Medicinal Products

Rosanelle 0,02 mg/3 mg filmom obložene tablete

Name Rosanelle 0,02 mg/3 mg filmom obložene tablete
Marketing Authorisation Number HR-H-813716141
Active Substance ethinylestradiolum, drospirenonum
Pharmaceutical Form filmom obložena tableta
Strength 0,02 mg/3 mg
Packaging [MA Number for Packaging] 28 tableta u blisteru, u kutiji  [HR-H-813716141-01]
Manufacturer Lek Pharmaceuticals d.d., Ljubljana, Slovenija;
Laboratorios Leon Farma S.A., Villaquialambre, Leon, Španjolska;
Salutas Pharma GmbH, Barleben, Njemačka
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb
Marketing Authorisation Date 08.11.2017
MA Period of Validity unlimited
Classification Number UP/I-530-09/16-02/473
Registration Number 381-12-01/38-17-05
Composition jedna filmom obložena tableta sadrži 0,02 mg etinilestradiola i 3 mg drospirenona
Prescription na recept
Type of prescription ponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code G03AA12
Medicinal product marketed in the Croatia Da
SmPC download
PL download
Educational materials
for healthcare professionals
Lista Provjere za lijecnike (3)
Popratno pismo za liječnike
Popratno pismo za ljekarnike
Educational materials
for patients / caregivers
Važne informacije za korisnicu (verzija 1)
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