| 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 |
| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
ograničeni recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
J07BK01 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
