Details

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

MR Number: HU/H/0534/001
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	PharmaSwiss Ceská republica s.r.o. Jankovcova 1569/2c Praha 7 170 00 Czech Republic
RMS	Hungary
Date of last change	30.06.2018
ATC-Code	G03FA15 Dienogest and Estrogen

CMS Country	Domestic Product Name
Bulgaria	Diener
Estonia	DIENER
Ireland
Latvia	Diener 2 mg/0,03 mg apvalkotās tabletes
Lithuania
Spain

Documents
Finalised Product Information:	HU_H_0534_001_FinalPI_1of2.pdf (30.08.2016)
Finalised Product Information:	HU_H_0534_001_FinalPI_2of2.pdf (30.08.2016)