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
00014/0509	The Boots Company Plc	Children’s Antiseptic Wipes	Cetrimide 1.000 wv	For cuts, grazes, insect bites, minor wounds, minor burns and minor scalds. General Sales List	6th March 1998
00014/0601	The Boots Company Plc	Lemon Antiseptic Throat Drops	Amylmetacresol .600 mg	For the short-term symptomatic relief of sore throats. General Sales List	26th February 1998
00014/0602	The Boots Company Plc	Cherry Menthol Antiseptic Throat Drops	Amylmetacresol .600 mg	(See PL 00014/0601). General Sales List	26th February 1998
00014/0603	The Boots Company Plc	Cherry Antiseptic Throat Drops with Menthol	Amylmetacresol .600 mg	(See PL 00014/0601). General Sales List	26th February 1998
00015/0213	Boehringer Ingelheim Limited	Dexa-Rhinaspray Duo	Dexamethasone 21-Isonicotinate .029 wv Tramazoline Hydrochloride .184 wv	Treatment of allergic rhinitis. Prescription Only Medicine	27th March 1998
00015/0232	Boehringer Ingelheim Limited	Syn-Ergel	Aluminium Phosphate Gel 20% 12.375 gm	For the symptomatic relief of dyspepsia associated with gastritis, reflux, oesophagitis, hiatus hernia, gastric and duodenal ulcers and hyperacidity. Pharmacy Medicine	31st December 1997
00017/0394	Astra Pharmaceuticals Limited	Colazide	Balsalazide Disodium 750.000 mg	For treatment of mild-to-moderate active ulcerative colitis. Prescription Only Medicine	27th March 1998
00019/0172	Warner Lambert (UK) Limited	Neurontin Capsules 100 mg	Gabapentin HSE 100.00 mg	An anti-epileptic drug indicated as add-on therapy for partial seizures and partial seizures with secondary generalisation in patients who have not achieved satisfactory control with or who are intolerant to standard anticonvulsants used alone or in combination. Prescription Only Medicine	31st December 1997
00019/0173	Warner Lambert (UK) Limited	Neurontin Capsules 300 mg	Gabapentin HSE 300.00 mg	(See PL/00019/0172). Prescription Only Medicine	31st December 1997
00019/0174	Warner Lambert (UK) Limited	Neurontin Capsules 400 mg	Gabapentin HSE 400.00 mg	(See PL/00019/0172). Prescription Only Medicine	31st December 1997
00022/0196	Pharmacia Laboratories Limited	Kabimix 11	Alanine 9.300 gm, Arginine 6.500 gm, Aspartic Acid 1.900 gm, Calcium Glycerophosphate Anhydrous .810 gm, Cysteine .330 gm, Glucose Monohydrate 256.000 gm, Glutamic Acid 3.300 gm, Glycine 4.600 gm, Histidine 4.000 gm, Isoleucine 3.300 gm, Leucine 4.600 gm, Lysine Acetate 7.400 gm, Magnesium Chloride Hexahydrate .790 gm, Methionine 3.300 gm, Phenylalanine 4.600 gm, Potassium Hydroxide 86.5% 3.010 gm, Proline 4.000 gm, Serine 2.600 gm, Sodium Glycerophosphate Anhydrous 2.510 gm, Sodium Hydroxide 100%, 1.600 gm, Soybean Oil Purified 78.000 gm, Threonine 3.300 gm, Tryptophan 1.100 gm, Tyrosine .130 gm and Valine 4.300 gm	In adult patients requiring intravenous nutrition to supply energy, essential fatty acids, essential and non-essential amino acids and electrolytes. It is particularly suitable for patients with basal or moderately increased nutritional requirements and/or fluid restriction. Prescription Only Medicine.	16th December 1997
00025/0316	Merck Sharp & Dohme Limited	Pepcid Melt 20 mg	Famotidine 20.000 mg	Duodenal ulcer Prevention of relapses of duodenal ulceration. Benign gastric ulcer. Hypersecretory conditions such as Zollinger-Ellison syndrome. Healing of oesophageal erosion or ulceration associated with gastro-oesophageal reflux disease. Symptomatic relief of gastro-oesophageal reflux disease. Prevention of relapse of symptoms and erosions or ulcerations associated with gastro-oesophageal reflux disease. Prescription Only Medicine.	27th March 1998
00025/0317	Merck Sharp & Dohme Limited	Pepcid Melt 40 mg	Famotidine 40.000 mg	See PL00025/0316. Prescription Only Medicine	8th December 1997
00030/0099	Novartis Consumer Health UK Limited	Ibuprofen Tablets 200 mg and Proflex Tablets 200 mg	Ibuprofen 200.000 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. General Sales List Pharmacy Medicine.	1st March 1998
00031/0509	Roche Products Limited	Transipeg	Macrogol 3350 2.950 gm	Symptomatic treatment of constipation in adults. Pharmacy Medicine.	4th December 1997
00039/0505	Evans Medical Ltd.	Fluvirin [Inactivated Influenza Vaccine Surface Antigen Ph Eur]	A/SINGAPORE/6/86 (H1N1)—LIKE 15.000 mcg, A/WUHAN/359/95 (H3N2)—LIKE 15.000 mcg and B/BEIJING/184/93—LIKE 15.000 mcg	To induce active immunity to influenza in those groups regarded as being at special risk, especially the elderly, which include those suffering from the following conditions: Chronic pulmonary disease, e.g. chronic bronchitis and emphysema, asthma, bronchiectasis, pulmonary tuberculosis and pulmonary fibrosis. Chronic heart disease, e.g. valvular and hypertensive heart disease. Chronic renal disease, e.g. chronic nephritis; patients with renal disease on immunosuppressive drugs. Diabetes and possibly other less common endocrine disorders. Patients who are, or who will be, immunosuppressed due to disease or treatment. Immunisation also recommended in: Persons living in residential establishments, especially the elderly, in which rapid spread is likely to follow the introduction of infection. Doctors, nurses, ambulance crew and others at special risk of infection by reason of their contacts with persons suffering from influenza. Prescription Only Medicine.	10th December 1997
00041/0067	Bioglan Laboratories Ltd.	Axsain	Capsaicin .75 ww	1. For the symptomatic relief of neuralgia associated with, and following Herpes Zoster infections (post-herpetic neuralgia) after open skin lesions have healed. 2. For the symptomatic management of painful diabetic peripheral polyneuropathy. Prescription Only Medicine.	27th March 1997
00101/0530	Novartis Pharmaceuticals UK Limited	Metopirone Capsules 250 mg	Metyrapone BP 250.0 mg	As a diagnostic aid in the differential diagnosis of ACTH-dependent Cushing’s syndrome. For the management of patients with Cushing’s syndrome. In conjunction with glucocorticoids in the treatment of resistant oedema due to increased aldosterone secretion in patients suffering from cirrhosis, nephrosis and congestive heart failure. Prescription Only Medicine.	19th December 1997
00101/0540	Novartis Pharmaceuticals UK Limited	Rogitine Ampoules 10 mg	Phentolamine Mesylate BP 10.0 mg	Management of hypertensive episodes that may occur in patients with phaeochromocytoma, for example during pre-operative preparation and surgical manipulation. Diagnosis of phaechromocytoma by Rogitine blocking test if other more specific tests are not available. Prescription Only Medicine.	19th December 1997
