI/05662/0471	Dowelhurst Limited	Risperdal 1 mg Tablets/ Risperidone 1 mg Tablets	Risperidone 1.000 mg	Schizophrenic psychoses. Prescription Only Medicine	20th July 1998
PI/05662/0480	Dowelhurst Limited	Lansox 30 capsules/Zoton capsules/Lansoprazole 30 mg capsules	Lansoprazole 30.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	24th June 1998
PI/05662/0486	Dowelhurst Limited	Prozac 20 mg/5 ml liquid/ Fluoxetine Liquid 20 mg/5 ml	Fluoxetive Hydrochloride 22.360	For the treatment of depressive illness. Prescription Only Medicine	15th July 1998
PI/05662/0491	Dowelhurst Limited	Adalat LA 30 Tablets	Nifedipine 30.000 mg	Hypertension; angina pectoris. Prescription Only Medicine	15th July 1998
PI/05662/0498	Dowelhurst Limited	Lansox 15 Capsules Lansoprazole 15 mg Capsules	Lansoprazole 15.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	21st July 1998
05723/0045	Lennon Pharmaceuticals Limited	Dothiepin Capsules 25 mg Thaden Capsules 25	Dothiepin Hydrochloride 25.000 mg	For the treatment of symptoms of depressive illness especially where an anti-anxiety effect is required. Prescription Only Medicine	3rd July 1998
05723/0046	Lennon Pharmaceuticals Limited	Dothiepin Tablets 75 mg Thaden Tablets 75	Dothiepin Hydrochloride 75.000 mg	(See PL05723/0045)	3rd July 1998
PI/06464/0448	Waymade PLC	Pulmicort Nebulisation Suspension 0.5 mg	Budesonide 0.250 mg/ml	Bronchial asthma Prescription Only Medicine	30th June 1998
PI/06464/0449	Waymade PLC	Pulmicort Nebulisation Suspension 1 mg	Budesonide 0.500 mg/ml	Bronchial asthma Prescription Only Medicine	30th June 1998
PI/06464/0489	Waymade PLC	Pradif MR Capsules	Tamsulosin Hydrochloride 400.000 mcg	Benign prostatic hyperplasia (BPH) Prescription Only Medicine	23rd July 1998
PI/06464/0503	Waymade PLC	Clarityn 10 mg Loratadine 10 mg Tablets	Loratadine 10.000 mg	Relief of symptoms of allergic rhinitis. Prescription Only Medicine	15th July 1998
PI/06464/0508	Waymade PLC	Augmentin Forte 500/125 Tablets	Amoxycillin 500.000 mg Clavulanic acid 125.000 mg	Short term treatment of bacterial infections. Prescription Only Medicine	6th July 1998
PI/06679/0216	Polyfarma Limited	Prepulsid 10 mg Tablets	Cisapride Monohydrate 10.387 mg	Treatment of symptoms of gastro-oesophageal reflux. Prescription Only Medicine	30th June 1998
06745/0093	Pasteur Merieux MSD Limited	Pneumovax 11 Vaccine	Pneumococcal Polysaccharide Type 1 (1): Danish (US) Numbering HSE 25.0 ug Pneumococcal Polysaccharide Type 2 (2) HSE 25.0 ug Pneumococcal Polysaccharide Type 3 (3) HSE 25.0 ug Pneumococcal Polysaccharide Type 4 (4) HSE 25.0 ug Pneumococcal Polysaccharide Type 5 (5) HSE 25.0 ug Pneumococcal Polysaccharide Type 6B (26) HSE 25.0 ug Pneumococcal Polysaccharide Type 7F (51) HSE 25.0 ug Pneumococcal Polysaccharide Type 8 (8) HSE 25.0 ug Pneumococcal Polysaccharide Type 9N (9) HSE 25.0 ug Pneumococcal Polysaccharide Type 9V (68) HSE 25.0 ug Pneumococcal Polysaccharide Type 10A (34) HSE 25.0 ug Pneumococcal Polysaccharide Type 11A (43) HSE 25.0 ug Pneumococcal Polysaccharide Type 12F (12) HSE 25.0 ug Pneumococcal Polysaccharide Type 14 (14) HSE 25.0 ug Pneumococcal Polysaccharide Type 15B (54) HSE 25.0 ug Pneumococcal Polysaccharide Type 17F (17) HSE 25.0 ug Pneumococcal Polysaccharide Type 18C (56) HSE 25.0 ug Pneumococcal Polysaccharide Type 19A (57) HSE 25.0 ug Pneumococcal Polysaccharide Type 19F (19) HSE 25.0 ug Pneumococcal Polysaccharide Type 20 (20) HSE 25.0 ug Pneumococcal Polysaccharide Type 22F (22) HSE 25.0 ug Pneumococcal Polysaccharide Type 23F (23) HSE 25.0 ug Pneumococcal Polysaccharide Type 33F (70) HSE 25.0 ug	For immunisation against pneumococcal disease caused by those pneumococcal types included in the vaccine. It will not immunise against capsular types of pneumococcus other than those contained in the vaccine. It should be considered for all persons two years of age or older in whom there is an increased risk of morbidity and mortality from pneumococcal pneumonia. Pneumovax II may not be effective in preventing infection resulting from basilar skull fracture or from external communication with cerebrospinal fluid. Prescription Only Medicine	1st April 1998
06934/0037	Laboratoires Ethyphram	Etinamol Retard 4 mg Capsules	Salbutamol Sulphate 4.800 mg	Continuous symptomatic treatment of asthma and other types of reversible obstructive airways disease: in patients requiring daily administration of quick-acting beta-2 agonists with a short duration of action; and/or with nocturnal symptoms. N.B.: in asthma, the treatment with Etinamol Retard should be combined with an anti-inflammatory treatment, such as inhaled corticosteroids. Prescription Only Medicine	16th April 1998
06934/0038	Laboratoires Ethypharm	Etinamol Retard 8 mg Capsules	Salbutamol Sulphate 9.600 mg	(See PL/06934/0037) Prescription Only Medicine	16th April 1998
PI/08747/0221	Chemilines Limited	Serevent Inhaler/Salmeterol Inhaler 25 micrograms	Salmeterol Xinafoate 36.300 mcg	Reversible Airways obstruction. Prescription Only Medicine	21st July 1998
08821/0053	Monsanto Plc	Primogam Capsules 80	Gamolenic acid 80.000 mg	For the symptomatic relief of atopic eczema. All features of the disease may improve but Primogam 80 is particularly effective in relieving the generalised itch of atopic eczema. Prescription Only Medicine	7th April 1998
08829/0074	Trinity Pharmaceuticals Limited	Nimodrel 5 mg	Nifedipine 5.000 mg	Used in the prophylaxis of chronic stable angina pectoris and in the treatment of hypertension and Raynaud’s phenomenon. It is a potent antagonist of calcium influx through the slow channel of the cell membrane of cardiac and smooth muscle cells. It is known to be an effective and relatively well tolerated prophylaxis for chronic stable angina and mild to severe hypertension. The antihypertensive effects of nifedipine are achieved by causing peripheral vasodilatation resulting in a reduction in peripheral resistance. It reduces blood pressure in hypertension but has little or no effect in normotensive individuals. It has no therapeutic antiarrhythmic effect. Prescription Only Medicine	17th April 1998
08829/0075	Trinity Pharmaceuticals Limited	Nimodrel 10 mg	Nifedipine 10.000 mg	(See PL/08829/007) Prescription Only Medicine	17th April 1998
10038/0024	Elan Pharma Limited	Dilzem SR 60	Diltiazem Hydrochloride USP 60.00 mg	Treatment of angina pectoris including prinzmetal’s angina. Treatment of mild to moderate hypertension. Prescription Only Medicine	30th April 1998
10038/0025	Elan Pharma Limited	Dilzem SR 90	Diltiazem Hydrochloride USP 90.00 mg	(See PL/10038/0024) Prescription Only Medicine	30th April 1998
10038/0026	Elan Pharma Limited	Dilzem SR 120	Diltiazem Hydrochloride USP 120.00 mg	(See PL/10038/0024) Prescription Only Medicine	30th April 1998
10038/0027	Elan Pharma Limited	Dilzem XL 120	Diltiazem Hydrochloride 120.000 mg	Prophylaxis and treatment of angina pectoris. For the treatment of mild to moderate hypertension. Prescription Only Medicine	30th April 1998
10038/0028	Elan Pharma Limited	Dilzem XL 180	Diltiazem Hydrochloride 180.000 mg	(See PL10038/0027) Prescription Only Medicine	30th April 1998
1038/0029	Elan Pharma Limited	Dilzem XL 240	Diltiazem Hydrochloride 240.000 mg	(See PL10038/0027) Prescription Only Medicine	30th April 1998
10038/0030	Elan Pharma Limited	Erymax Capsules	Erythromycin PH EUR 274.80 mg	Erythromycin is an antibiotic effective in the treatment of bacterial disease caused by susceptible organisms. Examples of its use are in the treatment of upper and lower respiratory tract infections of mild to moderate severity; skin and soft tissue infections including pustular acne. Prescription Only Medicine	30th April 1998
10038/0036	Elan Pharma Limited	Erymax Sprinkle Capsules 125 mg	Erythromycin EP 137.4 mg (Equivalent to erythromycin activity) 125.0 mg	(See PL10038/0030) Prescription Only Medicine	30th April 1998
