Gilenya
| Name | Gilenya |
|---|---|
| Active Substance | fingolimod hydrochloride |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| ATC Code | L04AA27 |
| Medicinal product marketed in the Croatia | Da |
| Educational materials for healthcare professionals |
Lista provjere za zdravstvene radnike, verzija 4 |
| Educational materials for patients / caregivers |
Vodič za bolesnike, verzija 4 Vodič za roditelje skrbnike čije dijete prima lijek Gilenya, verzija 2 Kartica za bolesnice s podsjetnikom o trudnoći, verzija 1 |
Note
The medicinal product has been authorised via centralised procedure in all Member States of the European Union based on the European Medicines Agency's expert opinion. Additional information on the medicinal product can be found under the following link:https://www.ema.europa.eu/en/medicines/human/EPAR/gilenya
The marketing authorisation has been granted by the European Commission. All marketing authorisations of the European Commission can be found under the following link: http://ec.europa.eu/health/documents/community-register/html/index_en.htm
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o ažuriranim preporukama za minimizaciju rizika od oštećenja jetre uzrokovanog lijekom Gilenya (fingolimod) | 10.11.2020 | Novartis Hrvatska d.o.o. |
| Pismo zdravstvenim radnicima o novoj kontraindikaciji primjene lijeka Gilenya (fingolimod) u trudnica i žena reproduktivne dobi koje ne upotrebljavaju učinkovitu kontracepciju | 02.09.2019 | Novartis Europharm Limited |
| Pismo zdravstvenim radnicima o novim kontraindikacijama za fingolimod (Gilenya) u bolesnika sa srčanim bolestima | 07.11.2017 | Novartis Hrvatska d.o.o. |
| Pismo zdravstvenim radnicima o rizicima povezanim s učincima fingolimoda (Gilenya) na imunološki sustav | 22.01.2016 | Novartis Hrvatska d.o.o. |
