Gemcitabin Kabi 200 mg prašak za otopinu za infuziju
| Name | Gemcitabin Kabi 200 mg prašak za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-485306394 |
| Active Substance | gemcitabinklorid |
| Composition | jedna bočica sadrži 200 mg gemcitabina (u obliku gemcitabinklorida). Nakon rekonstitucije s 5 ml otapala 1 ml rekonstituirane otopine sadrži 38 mg gemcitabina. |
| Pharmaceutical Form | prašak za otopinu za infuziju |
| Manufacturer | Fresenius Kabi Oncology Plc., Bordon Hampshire, Ujedinjeno Kraljevstvo
Fresenius Kabi Deutschland GmbH, Friedberg, Njemačka |
| Marketing Authorisation Holder | Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date | 18.01.2019 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 03.09.2024* |
| Classification Number | UP/I-530-09/17-02/824 |
| Registration Number | 381-12-01/70-19-06 |
| 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 | L01BC05 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
*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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
