Atremia 0,5 mg tvrde kapsule
| Name | Atremia 0,5 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-094685523 |
| Active Substance | anagrelidklorid hidrat |
| Composition | jedna kapsula sadrži 0,5 mg anagrelida (u obliku anagrelidklorid hidrata) |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Synthon Hispania S.L., Barcelona, Španjolska Synthon BV, Nijmegen, Nizozemska Teva Operations Poland Sp. z o.o., Krakow, Poljska Pliva Hrvatska d.o.o., Zagreb, Hrvatska |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 27.06.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/190 |
| Registration Number | 381-12-01/14-22-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01XX35 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od tromboze, uključujući cerebralni infarkt, nakon naglog prekida liječenja anagrelidom | 11.03.2022 | Stada d.o.o., Pliva Hrvatska d.o.o., Alpha-Medical d.o.o., Zentiva k.s., AOP Orphan Pharmaceuticals GmbH |
