Namaxir 20 mg otopina za injekciju u napunjenoj štrcaljki
Name | Namaxir 20 mg otopina za injekciju u napunjenoj štrcaljki |
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Marketing Authorisation Number | HR-H-989611817 |
Active Substance | metotreksat |
Composition | jedna napunjena štrcaljka od 0,50 ml sadrži 20 mg metotreksata |
Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
Manufacturer | Actavis Italy S.p.A., Nerviano (Milano), Italija S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
Marketing Authorisation Date | 24.02.2023 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/19-02/215 |
Registration Number | 381-12-01/38-23-13 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L04AX03 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Packaging
Direct Healthcare Professional Communication
Name | Date | Download |
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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 |