00116/0276	Baxter Healthcare Ltd.	Nutracel 400 Electrolyte Intravenous Infusion	Anhydrous Glucose BP 200.0 gm, Magnesium Chloride EP 3.66 gm, Calcium Chloride EP 2.21 gm, Zinc Acetate USP 17.56 mg and Manganese Chloride Tetrahydrate HSE 2.0 mg.	An energy source and electrolyte supplement in parenteral nutrition. Prescription Only Medicine.	1st December 1997
00116/0277	Baxter Healthcare Ltd.	Nutracel 800 Electrolyte Intravenous Infusion	Anhydrous Glucose BP 200.0 gm, Magnesium Chloride EP 1.83 gm, Calcium Chloride EP 1.10 gm, Zinc Acetate USP 8.78 mg and Manganese Chloride Tetrahydrate HSE 0.99 mg	See PL 00116/0276. Prescription Only Medicine.	16th December 1997
00116/0297	Baxter Healthcare Limited	Clinimix N9G15E	5.5% Amino Acid solution with electrolytes: L-Leucine 4.02 g/l; L-Phenylalanine 3.08 g/l; L-Methionine 2.20 g/l; L-Lysine 3.19 g/l (as L-Lysine chlorhydrate 4.00 g/l); L-Isoleucine 3.30 g/l; L-Valine 3.19 g/l; L-Histidine 2.64 g/l; L-Threonine 2.31 g/l; L-Tryptophan 0.99 g/l; L-Alanine 11.38 g/l; L-Arginine 6.32 g/l; Glycine 5.66 g/l; L-Proline 3.74 g/l; L-Serine 2.75 g/l; L-Tyrosine 0.22 g/l; Sodium Acetate, 3H O 4.31 g/l; Dibasic Potassium Phosphate 5.22 g/l; Sodium Chloride 2.24 g/l; Magnesium Chloride 6H O 1.02 g/l. 15% Glucose solution with calcium: Glucose 150 g/l (as monohydrate glucose 165 g/l); Calcium Chloride, 2H O 0.662 g/l	Parenteral nutrition when oral or enteral alimentation is impossible, insufficient or contra-indicated. For patient undergoing long term parenteral nutrition, the addition of a lipid emulsion to Clinimix in order to supply both calories and essential fatty acids is possible. Prescription Only Medicine.	1st December 1997
00116/0298	Baxter Healthcare Limited	Clinimix N9G20E	5.5% Amino Acid solution with electrolytes: L-Leucine 4.02 g/l; L-Phenylalanine 3.08 g/l; L-Methionine 2.20 g/l; L-Lysine 3.19 g/l (as L-Lysine chlorhydrate 4.00 g/l); L-Isoleucine 3.30 g/l; L-Valine 3.19 g/l; L-Histidine 2.64 g/l; L-Threonine 2.31 g/l; L-Tryptophan 0.99 g/l; L-Alanine 11.38 g/l; L-Arginine 6.32 g/l; Glycine 5.66 g/l; L-Proline 3.74 g/l; L-Serine 2.75 g/l; L-Tyrosine 0.22 g/l; Sodium Acetate, 3H O 4.31 g/l; Dibasic Potassium Phosphate 5.22 g/l; Sodium Chloride 2.24 g/l; Magnesium Chloride 6H O 1.02 g/l. 20% Glucose solution with calcium: Glucose 200 g/l (as monohydrate glucose 220 g/l); Calcium Chloride, 2H O 0.662 g/l	(See PL/00116/0297) Prescription Only Medicine	1st December 1997
00116/0299	Baxter Healthcare Limited	Clinimix N12G20E	7% Amino Acid solution with electrolytes: L-Leucine 5.11 g/l; L-Phenylalanine 3.92 g/l; L-Methionine 2.80 g/l; L-Lysine 4.06 g/l; (as L-Lysine chlorhydrate 5.07 g/l; L-Isoleucine 4.20 g/l; L-Valine 4.06 g/l; L-Histidine 3.36 g/l; L-Threonine 2.94 g/l; L-Tryptophan 1.26 g/l; L-Alanine 14.49 g/l; L-Arginine 8.05 g/l; Glycine 7.21 g/l; L-Proline 4.76 g/l; L-Serine 3.50 g/l; L-Tyrosine 0.28 g/l; Sodium Acetate, 3H O 5.15 g/l; Dibasic Potassium Phosphate 5.22 g/l; Sodium Chloride 1.88 g/l; Magnesium Chloride 6H O 1.02 g/l. 20% Glucose solution with calcium: Glucose 200 g/l (as monohydrate glucose 220 g/l); Calcium Chloride, 2H O 0.662 g/l	(See PL/00116/0297) Prescription Only Medicine	1st December 1997
00116/0300	Baxter Healthcare Limited	Clinimix N14G30E	8.5% Amino Acid solution with electrolytes: L-Leucine 6.20 g/l; L-Phenylalanine 4.76 g/l; L-Methionine 3.40 g/l; L-Lysine 4.93 g/l (as L-Lysine chlorhydrate 6.16 g/l; L-Isoleucine 5.10 g/l; L-Valine 4.93 g/l; L-Histidine 4.08 g/l; L-Threonine 3.57 g/l; L-Tryptophan 1.53 g/l; L-Alanine 17.6 g/l; L-Arginine 9.78 g/l; Glycine 8.76 g/l; L-Proline 5.78 g/l; L-Serine 4.25 g/l; L-Tyrosine 0.34 g/l; Sodium Acetate, 3H O 5.94 g/l; Dibasic Potassium Phosphate 5.22 g/l; Sodium Chloride 1.54 g/l; Magnesium Chloride 6H O 1.02 g/l. 30% Glucose solution with calcium: Glucose 300 g/l (as monohydrate glucose 330 g/l); Calcium Chloride, 2H O 0.662 g/l	(See PL/00116/0297) Prescription Only Medicine	1st December 1997
00116/0301	Baxter Healthcare Limited	Clinimix N17G35E	10% Amino Acid solution with electrolytes: L-Leucine 7.30 g/l; L-Phenylalanine 5.60 g/l; L-Methionine 4.00 g/l; L-Lysine 5.80 g/l (as L-Lysine chlorhydrate 7.25 g/l; L-Isoleucine 6.00 g/l; L-Valine 5.80 g/l; L-Histidine 4.80 g/l; L-Threonine 4.20 g/l; L-Tryptophan 1.80 g/l; L-Alanine 20.70 g/l; L-Arginine 11.50 g/l; Glycine 10.30 g/l; L-Proline 6.80 g/l; L-Serine 5.00 g/l; L-Tyrosine 0.40 g/l; Sodium Acetate, 3H O 6.80 g/l; Dibasic Potassium Phosphate 5.22 g/l; Sodium Chloride 1.17 g/l; Magnesium Chloride 6H O 1.02 g/l. 35% Glucose solution with calcium: Glucose 350 g/l (as monohydrate glucose 385 g/l); Calcium Chloride, 2H O 0.662 g/l	(See PL/00116/0297) Prescription Only Medicine	1st December 1997
00116/0302	Baxter Healthcare Limited	Clinimix N12G20	7% Amino acid solution without electrolytes L-Leucine 5.11 g/l L-Phenylalanine 3.92 g/l L-Methionine 2.80 g/l L-Lysine 4.06 g/l (as L-Lysine chlorhydrate 5.07 g/l) L-Isoleucine 4.20 g/l L-Valine 4.06 g/l L-Histidine 3.36 g/l L-Threonine 2.94 g/l L-Tryptophan 1.26 g/l L-Alanine 14.49 g/l L-Arginine 8.05 g/l Glycine 7.21 g/l L-Proline 4.76 g/l L-Serine 3.50 g/l L-Tyrosine 0.28 g/l 20% Glucose solution without calcium Glucose 200 g/l (as monohydrate glucose) 220 g/l	(See PL/00116/0297) Prescription Only Medicine	1st December 1997
00116/0303	Baxter Healthcare Limited	Clinimix N14G30	8.5% Amino acid solution without electrolytes L-Leucine 6.20 g/l L-Phenylalanine 4.76 g/l L-Methionine 3.40 g/l L-Lysine 4.93 g/l (as L-Lysine chlorhydrate 6.16 g/l) L-Isoleucine 5.10 g/l L-Valine 4.93 g/l L-Histidine 4.08 g/l L-Threonine 3.57 g/l L-Tryptophan 1.53 g/l L-Alanine 17.6 g/l L-Arginine 9.78 g/l Glycine 8.76 g/l L-Proline 5.78 g/l L-Serine 4.25 g/l L-Tyrosine 0.34 g/l 30% Glucose solution without calcium Glucose 300 g/l (as monohydrate glucose) 330 g/l	(See PL/00116/0297) Prescription Only Medicine	1st December 1997
00116/0304	Baxter Healthcare Limited	Clinimix N17G35	10% Amino acid solution without electrolytes L-Leucine 7.30 g/l L-Phenylalanine 5.60 g/l L-Methionine 4.00 g/l L-Lysine 5.80 g/l (as L-Lysine chlorhydrate 7.25 g/l) L-Isoleucine 6.00 g/l L-Valine 5.80 g/l L-Histidine 4.80 g/l L-Threonine 4.20 g/l L-Tryptophan 1.80 g/l L-Alanine 20.70 g/l L-Arginine 11.50 g/l Glycine 10.30 g/l L-Proline 6.80 g/l L-Serine 5.00 g/l L-Tyrosine 0.40 g/l 35% Glucose solution without calcium Glucose 350 g/l (as monohydrate glucose) 385 g/l	(See PL/00116/0297) Prescription Only Medicine	1st December 1997
