Xsotran 110 mg tvrde kapsule
| Name | Xsotran 110 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-261245435 |
| Active Substance | dabigatraneteksilatmesilat |
| Composition | jedna tvrda kapsula sadrži 110 mg dabigatraneteksilata (u obliku dabigatraneteksilatmesilata) |
| Pharmaceutical Form | Kapsula, tvrda |
| Manufacturer | Adamed Pharma S.A., Pabianice, Poljska |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 11.03.2025 |
| MA Period of Validity | 11.03.2030 |
| MA Revocation Date | 30.09.2025* |
| Classification Number | UP/I-530-09/22-01/30 |
| Registration Number | 381-12-01/171-25-19 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B01AE07 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Vodič za propisivače lijeka pSPAF, DVT, PE, verzija 6 Vodič za propisivače lijeka pVTE pedijatrijska populacija, verzija 2 Vodič za propisivače lijeka pVTE, verzija 6 |
| Educational materials for patients / caregivers |
Kartica s upozorenjima za bolesnika |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
