Details

Product Name in the RMS: Palexia

MR Number: DE/H/2020/002
Date of outcome: 10.08.2010

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	New Active Substance Additional Strength/Form Full Dossier Chemical Substance Prescription Only
Active Substances	tapentadol hydrochloride 87.36 mg
Form	Film coated tablet
MA Holder in the RMS	Gruenenthal GmbH Zieglerstrasse 6 52078 Aachen Germany
RMS	Germany
Date of last change	21.10.2012
ATC-Code	N02 ANALGESICS

CMS Country	Domestic Product Name
Austria	Donepezil STADA 10 mg Filmtabletten
Belgium
Bulgaria	Palexia
Cyprus	PALEXIA 75mg FC TABS
Czech Republic	Palexia® 75 mg potahované tablety
Denmark
Estonia	PALEXIA
Finland
France
Greece
Hungary	Palexia ftabl. 75mg
Iceland
Ireland
Italy
Latvia	Palexia 75 mg apvalkotās tabletes
Lithuania	Palexia 75 mg plėvele dengtos tabletės
Luxembourg
Malta	Palexia
Netherlands
Norway
Poland
Portugal
Romania	Palexia 75 mg comprimate filmate
Slovak Republic	Palexia
Slovenia
Spain
Sweden	Palexia
United Kingdom

Documents
PAR:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/parmod5_de20200103palexia.pdf (26.05.2011)
FinalSPC:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/spc_de20200103palexia.pdf (26.05.2011)
FinalPL:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/pllab_de202002palexia.pdf (26.05.2011)
FinalLabelling:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/pllab_de202002palexia.pdf (26.05.2011)