This brand name is authorized in Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey.
The drug ROTATEQ contains a combination of these active pharmaceutical ingredients (APIs):
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This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J07BH | Rota virus diarrhea vaccines | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines |
| J07BH02 | Rota virus, pentavalent, live, reassorted | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BH Rota virus diarrhea vaccines |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 525504401138411 |
| CA | Health Products and Food Branch | 02284413 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 27.200-08-06 |
| EE | Ravimiamet | 1255193, 1255205 |
| ES | Centro de información online de medicamentos de la AEMPS | 06348001, 06348001IP1, 06348001IP2, 06348001IP3 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 063215, 066678 |
| FR | Base de données publique des médicaments | 66396810 |
| HK | Department of Health Drug Office | 55037 |
| IT | Agenzia del Farmaco | 037455019, 037455021 |
| JP | 医薬品医療機器総合機構 | 631301AS1024 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1030735, 1030736 |
| NZ | Medicines and Medical Devices Safety Authority | 12153 |
| PL | Rejestru Produktów Leczniczych | 100161846 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W68781001, W68781002 |
| SG | Health Sciences Authority | 13303P |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699636650103, 8699636651483 |
| ZA | Health Products Regulatory Authority | A40/30.1/0730 |
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