Mispregnol 400 mikrograma tablete
| Name | Mispregnol 400 mikrograma tablete |
|---|---|
| Marketing Authorisation Number | HR-H-148237306 |
| Active Substance | mizoprostol |
| Composition | jedna tableta sadrži 400 mikrograma mizoprostola |
| Pharmaceutical Form | tableta |
| Packaging [MA Number for Packaging] | 1 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-148237306-01] 4 tablete u blisteru s jediničnom dozom, u kutiji [HR-H-148237306-02] 16 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-148237306-03] 40 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-148237306-04] |
| Manufacturer | Delpharm Lille S.A.S., Lys Lez Lannoy, Francuska Laboratoires MACORS, Auxerre, Francuska Nordic Pharma B.V., Hoofddorp, Nizozemska |
| 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-530-09/16-02/307 |
| Registration Number | 381-12-01/154-20-26 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | G02AD06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 1 |
| Educational materials for patients / caregivers |
Brošura za korisnice lijeka, verzija 1 Kartica s upozorenjima, verzija 1 |