PI10256/0318	Stephar (UK) Limited	Sertraline 100 mg Tablets	Sertraline Hydrochloride 111.900 mg	Symptoms of depressive illness. Prescription Only Medicine	10th July 1998
PI10256/0319	Stephar (UK) Limited	Sertraline 50 mg Tablets	Sertraline Hydrochloride 55.950 mg	Depressive illness and accompanying symptoms of anxiety. Prescription Only Medicine	30th June 1998
PI10256/0359	Stephar (UK) Limited	Cedax 400 mg Capsules	Ceftibuten 400.000 mg	Treatment of infections caused by strains of susceptible micro-organisms. Prescription Only Medicine	26th June 1998
PI10256/0360	Stephar (UK) Limited	Bricanyl Inhaler	Terbutaline Sulphate 0.250 mg	The relief and prevention of bronchospasm in bronchopulmonary disorders. Prescription Only Medicine	24th July 1998
PI/10380/0197	Swinghope Limited	Augmentine 625 mg Tablets/Co-Amoxiclav 500/125 mg Tablets	Amoxycillin 500.000 mg Clavulanic Acid 125.000 mg	An antibiotic for the treatment of broad spectrum bacterial pathogens. Prescription Only Medicine	21st July 1998
PI/10380/0201	Swinghope Limited	Lescol 20 Capsules/ Fluvastatin 20 mg capsules	Fluvastatin Sodium 21.060 mg	Hypercholestrolaemia. Prescription Only Medicine	15th July 1998
PI/10380/0213	Swinghope Limited	Risperdal 1 mg Tablets/ Risperidone 1 mg Tablets	Risperidone 1.000 mg	Schizophrenic psychoses. Prescription Only Medicine	20th July 1998
PI/10380/0217	Swinghope Limited	Half Sinemet CR Tablets	Carbidopa Anhydrous 25.000 mg Levodopa 100.000 mg	Treatment of Parkinson’s disease. Prescription Only Medicine	6th July 1998
PI/10380/0233	Swinghope Limited	Cozaar 50 mg Tablets/ Losartan Potassium 50 mg Tablets	Losartan Potassium 50.000 mg	Hypertension. Prescription Only Medicine	20th July 1998
PI/10383/0525	Primecrown Limited	Requip 5 mg tablets/ Ropinirole tablets 5 mg	Ropinirole Hydrochloride 5.700 mg	Treatment of Idiopathic Parkinson’s disease. Prescription Only Medicine	8th July 1998
PI/10383/0526	Primecrown Limited	Requip 1 mg Tablets/ Ropinirole Tablets 1 mg	Ropinirole Hydrochloride 1.140 mg	Parkinson’s Disease. Prescription Only Medicine	6th July 1998
PI/10383/0527	Primecrown Limited	Requip 2 mg tablets/ Ropinirole tablets 2 mg	Ropinirole Hydrochloride 2.280 mg	Treatment of Idiopathic Parkinson’s disease. Prescription Only Medicine	8th July 1998
PI/10383/0562	Primecrown Limited	Plendil 5 tablets/ Plendil 5 mg tablets	Felodipine 5.000 mg	Hypertension, Angina pectoris. Prescription Only Medicine	2nd July 1998
PI/10383/0566	Primecrown Limited	Mobic 7.5 mg tablets/ Meloxicam 7.5 mg tablets	Meloxicam 7.500 mg	Symptomatic treatment of ankylosing spondylitis, osteoarthrosis and rheumatoid arthritis. Prescription Only Medicine	26th June 1998
PI/10383/0601	Primecrown Limited	Ciproxin 500 mg Tablets Ciprofloxacin 500 mg Tablets	Ciprofloxacin Hydrochloride Monohydrate 582.000 mg	Treatment of infections caused by sensitive bacteria. Prescription Only Medicine	8th July 1998
10565/0010	AC-Pharma Vertriebs Aktiengesellschaft	Metformin 500 mg Tablets	Metformin Hydrochloride 500.000 mg	Non-insulin-dependent diabetes (NIDDM, type II) and, in particular, in obese patients, when adequate dietary treatment has failed. Metformin 500 mg Tablets can be given alone as initial therapy, or can be administered in combination with sulphonylureas are careful assessment of the contra-indications. Prescription Only Medicine	7th July 1998
10565/0011	AC-Pharma Vertriebs Aktiengesellschaft	Metformin 850 mg Tablets	Metformin Hydrochloride 850.000 mg	(See PL10565/0010) Prescription Only Medicine	7th July 1998
10592/0113	SmithKline Beecham PLC	Lumavir Intravenous 250 mg	Penciclovir 250.000 mg	Penciclovir i.v is indicated in immunocompromised patients with herpes simplex and herpes zoster infections. Prescription Only Medicine	27th April 1998
10592/0114	SmithKline Beecham PLC	Lumavir Intravenous 500 mg	Penciclovir 500.000 mg	(See PL10592/0113) Prescription Only Medicine	27th April 1998
10949/0275	Glaxo Wellcome UK Limited	Respontin Nebules	Ipratropium Bromide 0.250 mg/ml	Respontin Nebules are indicated for the treatment of reversible airways obstruction. Prescription Only Medicine	16th April 1998
