| EMA number | EMEA/H/C/000192 |
| ATC code | J07BH |
| Authorisation | 7 May 1999 |
| Withdrawn | 22 January 2001 |
| Revision | - |
RotaShield is indicated for active immunisation of infants aged 6 weeks to 30 weeks for prevention of severe clinical manifestations of gastro-enteritis caused by rotavirus serotypes 1, 2, 3 and 4 of group A.