Details

Product Name in the RMS: Zolpidem Aurobindo

MR Number: PT/H/0866/002
Date of outcome: 10.09.2013

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Generic Chemical Substance Prescription Only
Active Substances	zolpidem tartrate 10 mg
Form	Film coated tablet
MA Holder in the RMS	Aurobindo Pharma (Portugal), Unipessoal Limitada
RMS	Portugal
Date of last change	17.12.2020
ATC-Code	N05CF02 Zolpidem

CMS Country	Domestic Product Name
Cyprus	ZOLPIDEM AUROBINDO FC TABS 10mg
Denmark
Italy
Malta
Norway
Romania	Zolpidem Aurobindo 5 mg/10 mg comprimate filmate
Spain
Sweden

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