Rotavirus vaccine is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection. In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most common genotypes G1P [8], G2P [4], G3P [8], G4P [8] and G9P [8].
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J07BH | Rota virus diarrhea vaccines | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| ROTARIX Powder and solvent for oral suspension | European Medicines Agency (EU) | MPI, EU: SmPC |
Rota virus is an active ingredient of these brands:
Austria (AT)
Brazil (BR)
Croatia (HR)
Cyprus (CY)
Ecuador (EC)
Estonia (EE)
France (FR)
Hong Kong (HK)
Ireland (IE)
Italy (IT)
Japan (JP)
Lithuania (LT)
Netherlands (NL)
New Zealand (NZ)
Poland (PL)
Romania (RO)
Singapore (SG)
South Africa (ZA)
Spain (ES)
Tunisia (TN)
Turkey (TR)
United Kingdom (UK)
Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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