Klofarabin Makpharm 1 mg/ml koncentrat za otopinu za infuziju
Name | Klofarabin Makpharm 1 mg/ml koncentrat za otopinu za infuziju |
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Marketing Authorisation Number | HR-H-540393693 |
Active Substance | klofarabin |
Composition | jedan ml koncentrata sadrži 1 mg klofarabina |
Pharmaceutical Form | koncentrat za otopinu za infuziju |
Manufacturer | Synthon Hispania S.L., Barcelona, Španjolska Synthon s.r.o., Blansko, Češka Synthon BV, Nijmegen, Nizozemska |
Marketing Authorisation Holder | Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
Marketing Authorisation Date | 07.12.2021 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/119 |
Registration Number | 381-12-01/154-21-03 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01BB06 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |