Estal 0,03 mg + 2 mg filmom obložene tablete
| Name | Estal 0,03 mg + 2 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-389030632 |
| Active Substance | etinilestradiol klormadinonacetat |
| Composition | 1 filmom obložena tableta sadrži 0,03 mg etinilestradiola i 2 mg klormadinonacetata |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 21 tableta u blisteru, u kutiji [HR-H-389030632-01] 63 tablete u blisteru, u kutiji [HR-H-389030632-02] |
| Manufacturer | mibe GmbH Arzneimittel, Brehna, Njemačka |
| Marketing Authorisation Holder | Mibe Pharmaceuticals d.o.o., Zavrtnica 17, Zagreb, Hrvatska |
| Marketing Authorisation Date | 15.06.2018 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/270 |
| Registration Number | 381-12-01/70-18-04 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G03AA15 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Educational materials for healthcare professionals |
Lista provjere za liječnike (verzija 1) Popratno pismo za liječnike Popratno pismo za ljekarnike |
| Educational materials for patients / caregivers |
Važne informacije za korisnicu (verzija 1) |
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o mjerama minimizacije rizika od meningeomapovezanog s primjenom lijekova koji sadrže klormadinonacetat i nomegestrolacetat | 09.11.2022 | Gedeon Richter Plc., Theramex Ireland Limited, Zentiva k.s., Mibe Pharmaceuticals d.o.o. |
