Details

Product Name in the RMS: Omisson daily 2 mg/0,03 mg Filmtabletten

MR Number: HU/H/0575/001
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	EGIS Pharmaceuticals PLC Keresztúri út 30-38 H-1106 BUDAPEST
RMS	Hungary
Date of last change	21.06.2018
ATC-Code	G03FA15 Dienogest and Estrogen

CMS Country	Domestic Product Name
Czech Republic	Gellagin Conti 2 mg/0.03 mg, 28 film-coated tablets
Poland
Slovak Republic	Gellagin Conti

Documents
PAR:	HU_H_0575_001_PAR.pdf (15.02.2018)
Finalised Product Information:	HU_H_0575_001_FinalPI_1of2.pdf (02.06.2016)
Finalised Product Information:	HU_H_0575_001_FinalPI_2of2.pdf (02.06.2016)