10949/0285	Glaxo Wellcome UK Limited	Triprolidine, Pseudoephedrine and Dextromethorphan Linctus	Dextromethorphan Hydrobromide 10.000 mg Pseudoephedrine Hydrochloride 30.000 mg Triprolidine Hydrochloride 1.250 mg	For the symptomatic relief of upper respiratory tract disorders which are benefited by a combination of a nasal decongestant, a histamine H1-receptor and an antitussive. Pharmacy Medicine	10th July 1998
10949/0263	Glaxo Wellcome UK Limited	Zofran Melt 4 mg	Ondansetron 4.000 mg	The management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention of post-operative nausea and vomiting in adults. Prescription Only Medicine	3rd April 1998
10949/0264	Glaxo Wellcome UK Limited	Zofran Melt 8 mg	Ondansetron 8.000 mg	(See PL10949/0263) Prescription Only Medicine	3rd April 1998
PI/110256/0311	Stephar (UK) Limited	Mobic 7.5 mg Tablets	Meloxicam 7.500 mg	Treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Prescription Only Medicine	14th July 1998
12724/0218	Regent-GM Laboratories Limited	Diltiazem Modified release Tablets 60 mg	Diltiazem Hydrochloride 60.000 mg	Prophylaxis and treatment of angina pectoris. Prescription Only Medicine	30th June 1998
12762/0024	Goldsheild Pharmaceuticals Limited	Pitressin Ampoules	Argripressin 20.000 pu	For use in diabetes insipidus, when this is not of nephrogenic origin and control of bleeding from oesophageal varices. Prescription Only Medicine	3rd April 1998
13402/0090	Hoechst Marion Roussel Limited	Cortisyl Tablets 25 mg	Cortisone Acetate BP 25.0 mg	Replacement therapy as in Addison’s disease or when the adrenals have been removed surgically or damaged as a result of haemorrhage or shock. Prescription Only Medicine	15th April 1998
13402/0092	Hoechst Marion Roussel Limited	Precortisyl Forte Tablets 25 mg	Prenisolone BP 25.0 mg	Collagen diseases: Systemic lupus erythematous, acute rheumatic fever Haematological disorders: Acute granulocytic leukaemia, acute monocytic leukaemia, chronic lymphocytic leukaemia, thrombocytopenia haemolytic anaemia Miscellaneous: Ulcerative colitis, pemphigus, nephrosis. Prescription Only Medicine	15th April 1998
13402/0093	Hoechst Marion Roussel Limited	Procosedyle Ointment	Cinchocain Hcl (Micro) BP 0.5% w/w Hydrocortisone (Micro) EP 0.5% w/w	The local anaesthetic cinchocaine relieves pain and relaxes sphincteric spasm. Pruritis and inflammation are relieved by hydrocortisone which also decreases serious discharge. It is therefore useful for the short term relief (not more than 7 days) of pain, irritation and pruritis associated with haemorrhoids, pruritis ani. Prescription Only Medicine	30th April 1998
13606/0066	Co-Pharma Limited	Baclofen Tablets BP 10 mg	Baclofen 10.000 mg	For the relief of spasticity of voluntary muscle resulting from such disorders as multiple sclerosis, other spinal lesions, e.g. tumors of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord. It is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury. Patient selection is important when initiating baclofen therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy. Treatment should not be commenced until the spastic state has become stabilised. Prescription Only Medicine	29th June 1998
PI/13826/0034	Caseview (PL) Limited	Creon Capsules	Pancreatin 300.000 mg Lipase 8000.000 iu Amylase 9000.000 iu Protease 450.000 iu	Pancreatic exocrine insufficiency. Prescription Only Medicine	17th July 1998
PI/13826/0102	Caseview (PL) Limited	Modopar 125 mg Capsules	Levodopa 100.000 mg Benserazide Hydrochloride 28.500 mg	For the treatment of Parkinson’s disease. Prescription Only Medicine	17th July 1998
PI/13826/0116	Caseview (PL) Limited	Secu-Vera 240 mg SR Tablets	Verapamil Hydrochloride 240.000 mg	Mild to moderate hypertension angina pectoris. Prescription Only Medicine	7th July 1998
