Details

Product Name in the RMS: Gesffiset

MR Number: PT/H/0499/002
Date of outcome: 26.06.2012

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	ethinyl estradiol 0,02 mg levonorgestrel 0,1 mg
Form	Film coated tablet
MA Holder in the RMS	Lab. Effik, Soc. Unip., Lda. Estrada Consiglieri Pedroso, 123 Queluz de Baixo 2730-056 Barcarena Portugal
RMS	Portugal
Date of last change	09.12.2018
ATC-Code	G03AA07 Levonorgestrel and estrogen

CMS Country	Domestic Product Name
Austria
Belgium
Czech Republic	Asumate, film-coated tablets 0.10 mg/ 0.02mg
Estonia
Germany	Levobel andauernd 0,10mg/0,02 mg Filmtabletten
Hungary	MISSEE 0,10 mg/0,02 mg filmtabletta
Latvia	Asumate 100 mikrogrami/20 mikrogrami apvalkotās tabletes
Lithuania	Asumate 100 mikrogramų/20 mikrogramų plėvele dengtos tabletės
Luxembourg
Poland	Orlifique
Slovak Republic
Spain

Documents
FinalSPC:	http://mri.medagencies.org/download/PT_H_0499_002_FinalSPC.pdf (04.10.2013)