Details

Product Name in the RMS: Palexia retard

MR Number: DE/H/2020/004
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 58.24 mg
Form	Prolonged release 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
Belgium
Bulgaria	Palexia retard
Cyprus	PALEXIA R 50mg PR TABS
Czech Republic	Palexia® retard 50 mg tablety s prodlouženým uvolňováním
Denmark
Estonia	PALEXIA RETARD
Finland
France
Greece
Hungary	Palexia retard tabl. 50mg
Iceland
Ireland
Italy
Latvia	Palexia retard 50 mg ilgstošās darbības tabletes
Lithuania	Palexia retard 50 mg pailginto atpalaidavimo tabletės
Luxembourg
Malta	Palexia retard
Netherlands
Norway
Poland
Portugal
Romania	Palexia retard 50 mg comprimate cu eliberare prelungită
Slovak Republic	Palexia
Slovenia
Spain
Sweden	Palexia Depot
United Kingdom

Documents
PAR:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/parmod5_de20200408palexia.pdf (26.05.2011)
FinalSPC:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/spc_de20200408palexia.pdf (26.05.2011)
FinalPL:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/pllab_de202004palexia.pdf (26.05.2011)
FinalLabelling:	http://www.hma.eu/fileadmin/dateien/pipar/de2020/pllab_de202004palexia.pdf (26.05.2011)