PI/14069/0030	Denfleet International Limited	Flutamide 250 mg Tablets	Flutamide 250.000 mg	Treatment of advanced prostatic carcinoma. Prescription Only Medicine	3rd July 1998
PI/14069/0038	Denfleet International Limited	Flutamide 250 mg Tablets	Flutamide 250.000 mg	Treatment of advanced prostatic carcinoma. Prescription Only Medicine	3rd July 1998
PI/14069/0039	Denfleet International Limited	Zocor 10 mg Tablets/Simvastatin 10 mg Tablets	Simvastatin 10.000 mg	Primary hypercholesterolaemia. Prescription Only Medicine	10th July 1998
PI/14069/0040	Denfleet International Limited	Zocor 20 mg Tablets/Simvastatin 20 mg Tablets	Simvastatin 20.000 mg	Primary hypercholesterolaemia. Prescription Only Medicine	10th July 1998
PI/14069/0041	Denfleet International Limited	Enalapril Maleate 5 mg Tablets	Enalapril Maleate 5.000 mg	Hypertension, congestive heart failure. Prescription Only Medicine	10th July 1998
PI/14069/0042	Denfleet International Limited	Enalapril Maleate 10 mg Tablets	Enalapril Maleate 10.000 mg	Hypertension, congestive heart failure. Prescription Only Medicine	10th July 1998
PI/14069/0043	Denfleet International Limited	Enalapril Maleate 20 mg Tablets	Enalapril Maleate 20.000 mg	Hypertension, congestive heart failure. Prescription Only Medicine	10th July 1998
PI/14069/0047	Denfleet International Limited	Nizatidine 300 mg Capsules	Nizatidine 300.000 mg	Duodenal and benign gastric ulcer. Prescription Only Medicine	21st July 1998
14229/0040	Parkfields Pharmaceuticals Ltd	Ipratropium Bromide Nebuliser Solution	Ipratropium Bromide 0.026% w/v	For treatment of reversible airways obstruction. Prescription Only Medicine	22nd July 1998
15036/0011	Centeon Pharma GMBH	Beriate P 250	Human Plasma Coagulation Factor VIII 250.000 iu	Prophylaxis and treatment of bleeding in:—haemophilia A (congenital factor VIII deficiency)—acquired factor VIII deficiency Treatment of patients with low titre of antibodies against factor VIII (<10 BU). Prescription Only Medicine	3rd April 1998
15036/0012	Centeon Pharma GMBH	Beriate P 500	Human Plasma Coagulation Factor VIII 500.000 iu	(See PL/15036/0011) Prescription Only Medicine	3rd April 1998
15036/0013	Centeon Pharma GMBH	Beriate P 1000	Human Plasma Coagulation Factor VIII 1000.000 iu	(See PL/15036/0011) Prescription Only Medicine	3rd April 1998
15072/0001	Apogepha Arzneimittel GMBH	Detrunorm	Propiverine Hydrochloride 15.000 mg	It has been shown to be efficacious in those patients who have either idiopathic bladder instability, or neurogenic bladder (detrusor hyperreflexia) from spinal cord injuries, eg transverse lesion paraplegia, for urinary incontinence, urgency and frequency in unstable bladder conditions. Prescription Only Medicine	23rd April 1998
15072/0002	Apogepha Arzneimittel GMBH	Mictonorm	Propiverine Hydrochloride 15.000 mg	(See PL15072/0001) Prescription Only Medicine	23rd April 1998
15361/0018	P.I.E. Pharma Ltd	Renitec 5 mg Tablets Innovance 5 mg Tablets Enalapril Maleate 5 mg Tablets	Enalapril Maleate 5.000 mg	Hypertension and congestive heart failure. Prescription Only Medicine	22nd July 1998
15361/0024	P.I.E. Pharma Ltd	Zoton 30 mg Capsules Lansoprazole 30 mg Capsules	Lansoprazole 30.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	21st July 1998
15361/0027	P.I.E. Pharma Ltd	Movalis 7.5 mg Tablets Meloxicam 7.5 mg Tablets	Meloxicam 7.500 mg	Symptomatic treatment of acute exacerbation of osteoarthrosis, rheumatoid arthritis and ankylosing spondylitis. Prescription Only Medicine	24th June 1998
15361/0035	P.I.E. Pharma Ltd	Lescol 20 mg Capsules Fluvastatin 20 mg Capsules	Fluvastatin Sodium 21.060 mg	Treatment of primary hypercholesterolaemia. Prescription Only Medicine	14th July 1998
15361/0036	P.I.E. Pharma Ltd	Lescol 40 mg Capsules Fluvastatin 40 mg Capsules	Fluvastatin Sodium 42.120 mg	Treatment of primary hypercholesterolaemia. Prescription Only Medicine	14th July 1998
15362/0042	P.I.E. Pharma Ltd	Clarityne 10 mg Tablets Clarityn 10 mg Tablets Loratadine 10 mg Tablets	Laratadine 10.000 mg	Seasonal and perennial rhinitis, chronic articaria. Prescription Only Medicine	24th June 1998