PL 00142/0408	A H Cox & Company Limited	Nivaten Retard Tablets 10 mg	Nifedipine 10 mg	(1) Prophylaxis of chronic stable angina pectoris and the treatment of Prinzmetal’s (variant) angina (under a cardiologist’s supervision). (2) Treatment of hypertension. Prescription Only Medicine	5th December 1997
PL 00322/0076	Norgine Ltd	Destolit 150 mg Tablets	Ursodeoxycholic Acid 150.00 mg	For the dissolution of radiolucent (ie non-radio opaque) cholesterol gallstones in patients with a functioning gallbladder. Prescription Only Medicine	4th December 1997
00427/0115	Rosemont Pharmaceuticals Limited	Amitriptyline Oral Solution 25 mg/5ml	Amitriptyline Hydrochloride BP 25 mg	Symptoms of depression (especially where sedation is required). Nocturnal enuresis where organic pathology is excluded. Prescription Only Medicine	27th March 1998
00427/0116	Rosemont Pharmaceuticals Limited	Amitriptyline Oral Solution 50 mg/5ml	Amitriptyline Hydrochloride BP 50 mg	(See PL 00427/0115). Prescription Only Medicine	27th March 1998
01906/0029	Unicliffe Limited	Tinidazole Tablets	Tinidazole 500.000 mg	Treatment of the following infections: Eradication of Helicobacter pylori associated with duodenal ulcers, in the presence of antibiotic and acid suppressant therapy. Prescription Only Medicine	12th March 1998
02848/0196	Antigen Internationals Limited	Glycopyrrolate Injection	Glycopyrrolate .200 gm	To protect against the peripheral muscarinic actions of anticholinesterases such as neostigmine and pyridostigmine, used to reverse residual neuromuscular blockade produced by non-depolarising muscle relaxants. As a pre-operative antimuscarinic agent to reduce salivary tracheobronchial and pharyngeal secretions, and to reduce the acidity of the gastric contents. As a pre-operative or intra-operative antimuscarinic to attenuate or prevent intra-operative bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes. Prescription Only Medicine	3rd March 1998
02848/0200	Antigen International Ltd	Glycopyrrolate-Neostigmine Injection	Glycopyrrolate .500 mg Neostigmine Methylsulphate 2.500 mg	Reversal of residual non-depolarising (competitive) neuromuscular block. Prescription Only Medicine	3rd March 1998
03243/0325	Munro Wholesale Medical Supplies Limited	Canesten 1% Cream	Clotrimazole 1.000% w/w	Broad spectrum anti-fungal. Pharmacy Medicine	12th March 1998
03457/0007	Fresenius AG	Enflurane	Enflurane 100.00 ww	Induction and maintenance of general anaesthesia. Pharmacy Medicine	1st March 1998
03787/0436	Swingward Limited (t/a Medihealth).	Cardura 1 mg tablets	Doxazosin Mesylate 1.213 mg.	Hypertension. Treatment of urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia. Prescription Only Medicine	16th March 1998
3787/0450	Swingward Limited (t/a Medihealth)	Betoptic Eye Drops	Betaxolol Hydrochloride 0.560% ww	Reduction of elevated intraocular pressure in patients with ocular hypertension and chronic open angle glaucoma. Prescription Only Medicine	4th March 1998
3787/0473	Swingward Limited (t/a Medihealth)	Doxazosin 2 mg Tablets	Doxazosin 2.000 mg	Treatment of hypertension. Prescription Only Medicine	11th March 1998
3787/0492	Swingward Limited (t/a Medihealth)	Gopten 2 mg Capsules	Trandolapril 2.000mg	For mild to moderate hypertension. Prescription Only Medicine	24th February 1998
04416/0287	Lagap Pharmaceuticals Limited	Nifedipine Capsules 5 mg	Nifedipine 5.000 mg	Hypertension. The treatment and prophylaxis of chronic stable angina pectoris. The treatment of Raynaud’s phenomenon. Prescription Only Medicine	25th February 1998
04416/0288	Lagap Pharmaceuticals Limited	Nifedipine Capsules 10 mg	Nifedipine 10.000 mg	See PL 04416/0287. Prescription Only Medicine	25th February 1998
04423/0251	Doncaster Pharmaceuticals Group Limited	Locoid Ointment 0.1%	Hydrocortisone Butyrate 0.100% ww	Eczema and dermatitis. Psoriasis (excluding widespread plaque psoriasis). Prescription Only Medicine	2nd March 1998
04423/0263	Doncaster Pharmaceuticals Group Limited	Zestril 5 mg tablets/Lisinopril tablets 5 mg	Lisinopril Dihydrate 5.446 mg	Hypertension. Treatment of congestive heart failure. Renal and retinal complications of diabetes mellitus. Prescription Only Medicine	24th February 1998
04543/0387	CP Pharmaceuticals Limited	Sulpiride Tablets 400 mg	Sulpiride 400.000 mg	The treatment of acute and chronic schizophrenia. Prescription Only Medicine	6th March 1998
04543/0386	CP Pharmaceuticals Limited	Sulpiride Tablets 200 mg	Sulpiride 200.000 mg	The treatment of acute and chronic schizophrenia. Prescription Only Medicine	6th March 1998
04569/0363	Generics (UK) Limited	Domperidone Tablets 10 mg	Domperidone Maleate 12.700 mg	1. For the acute treatment of nausea and vomiting, from any cause, in adults. 2. For the treatment of nausea and vomiting caused by L-dopa and bromocriptine. 3. May be used for the treatment of symptoms of functional dyspepsia. Prescription Only Medicine	23rd March 1998
5662/0370	Dowelhurst Limited	Tibolone 2.5 mg Tablets/Livial 2.5 mg Tablets	Tibolone 2.5000 mg	Treatment of vasomotor symptoms resulting from natural or surgical menopause. Prescription Only Medicine	11th March 1998
5662/0423	Dowelhurst Limited	Mobic 15 mg Tablets/ Meloxicam 15 mg Tablets/ Mobic Tablets 15 mg	Meloxicam 15.000 mg	Short-term symptomatic treatment of acute osteoarthrosis. Long-term treatment of rheumatoid arthritis (chronic polyarthritis). Prescription Only Medicine	11th March 1998
05662/0447	Dowelhurst Limited	Indocid Retard 75 mg Capsules	Indomethacin 75.000 mg	Non-steroidal anti-inflammatory agent. Prescription Only Medicine	12th March 1998
05662/0477	Dowelhurst Limited	Boltin 2.5 mg Tablets/Boltin Tablets/Tibolone 2.5 mg	Tibolone 2.5 mg	Oestrogen deficiency. Prescription Only Medicine	23rd March 1998
06464/0486	Waymade Plc	Creon 25000 Capsules	Pancreatin 300.00 mg	Pancreatic exocrine insufficiency. Prescription Only Medicine	4th March 1998
06464/0495	Waymade Plc	Serevent 25 microgram Inhaler	Salmeterol Xinafoate 36.300 mcg	Reversible airways obstruction. Prescription Only Medicine	13th March 1998
6464/0498	Waymade Plc	Arimidex 1 mg Tablets/ Anastrozole 1 mg Tablets	Anastrozole 1.000 mg	Treatment of advanced breast cancer in post-menopausal women. Prescription Only Medicine	6th March 1998
06464/0500	Waymade Plc	Flixotide 125 Inhaler/Fluticasone Propionate 125 microgram Inhaler	Fluticasone propionate 125.000 mcg	Asthma. Prescription Only Medicine	16th March 1998
6679/0225	Polyfarma Limited	Lansoprazole 30 mg Capsules	Lansoprazole 30.000 mg	Acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine	11th March 1998
