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 | etinilestradiol drospirenon |
| Composition | jedna filmom obložena tableta sadrži 0,02 mg etinilestradiola i 3 mg drospirenona |
| Pharmaceutical Form | filmom obložena tableta |
| 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 |
| 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) |