15513/0076	Warner-Lambert Consumer Healthcare	Actigesic Tablets	Triprolidine Hydrochloride BP 2.5 mg Pseudoephedrine Hydrochloride BP 60.0 mg Paracetamol EP500.0 mg In one tablet	For the symptomatic relief of conditions where upper respiratory tract congestion is associated with pyrexia and/or pain, for example, the common cold and influenza, sinusitis and nasopharyngitis. Pharmacy Medicine	30th April 1998
15669/0001	Bertek Pharmaceuticals International Limited	Nitrek®15-Glyceryl Trinitrate Transdermal Patch	Glyceryl Trinitrate 67.200 mg	The prophylactic treatment of attacks of angina pectoris. Pharmacy Medicine	28th April 1998
15669/0002	Bertek Pharmaceuticals International Limited	Nitrek® 10 Glyceryl Trinitrate Transdermal Patch	Glyceryl Trinitrate 44.800 mg	The prophylactic treatment of attacks of angina pectoris. Pharmacy Medicine	28th April 1998
15669/0003	Bertek Pharmaceuticals International Limited	Nitrek® 5 Glyceryl Trinitrate Transdermal Patch	Glyceryl Trinitrate 22.400 mg	The prophylactic treatment of attacks of angina pectoris. Pharmacy Medicine	28th April 1998
PI/15814/0050	O.P.D. Laboratories Limited	Zovirax Cream 5%/Aciclovir 5% Cream	Aciclovir 5.000% w/w	Treatment of Herpes simplex virus infections of the skin. Prescription Only Medicine	24th June 1998
PI/15814/0053	O.P.D. Laboratories Limited	Dalacin Topical Solution	Clindamycin 10.000 mg	Treatment of acne vulgaris. Prescription Only Medicine	9th July 1998
PI/15814/0079	O.P.D. Laboratories Limited	Cardura 2 mg Tablets/ Doxazosin Tablets 2 mg	Doxazosin Mesylate 2.430 mg.	Treatment of hypertension. Prescription Only Medicine	14th July 1998
PI/15814/0080	O.P.D. Laboratories Limited	Cardura 4 mg Tablets/ Doxazosin Tablets 4 mg	Doxazosin Mesylate 4.850 mg.	Treatment of hypertension. Prescription Only Medicine	14th July 1998
PI/15814/0086	O.P.D. Laboratories Limited	Mobic 7.5 mg Tablets Meloxicam 7.5 mg Tablets	Meloxicam 7.500 mg	Osteoarthrosis, rheumatoid arthritis and ankylosing spondylitis. Prescription Only Medicine	14th July 1998
PI/15814/0089	O.P.D. Laboratories Limited	Mobic 15 mg Tablets/Meloxicam 15 mg Tablets/Mobic Tablets 15 mg	Meloxicam 15.000 mg	Treatment of osteoarthrosis, rheumatoid arthritis, ankylosing spondylitis. Prescription Only Medicine	10th July 1998
15842/0001	Taro Pharmaceuticals (UK) Limited	Teril CR Tablets 200 mg	Carbamazepine 200.000 mg	Epilepsy (generalised tonic-clonic and partial seizures). The paroxysmal pain of trigeminal neuralgia. For the prophylaxis of manic-depressive psychosis in patients unresponsive of lithium therapy. Prescription Only Medicine	17th April 1998
15842/0002	Taro Pharmaceuticals (UK) Limited	Teril CR Tablets 400 mg	Carbamazepine 400.000 mg	(See PL 15842/0001)	17th April 1998
16028/0032	Galpharm Healthcare Ltd	Enterocalm Loperamide Capsules Loperamide Capsules 2 mg	Loperamide Hydrochloride 2.000 mg	For symptomatic treatment of acute diarrhoea. General Sales List Pharmacy Medicine	17th July 1998
16108/0032	Adams Healthcare Limited	Povidone-Iodine Surgical Scrub	Povidone-Iodine 7.500 ww	It is a broad-spectrum antiseptic for topical use. It is indicated for pre-operative hand disinfection by the surgical team, or for disinfecting the site of incision prior to elective surgery. Pharmacy Medicine	26th June 1998
16108/0033	Adams Healthcare Limited	Povidone-Iodine Antiseptic Solution	Povidone-Iodine 10.000 ww	It is a broad-spectrum antiseptic for topical use. It is indicated for use as a pre-operative skin disinfectant. Pharmacy Medicine	26th June 1998
16108/0034	Adams Healthcare Limited	Povidone-Iodine Antiseptic Tincture	Polyvidone-Iodine 10.000 ww	It is a broad-spectrum antiseptic for topical application. It is indicated for quick-drying pre-operative skin disinfection, particularly in orthopaedic surgery. Pharmacy Medicine	26th June 1998
