Details

Product Name in the RMS: Seasonique

MR Number: FR/H/0516/001
Date of outcome: 13.01.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Fixed Combination Chemical Substance Prescription Only
Active Substances	ethinyl estradiol 10 µg ethinyl estradiol 30 µg levonorgestrel 150 µg
Form	Film coated tablet
MA Holder in the RMS	TEVA pharma B.V
RMS	France
Date of last change	28.12.2020
ATC-Code	G03AA07 Levonorgestrel and estrogen

CMS Country	Domestic Product Name
Austria	Seasonique 150 Mikrogramm/30 Mikrogramm + 10 Mikrogramm Filmtabletten
Belgium	Seasonique, filmomhulde tabletten
Croatia
Czech Republic	Seasonique
Denmark
Estonia	SEASONIQUE
Finland
Germany	Seasonique 150 Mikrogramm/30 Mikrogramm + 10 Mikrogramm Filmtabletten
Hungary	SEASONIQUE 150 mikrogramm/30 mikrogramm + 10 mikrogramm filmtabletta
Italy
Latvia	Seasonique 150 mikrogrami/30 mikrogrami + 10 mikrogrami apvalkotās tabletes
Luxembourg
Netherlands
Poland	Seasonique
Portugal
Romania	SEASONIQUE 150 micrograme/30 micrograme + 10 micrograme comprimate filmate
Slovak Republic	Seasonique
Slovenia
Spain
Sweden
United Kingdom

Documents
PAR:	FR_H_0516_001_PAR.pdf (22.06.2015)
FinalSPC:	FR_H_0516_001_FinalSPC.pdf (05.12.2017)