| Product No | EMEA/H/C/000669 |
|---|---|
| Brand Name | RotaTeq |
| Nonproprietary Name | rotavirus vaccine, live |
| API | rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1 |
| ATC Code | J07BH02 |
| Indications | RotaTeq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection.RotaTeq is to be used on the basis of official recommendations. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Merck Sharp & Dohme B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2006-06-26 |
| Version | 35 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information