Details

Product Name in the RMS: Priligy

MR Number: SE/H/0718/002
Date of outcome: 17.12.2008

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	dapoxetine hydrochloride 60 mg
Form	Film coated tablet
MA Holder in the RMS	Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Germany
RMS	Sweden
Date of last change	05.04.2019
ATC-Code	G04BX14 dapoxetine

CMS Country	Domestic Product Name
Austria	Priligy 60 mg Filmtabletten
Belgium
Bulgaria	Priligy
Croatia
Cyprus	PRILIGY 60mg FC TABS
Czech Republic	Priligy
Denmark
Estonia
Finland
France
Germany	Priligy 60 mg Filmtabletten
Greece
Hungary	PRILIGY 60 mg filmtabletta
Iceland
Ireland
Italy
Latvia	Priligy 60 mg apvalkotās tabletes
Lithuania	Priligy 60 mg plėvele dengtos tabletės
Luxembourg
Malta	MA018/03102
Netherlands
Norway
Poland	Priligy
Portugal	Priligy
Romania	Priligy 60 mg comprimate filmate
Slovak Republic	Priligy
Slovenia
Spain
United Kingdom

Documents
PAR:	https://www.lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20071127000130 (15.01.2014)
FinalSPC:	https://www.lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20071127000130 (15.01.2014)
FinalPL:	https://www.lakemedelsverket.se/LMF/Lakemedelsinformation/?nplid=20071127000130 (15.01.2014)