Inzolfi 0,5 mg tvrde kapsule
| Name | Inzolfi 0,5 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-552241724 |
| Active Substance | fingolimodklorid |
| Composition | jedna tvrda kapsula sadrži 0,5 mg fingolimoda (u obliku fingolimodklorida) |
| Pharmaceutical Form | Kapsula, tvrda |
| Packaging [MA Number for Packaging] | 7 kapsula u blisteru, u kutiji [HR-H-552241724-01] 28 kapsula u blisteru, u kutiji [HR-H-552241724-02] 98 kapsula u blisteru, u kutiji [HR-H-552241724-03] 84 (3 pakiranja sa po 28 kapsula u kutiji) kapsule u, kutiji [HR-H-552241724-04] 7 kapsula u blisteru s jediničnom dozom, u kutiji [HR-H-552241724-05] 7 kapsula u blisteru u ovitku, u kutiji [HR-H-552241724-06] 28 kapsula u blisteru u ovitku, u kutiji [HR-H-552241724-07] 98 kapsula u blisteru u ovitku, u kutiji [HR-H-552241724-08] 84 (3 pakiranja sa po 28 kapsula u ovitku, u kutiji) kapsule, u kutiji [HR-H-552241724-09] |
| Manufacturer | Novartis Pharma GmbH, Nürnberg, Njemačka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 24.06.2021 |
| MA Period of Validity | 24.06.2026 |
| MA Revocation Date | 31.08.2023* |
| Classification Number | UP/I-530-09/19-01/100 |
| Registration Number | 381-12-01/70-21-03 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L04AA27 |
| Medicinal product marketed in the Croatia | Trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Lista provjere za zdravstvene radnike, verzija 5 |
| Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 5 Vodič za roditelje skrbnike, verzija 3 Kartica za bolesnice s podsjetnikom o trudnoći, verzija 1 |
*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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
