MEDICINES CONTROL AGENCY

Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Telephone 020-7273 0422, or 0425 Product Licences Granted

Product Licence Number	Company Name	Product Name	Active Ingredients	Indications	Date of Authorisation
00003/0374	The Wellcome Foundation Limited	Ergotamine Tartrate, Cyclizine HC1, Caffeine Tablets	Caffeine 91.500 mg Cyclizine Hydrochloride 50.000 mg Ergotamine Tartrate 2.000 mg	Relief of the acute migraine attack. Prescription Only Medicine	13th March 2001
00003/0375	The Wellcome Foundation Limited	Lamictal Dispersible 2 mg	Lamotrigine 2.000 mg	Epilepsy: Monotherapy in adults and children over 12 years of age: 1. Simple partial seizures. 2. Complex partial seizures. 3. Secondarily generalised tonic-clonic seizures. 4. Primary generalised tonic-clonic seizures. Monotherapy in children under 12 years of age is not recommended until such time as adequate information is made available from controlled trials in this particular target population. Add-on therapy in adults and children over 2 years of age: 1. Simple patrial seizures. 2. Complex partial seizures. 3. Secondarily generalised tonic-clonic seizures. 4. Primary generalised tonic-clonic seizures. For the treatment of seizures associated with Lennox-Gastaut Syndrome. Prescription Only Medicine	18th December 2000
00003/0381	The Wellcome Foundation Limited	Morphine Tartrate 10 mg and Cyclizine Tartrate 50 mg Injection	Cyclizine 39.010 mg Morphine Tartrate 10.000 mg	Relief of moderate to severe pain in all suitable medical and surgical conditions (see Contraindications and Precautions & Warnings) in which reduction of the nausea and vomiting associated with the administration of morphine is required. Prescription Only Medicine	27th March 2001
00003/0382	The Wellcome Foundation Limited	Morphine Tartrate 15 mg and Cyclizine Tartrate 50 mg Injection	Cyclizine 39.010 mg Morphine Tartrate 15.000 mg	(See PL 00003/0381) Prescription Only Medicine	27th March 2001
00015/0253	Boehringer Ingelheim Limited	Hyoscine butylbromide 10 mg tablets	Hyoscine Butylbromide 10.000 mg	Relief of spasm of the genito-urinary tract or gastro-intestinal tract, for the symptomatic relief of Irritable Bowel Syndrome, and in the prevention and treatment of spasmodic dysmenorrhoea. Prescription Only Medicine Pharmacy Medicine	27th March 2001
00030/0184	Novartis Consumer Health UK Limited	Tavegil Elixir	Clemastine Hydrogen Fumarate .670 mg	Allergic rhinitis, including hay fever and perennial rhinitis, vasomotor rhinitis, allergic dermatoses, including pruritis, atopic eczema and contact dermatitis, urticaria, angioneurotic oedema, drug allergy. Pharmacy Medicine	28th February 2001
00030/0185	Novartis Consumer Health UK Limited	NCH Fruit E 2 mg	Nicotine 2.000 mg	For the relief of nicotine withdrawal symptoms, in nicotine dependency as an aid to smoking cessation. General Sales List	1st December 2000
00030/0186	Novartis Consumer Health UK Limited	NCH Fruit E 4 mg	Nicotine 4.000 mg	(See PL 00030/0185) Pharmacy Medicine	1st December 2000
00030/0187	Novartis Consumer Health UK Limited	NCH Fruit F 2 mg	Nicotine 2.000 mg	(See PL 00030/0185) General Sales List	1st December 2000
00030/0188	Novartis Consumer Health UK Limited	NCH Fruit F 4 mg	Nicotine 4.000 mg	(See PL 00030/0185) Pharmacy Medicine	1st December 2000
00030/0189	Novartis Consumer Health UK Limited	NCH Mint F 2 mg	Nicotine 2.000 mg	(See PL 00030/0185) General Sales List	1st December 2000
00030/0190	Novartis Consumer Health UK Limited	NCH Mint F 4 mg	Nicotine 4.000 mg	(See PL 00030/0185) Pharmacy Medicine	1st December 2000

00030/0192	Novartis Consumer Health UK Limited	CAC 1000 Effervescent Tablets (Lemon)	Ascorbic Acid 1.000 gm Calcium Carbonate .327 gm Calcium Lactate Gluconate 1.000 gm	As a source of vitamin C and calcium, where there is likely to be an increased requirement, e.g. during pregnancy and lactation, in childhood and adolescence, in old age and during convalescence. General Sales List	28th February 2001
00030/0193	Novartis Consumer Health UK Limited	CAC 1000 Effervescent Tablets (Orange)	(See PL 00030/0192)	(See PL 00030/0192) General Sales List	28th February 2001
00049/0039	Colgate-Palmolive (UK) Limited	Duraphat 2800 ppm Fluoride Toothpaste	Sodium Fluoride .619 % w/w	For the prevention and treatment of dental caries (coronal and root). Prescription Only Medicine	4th December 2000
00053/0313	Schering Health Care Limited	Water for Injections	None	Not applicable. Prescription Only Medicine	22nd March 2001