06745/0095	Pasteur Merieux MSD Ltd.	Inactivated Influenza Vaccine (Split Virion) BP Pasteur Merrieux	A/Wuhan/359/95 (H3N2)-Like 15.000 mcg Virus Influenza A/Singapore/6/86 (H1N1)-Like Strain 15.000 mcg Virus Influenza B/Beijing/184/93-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
6792/0358	Europharm of Worthing Limited	Omeprazole 20 mg Capsules	Omeprazole 20.000 mg	Treatment of oesophageal reflux disease. Prescription Only Medicine	11th March 1998
6792/0361	Europharm of Worthing Limited	Tibolone 2.5 mg Tablets	Tiblone 2.5000 mg	Hormone replacement therapy. Prescription Only Medicine	26th February 1998
08336/0089	Asta Medica Limited	Tramquel SR Capsules 50 mg	Tramadol Hydrochloride 50.000 mg	Moderate to severe pain. Prescription Only Medicine	3rd December 1997
08336/0090	Asta Medica Limited	Tramquel SR Capsules 100 mg	Tramadol Hydrochloride 100.000 mg	Moderate to severe pain. Prescription Only Medicine	3rd December 1997
08336/0091	Asta Medica Limited	Tramquel SR Capsules 150 mg	Tramadol Hydrochloride 150.000 mg	Moderate to severe pain. Prescription Only Medicine	3rd December 1997
08336/0092	Asta Medica Limited	Tramquel SR Capsules 200 mg	Tramadol Hydrochloride 200.000 mg	Moderate to severe pain. Prescription Only Medicine	3rd December 1997
08557/0036	Shire Pharmaceuticals Limited	Calcort Tablets 1 mg	Deflazacort HSE 1.0 mg	A wide range of conditions may sometimes need treatment with glucocorticosteroids. The indications include: anaphylaxis, asthma, severe hypersensitivity reactions; rheumatoid arthritis, juvenile chronic arthritis, polymyalgia rheumatica, systemic lupus erythematosus, dermatomyositis, mixed connective tissue disease (other than systemic sclerosis), polyarteritis nodosa; sarcoidosis; pemphigus, bullous pemphigoid, pyoderma gangrenosum; minimal change nephrotic syndrome, acute interstitial nephritis; rheumatic carditis; ulcerative colitis, Crohn’s disease; uveitis, optic neuritis; autoimmune haemolytic anaemia, idiopathic thrombocytopenic purpura, acute and lymphatic leukaemia, malignant lymphoma, multiple myeloma; immune suppression in transplantation. Prescription Only Medicine	14th December 1997
08557/0037	Shire Pharmaceuticals Limited	Calcort Tablets 6 mg	Deflazacort HSE 6.0 mg	See PL 08557/0036. Prescription Only Medicine	14th December 1997
08821/0007	Monsanto plc	Maxaquin Tablets 400 mg	Lomefloxacin Hydrochloride HSE 441.6 mg	For the treatment of single infections or mixed infections caused by two or more susceptible organisms. Recommended for the treatment of acute exacerbation of chronic bronchitis, upper and lower urinary tract infections (complicated and uncomplicated) and prophylaxis in trans-urethral surgery. Prescription Only Medicine	23rd December 1997
08821/0008	Monsanto plc	Maxaquin Capsules 200 mg	Lomefloxacin Hydrochloride HSE 220.8 mg	See PL 8821/0007 Prescription Only Medicine	23rd December 1997
08821/0010	Monsanto plc	Aldactone 50 mg Tablets	Spironolactone BP 500 mg	Congestion cardiac failure, Hepatic cirrohosis with ascites and oedema. Malignant ascites nephrotic syndrome. Diagnosis and treatment of primary aldosteronism. Prescription Only Medicine.	23rd December 1997
08821/0016	Monsanto plc	Norpace Capsules 100 mg	Disopyramide Phospate (Densified) BP 128.8 mg	Atrial arrhythmias: - Control of premature atrial contractions (P.A.C.) - Control of Paroxysmal Atrial Tachycardia (P.A.T.) - Maintenance of sinus rhythm following electroconversion for atrial fibrillation and atrial flutter of short duration. Ventricular Arrhythmias: - Control of Premature Ventricular Contractions (P.V.C.) both unifocal and multifocal. - Control of Paroxysmal Ventricular Tachycardia (P.V.T.) - Control of ventricular tachyarrhythmias in patients with suspected or proven myocardial infarction. Others: - Treatment of arrhythmias associated with Wolff-Parkinson-White syndrome. - Norpace is equally effective in treating the above arrhythmias in both digitalised and non-digitalised patients. Prescription Only Medicine.	23rd December 1997
08821/0017	Monsanto plc	Norpace Capsules 150 mg	Disopyramide Phospate (Densified) BP 193.2 mg	See PL/08821/0016 Prescription Only Medicine.	23rd December 1997
08821/0019	Monsanto plc	Cytotec 200 mcg Tablets	Misoprostol HSE 200.00 UG	For the healing of duodenal ulcer and gastric ulcer including those induced by non-steroidal anti-inflammatory drugs (nsaid) in arthritic patients at risk, whilst continuing their nsaid therapy. In addition it can be used for the prophylaxis of nsaid-induced ulcers. Prescription Only Medicine.	23rd December 1997
08821/0020	Monsanto plc	Cytotec 400 mcg Tablets	Misoprostol HSE 400.00 UG	For the healing of duodenal ulcer and gastric ulcer including those induced by non-steroidal anti-inflammatory drugs (nsaid) in arthritic patients at risk, whilst continuing their nsaid therapy. In addition it can be used for the prophylaxis of nsaid-induced ulcers. Prescription Only Medicine.	23rd December 1997
08821/0027	Monsanto plc	Topilith Ointment	Lithium Succinate HSE 8.0 ww Lithium (Base) 0.85 ww Zinc Sulphate EP 0.05 ww Zinc (Base) 0.011 ww	Topical treatment and symptomatic relief of seborrhoetic dermatitis Prescription Only Medicine.	23rd December 1997
08829/0079	Trinity Pharmaceuticals Limited	Ibuprofen Tablets BP 200 mg	Ibuprofen 200.000 mg	In the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis, other non-rheumatoid (seronegative) arthropathics, periarticular conditions such as frozen shoulder, bursitis, tendinitis, etc., low back pain, sprains, strains, dysmenorrhoea, dental and post operative pain and migraine. Prescription Only Medicine. For the relief of rheumatic and muscular pain, backache, neuralgia, migraine, headache, colds and flu, fever, dental and period pain. Pharmacy Medicine.	23rd March 1998
08829/0080	Trinity Pharmaceuticals Limited	Ibuprofen Tablets BP 400 mg	Ibuprofen 400.000 mg	For the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis, other non-rheumatoid (seronegative) athropathies, periarticular conditions such as frozen shoulder, bursitis, tendinitis, etc., low back pain, sprains, strains, dysmenorrhoea, dental and post operative pain and migraine. Prescription Only Medicine.	23rd March 1998
08829/0081	Trinity Pharmaceutical Limited	Ibuprofen Tablets BP 600 mg	Ibuprofen 600.000 mg	See PL 08829/0080 Prescription Only Medicine	23rd March 1998
10256/0328	Stephar (UK) Limited	Zoton 30 mg Capsules	Lansoprazole 30.000 mg	Treatment of acid-related disorders of the upper gastro-intestinal tract. Prescription Only Medicine.	24th February 1998
