Details

Product Name in the RMS: LENZETTO 1,53 mg/spray transdermal spray, solution

MR Number: HU/H/0361/001
Date of outcome: 25.06.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Known Active Substance Initial Application Full Dossier Chemical Substance Prescription Only
Active Substances	estradiol hemihydrate 1,53 mg/dose
Form	TRANSDERMAL SPRAY, SOLUTION
MA Holder in the RMS	Gedeon Richter Plc. Gyömrői út 19-21. 1103 Budapest Hungary
RMS	Hungary
Date of last change	11.07.2018
ATC-Code	G03CA03 Estradiol

CMS Country	Domestic Product Name
Belgium	Lenzetto 1,53 mg/dosis, transdermale spray, oplossing
Bulgaria	Lenzetto
Croatia	Lenzetto 1,53 mg po potisku, transdermalni sprej, otopina
Cyprus	LENZETTO TRASDERMAL SPRAY
Czech Republic	LENZETTO 1,53 MG-DÁVKA
Denmark
Estonia	Lenzetto
Finland
Germany	LENZETTO
Greece	LENZETTO
Iceland	Lenzetto 1,53 mg Úði til notkunar um húð
Ireland
Italy
Latvia	Lenzetto 1,53 mg/izsmidzinājumā transdermāls aerosols, šķīdums
Lithuania	Lenzetto 1,53 mg/išpurškime transderminis purškalas (tirpalas)
Luxembourg
Malta	Lenzetto 1.5 mg/spray transdermal spray
Netherlands
Norway	Lenzetto
Poland	Lenzetto
Romania	Lenzetto
Slovak Republic	Lenzetto 1,53 mg/dávka
Slovenia
Spain
Sweden
United Kingdom

Documents
PAR:	HU_H_0361_001_PAR.pdf (22.10.2015)
Finalised Product Information:	HU_H_0361_001_FinalPI_1of4.pdf (07.04.2016)
Finalised Product Information:	HU_H_0361_001_FinalPI_2of4.pdf (07.04.2016)
Finalised Product Information:	HU_H_0361_001_FinalPI_3of4.pdf (07.04.2016)
Finalised Product Information:	HU_H_0361_001_FinalPI_4of4.pdf (07.04.2016)