00068/0187	3M Health Care Limited	Flecainide Acetate 100 mg Tablets	Flecainide Acetate 100.000 mg	AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways. Paroxysmal atrial fibrillation in patients with disabling symptoms. Arrhythmias of recent onset will respond more readily. Symptomatic sustained ventricular tachycardia. Premature ventricular contractions and/or non-sustained ventricular tachycardia. Prescription Only Medicine	16th March 2001
00068/0188	3M Health Care Limited	Flecainide Acetate 50 mg Tablets	Flecainide Acetate 50.000 mg	(See PL 00068/0187) Prescription Only Medicine	16th March 2001
00071/0442	Smithkline Beecham (SWG) Limited	Paracetamol and Caffeine 500 mg/65 mg Tablets	Caffeine 65.000 mg Paracetamol 500.000 mg	For the treatment of most painful febrile conditions, for example, headache, including migraine, toothache, neuralgia, rheumatic pain and dysmenorrhoea, and the relief of the symptoms of colds, influenza and sore throat. General Sales List Pharmacy Medicine	14th March 2001
00071/0443	Smithkline Beecham (SWG) Limited	Paracetamol and Caffeine 500 mg/65 mg Soluble Tablets	Caffeine 65.000 mg Paracetamol 500.000 mg	(See PL 00071/0442) General Sales List Pharmacy Medicine	14th March 2001
00094/0041	Ernest Jackson & Co Limited	Mac Sore Throat Honey and Lemon Lozenges	Hexylresorcinol 2.400 mg	As an antiseptic, demulcent and local anaesthetic for the relief of sore throat and its associated pain. General Sales List	8th December 2000
00116/0263	Baxter Healthcare Limited	Sodium Chloride Intravenous Infusion BP 0.9 % w/v	Sodium Chloride .900 % w/v	Fluid replacement, and for restoring and maintaining the concentrations of sodium and choride ions, in the treatment of conditions such as dehydration, mild shock as a result of fluid and electrolyte loss, vomiting, diarrhoea and excessive sweating. It may also be used as a vehicle for the reconstitution and administration of intravenous medications. Prescription Only Medicine	27th March 2001
00116/0264	Baxter Healthcare Limited	Glucose Intravenous Infusion BP 5 % w/v	Glucose Monohydrate 5.500 % w/v	Fluid replacement in cases of shock, haemorrhage, chronic diarrhoea and vomiting. The solution may also be used to supply water and energy to patients where the intake of food and fluids by normal routes is restricted (e.g. in pre- and post-operative care and in cases of hepatic, renal, cardiac and gastrointestinal disorders). The solution may also be used as a vehicle for the reconstitution and administration of intravenous medications known to be compatible with 5% glucose. Prescription Only Medicine	27th March 2001

00129/0133	Procter & Gamble (Health &Beauty Care) Limited	Vicks Sinex Nasal Pump Spray	Oxymetazoline Hydrochloride 0.050 % w/v	The symptomatic relief of congestion of the upper respiratory tract due to the common cold, hayfever, and sinusitis. General Sales List	8th December 2000
00142/0499	A H Cox & Company Limited	Hydralazine Tablets BP 25 mg	Hydralazine Hydrochloride 25.000 mg	Hydralazine is indicated for: 1. Moderate to severe hypertension (in conjunction with a beta-adrenoceptor blocking agent or diuretic) and hypertensive crisis. 2. The management of moderate to severe congestive cardiac failure (reduces afterload), where optimal doses of diuretics and cardiac glycosides prove insufficient. Prescription Only Medicine	6th March 2001
00142/0500	A H Cox & Company Limited	Hydralazine Tablets BP 50 mg	Hydralazine Hydrochloride 50.000 mg	(See PL 00142/0499) Prescription Only Medicine	6th March 2001
00173/0186	Diomed Developments Limited	Diomed Mouth Ulcer Gel	Aminoacridine Hydrochloride .050 % w/w Lidocaine Hydrochloride .660 % w/w	For fast, effective relief from the pain of common mouth ulcers, soreness of gums and denture rubbing. General Sales List	7th March 2001
00289/0392	Approved Prescription Services Limited	Cefalexin Capsules 250 mg	Cefalexin Anhydrous 250.000 mg	Treatment of the following infections due to susceptible micro-organisms; respiratory tract infections; otitis media; skin and soft tissue infections; bone and joint infections; genito-urinary tract infections, including acute prostatitis; dental infections. Prescription Only Medicine	12th March 2001
00289/0393	Approved Prescription Services Limited	Cefalexin Capsules 500 mg	Cefalexin Anhydrous 500.000 mg	(See PL 00289/0392) Prescription Only Medicine	12th March 2001
00322/0079	Norgine Limited	Spasmonal IBS	Alverine Citrate 60.000 mg	For the use in the relief of smooth muscle spasm, in conditions such as irritable bowel syndrome and painful diverticular disease of the colon. Pharmacy Medicine	5th December 2000
