Medicinal Products

Metotreksat Sandoz 2,5 mg tablete

Name Metotreksat Sandoz 2,5 mg tablete
Marketing Authorisation Number HR-H-702520895
Active Substance dinatrijev metotreksat
Composition jedna tableta sadrži 2,5 mg metotreksata, u obliku dinatrijevog metotreksata
Pharmaceutical Form tableta
Manufacturer Salutas Pharma GmbH, Barleben, Njemačka
Marketing Authorisation Holder Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska
Marketing Authorisation Date 22.05.2018
MA Period of Validity unlimited
Classification Number UP/I-530-09/17-02/244
Registration Number 381-12-01/70-18-07
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 L01BA01; L04AX03
Marketing status stavljeno u promet
Shortage status nema nestašice
SmPC download
PL download
Educational materials
for healthcare professionals
Lista provjere za farmaceute koji izdaju oralne oblike metotreksata, verzija 1
Educational materials
for patients / caregivers
Kartica za bolesnike, verzija 1

Packaging

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o preporukama za sprječavanje potencijalno fatalnih pogrešaka u doziranju metotreksata za liječenje upalnih bolesti 02.12.2019 Sandoz d.o.o., Pliva Hrvatska d.o.o., Actavis Group PTC ehf, Cipla Europe NV
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