This is a summary of the European public assessment report (EPAR) for RotaTeq. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for RotaTeq.
Therapeutic Indication
### Therapeutic indication 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.
Therapeutic Area (MeSH)
ATC Code
J07BH02
ATC Item
rota virus, pentavalent, live, reassorted
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| rotavirus serotype G1 | N/A | rotavirus serotype g 1 |
| rotavirus serotype G2 | N/A | rotavirus serotype g 2 |
| rotavirus serotype G3 | N/A | rotavirus serotype g 3 |
| rotavirus serotype G4 | N/A | rotavirus serotype g 4 |
| rotavirus serotype P1 | N/A | rotavirus serotype p 1 |
| rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1 | N/A | rotavirus serotype g 1, serotype g 2, serotype g 3, serotype g 4, serotype p 1 |
EMA Name
RotaTeq
Medicine Name
RotaTeq
Aliases
N/A
