Priorix, prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki, cjepivo protiv morbila, parotitisa i rubele, živo
| Name | Priorix, prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki, cjepivo protiv morbila, parotitisa i rubele, živo |
|---|---|
| Marketing Authorisation Number | HR-H-788122655 |
| Active Substance | virus morbila, soj Schwarz (živi, atenuirani) virus parotitisa, soj RIT 4385, porijeklom iz soja Jeryl Lynn (živi, atenuirani) virus rubele, soj Wistar RA 27/3 (živi, atenuirani) |
| Composition | jedna doza (0,5 ml otopine) sadržava najmanje 10³·⁰ CCID₅₀ živog atenuiranog virusa morbila (soj Schwarz), najmanje 10³·⁷ CCID₅₀ živog atenuiranog virusa parotitisa [soj RIT 4385 (porijeklom iz soja Jeryl Lynn)] i najmanje 10³·⁰ CCID₅₀ živog atenuiranog virusa rubele (soj Wistar RA 27/3) |
| Pharmaceutical Form | prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki |
| Manufacturer | GlaxoSmithKline Biologicals S.A., Rixensart, Belgija |
| Marketing Authorisation Holder | GlaxoSmithKline Biologicals S.A., Rue de l'Institut 89, Rixensart, Belgija |
| Marketing Authorisation Date | 20.08.2021 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/15-02/282 |
| Registration Number | 381-12-01/70-21-62 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | J07BD52 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o istjecanju cjepiva iz štrcaljki nekoliko različitih cjepiva nositelja odobrenja GlaxoSmithKline Biologicals | 04.04.2018 | GlaxoSmithKline d.o.o. |