16201/0003	Goldshield Generics Limited	Warfarin 1 mg Tablets	Warfarin Sodium 1.000 mg	Prophylaxis of systemic embolism in patients with rheumatic heart disease and atrial fibrillation. Prophylaxis after insertion of prosthetic heart valves. Prophylaxis and treatment of venous thrombosis and pulmonary embolism. Transient attacks of cerebral ischaemia. Prescription Only Medicine	14th July 1998
16201/0004	Goldshield Generics Limited	Warfarin 3 mg Tablets	Warfarin Sodium 3.000 mg	(See PL16201/0003). Prescription Only Medicine	14th July 1998
16201/0005	Goldshield Generics Limited	Warfarin 5 mg Tablets	Warfarin Sodium 5.000 mg	(See PL16201/0003). Prescription Only Medicine	14th July 1998
PI/16782/0001	BR Pharma International	Flutamide Tablets 250 mg	Flutamide 250.000 mg	Advanced prostatic carcinoma. Prescription Only Medicine	17th July 1998
16784/0001	HK Pharma Limited	Phosphate Sandoz Effervescent Tablets	Potassium Bicarbonate 0.315 gm Sodium Acid Phosphate Anhydrous 1.936 gm Sodium Bicarbonate 0.350 gm	Hypercalcaemia associated with such conditions as hyperparathyroidism, multiple myelomatosis and malignancy. Hypophosphataemia associated with vitamin D resistant rickets and vitamin D resistant hypophosphataemic osteomalacia. General Sales List	28th April 1998
16784/0002	HK Pharma Limited	Sando-K	Potassium Bicarbonate 0.400 gm Potassium Chloride 0.600 gm	Prevention and treatment of hypokalaemic states such as those associated with: (1) Use of drugs which can induce potassium depletion e.g. frusemide, thiazide diuretics, corticosteroids, carbenoxolone and cardiac glycosides, especially in combination with diuretics; (2) Potassium loss resulting from severe diarrhoea, vomiting or fistulas; (3) Acid-base disturbances e.g. alkalosis, renal tubular acidosis, states in which there is aldosterone excess, Cushing syndrome; (4) Decreased intake of potassium e.g. malnutrition, alcoholism, some elderly patients with deficient diets; 5) Since tablets contain Cl- they may be used in the treatment of hypokalaemia associated with hypochloraemic alkalosis. Pharmacy Medicine	28th April 1998
16784/0003	HK Pharma Limited	Slow Sodium	Sodium Chloride 600.000 mg	For the treatment and prophylaxis of sodium chloride deficiency. General Sales List	28th April 1998
16794/0001	Cambridge Healthcare Suppliers Limited	Ionamin 15	Phentermine 15.000 mg	II-is an anorectic agent intended at an adjunctive therapy to diet in patients with obesity and a body mass index (BMI) of 30 kg/m2 or higher, who have not responded to an appropriate weight reducing regimen alone.   Note:  Short term efficacy only has been demonstrated with regard to weight reduction. No significant data on changes in morbidity or mortality are yet available. Prescription Only Medicine	30th April 1998
16794/0002	Cambridge Healthcare Suppliers Limited	Ionamin 30	Phentermine 30.000 mg	See PL 16794/0001	30th April 1998
16900/0023	Dallas Burston Healthcare Limited	Tamoxifen Tablets BP 10 mg Oestrifen 10	Tamoxifen Citrate 15.200 mg	1. Treatment for breast cancer 2. Treatment of anovulatory infertility. Prescription Only Medicine.	17th July 1998
16900/0024	Dallas Burston Healthcare Limited	Tamoxifen Tablets BP 20 mg Oestrifen 20	Tamoxifen Citrate 30.400 mg	1. Treatment for breast cancer 2. Treatment of anovulatory infertility. Prescription Only Medicine.	17th July 1998
16900/0025	Dallas Burston Healthcare Limited	Tamoxifen Tablets BP 40 mg Oestrifen 40	Tamoxifen Citrate 60.800 mg	1. Treatment for breast cancer 2. Treatment of anovulatory infertility. Prescription Only Medicine	17th July 1998
16946/0006	Castlemead Healthcare Limited	Stemetil Tablets 5 mg Prochlorperazine Tablets BP 5 mg	Prochlorperazine Maleate 5.000 mg	Vertigo due to Meniere’s Syndrome, labyrinthitis and other causes, and for nausea and vomiting from whatever cause including that associated with migraine. It may also be used for schizophrenia, (particularly in the chronic stage), acute mania and as an adjunct to the short-term management of anxiety. Prescription Only Medicine	1st July 1998
