Medicines

2000-08-042000-07-272000-08-022000-08-172000-08-092000-08-072000-08-25TSO (The Stationery Office), St Crispins, Duke Street, Norwich, NR3 1PD, 01603 622211, customer.services@tso.co.uk55953UN014UN014

PI 15814/0217	OPD Laboratories Limited	Gabitril 15 mg Tablets Tiagabine 15 mg Tablets	Tiagabine Hydrochloride Monohydrate 17.190 mg	Antiepileptic. Prescription Only Medicine	7th August 2000
15872/0001	FDC International Limited	Timolol Eye Drops 0.25%	Timolol Maleate .340 % w/v	Reduction of elevated intraocular pressure in conditions such as: Ocular hypertension; Chronic open-angle glaucoma (including aphakic patients); Some cases of secondary glaucoma. Prescription Only Medicine	9th August 2000
15872/0002	FDC International Limited	Timolol Eye Drops 0.5%	Timolol Maleate .680 % w/v	(See PL 15872/0001) Prescription Only Medicine	9th August 2000
15894/0001	Quantum Generics Limited	Ranitidine Tablets 150 mg	Ranitidine Hydrochloride 168.000 mg	For the treatment of duodenal ulcer and benign gastric ulcer; for the treatment of post-operative ulcer, Zollinger-Ellison syndrome and oesophageal reflux disease. Patients with chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but is not associated with the preceding conditions may benefit from ranitidine treatment. For the following conditions where reduction of gastric secretion and acid output is desirable; the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients, the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson’s syndrome), particularly obstetric patients during labour. Prescription Only Medicine	17th August 2000
15894/0002	Quantum Generics Limited	Ranitidine Tablets 300 mg	Ranitidine Hydrochloride 336.000 mg	(See PL 15894/0001) Prescription Only Medicine	17th August 2000
15922/0004	Apotex Europe Limited	Ranitidine Tablets 150 mg	Ranitidine Hydrochloride 167.400 mg	For the treatment of duodenal ulcers (including those associated with Helicobacter pylori infection) and for the treatment of benign gastric ulcers, including those associated with non-steroidal anti-inflammatory agents (NSAIDs). For the prevention of duodenal ulcers associated with NSAIDs. For the treatment of post-operative ulcers, Zollinger-Ellison syndrome and oesophageal reflux disease including the long-term management of healed oesophagitis. Ranitidine treatment may also be beneficial in patients with chronic episodic dyspepsia, characterised by epigastric or retrosternal pain related to meals, or disturbed sleep, but which is not associated with the above conditions. Also indicated in the following condictions where reduction of gastric secretion and acid output is required: the prevention of recurrent haemorrhage in patients with bleeding peptic ulcers and before administration of a general anaesthetic to patients considered to be at risk of acid aspiration (Mendelson’s syndrome), particularly obstetric patients during labour; and the prevention of gastrointestinal haemorrhage from stress ulceration in seriously ill patients. Prescription Only Medicine	7th August 2000
15922/0005	Apotex Europe Limited	Ranitidine Tablets 300 mg	Ranitidine Hydrochloride 334.800 mg	(See PL 15922/0004) Prescription Only Medicine	7th August 2000
16075/0080	Special Concept Development BV	Tetracycline 250 mg Tablets BP	Tetracycline Hydrochloride 250.000 mg	Treatment of infections due to Brucella, Myocoplasma, Rickettsia, Chlamydia and other sensitive organisms. May also be used for prophylaxis and treatment of chronic bronchitis, gonorrhoea, syphilis, non-gonococcal urethritis, other urinary tract infections and severe acne. Prescription Only Medicine	2nd August 2000
16108/0001	Adams Healthcare Limited	Metronidazole Gel 0.75% w/w	Metronidazole .750 % w/w	(i) The treatment of acute inflammatory exacerbations of rosacea. Prescription Only Medicine	27th July 2000
PI 16369/0055	G-Pharma Limited	Estraderm MX 100	Estradiol 3.000 mg	Estrogen replacement therapy. Prescription Only Medicine	4th August 2000