00327/0096	Crookes Healthcare Limited	Nurofen Honey & Lemon Original	Pseudoephedrine Hydrochloride 30.000 mg Sodium Ibuprofen Dihydrate 256.000 mg	For the fast relief of the symptoms of cold and flu with associated congestion, including aches and pains, headaches, fever, sore throat, sneezing, runny nose and sinus pain and pressure. Pharmacy Medicine	5th December 2000
00418/0039	Peter Black Healthcare Ltd	Peter Black Kelp Tablets	Fucus Vesiculosus 200.000 mg Fucus Vesiculosus Pulverised Extract 5 : 1 32.000 mg	Treatment of obesity and symptomatic relief of rheumatic pains. General Sales List	14th March 2001
00418/0042	Peter Black Healthcare Limited	Sinitol	Paracetamol 500.000 mg Pseudoephedrine Hydrochloride 20.000 mg	Relief of pain, fever and congestion. Pharmacy Medicine	16th March 2001
00649/0159	Alcon Laboratories (UK) Limited	Alomide Allergy Eye Drops	Lodoxamide Trometamol .178 % w/w	Treatment of the ocular signs and symptoms of allergic conjunctivitis. Pharmacy Medicine	14th December 2000
02142/0017	Chatfield Pharmaceuticals Limited	Erythromycin 125 mg/5 ml Oral Suspension	Erythromycin 125000.000 U	(See PL 02142/0018) Prescription Only Medicine	20th March 2001
02142/0018	Chatfield Pharmaceuticals Limited	Erythromycin 250 mg/5 ml Oral Suspension	Erythromycin 250000.000 U	1. Upper respiratory tract infections. 2. Lower respiratory tract infections. 3. Eye infections. 4. Ear infections. 5. Oral/dental infections. 6. Skin and soft tissue infections. 7. Gastro intestinal infections. 8. Sexually transmitted diseases. 9. Prophylaxis. Prescription Only Medicine	20th March 2001

04425/0190	Aventis Pharma Limited	Dioralyte Effervescent Tablets Blackcurrant	Citric Acid Anhydrous .384 gm Glucose 1.620 gm Potassium Chloride .186 gm Sodium Bicarbonate .336 gm Sodium Chloride .117 gm	Oral treatment of fluid and electrolyte loss and the management of conditions associated with mild to moderate dehydration in all age groups particularly acute diarrhoea of varying aetiologies. Pharmacy Medicine	5th March 2001
04425/0191	Aventis Pharma Limited	Dioralyte Effervescent Tablets Citrus	(See PL 04425/0190)	(See PL 04425/0190) Pharmacy Medicine	5th March 2001
04515/0112	Faulding Pharmaceuticals Plc	Flucloxacillin Sodium for Injection 250 mg	Flucloxacillin Sodium 272.500 mg	For the treatment of infections due to Gram-positive organisms, including infections caused by - lactamase-producing staphylococci and streptococci. Typical indications include: Skin and soft tissue infections: boils, abscesses, carbuncles, furunculosis, cellulitis; infected skin conditions, e.g. ulcer, eczema and acne; infected wounds, infected burns, protection for skin grafts and impetigo. Respiratory tract infections: pneumonia, lung abscess, empyema, sinusitis, pharyngitis, tonsillitis, quinsy, otitis media and externa. Other infections caused by flucloxacillin-sensitive organisms: osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicaemia. Also indicated for use as a prophylactic agent during major surgical procedures where appropriate: for example, cardiothoracic and orthopaedic surgery. Prescription Only Medicine	8th March 2001
04515/0113	Faulding Pharmaceuticals Plc	Flucloxacillin Sodium for Injection 500 mg	Flucloxacillin Sodium 545.000 mg	(See PL 04515/0112) Prescription Only Medicine	8th March 2001
04515/0114	Faulding Pharmaceuticals Plc	Flucloxacillin Sodium for Injection 1 g	Flucloxacillin Sodium 1090.000 mg	(See PL 04515/0112) Prescription Only Medicine	8th March 2001
04515/0115	Faulding Pharmaceuticals Plc	Flucloxacillin Sodium for Injection 2 g	Flucloxacillin Sodium 2180.000 mg	(See PL 04515/0112) Prescription Only Medicine	8th March 2001
05276/0017	Medimpex UK Limited	Levonelle	Levonorgestrel 750.000 mcg	Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. Pharmacy Medicine	19th December 2000
06464/0583	Waymade Plc	Piroxicam 0.5 % Gel	Piroxicam .500 gm	Treatment of osteoarthritis of superficial joints such as the knee, acute musculoskeletal injuries, periarthritis, epicondylitis, tendinitis, and tenosynovitis. Prescription Only Medicine	16th March 2001
06831/0069	Schein Pharmaceutical UK Limited	Ceftriaxone Sodium 1 g Injection	Ceftriaxone Sodium 1193.700 mg	Treatment of pneumonia, septicaemia, bacterial meningitis, gonorrhoea and infections of bone, skin and soft tissue. Treatment of infections in neutropenic patients. Prophylaxis of peri- post-operative infection associated with surgery. Prescription Only Medicine	20th March 2001
06831/0070	Schein Pharmaceutical UK Limited	Ceftriaxone Sodium 2 g Injection	Ceftriaxone Sodium 2387.400 mg	(See PL 06831/0069) Prescription Only Medicine	20th March 2001

