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 | 20.08.2020 |
ATC-Code |
G03FA15 Dienogest and Estrogen |
CMS Country | Domestic Product Name |
---|---|
Belgium | Serisima Continu 2 mg/0.03 mg comprimés pelliculés |
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_2of2.pdf (30.04.2019) |