Details

Product Name in the RMS: Velafee 21+7 0,03 mg/2,0 mg Filmtabletten

MR Number: DE/H/3561/001
Date of outcome: 19.12.2013

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	dienogest 2 mg ethinyl estradiol 0,03 mg
Form	Film coated tablet
MA Holder in the RMS	Exeltis Germany GmbH Adalperostr. 84 D-85737 Ismaning Germany
RMS	Germany
Date of last change	16.01.2019
ATC-Code	G03FA15 Dienogest and Estrogen

CMS Country	Domestic Product Name
Austria
Belgium	Serisima Continu 2 mg/0.03 mg comprimés pelliculés
Bulgaria	Dienorette
Czech Republic	Velafee 0.02 mg/ 3 mg
France
Hungary	DIEDITA 2 mg/0,03 mg filmtabletta
Italy
Luxembourg
Poland	Atywia Daily
Romania	Dienorette 2 mg/0,03 mg comprimate filmate
Slovak Republic
Spain

Documents
PAR:	DE_H_3561_001_PAR.pdf (15.02.2018)
FinalSPC:	DE_H_3561_001_FinalSPC_1of3.pdf (07.05.2016)
FinalSPC:	DE_H_3561_001_FinalSPC_2of3.pdf (07.05.2016)
FinalSPC:	DE_H_3561_001_FinalSPC_3of3.pdf (07.05.2016)
FinalPL:	DE_H_3561_001_FinalPL_1of2.pdf (07.05.2016)
FinalPL:	DE_H_3561_001_FinalPL_2of2.pdf (07.05.2016)
FinalLabelling:	DE_H_3561_001_FinalLabelling.pdf (30.10.2015)
Finalised Product Information:	DE_H_3561_001_FinalPI_1of2.pdf (18.05.2017)