| Name |
Mifegyne 200 mg tablete |
| Marketing Authorisation Number |
HR-H-135441123 |
| Active Substance |
mifepriston |
| Composition |
jedna tableta sadrži 200 mg mifepristona |
| Pharmaceutical Form |
tableta |
| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
G03XB01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