16981/0001	Goldham Bioglan Pharma GMBH	Iopamidol Injection 61.2% w/v	Iopamidol 612.000 mg	X-ray contrast media for peripheral arteriography and venography, angiocardiography, digital subtraction angiography, left ventriculography and coronary arteriography, computer tomography enhancement and urography. Prescription Only Medicine	26th June 1998
16981/0002	Goldham Bioglan Pharma GMBH	Iopamidol Injection 69.4% w/v	Iopamidol 694.000 mg	(See PL 16981/0001). Prescription Only Medicine	26th June 1998
16981/0003	Goldham Bioglan Pharma GMBH	Iopamidol Injection 75.5% w/v	Iopamidol 755.000 mg	(See PL 16981/0001). Prescription Only Medicine	26th June 1998
16900/0011	Dallas Burston Healthcare Limited	Buspirone 5 mg Tablets	Buspirone Hydrochloride 5.000 mg	Short term treatment of anxiety disorders (anxiety and phobic neuroses) and symptomatic relief of anxiety with or without accompanying depression. Prescription Only Medicine	30th June 1998
16900/0012	Dallas Burston Healthcare Limited	Buspirone 10 mg Tablets	Buspirone Hydrochloride 10.000 mg	(See PL 16900/0011). Prescription Only Medicine	30th June 1998
16900/0015	Dallas Burston Healthcare Limited	Capotace 12.5 mg Captopril Tablets 12.5 mg	Captopril 12.500 mg	Treatment of mild to moderate hypertension and severe hypertension where standard therapy is ineffective or inappropriate. Congestive heart failure with concomitant use of diuretics and, where appropriate, digitalis. Indicated following myocardial infarction in clinically stable patients with asymptomatic and symptomatic left ventricular dysfunction to improve survival, delay the onset of asymptomatic heart failure, reduce hospitalisations for heart failure and reduce recurrent myocardial infarction and coronary revascularisation procedures. Determinationof cardiac function by radionuclide ventriculography or echocardiography should be undertaken prior to initiation of preventative treatment with captopril in post-myocardial infarction patients. Prescription Only Medicine	31st July 1998
16900/0016	Dallas Burston Healthcare Limited	Captopril Tablets 25 mg Capotace 25 mg	Captopril 25.000 mg	(See PL16900/0015). Prescription Only Medicine	31st July 1998
16900/0017	Dallas Burston Healthcare Limited	Capotace 50 mg Captopril Tablets 50 mg	Captopril 50.000 mg	(See PL16900/0015). Prescription Only Medicine	31st July 1998
The following notice is in substitution for that which appeared on page 7011 of The London Gazette dated 26th June 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 muscular pain, sprains, strains, lumbago and fibrositis, and neuralgia. Also for the symptomatic relief of pain due to non-serious arthritis conditions. Pharmacy Medicine	11th March 1998
The following notice is in substitution for that which appeared on page 7011 of The London Gazette dated 26th June 1998.
01932/0033	Seven Seas Limited	Bioral Gel	Carbenoxolone Sodium 2.000 ww	For the treatment of mouth ulcers. Pharmacy Medicine	31st March 1998
The following notice is in substitution for that which appeared on page 7012 of The London Gazette dated 26th June 1998.
0453/0397	CP 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 artertial occlusion. Prophylaxis of mural thrombosis following myocardial infarction. In extracorporeal circulation and haemodialysis. Prescription Only Medicine	6th March 1998
The following notice is in substitution for that which appeared on page 7013 of The London Gazette dated 26th June 1998.
PLPI06792/0394	Europharm of Worthing Limited	Didronel 200 mg tablets	Etidronate Disodium 200.000 mg	Osteitis Deformans. Prescription Only Medicine	27th May 1998
The following notice is in substitution for that which appeared on page 7017 of The London Gazette dated 26th June 1998.
14919/0007	Genthon GMBH	Midazolam 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 catherterisation. 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 fentanyl. Prescription Only Medicine	11th June 1998