06934/0054	Ethypharm S A	Bi-Carzem SR 60 mg Horizem SR 60 mg Zildil SR 60 mg	Diltiazem Hydrochloride 60.000 mg	The treatment of angina pectoris. The treatment of mild to moderate hypertension. Prescription Only Medicine	23rd February 2001
06934/0055	Ethypharm S A	Bi-Carzem SR 90 mg Horizem SR 90 mg Zildil SR 90 mg	Diltiazem Hydrochloride 90.000 mg	(See PL 06934/0054) Prescription Only Medicine	23rd February 2001
06934/0056	Ethypharm S A	Bi-Carzem SR 120 mg Horizem SR 120 mg Zildil SR 120 mg	Diltiazem Hydrochloride 120.000 mg	The treatment of angina pectoris. The treatment of mild to moderate hypertension. Prescription Only Medicine	23rd February 2001
06934/0064	Ethypharm S A	Ketil Gel 2.5 % Solpaflex Gel	Ketoprofen 2.500 % w/w	Symptomatic relief of pain in such conditions as soft tissue injuries, including sport injuries, sprains, strains, and musculo-tendonitis, swelling backache and rheumatic pain. Prescription Only Medicine Pharmacy Medicine	1st March 2001
08137/0026	Neolab Limited	Enalapril Maleate Tablets 2.5 mg	Enalapril Maleate 2.500 mg	Treatment of hypertension. All grades of essential hypertension and renovascular hypertension. Treatment of heart failure. Prevention of symptomatic heart failure. Prevention of coronary ischaemic events in patients with left ventricular dysfunction. Prescription Only Medicine	8th March 2001
08137/0027	Neolab Limited	Enalapril Maleate Tablets 5 mg	Enalapril Maleate 5.000 mg	(See PL 08137/0026) Prescription Only Medicine	8th March 2001
08137/0028	Neolab Limited	Enalapril Maleate Tablets 10 mg	Enalapril Maleate 10.000 mg	(See PL 08137/0026). Prescription Only Medicine	8th March 2001
08137/0029	Neolab Limited	Enalapril Maleate Tablets 20 mg	Enalapril Maleate 20.000 mg	(See PL 08137/0026) Prescription Only Medicine	8th March 2001
08137/0037	Neolab Limited	Cimetidine 200 mg Tablets	Cimetidine 200.000 mg	1. In the treatment of duodenal and benign gastric ulceration, recurrent and stomal ulceration and oesophageal reflux disease. 2. In the treatment of persistent dyspeptic symptoms with or without ulceration, particularly meal-related upper abdominal pain. 3. In the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients. 4. Before general anaesthesia in patients thought to be at risk of acid aspiration (Mendelson’s) syndrome, particularly obstetric patients during labour. 5. To reduce malabsorption and fluid loss in short bowel syndrome. 6.  To reduce degradation of enzyme supplements in pancreatic insufficiency. 7. In the management of Zollinger-Ellison syndrome. Prescription Only Medicine	15th March 2001
08137/0038	Neolab Limited	Cimetidine 400 mg Tablets	Cimetidine 400.000 mg	(See PL 08137/0037) Prescription Only Medicine	15th March 2001

08137/0039	Neolab Limited	Cimetidine 800 mg Tablets	Cimetidine 800.000 mg	1. In the treatment of duodenal and benign gastric ulceration, including that associated with non-steroidal anti-inflammatory agents, recurrent and stomal ulceration and oesophageal reflux disease, and other conditions where reduction of gastric acid by cimetidine has been shown to be beneficial. 2. In the treatment of persistent dyspeptic symptoms with or without ulceration, particularly meal-related upper abdominal pain, including such symptoms associated with non-steroidal anti-inflammatory agents. 3. In the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients. 4. Before general anaesthesia in patients thought to be at risk of acid aspiration (Mendelson’s) syndrome, particularly obstetric patients during labour. 5. To reduce malabsorption and fluid loss in short bowel syndrome. 6.  To reduce degradation of enzyme supplements in pancreatic insufficiency. 7. In the management of Zollinger-Ellison syndrome. Prescription Only Medicine	15th March 2001
08137/0041	Neolab Limited	Naproxen 500 mg Tablets	Naproxen 500.000 mg	(See PL 08137/0040) Prescription Only Medicine	16th March 2001
08137/0068	Neolab Limited	Asmasal Spacehaler	Salbutamol .100 mg	(i) Treatment and prophylaxis of bronchial asthma. (ii) Treatment of bronchitis and conditions associated with reversible airways obstruction. (iii) Relief of acute dyspnoea associated with reversible airways obstruction. (iv) Particularly suitable for treatment of bronchospasm and in patients with co-existing heart disease or hypertension. Prescription Only Medicine	28th February 2001
11382/0060	Eastern Pharmaceuticals Limited	Oxytetracycline 250 mg Tablets	Oxytetracycline Dihydrate 250.000 mg	The treatment of infection due to chlamydia, Brucella, Mycoplasma, Rickettsia and other sensitive organisms. It can also be used in the prophylaxis and treatment of chronic bronchitis, non gonococcal urethiritis, gonorrhoea, syphilis, urinary tract infection and severe acne vulgaris. Prescription Only Medicine	14th March 2001