10256/0329	Stephar (UK) Limited	Serevent Inhaler	Salmeterol Xinafoate 36.300 mcg	Treatment of reversible airways obstruction. Prescription Only Medicine.	16th March 1998
10256/0332	Stephar (UK) Limited	Creon 25000 Capsules	Pancreatin Porcine 300.000 mg	Treatment of Pancreatic Exocrine insufficiency. Prescription Only Medicine	26th February 1998
10256/0337	Stephar (UK) Limited	Paludrine Tablets	Proguanil Hydrochloride 100.000 mg	Anti-malarial agent. Pharmacy Medicine	27th February 1998
10256/0340	Stephar (UK) Limited	Capoten 25 mg	Captopril 25.000 mg	Mild to moderate hypertension. Prescription Only Medicine	11th March 1998
10256/0341	Stephar (UK) Limited	Capoten 50 mg	Captopril 50.000 mg	Mild to moderate hypertension. Congestive heart failure. Myocardial Infarction. Diabetic Nephropathy. Prescription Only Medicine	13th March 1998
10256/0344	Stephar (UK) Limited	Clarityne Tablets	Loratadine 10.000 mg	Allergic rhinitis. Prescription Only Medicine.	16th March 1998
10256/0347	Stephar (UK) Limited	Clarithromycin 250 mg Tablets	Clarithromycin 250.00 mg	Antibiotic. Prescription Only Medicine	18th March 1998
10256/0349	Stephar (UK) Limited	Tibolone 2.5 mg Tablets	Tibolone	Vasomotor symptoms and osteoporosis. Prescription Only Medicine	16th March 1998
10256/0352	Stephar (UK) Limited	Neurontin 100 mg	Gabapentin 100.000 mg	Anti-epileptic drug for partial seizures. Prescription Only Medicine	13th March 1998
10256/0353	Stephar (UK) Limited	Neurontin 300 mg	Gabapentin 300.000 mg	Anti-epileptic drug for partial seizures. Prescription Only Medicine	13th March 1998
10256/0356	Stephar (UK) Limited	Prozac 20 mg/5 ml Liquid	Fluoxetine Hydrochloride 22.36 mg	Depression and Bulimia Nervosa. Prescription Only Medicine	16th March 1998
10380/0190	Swinghope Limited	Bactroban Ointment/Mupirocin 2% Ointment	Mupirocin 2.000% w/w	Bacterial skin infections. Prescription Only Medicine	4th March 1998
10380/0196	Swinghope Limited	Plumicort Turbohaler200/Budesonide 200 micrograms Turbohaler	Budesonide 200..000 mcg	Bronchial Asthma. Prescription Only Medicine	18th March 1998
1038010202	Swinghope Limited	Estracombi/Estracomb TTS	17-Beta Oestradiol 14.000 mg Norethisterone Acetate 30.000 mg	Oestrogen replacement therapy. Prescription Only Medicine	23rd March 1998
10383/0492	Primecrown Limited	Otosporin Ear Drops	Polymyxin B Sulphate 10000.000 IU Neomycin Sulphate 3400.00 IU Hydrocortisone 1.000 mg	Treatment of Otitis Externa due to bacterial infection. Prescription Only Medicine	12th March 1998
10383/0512	Primecrown Limited	Flixotide 125 microgram inhaler/Fluticasone Propionate 125 microgram inhaler	Fluticasone Propionate 125.mcg	Asthma. Prescription Only Medicine	27th February 1998
10383/0529	Primecrown Limited	Famvir 250 mg Tablets/ Famciclovir Tablets 250 mg	Famciclovir 250.000 mg	Herpes zoster infections. Prescription Only Medicine	11th March 1998
10383/0551	Primecrown Limited	Clarityne Tablets/Clarityn Tablets/Loratadine 10 mg tablets	Loratadine Micronised 10.000 mg	Allergic rhinitis. Idiopathic chronic urticaria. Prescription Only Medicine	12th March 1998
10592/0110	Smithkline Beecham Plc	Priorix	Live attenuated Mumps Virus (Rit 43585 derived from Jeryl Lynn) 5011.000 Cid50 Live attenuated Measles Virus (Schwartz Strain) 1000.000 Cid50 Live Attenuated Rubella (Wistar RA 27/3 Strain) 1000.000 Cid50	For active immunisation against measles, mumps and rubella. Prescription Only Medicine	4th December 1997
10592/0122	Smithkline Beecham Plc	Amoxi-co 375 mg Co-Amoxiclav Tablets BP 250 mg/125 mg	Amoxycillin Trihydrate 250.000 mg Potassium Clavulanate 125.000 mg	For short term treatment of bacterial infections at the following sites when amoxycillin resistant beta-lactamase producing strains are suspected as the cause. In other situations, amoxycillin alone should be considered. Upper Respiratory Tract Infections (including ENT) in particular sinusitis, otitis media, recurrent tonsillitis. These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae*, Moraxella catarrhalis* and Streptococcus pyogenes. Lower Respiratory Tract Infections in particular acute exacerbations of chronic bronchitis (especially if considered severe), bronchopneumonia (especially in high risk patients). These infections are often caused by Streptococcus pneumoniae, Haemophilus influenzae*, Moraella catarrhalis*. Genito-urinary Tract and Abdominal Infections in particular cystitis. (especially when recurrent or complicated—excluding prostatis) septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis which are often caused by Enterbacteriaceae* (mainly Escherichia Coli*), Staphylococcus saprophyticus species, Enterococcus sapp. Skin and Soft Tissue Infections in particular cellulitis, animal bites and severe dental abscess with spreading cellulitis which are often caused by Staphylococcus aureus*, Streptococcus pyogens and Bacteroides species*. *Some members of these species of bacteria produced beta-lactamase rendering them insensitive to amoxycillin alone. Mixed infections caused by amoxycillin susceptible organisms in conjunction with Co-amoxiclav susceptible beta-lactamase producing organisms may be treated by Co-amoxiclav. These infections should not require the addition of another antibiotic resistant to beta-lactamases. Prescription Only Medicine	9th March 1998
10592/0123	Smithkline Beecham Plc	Amoxi-co 625 mg Co-Amoxiclav Tablets BP 500 mg/125 mg	Amoxycillin Trihydrate 500.000 mg Potassium Clavulanate 125.000 mg	(See PL/10592/0122). Prescription Only Medicine	9th March 1998
10592/0124	Smithkline Beecham Plc	Amoxi-co 125/31 Co-Amoxiclav Oral Suspension 125 mg/31.25 mg/5 ml	Amoxycillin Trihydrate 125.000 mg Potassium Clavulanate 31.250 mg	(See PL/10592/0122). Prescription Only Medicine	9th March 1998
10592/0125	Smithkline Beecham Plc	Amoxi-co 250/62 Co-Amoxiclav Oral Suspension 250/62.5 mg/5 ml	Amoxycillin Trihydrate 250.000 mg Potassium Clavulanate 62.500 mg	(See PL/10592/0122). Prescription Only Medicine	9th March 1998
10949/0286	Glaxo Wellcome UK Limited	Triprolidine, Pseudoephedrine and Guiaphenesin Expectorant	Guaiphenesin 100.000 mg Pseudoephedrine Hydrochloride 30.000 mg Triprolidine Hydrochloride 1.250 mg	For the symptomatic relief of upper respiratory tract disorders accompanied by productive cough, which benefit from the administration of a nasal decongestant, a histamine HI-receptor antagonist and an expectorant combination. Pharmacy Medicine	20th March 1998
