Rabipur prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki, cjepivo protiv bjesnoće, inaktivirano
Name | Rabipur prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki, cjepivo protiv bjesnoće, inaktivirano |
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Marketing Authorisation Number | HR-H-512237923 |
Active Substance | virus bjesnoće, soj Flury LEP (inaktiviran) |
Composition | 1 bočica (1,0 ml) nakon rekonstitucije sadrži: virus bjesnoće (inaktivirani, soj Flury LEP) ≥ 2,5 internacionalne jedinice (IU), proizveden na pročišćenim stanicama pilećih embrija (PCEC) |
Pharmaceutical Form | prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki |
Manufacturer | GSK Vaccines GmbH, Marburg, Njemačka Bavarian Nordic A/S, Kvistgaard, Danska |
Marketing Authorisation Holder | Bavarian Nordic A/S, Philip Heymans Allé 3, Hellerup, Danska |
Marketing Authorisation Date | 01.03.2021 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/19-02/159 |
Registration Number | 381-12-01/154-21-17 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | J07BG01 |
Medicinal product marketed in the Croatia | Nestašica |
SmPC | download |
PL | download |
Public Assessment Report | download |