This brand name is authorized in Austria, Brazil, Croatia, Cyprus, Ecuador, Estonia, France, Hong Kong SAR China, Ireland, Italy, Japan, Lithuania, Netherlands, New Zealand, Nigeria, Poland, Romania, Singapore, South Africa, Spain, Tunisia, Turkey, UK.
The drug ROTARIX contains one active pharmaceutical ingredient (API):
1
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UNII
KZ3L01D2PC - HUMAN ROTAVIRUS A TYPE G1P(8) STRAIN RIX4414 LIVE ANTIGEN
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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]. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| ROTARIX Powder and solvent for oral suspension | MPI, EU: SmPC | European Medicines Agency (EU) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J07BH01 | Rota virus, live attenuated | 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 | 510618020059307 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 29094-11-09 |
| EE | Ravimiamet | 1250727, 1250738, 1250749, 1250750, 1477537, 1477548, 1477559, 1477560, 1477571, 1477582, 1477593, 1791301 |
| ES | Centro de información online de medicamentos de la AEMPS | 05330005IP, 05330005IP1, 05330005IP2, 05330009, 05330009IP |
| FR | Base de données publique des médicaments | 60886387 |
| GB | Medicines & Healthcare Products Regulatory Agency | 346100 |
| HK | Department of Health Drug Office | 54546 |
| IT | Agenzia del Farmaco | 037045010, 037045022, 037045034, 037045046, 037045059, 037045061, 037045073, 037045085, 037045097, 037045109, 037045111, 037045123 |
| JP | 医薬品医療機器総合機構 | 631300AS1020 |
| LT | Valstybinė vaistų kontrolės tarnyba | 1030731, 1030732, 1030733, 1030734, 1056565, 1056566, 1056567, 1056568, 1056569, 1056570, 1056571, 1086095 |
| NG | Registered Drug Product Database | A6-0136 |
| NL | Z-Index G-Standaard, PRK | 108413, 204048 |
| NZ | Medicines and Medical Devices Safety Authority | 11925, 13344 |
| PL | Rejestru Produktów Leczniczych | 100159915, 100197347 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W51710001, W51710002, W51710003, W51710004, W53550001, W53550002, W53550003, W53550004, W53550005, W53550006, W53550007 |
| SG | Health Sciences Authority | 13150P, 13743P, 13813P |
| TN | Direction de la Pharmacie et du Médicament | 7063122 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8699522967582, 8699522967599, 8699522967605, 8699522967612, 8699522967636, 8699522967643, 8699522967650 |
| ZA | Health Products Regulatory Authority | 43/30.2/0290 |
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