Mifegyne 200 mg tablete
| Name | Mifegyne 200 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-135441123 |
| Active Substance | mifepriston |
| Composition | jedna tableta sadrži 200 mg mifepristona |
| Pharmaceutical Form | tableta |
| Packaging [MA Number for Packaging] | 1 tableta u blisteru, u kutiji [HR-H-135441123-01] 3 tablete u blisteru s jediničnom dozom, u kutiji [HR-H-135441123-02] 15 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-135441123-03] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-135441123-04] |
| Manufacturer | Laboratoires MACORS, Auxerre, Francuska |
| Marketing Authorisation Holder | Exelgyn, 216 Bd Saint-Germain, Pariz, Francuska |
| Marketing Authorisation Date | 11.11.2020 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/19-02/251 |
| Registration Number | 381-12-01/38-20-13 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G03XB01 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