10949/0299	Glaxo Wellcome UK Limited	Raxar Tablets 400 mg	Grepafloxacin Hydrochloride Sesquihydrate Milled 472.800 mg	For the treatment of infections caused by strains of bacteria susceptible to grepafloxacin in the following diseases: Community-acquired pneumonia, except severe pneumonia requiring parenteral therapy—Acute bacterial exacerbations of chronic bronchitis—Uncomplicated gonorrhoea (urethritis and cervicitis)—Urethritis and cervicitis caused by Chlamydia trachomatis. Consideration should be given to national and/or local guidance regarding the appropriate use of antibacterial agents. Prescription Only Medicine	9th December 1997
10949/0300	Glaxo Wellcome UK Limited	Raxar Tablets 600 mg	Grepafloxacin Hydrochloride Sesquihydrate Milled 709.200 mg	(See PL/10949/0300) Prescription Only Medicine	9th December 1997
11204/0043	Stada Arzneimittel AG	Fluoxetine 20 mg Felicium	Fluoxetine Hydrochloride 22.400 mg	For treatment of the symptoms of depressive illness. Prescription Only Medicine	13th March 1998
11311/0070	Tillomed Laboratories Limited	Sotalol Hydrochloride Tablets 40 mg	Sotalol Hydrochloride 40.000 mg	Ventricular arrhythmias: treatment of life-threatening ventricular tachyarrhythmias; treatment of symptomatic non-sustained ventricular tachyarrhythmias. Supraventricular arrhythmias: prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal A-V nodal re-entrant tachycardia, paroxysmal A-V re-entrant tachycardia, using accessory pathways, and paroxysmal supraventricular tachycardia after cardiac surgery; maintenance of normal sinus rhythm following conversion of atrial fibrillation or atrial flutter. Prescription Only Medicine	3rd March 1998
11311/0071	Tillomed Laboratories Limited	Sotalol Hydrochloride Tablets 80 mg	Sotalol Hydrochloride 80.000 mg	(See PL/11311/0070). Prescription Only Medicine	3rd March 1998
11311/0072	Tillomed Laboratories Limited	Sotalol Hydrochloride Tablets 160 mg	Sotalol Hydrochloride 160.000 mg	(See PL/11311/0070) Prescription Only Medicine	3rd March 1998
11648/0023	Merck Limited	FemSeven 75	Estradiol Hemihydrate	Hormone replacement therapy for the symptomatic relief of menopausal symptoms including: Vasomotor symptoms such as sweating and flushing. Other symptoms related to oestrogen deficiency e.g. urogenital atrophy, urinary urgency, sleeping disorders, and mood swings. Hormone replacement therapy is also indicated for the: Prevention of post menopausal bone loss in women considered at risk of developing fractures. Prescription Only Medicine	22nd December 1997
11648/0024	Merck Limited	FemSeven 100	Estradiol Hemihydrate 3.000 mg	(See PL/11648/0023) Prescription Only Medicine	22nd December 1997
12064/0045	Aurum Pharmaceuticals Limited	Magnesium Sulphate Injection BP 50% w/v	Magnesium Sulphate 50.000 wv	Treatment of Magnesium deficiency in hypomagnesaemia. To prevent further seizures associated with Eclampsia. Prescription Only Medicine	26th February 1998
12070/0020	Cambridge Selfcare Diagnostics Ltd.	Peptavlon Injection	Pentagastrin BP 0.025 w/v	Used for the diagnostic testing of gastric secretion. Prescription Only Medicine	29th December 1997
13402/0027	Hoechst Marion Roussel Limited	Daonil 5 mg Tablets	Glibenclamide BP 5.0 mg	Hypoglycaemic agent for the treatment of non-insulin dependent diabetic patients who do not respond adequately to dietary therapy. Prescription Only Medicine	31st December 1997
13402/0028	Hoechst Marion Roussel Limited	Semi-Daonil Tablets	2.5 mg Glibenclamide BP	Hypoglycaemic agent, indicated for the oral treatment of patients with maturity onset diabetes who respond inadequately to dietary measures alone. Prescription Only Medicine	31st December 1997
13402/0029	Hoechst Marion Roussel Ltd	Fertiral	Gonadorelin BP 0.05 w/v	The treatment of amenorroea and infertility associated with 1. Hypogonadotrophic hypogonadism. 2. Multifollicular ovaries: where this finding implies that pulse frequency and amplitude of endogenous LHRH are abnormal, eg in patients in whom weight related amenorrhoea has been corrected. Prescription Only Medicine	31st December 1997
13402/0030	Hoechst Marion Roussel Limited	Frisium Tablets 10 mg	Clobazam 10.000 mg	For the short-term relief (2-4 weeks) only 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. Its use to treat short-term “mild” anxiety is inappropriate and unsuitable. May be used as adjunctive therapy in epilepsy. Prescription Only Medicine	31st December 1997
13402/0031	Hoechst Marion Roussel Ltd	Haemaccel	Polygelin HSE 35 GM	1. As a plasma volume substitute in the initial treatment of hypovolaemic shock due to: (a) Haemorrhage (visible or concealed), (b) burns, pertitonitis, pancreatitis, crush injuries. 2. Fluid replacement in plasma exchange. 3. Extra-corporeal circulation. 4. Isolated organ perfusion. 5. As a carrier solution for insulin. Prescription Only Medicine	31st December 1997
13402/0032	Hoechst Marion Roussel Ltd	Lasikal	Frusemide BP 20 mg Potassium Chloride BP 750 mg	Treatment of oedema in patients who require potassium supplementation. Prescription Only Medicine	31st December 1997
13402/0033	Hoechst Marion Roussel Limited	Lasilactone	Frusemide EUR 20.00 mg Spironolactone EUR 50.00 mg	Lasilactone contains a short-acting diuretic and a long-acting aldosterone antagonist. It is indicated in the treatment of resistant oedema where this is associated with secondary hyperaldosteronism; conditions include chronic congestive cardiac failure and Hepatic cirrhosis. Treatment with Lasilactone should be reserved for cases refractory to a diuretic alone at conventional dosage. This fixed ration combination should only be used if titration with the component drugs separately indicates that this product is appropriate. The use of Lasilactone in the management of essential hypertension should be restricted to patients with demonstrated hyperaldosteronism. It is recommended that in these patients also, this combination should only be used if titration with the component drugs separately indicates that this product is appropriate. Prescription Only Medicine	31st December 1997
13402/0034	Hoechst Marion Roussel Limited	Lasikal+K	Frusemide 40 mg Potassium Chloride 750 mg	As a diuretic with potassium supplementation for patients on a fixed dose of Lasix (40 mg daily) during long-term treatment of oedema (cardiac, renal, hepatic) and requiring a fixed dose of potassium. The combination is not intended for patients requiring individual titration of dosage. Prescription Only Medicine	31st December 1997
13402/0035	Hoechst Marion Roussel Limited	Lasix Injection 20 mg/2 ml	Frusemide BP 20 mg	For use when prompt and effective diuresis is required. Appropriate for use in emergencies or when oral therapy is precluded. Indications include: cardiac, pulmonary, hepatic and renal oedema. Prescription Only Medicine	31st December 1997
