Ireland - English - HPRA (Health Products Regulatory Authority)

aop orphan pharmaceuticals gmbh - tetrabenazine - tablet - 25 milligram(s) - other nervous system drugs; tetrabenazine

European Union - English - EMA (European Medicines Agency)

zentiva k.s. - riluzole - amyotrophic lateral sclerosis - other nervous system drugs - riluzole zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (als).clinical trials have demonstrated that riluzole zentiva extends survival for patients with als. survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free.there is no evidence that riluzole zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. riluzole zentiva has not been shown to be effective in the late stages of als.safety and efficacy of riluzole zentiva has only been studied in als. therefore, riluzole zentiva should not be used in patients with any other form of motor-neurone disease.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

aop orphan ltd - tetrabenazine - oral tablet - 25mg

European Union - English - EMA (European Medicines Agency)

jenson pharmaceutical services limited - dextromethorphan, quinidine - neurobehavioral manifestations - other nervous system drugs - nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (pba) in adults. efficacy has only been studied in patients with underlying amyotrophic lateral sclerosis or multiple sclerosis.

Ireland - English - HPRA (Health Products Regulatory Authority)

lundbeck uk llp - tetrabenazine - tablet - 25 milligram(s) - other nervous system drugs; tetrabenazine

Ireland - English - HPRA (Health Products Regulatory Authority)

valeant pharma poland sp. z o.o. - tetrabenazine - tablet - 25 milligram(s) - other nervous system drugs; tetrabenazine

Ireland - English - HPRA (Health Products Regulatory Authority)

bausch health ireland limited - tetrabenazine - tablet - 25 milligram(s) - other nervous system drugs; tetrabenazine

Israel - English - Ministry of Health

sanofi israel ltd - riluzole - film coated tablets - riluzole 50 mg - riluzole - riluzole - rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (als).

Israel - English - Ministry of Health

medison pharma ltd - fampridine - tablets prolonged release - fampridine 10 mg - fampridine - fampridine - fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis with walking disability (edss 4-7)

Malta - English - Medicines Authority

actavis group ptc ehf revkjavikurvegi 76-78, 220 hafnarfjordur, iceland - riluzole - coated tablet - riluzole 50 mg - other nervous system drugs