11382/0063	Eastern Pharmaceuticals Limited	Propranolol 10 mg Tablets	Propranolol Hydrochloride 10.000 mg	The control of hypertension. The management of angina pectoris. The long term prophylaxis after recovery from acute myocardial infarction. The control of most forms of cardiac dysrhythmias. The prophylaxis of migraine. The management of essential tremor. The relief of situational anxiety and generalised anxiety symptoms, particularly those of somatic type. Prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and oesophageal varices. The adjunctive management of thyrotoxicosis and thyrotoxic crisis. Management of hypertropic obstructive cardiomyopathy. Management of phaeochromocytoma perioperatively (with alpha blocker). Prescription Only Medicine	15th March 2001
11382/0064	Eastern Pharmaceuticals Limited	Propranolol 40 mg Tablets	Propranolol Hydrochloride 40.000 mg	(See PL 11382/0063) Prescription Only Medicine	15th March 2001
11382/0065	Eastern Pharmaceuticals Limited	Propranolol 80 mg Tablets	Propranolol Hydrochloride 80.000 mg	(See PL 11382/0063) Prescription Only Medicine	15th March 2001
11648/0025	Merck Limited	Ostram-D3	Calcium Phosphate 3300.000 mg Cholecalciferol Concentrate (Powder Form) 8.000 mg	Treatment of combined calcium and vitamin D deficiencies in the elderly. Supplementation of calcium and vitamin D as an adjunct to specific treatment of osteoporosis (postmenopausal, senile, under corticosteroid therapy). Pharmacy Medicine	5th December 2000
11723/0251	Sanofi Winthrop Limited	Depakote 250 mg Tablets	Valproate Semisodium 269.100 mg	For the acute treatment of the manic episode associated with bipolar disorder. Prescription Only Medicine	21st December 2000
11723/0252	Sanofi Winthrop Limited	Depakote 500 mg Tablets	Valproate Semisodium 538.200 mg	(See PL 11723/0251) Prescription Only Medicine	21st December 2000

11723/0267	Sanofi Winthrop Limited	Co-danthrusate Capsules	Dantron 50.000 mg Docusate Sodium 60.000 mg	Treatment of constipation in terminally ill patients over six years old. Prescription Only Medicine	8th March 2001
11723/0308	Sanofi Winthrop Limited	Solian 50	Amisulpride 50.000 mg	For the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms. Prescription Only Medicine	1st February 2001
11723/0320	Sanofi Winthrop Limited	Dicynene Injection	Etamsylate 250.000 mg	For the prophylaxis and treatment of perventricular haemorrhage (bleeding into the brain immediately adjacent to cerebral ventricles) in low birth weight infants (<1.5 kg). Prescription Only Medicine	19th February 2001
11723/0324	Sanofi Winthrop Limited	Stilnoct 10 mg	Zolpidem Hemitartrate 10.000 mg	The short-term treatment of insomnia in situations where the insomnia is debilitating or is causing severe distress for the patient. Prescription Only Medicine	22nd February 2001
12063/0020	Wrafton Laboratories Limited	Ibuprofen 200 mg Tablets	Ibuprofen 200.000 mg	For the relief of headache, rheumatic, muscular, dental and period pains and pains in backache, neuralgia and migraine. Also for the symptomatic relief of colds, influenza and feverishness. General Sales List	12th March 2001
15033/0005	Curamed Pharma Gmbh	Midazolam 1 mg/ml Injection	Midazolam 1.000 mg	Sedation before and during diagnostic procedures and therapeutic interventions with or without local anaesthesia. Premedication before and induction of general anaesthesia. Prolonged continuous sedation in patients under assisted ventilation in intensive care. Prescription Only Medicine	19th March 2001
15033/0006	Curamed Pharma Gmbh	Midazolam 2 mg/ml Injection	Midazolam 2.000 mg	(See PL 15033/0005) Prescription Only Medicine	19th March 2001
15033/0007	Curamed Pharma Gmbh	Midazolam 5 mg/ml Injection	Midazolam 5.000 mg	(See PL 15033/0005) Prescription Only Medicine	19th March 2001
15773/0036	Ratiopharm Gmbh	Bisoprolol Fumarate 5 mg Tablets	Bisoprolol Hemifumarate 5.000 mg	Hypertension. Chronic stable angina pectoris. Prescription Only Medicine	25th January 2001
15773/0037	Ratiopharm Gmbh	Bisoprolol Fumarate 10 mg Tablets	Bisoprolol Hemifumarate 10.000 mg	(See PL 15773/0036) Prescription Only Medicine	25th January 2001
15773/0038	Ratiopharm Gmbh	Cetirizine Dihydrochloride 10 mg Tablets	Cetirizine Dihydrochloride 10.000 mg	For the treatment of perennial rhinitis, seasonal allergic rhinitis (hay fever) and chronic idiopathic urticaria in adults and children aged 6 years and over. Prescription Only Medicine Pharmacy Medicine	14th March 2001
