Gitrabin 200 mg prašak za otopinu za infuziju
| Name | Gitrabin 200 mg prašak za otopinu za infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-499292652 |
| Active Substance | gemcitabinklorid |
| Composition | svaka bočica sadrži 200 mg gemcitabina (u obliku gemcitabinklorida) |
| Pharmaceutical Form | prašak za otopinu za infuziju |
| Manufacturer | S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska
Actavis Italy S.p.A., Nerviano (Milano), Italija |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 07.10.2020 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 18.03.2025* |
| Classification Number | UP/I-530-09/14-02/318 |
| Registration Number | 381-12-01/70-20-24 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01BC05 |
| Marketing status | Not marketed |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