13402/0036	Hoechst Marion Roussel Limited	Lasix Paediatric Liquid	Frusemide BP 1% w/v	A diuretic for treatment of oedema in children or in patients unable to take solid oral dosage forms of lasix. Prescription Only Medicine	31st December 1997
13402/0037	Hoechst Marion Roussel Limited	Lasix 20 mg Tablets	Frusemide BP 20 mg	Maintenance therapy of mild oedema states of any origin. Prescription Only Medicine	31st December 1997
13402/0038	Hoechst Marion Roussel Limited	Lasix Tablets 40 mg	Frusemide BP 40 mg	For the treatment of Oedema states and hypertension. Prescription Only Medicine	31st December 1997
13402/0040	Hoechst Marion Roussel Limited	Lasoride	Amiloride Hydrochloride 5.0 mg Frusemide 40.0 mg	Where a prompt diuresis is required and where potassium conservation is important. Prescription Only Medicine	31st December 1997
13402/0041	Hoechst Marion Roussel Limited	Metenix 5 Tablets	Metolazone 5.0 mg	For use in the treatment of mild and moderate hypertension. It may be used in conjunction with non-diuretic antihypertensive agents and, in these circumstances, it is usually possible to achieve satisfactory control of blood pressure with a reduced dose of the non-diuretic agent. Patients who have become resistant to therapy with these agents may respond to the addition of Metenix 5 to their antihypertensive regimen. It may also be used for the treatment of cardiac, renal and hepatic oedema, ascites or toxaemia of pregnancy. Prescription Only Medicine	31st December 1997
13402/0042	Hoechst Marion Roussel Limited	Rastinon Tablets	Tolbutamide BP 500.0 mg	For the oral treatment of patients with non-insulin dependent diabetes. (Maturity onset on type II diabetes) who respond inadequately to dietary treatment alone. Rastinon is particularly suitable for elderly patients. Prescription Only Medicine	31st December 1997
13402/0043	Hoechst Marion Roussel Limited	Relefact LH-RH	Gonadorelin 0.1 mg	Intravenous injection causes release of LH (luteinizing hormone) and FSH (follicle-stimulating hormone) from the pituitary gland. It provides a means of assessing the reserve of LH and FSH in the pituitary glands of patients with suspected pituitary impairment. In addition, it may be of value in the differential diagnosis of delayed puberty and hypogonadism. Prescription Only Medicine	31st December 1997
13402/0044	Hoechst Marion Roussel Limited	Streptase Injection 1.5 Million I.U.	Streptokinase (1,500,000 I.U.) BP 1,500,000 I.U.	Treatment of acute myocardial infarction. Prescription Only Medicine	31st December 1997
13402/0045	Hoechst Marion Roussel Limited	Streptase Injection 250,000 I.U.	Streptokinase BP 250,000 I.U.	Intravascular dissolution of thrombi and emboli in; extensive deep venous thrombosis, pulmonary embolism, acute or subacute occlusion of peripheral arteries and central retinal venous or arterial thrombosis. Prescription Only Medicine	31st December 1997
13402/0046	Hoechst Marion Roussel Limited	Streptase Injection 750,000 IU	Streptokinase BP 750,000 IU	Intravascular dissolution of thrombi and emboli in; extensive deep venous thrombosis, pulmonary embolism, acute or subacute occlusion of peripheral arteries and central retinal venous or arterial thrombosis. Prescription Only Medicine	31st December 1997
13402/0047	Hoechst Marion Roussel Limited	Suprecur Injection	Buserelin Acetate .105 wv	Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins. Prescription Only Medicine	31st December 1997
13402/0048	Hoechst Marion Roussel Limited	Suprecur Nasal Spray	Buserelin Acetate HSE 0.158 mg	The treatment of endometriosis in cases that do not require surgery as primary therapy. Pituitary Desensitisation in preparation for ovulation induction regimens using gonadotrophins. Prescription Only Medicine
13402/0049	Hoechst Marion Roussel Limited	Suprefact Depot	Buserelin Acetate 6.600 mg mg	For the long-term endocrine treatment of advanced prostatic carcinoma, with a dose interval of 2 months, which in exceptional cases can be extended by a few days, because a considerable release reserve is still present at the end of the dosage interval. This ensures continuous suppression of testosterone, but does not lead to cumulation of buserelin release after repeated dosing. Buserelin acts by suppressing the pituitary-gonadol axis. The secretion of testosterone is suppressed to the castration range by controlled release of buserelin. Prescription Only Medicine	31st December 1997
13402/0050	Hoechst Marion Roussel Limited	Suprefact (S/C) Injection 1 mg/ml	Buserelin Acetate .105 wv	For the treatment of advanced prostatic carcinoma (stage C or D according to the classification of Murphy et al, in Cancer 45, p1889-95, 1980) in which suppression of testosterone is indicated. Prescription Only Medicine	31st December 1997
13402/0052	Hoechst Marion Roussel Limited	Tarivid IV Infusion Solution 2 mg/ml	Ofloxacin Hydrochloride HSE 0.22 wv	Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of gram-negative and gram-positive organisms. It is indicated for the treatment of the following infections when caused by sensitive organisms: lower respiratory tract acute and chronic infections; upper and lower urinary tract: acute and chronic lower urinary tract infections; acute and chronic upper urinary tract infections (Pyelonephritis), septicaemia; skin and soft tissue infections. Prescription Only Medicine	31st December 1997
13402/0053	Hoechst Marion Roussel Limited	Tarivid 200 mg tablets	Ofloxacin 200.00 mg	(See PL/13402/0052) Prescription Only Medicine	31st December 1997
13402/0054	Hoechst Marion Roussel Limited	Tarivid Tablets 400 mg	Ofloxacin HSE 400 mg	(See PL/13402/0052) Prescription Only Medicine	31st December 1997
13402/0055	Hoechst Marion Roussel Limited	Trental 400	Oxpentifylline 400.000 mg	Treatment of peripheral vascular disease, including intermittent claudication and rest pain. Prescription Only Medicine	31st December 1997
13606/0056	Co-Pharma Limited	Nifedipine Capsules 5 mg	Nifedipine 5.000 mg	For the prophylaxis of chronic stable angina pectoris, the treatment of Raynaud’s phenomenon and hypertension. Prescription Only Medicine	4th March 1998
13606/0057	Co-Pharma Limited	Nifedipine Capsules 10 mg	Nifedipine 10.000 mg	(See PL/13606/0056) Prescription Only Medicine	4th March 1998
13606/0063	Co-Pharma Limited	Naproxen Tablets 250 mg	Naproxen 250.000 mg	For the treatment of rheumatoid arthritis, osteoarthrosis (degenerative arthritis), ankylosing spondylitis, juvenile rheumatoid arthritis, acute gout and acute musculoskeletal disorders (including sprains and strains, direct trauma and lumbosacral pain, cervical spondylitis, tenosynovitis and fibrositis). Prescription Only Medicine	4th March 1998