15773/0039	Ratiopharm Gmbh	Cetirizine Dihydrochloride 10 mg Tablets	Cetirizine Dihydrochloride 10.000 mg	(See PL 15773/0038) Prescription Only Medicine Pharmacy Medicine	14th March 2001

16363/0023	Milpharm Limited	Trimethoprim 100 mg Tablets	Trimethoprim 100.000 mg	Treatment of susceptible infections caused by trimethoprim sensitive organisms including urinary and respiratory tract infections and for the prophylaxis of recurrent urinary tract infections. Prescription Only Medicine	8th March 2001
16363/0024	Milpharm Limited	Trimethoprim 200 mg Tablets	Trimethoprim 200.000 mg	(See PL 16363/0023) Prescription Only Medicine	8th March 2001
16363/0071	Milpharm Limited	Aciclovir 200 mg Tablets BP	Aciclovir 200.000 mg	Treatment of immunocompetent patients with severe infections of the skin and the mucous membranes caused by the herpes simplex virus, in particular initial herpes genitalis. Prophylaxis of herpes simplex infections in bone marrow and organ transplant and in remission-induction courses in case of acute leukaemia. Prescription Only Medicine	14th March 2001
16363/0072	Milpharm Limited	Aciclovir 400 mg Tablets BP	Aciclovir 400.000 mg	Prophylaxis of severe forms of frequently recurrent herpes genitalis in immunocompetent patients. Prescription Only Medicine	14th March 2001
16363/0073	Milpharm Limited	Aciclovir 800 mg Tablets BP	Aciclovir 800.000 mg	Treatment of immunocompetent patients with Varicella zoster infections of the skin or the mucous membranes (herpes zoster), in whom a severe course can be anticipated, including herpes zoster ophthalmicus. Prescription Only Medicine	14th March 2001
16853/0027	Alliance Pharmaceuticals Limited	Amantadine Hydrochloride 100 mg Capsules	Amantadine Hydrochloride 100.000 mg	(See PL 16853/0028) Prescription Only Medicine	16th March 2001
16853/0028	Alliance Pharmaceuticals Limited	Amantadine Hydrochloride 50 mg/5 ml Syrup	Amantadine Hydrochloride 50.000 mg	Influenza A virus. Parkinsons disease. Herpes zoster. Prescription Only Medicine	16th March 2001
16874/0004	Dermapharm Limited	Thwart	Salicylic Acid 26.000 % w/w	For the treatment and removal of common and plantar warts, (verrucae). Pharmacy Medicine	5th December 2000
17096/0002	Collagenex International Limited	Periostat 20 mg Tablets	Doxycycline Hyclate 23.080 mg	For patients with adult periodontitis. For treatment periods of 3 months as an adjunct to supra-gingival and sub-gingival scaling and root planing, with oral hygiene instruction, carried out by a dental practitioner or hygienist. Prescription Only Medicine	21st December 2000
17246/0002	DR Regenold Gmbh	Lisinopril 2.5 mg Tablets	Lisinopril Dihydrate 2.780 mg	Hypertension: Treatment of all grades of essential hypertension and renovascular hypertension. Congestive heart failure. Treatment of congestive heart failure as adjunctive therapy with non-potassium sparing diuretics and, where appropriate, digitalis. Acute myocardial infarction: Treatment of haemodynamically stable patients, defined as patients who are not in cardiogenic shock and who have a systolic blood pressure greater than 100 mmHg. Renal complications of diabetes mellitus: In normotensive insulin-dependant and hypertensive non-insulin-dependent diabetes mellitus patients who have incipient nephropathy characterise by microalbuminuria, lisinopril reduces urinary albumin excretion rate. Prescription Only Medicine	7th March 2001
17246/0003	DR Regenold Gmbh	Lisinopril 5 mg Tablets	Lisinopril Dihydrate 5.560 mg	(See PL 17246/0002) Prescription Only Medicine	7th March 2001
17246/0004	DR Regenold Gmbh	Lisinopril 10 mg Tablets	Lisinopril Dihydrate 11.120 mg	(See PL 17246/0002) Prescription Only Medicine	7th March 2001
17246/0005	DR Regenold Gmbh	Lisinopril 20 mg Tablets	Lisinopril Dihydrate 22.240 mg	(See PL 17246/0002) Prescription Only Medicine	7th March 2001

17521/0014	Metwest Pharmaceuticals Limited	Trifluoperazine 1 mg Tablets	Trifluoperazine Hydrochloride 1.180 mg	Treatment of the symptoms of schizophrenia and for the prevention of relapse. Paranoid Psychosis; mania and hypomania. As an adjunct to the short-term management of anxiety, severe psychomotor agitation, excitement, violent or dangerously impulsive behaviour. Prescription Only Medicine	16th March 2001
17521/0015	Metwest Pharmaceuticals Limited	Trifluoperazine 5 mg Tablets	Trifluoperazine Hydrochloride 5.900 mg	(See PL 17521/0014) Prescription Only Medicine	16th March 2001
17521/0023	Metwest Pharmaceuticals Limited	Nitrofurantoin 50 mg Tablets	Nitrofurantoin 50.000 mg	Treatment of and prophylaxis against acute or recurrent uncomplicated pyelitis or lower urinary tract infection proven to be due to E. coli, Staph. aureus or Strep. faecalis—either spontaneous or following surgical procedures. Prescription Only Medicine	13th March 2001
