Medicinal Products

Xeljanz

Name Xeljanz
Active Substance tofacitinib
Prescription na recept
Type of prescription ograničeni recept
Distribution u ljekarni
ATC Code L04AA29
Medicinal product marketed in the Croatia Da
Educational materials
for healthcare professionals
Vodič za zdravstvenog radnika, verzija 3
Lista provjere na početku liječenja za zdravstvenog radnika, verzija 3
Lista provjere tijekom liječenja za zdravstvenog radnika, verzija 3
Educational materials
for patients / caregivers
Kartica s upozorenjima za bolesnika, verzija 3

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/xeljanz

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 kontraindikaciji primjene lijeka Xeljanz (tofacitinib) u dozi od 10 mg, dva puta dnevno kod bolesnika koji imaju povećani rizik od plućne embolije 28.05.2019 Pfizer Croatia d.o.o.
Pismo zdravstvenim radnicima o povećanom riziku od plućne embolije i smrtnosti u bolesnika s reumatoidnim artritisom koji su primili dozu od 10 mg tofacitiniba dva puta dnevno u kliničkom ispitivanju lijeka Xeljanz (tofacitinib) 27.03.2019 Pfizer Croatia d.o.o.
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