Teruma 14 mg filmom obložene tablete
| Name | Teruma 14 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-404723862 |
| Active Substance | teriflunomid |
| Composition | jedna filmom obložena tableta sadrži 14 mg teriflunomida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska
Teva Operations Poland Sp. z o.o., Krakow, Poljska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 26.07.2023 |
| MA Period of Validity | 26.07.2028 |
| MA Revocation Date | 10.09.2024* |
| Classification Number | UP/I-530-09/21-01/242 |
| Registration Number | 381-12-01/154-23-08 |
| 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 | L04AK02 |
| Marketing status | trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Vodič za zdravstvene radnike, verzija 5 |
| Educational materials for patients / caregivers |
Kartica za bolesnika, verzija 4 |
*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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