17521/0024	Metwest Pharmaceuticals Limited	Nitrofurantoin 100 mg Tablets	Nitrofurantoin 100.000 mg	(See PL 17521/023) Prescription Only Medicine	13th March 2001
17672/0001	Mallinckrodt UK Limited	Gallium (Ga67) Citrate Injection	Gallium Citrate Ga 67 37.000 mbq	Diagnosis, staging and subsequent management of malignant lymphomas such as Hodgkin and non-Hodgkin lymphoma. It may also be of subsequent use in establishing response to chemotherapy. Prescription Only Medicine	21st March 2001
17672/0002	Mallinckrodt UK Limited	Ultra-TechneKow FM	Molybdenum-99 34.400 gbq Molybdenum-99  4.300 gbq Molybdenum-99  6.450 gbq Molybdenum-99  8.600 gbq Molybdenum-99 10.750 gbq Molybdenum-99  2.150 gbq Molybdenum-99 12.900 gbq Molybdenum-99 43.000 gbq Molybdenum-99 17.200 gbq Molybdenum-99 21.500 gbq Molybdenum-99 25.800 gbq Molybdenum-99 30.100 gbq Sodium pertechnetate Tc 99m 87.500 % w/v	Used as a reagent for labelling of various carrier compounds supplied as kits or administered directly in-vivo. When administered intravenously, the sterile sodium pertechnetate (99mTc) solution is used as a diagnostic aid in the following: (a) Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in thyroid disease. (b) Salivary gland scintigraphy: to assess salivary gland function and duct patency. (c) Location of ectopic gastric mucosa: Meckel’s diverticulum. (d) Cerebral scintigraphy: to identify breaches in the blood-brain barrier caused by tumour, infarction, haemorrhage and oedema, when no other methods are available. When used in conjunction with pre-treatment with a reducing agent to effect technetium-99m-labelling of red blood cells. When used in conjunction with pre-treatment with a reducing agent to effect technetium (99mTc)-labelling of red blood cells. (e) Cardiac and vascular scintigraphy—angiocardioscintigraphy for: evaluation of ventricular ejection fraction, evaluation of global and regional cardiac wall motion, myocardial phase imaging—organ perfusion or vascular abnormalities imaging. (f) Diagnosis and localisation of occult gastrointestinal bleeding. Following instillation of sterile sodium pertechnetate (99mTc) solution into the eye. (g) Lacrimal duct scintigraphy: to assess patency of tear ducts. Prescription Only Medicine	21st March 2001
17672/0003	Mallinckrodt UK Limited	TechneScan MAG3	Betiatide 1.000 mg	Evaluation of nephrological and urological disorders in particular for the study of morphology, perfusion, function of the kidney and characterisation of urinary outflow. Prescription Only Medicine	21st March 2001
17672/0004	Mallinckrodt UK Limited	TechneScan PYP	Sodium Pyrophosphate 11.930 mg	Angiocardioscintigraphy for: evaluation of ventricular ejection fraction, evaluation of global and regional cardiac wall motion, myocardial phase imaging, organ perfusion and vascular abnormalities imaging, diagnosis and localisation of occult gastro-intestinal bleeding. (b) Determination of blood volume. (c) Spleen scintigraphy. Prescription Only Medicine	21st March 2001
17672/0005	Mallinckrodt UK Limited	TechneScan DTPA	Calcium Trisodium Diethylenetriamine Pentaacetate 25.000 mg	Dynamic renal scintigraphy for perfusion, function and urinary tract studies. Measurement of glomerular filtration rate. Cerebral angiography and brain scanning; as an alternative method when computed tomography and/or magnetic resonance imaging are not available. (b) After inhalation of the nebulised technetium (99mTc) labelled substance. Lung ventilation imaging. (c) After oral administration of the technetium (99mTc) labelled substance. Studies of gastro-oesophageal reflux and gastric emptying. Prescription Only Medicine	21st March 2001
17672/0006	Mallinckrodt UK Limited	TechneScan HDP	Sodium Oxidronate 3.000 mg	For bone scintigraphy, where it delineates areas of altered osteogenesis. Prescription Only Medicine	21st March 2001

17672/0009	Mallinckrodt UK Limited	OctreoScan	Indium-111 Trichloride 122.000 mbq Pentetreotide 10.000 mcg	Adjunct in the diagnosis and management of receptor bearing gastro-entero-pancreatic neuroendocrine (GEP) tumours and carcinoid tumours, by aiding in their localisation. Prescription Only Medicine	21st March 2001
17672/0010	Mallinckrodt UK Limited	Sodium Iodide (I131) Capsule T	Sodium Iodide I 131 Solution 7400.000 mbq	Treatment of Graves disease, toxic multinodular goitre or autonomous nodules. Treatment of papillary and follicular thyroid carcinoma including metastatic disease. Prescription Only Medicine	21st March 2001