13606/0064	Co-Pharma Limited	Naproxen Tablets 500 mg	Naproxen 500.000 mg	(See PL/13606/0063) Prescription Only Medicine	4th March 1998
13826/0091	Caseview (PL) Limited	Kalten Capsules	Atenolol 50.000 mg Hydrochlorothiazide 25.000 mg Amiloride Hydrochloride dihydrate 2.840 mg	Management of hypertension. Prescription Only Medicine	13th March 1998
14069/0023	Denfleet International Limited	Flixonase Aqueous Nasal Spray	Fluticasone Propionate 50.000 mcg	Seasonal allergic rhinitis and perennial rhinitis. Prescription Only Medicine	4th March 1998
14994/0001	Vitaline Pharmaceuticals UK Limited	Phosex	Calcium Acetate 1000.000 mg	A phosphate binder in hyperphosphataemia associated with renal failure. Prescription Only Medicine	22nd December 1997
14998/0002	PH&T SRL	Flutamide Tablets 250 mg	Flutamide .250 gm	Advanced prostatic carcinoma, in which suppression of testosterone effects is indicated. Prescription Only Medicine	4th March 1998
15361/0006	P.I.E. Pharma Limited	Pulmicort Respules 1 mg	Budesonide 0.500 mg/ml	Bronchial asthma. Prescription Only Medicine	13th March 1998
15513/0069	Warner Lambert Consumer Healthcare	Sinutab Tablets	Paracetamol EP 500 mg Phenylpropanolamine Hydrochloride EP 12.5 mg	For the relief of nasal and sinus congestion and associated headache. For the relief of sinus pain, fever and congestive symptoms associated with the common cold, influenza and hay fever. Pharmacy Medicine	12th December 1997
15814/0056	OPD Laboratories Limited	Metrodin HP 75/Metrodin High Purity 75	Urofollitrophin 75.000 IU	Ovulation induction; the stimulation of spermatogenesis due to hypogonadotrophic hypogonadism. Prescription Only Medicine	27th February 1998
15814/0060	OPD Laboratories Limited	Sodium Chloride Injection 0.9% w/v	Sodium Chloride 0.900 wv	For reconstitution of any parental product requiring 0.9% sodium chloride solution as diluent. Prescription Only Medicine	27th February 1998
15814/0082	OPD Laboratories Limited	Half Sinemet CR Tablets	Carbidopa Anhydrous 25.000 mg Levodopa 100.000 mg	Antiparkinson agent. Prescription Only Medicine	12th March 1998
15819/0025	Lorex Synthelabo UK & Ireland Ltd	Priadel	Lithium Carbonate EP 400.0 mg	1. In the management of acute manic or hypomanic episodes. 2. In the management of episodes of recurrent depressive disorders where treatment with other antidepressants has been unsuccessful. 3. In the prophylaxis against bipolar affective disorders. 4. Control of aggressive behaviour or intentional self harm. Prescription Only Medicine	1st December 1997
15819/0026	Lorex Synthelabo UK & Ireland Ltd	Priadel 200	Lithium Carbonate 200.000 mg	In the management of acute manic or hypomanic episodes. In the management of episodes of recurrent depressive disorders where treatment with other antidepressants has been unsuccessful. In the prophylaxis against bipolar affective disorders. Contol of aggressive behaviour or intentional self harm. Prescription Only Medicine	1st December 1997
15819/002	Lorex Synthelabo UK & Ireland Ltd	Priadel Liquid	Lithium Citrate USP 10.4 w/v	Treatment of mania and hypomania. Lithium may also be tried in the treatment of some patients with recurrent bipolar depression, where treatment with other antidepressants has been unsuccessful. Prophylactic treatment of recurrent affective disorders. Control of aggressive or self-mutilating behaviour. Prescription Only Medicine	1st December 1997
15929/0003	Linde Gas UK Limited	Medical Helium	Helium 100.000 vv	To prevent atelectasis and to assist oxygen flow into lung alveoli in cases of severe respiratory obstruction. Also for use in respiratory function tests. Pharmacy Medicine.	19th March 1998
15929/0006	Linde Gas UK Limited	Medical Oxygen 21% Helium 79%	Helium 79.000 vv Oxygen 21.000 vv	See PL 15929/0003	19th March 1998
16028/0019	Galpham Healthcare Limited	Dispersable Aspirin Tablets BP 300 mg	Aspirin BP 300.0 mg	Pack sizes of up to 16 tablets-General Sales List Pack sizes of 17-32 tablets. Pharmacy Medicine. Pack size over 32 tablets. Prescription Only Medicine.	1st March 1998
Pharmacy Only Packs As an analgesic, antipyretic and anti-inflammatory including use for rheumatoid arthritis, osteoarthritis and acute and chronic rheumatic conditions. For the symptomatic relief of influenza and feverish colds. For mild to moderate pain including headache, toothache and dysmenorrhoea. GSL Packs. Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. For mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains. For the symptomatic relief of influenza feverishness and feverish colds.
16108/0030	Adams Healthcare Limited	Chlorhexidine Gluconate Mouthwash Natural Flavour	Chlorhexidine Gluconate .200 wv	In antimicrobial solution which inhibits the formation of dental plaque. It is indicated as an aid to the treatment and prevention of gingivitis and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (e.g. following oral surgery or in physically handicapped patients,). It is used to promote gingival healing following periodontal surgery, to manage recurrent oral ulceration. Additionally it is useful in the treatment of denture stomatitis and thrush. General Sales List.	13th March 1998
16108/0031	Adams Healthcare Limited	Chlorhexidine Gluconate Mouthwash Peppermint Flavour	Chlorhexidine Gluconate .200 wv	See PL 16108/0030. General Sales List.	13th March 1998
16239/0001	Menarini International Operations Luxembourg S.A. (M.I.O.L)	Balzide	Balsalazide Disodium 750.000 mg	For treatment of mild-to-moderate active ulcertive colitis. Prescription Only Medicine.	18th March 1998
16239/0001	Menarini International Operations Luxembourg S.A. (M.I.O.L)	Balzide	Balsalazide Disodium 750.000 mg	For treatment of mild-to-moderate active ulcertive colitis. Prescription Only Medicine.	18th December 1997
16431/0007	Ayrton Saunders Limited	Squill Opiate Linctus BP Gees Linctus BP	Camphorated Opium Tincture BP 1.67 ml Squill Oxymel BP 1.67 ml	Symptomatic relief of troublesome coughs. Pharmacy Medicine.	5th December 1997
16431/0009	Ayrton Saunders Limited	Beehive Balsam	Honey 0.75 gm Glycerin BP 0.50 ml Extract Ipecacuanha Liquid BP 0.015 ml Oil Lemon Terpeneless 0.00025 ml BP	For stubborn coughs. General Sales List.	5th December 1997
16431/0012	Ayrton Saunders Limited	Touch and Go	Clove Oil BP 100.00	As a toothache remedy, for temporary relief of toothache due to dental cavity. General Sales List	5th December 1997