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 |