Details

Product Name in the RMS: Metformine HCl Mylan 1000 mg filmomhulde tabletten

MR Number: NL/H/1570/003
Date of outcome: 29.11.2009

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	metformin hydrochloride 1000 mg
Form	Film coated tablet
MA Holder in the RMS	Mylan B.V. Dieselweg 25, 3752 LB Bunschoten The Netherlands
RMS	Netherlands
Date of last change	29.01.2013
ATC-Code	A10BA02 Metformin

CMS Country	Domestic Product Name
Austria	Arcamet 1000 mg - Filmtabletten
Belgium
Bulgaria	Metformin Vale
Czech Republic	Metformin Vale 1000 mg film-coated tablets
Denmark	Metformin "Vale"
Finland
France
Germany	Metformin Vale 1000 mg Filmtabletten
Hungary
Ireland
Norway
Poland
Portugal
Romania	Metformin Vale 1000 mg
Slovak Republic	Metformin Vale 1000 mg
Spain
Sweden
United Kingdom

Documents
PAR:	http://db.cbg-meb.nl/mri/par/nlh-1570-001-002-003.pdf (01.03.2010)
FinalSPC:	http://mri.medagencies.org/download/NL_H_1570_003_FinalSPC.pdf (17.10.2012)
FinalPL:	http://mri.medagencies.org/download/NL_H_1570_003_FinalPL.pdf (17.10.2012)
FinalLabelling:	http://db.cbg-meb.nl/mri/pil/nlh-1570-001-002-003.pdf (28.11.2009)