This is a summary of the European public assessment report (EPAR) for Rotarix. 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 Rotarix.
Therapeutic Indication
### Therapeutic indication Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection. The use of Rotarix should be based on official recommendation.
Therapeutic Area (MeSH)
ATC Code
J07BH01
ATC Item
rota virus, live attenuated
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| human rotavirus, live attenuated | N/A | human rotavirus, live attenuated |
EMA Name
Rotarix
Medicine Name
Rotarix
Aliases
N/A