Fluorouracil Pliva 50 mg/ml otopina za injekciju/infuziju
| Name | Fluorouracil Pliva 50 mg/ml otopina za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-111487546 |
| Active Substance | fluorouracil |
| Composition | 1 ml otopine za injekciju sadrži 50 mg fluorouracila |
| Pharmaceutical Form | otopina za injekciju/infuziju |
| Manufacturer | Pliva Hrvatska d.o.o., Zagreb, Hrvatska
Pharmachemie B.V., Haarlem, Nizozemska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 14.09.2015 |
| MA Period of Validity | unlimited |
| MA Revocation Date | 11.11.2025* |
| Classification Number | UP/I-530-09/14-02/551 |
| Registration Number | 381-12-01/14-15-08 |
| 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 | L01BC02 |
| Marketing status | trajni prekid opskrbe |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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.
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od preniskog doziranja lijekova koji sadrže fluorouracil uslijed potencijalno pogrešnog tumačenja rezultata fenotipske karakterizacije DPD-a u bolesnika s umjerenim ili teškim oštećenjem bubrega | 24.10.2024 | Pliva Hrvatska d.o.o., Sandoz d.o.o. |
| Pismo zdravstvenim radnicima o potrebi testiranja bolesnika prije započinjanja liječenja lijekovima s djelatnim tvarima fluorouracil, kapecitabin ili tegafur radi utvrđivanja mogućeg nedostatka DPD enzima koji bolesnike izlaže povećanom riziku od teške toksičnosti | 04.06.2020 | Roche Registration GmbH, Jadran Galenski laboratorij d.d. (JGL), Alpha-Medical d.o.o., Sandoz d.o.o., Alvogen Pharma Trading Europe EOOD, Pliva Hrvatska d.o.o., Krka-farma d.o.o., Teva B.V., Accord Healthcare S.L.U. |
