Medicinal Products

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
Kontrolna lista provjere za liječnike prije propisivanja, verzija 3
Educational materials
for patients / caregivers
Kartica podsjetnik za bolesnika, verzija 3
Kartica podsjetnik za skrbnike, 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 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.
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