Varivax prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki
| Name | Varivax prašak i otapalo za suspenziju za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-920622763 |
| Active Substance | virus varičele, soj Oka/Merck (živi, atenuirani) |
| Composition | nakon rekonstitucije, jedna doza (0,5 ml) sadrži: virus varičele soj Oka/Merck (živi, atenuirani) ≥1350 PFU, proizveden na ljudskim diploidnim (MRC-5) stanicama |
| Pharmaceutical Form | prašak i otapalo za suspenziju za injekciju |
| Packaging [MA Number for Packaging] | 1 bočica s praškom i 1 napunjena štrcaljka s otapalom bez igle, u kutiji [HR-H-920622763-03] 10 bočica s praškom i 10 napunjenih štrcaljki s otapalom bez igle, u kutiji [HR-H-920622763-04] 1 bočica s praškom i 1 napunjena štrcaljka s otapalom i 2 priložene igle, u kutiji [HR-H-920622763-05] 10 bočica s praškom i 10 napunjenih štrcaljki s otapalom i 20 priloženih igala, u kutiji [HR-H-920622763-06] |
| Manufacturer | Merck Sharp & Dohme B.V., Haarlem, Nizozemska |
| Marketing Authorisation Holder | Merck Sharp & Dohme d.o.o., Ivana Lučića 2a, Zagreb, Hrvatska |
| Marketing Authorisation Date | 30.08.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/89 |
| Registration Number | 381-12-01/70-23-05 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | J07BK01 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
