Details

Product Name in the RMS: Levonorgestrel/Ethinylestradiol Laboratorios Leon Farma 150/30 microgram, film-coated tablets

MR Number: NL/H/2651/001
Date of outcome: 15.08.2013

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 30 µg levonorgestrel 150 µg
Form	Film coated tablet
MA Holder in the RMS	Laboratorios Leon Farma, S.A. C/La Vallina s/n Pol. Ind. Navatejera 24008 Navatejera Leon Spain
RMS	Netherlands
Date of last change	28.01.2019
ATC-Code	G03AA07 Levonorgestrel and estrogen

CMS Country	Domestic Product Name
Austria	Leverette 150 Mikrogramm / 30 Mikrogramm Filmtabletten
Belgium
Czech Republic	Zinnia 0.150 mg / 0.030 mg film-coated tablets
Denmark
Estonia	LEVERETTE
Finland
Germany	Leverette 150/30 microgram, Filmtabletten
Hungary	MISSEE 0,15 mg/0,03 mg filmtabletta
Iceland
Italy
Latvia	Leverette 0,15 mg/0,03 mg apvalkotās tabletes
Lithuania	Leverette 0,15 mg / 0,03 mg plėvele dengtos tabletės
Luxembourg
Norway
Poland	Leverette
Slovak Republic	Leverette 0,15mg/0,03mg filmom obalené tablety
Spain
Sweden

Documents
PAR:	NL_H_2651_001_PAR.pdf (05.11.2013)
FinalSPC:	NL_H_2651_001_FinalSPC.pdf (05.06.2018)
FinalPL:	NL_H_2651_001_FinalPL.pdf (05.06.2018)
FinalLabelling:	NL_H_2651_001_FinalLabelling.pdf (05.06.2018)
Finalised Product Information:	NL_H_2651_001_FinalPI.pdf (15.09.2014)