ROTATEQ

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, Singapore, Turkey, South Africa

Active ingredients

The drug ROTATEQ contains a combination of these active pharmaceutical ingredients (APIs):

1 Human-bovine rotavirus reassortant (live) serotype G1
Read about Rota virus, type G1
2 Human-bovine rotavirus reassortant (live) serotype G2
Read about Rota virus, type G2
3 Human-bovine rotavirus reassortant (live) serotype G3
Read about Rota virus, type G3
4 Human-bovine rotavirus reassortant (live) serotype G4
Read about Rota virus, type G4
5 Human-bovine rotavirus reassortant (live) serotype P1[8]
Read about Rota virus, type P1(8)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
J07BH Rota virus diarrhea vaccines J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines
Discover more medicines within J07BH
J07BH02 Rota virus, pentavalent, live, reassorted J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BH Rota virus diarrhea vaccines
Discover more medicines within J07BH02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 525504401138411
Country: CA Health Products and Food Branch Identifier(s): 02284413
Country: EC Agencia Nacional de Regulación, Control y Vigilancia Sanitaria Identifier(s): 27.200-08-06
Country: EE Ravimiamet Identifier(s): 1255193, 1255205
Country: ES Centro de información online de medicamentos de la AEMPS Identifier(s): 06348001, 06348001IP1, 06348001IP2, 06348001IP3
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 063215, 066678
Country: FR Base de données publique des médicaments Identifier(s): 66396810
Country: HK Department of Health Drug Office Identifier(s): 55037
Country: IT Agenzia del Farmaco Identifier(s): 037455019, 037455021
Country: JP 医薬品医療機器総合機構 Identifier(s): 631301AS1024
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1030735, 1030736
Country: NZ Medicines and Medical Devices Safety Authority Identifier(s): 12153
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100161846
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W68781001, W68781002
Country: SG Health Sciences Authority Identifier(s): 13303P
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699636650103, 8699636651483
Country: ZA Health Products Regulatory Authority Identifier(s): A40/30.1/0730

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