17672/0011	Mallinckrodt UK Limited	Sodium Iodide (I123) Injection	Sodium Iodide I 123 37.000 mbq	Diagnostic agent in the functional or morphological study of the thyroid gland by means of: Scintigraphy. Prescription Only Medicine	21st March 2001
17672/0012	Mallinckrodt UK Limited	MIBG (I123) Injection	3-Iodobenzylguanidine Sulphate .500 mg Iobenguane (123-I) 74.000 mbq	Diagnostic scintigraphic localisation of tumours originating in tissue that embryologically stems for the neural crest. These are pheochromocytomas, paragangliomas, chemodectomas and ganglioneuromas. Prescription Only Medicine	21st March 2001
17672/0014	Mallinckrodt UK Limited	Thallous Chloride (T1 201) Injection	Thallous Chloride T1 201 37.000 mbq	Myocardial scintigraphy in the evaluation of coronary perfusion and cellular viability; ischaemic heart disease, cardiomyopathies, myocarditis, myocardial contusions and secondary cardiac lesions. Scintigraphy of the muscles; muscle perfusion in peripheral vascular disorders. Parathyroid scintigraphy. Thallium-avid tumour visualisation in different organs, especially for the brain tumours and thyroid tumours and metastases. Prescription Only Medicine	21st March 2001
17907/0006	Bristol Laboratories Limited	Amoxycillin Capsules BP 250 mg	Amoxycillin Trihydrate 250.000 mg	Treatment of otitis media, chronic bronchitis, gonorrhoea, typhoid fever. It may also be used to treat susceptible organisms in upper respiratory tract infections, lobar and bronchopneumonia, cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, gynaecological infections including puerperal sepsis and septic abortion, peritonitis, intra-abdominal sepsis, septicaemia, bacterial endocarditis, skin and soft tissue infections and osteomyelitis. Prescription Only Medicine	13th March 2001
17907/0007	Bristol Laboratories Limited	Amoxycillin Capsules BP 500 mg	Amoxycillin Trihydrate 500.000 mg	(See PL 17907/0006) Prescription Only Medicine	13th March 2001
17907/0008	Bristol Laboratories Limited	Amoxycillin Mixture BP 125 mg/5 ml	Amoxycillin Trihydrate 125.000 mg	(See PL 17907/0006) Prescription Only Medicine	13th March 2001
17907/0009	Bristol Laboratories Limited	Amoxycillin Mixture BP 250 mg/5 ml	Amoxycillin Trihydrate 250.000 mg	(See PL 17907/0006) Prescription Only Medicine	13th March 2001
18023/0004	Breathe Easy Limited	Terbutaline Sulphate Nebuliser Solution 5 mg/2 ml	Terbutaline Sulphate .250 % w/v	For the relief of severe bronchospasm in bronchial asthma and in chronic bronchitis, emphysema and other bronchopulmonary disorders in which bronchospasm is a complicating factor. Prescription Only Medicine	19th March 2001

18194/0003	Otsuka Pharma Gmbh	Ubit 100 mg/dose granules for oral solution	Urea C-13 .100 gm	For the in vivo diagnosis of gastroduodenal Helicobacter pylori infection. Prescription Only Medicine	21st December 2000
18467/0006	Cenes Limited	Xefo 4 mg Tablets	Lornoxicam 4.000 mg	Short term treatment of moderate postoperative pain such as pain after dental surgery. Treatment of pain associated with acute lumbo-sciatica. Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis. Prescription Only Medicine	15th March 2001
18467/0007	Cenes Limited	Xefo 8 mg Tablets	Lornoxicam 8.000 mg	(See PL 18467/0006) Prescription Only Medicine	15th March 2001
18467/0008	Cenes Limited	Xefo 8 mg Powder for Injection	Lornoxicam 8.000 mg	(See PL 18467/0006) Prescription Only Medicine	15th March 2001
18532/0030	Evans Vaccines Limited	Water for Injections BP	Water for Injections 100.000 % v/v	Dissolvent and diluent for injectable medicines. Prescription Only Medicine	1st March 2001
18532/0031	Evans Vaccines Limited	Sodium Chloride Injection BP 0.9 %	Sodium Chloride .900 % w/v	1. For use in prophylactic and replacement therapy requiring the use of isotonic saline solution. 2. In the reconstitution, dilution and making up of certain drugs. As a saline irrigant. 3. As a priming fluid for haemodialysis procedures and to initiate and terminate blood transfusions. Prescription Only Medicine	1st March 2001

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The following notice is in substitution for that which appeared on page 2322 of The London Gazette dated 23rd February 2001: Product Licences Granted

Product Licence Number	Company Name	Product Name	Active Ingredients	Indications	Date of Authorisation
12557/0045	BCM Limited	Junior Strawberry Pain Relief 250 ml/5 ml Suspension Tixymol Six Plus	Paracetamol 250.000 mg	To relieve mild to moderate pain and to reduce fever in many conditions including headache, toothache, feverishness, colds and influenza. Pharmacy Medicine	27th November 2000