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 |
| Packaging [MA Number for Packaging] | 30 tableta u blisteru, u kutiji [HR-H-702520895-01] |
| 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 | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01BA01; L04AX03 |
| Medicinal product marketed in the Croatia | Da |
| 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 |
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 |
