MedPath
NMPA Approval

Reassortant Rotavirus Vaccine, Live, Oral, Pentavalent (Vero Cell)

国药准字SJ20180002

March 20, 2023

S20180002

Drug Information

口服五价重配轮状病毒减毒活疫苗(Vero细胞)

乐儿德

口服溶液剂

每支2ml,每1次人用剂量2ml;所含5种人-牛轮状病毒重配株效价不低于如下限值:G1:2.2×10^6感染单位;G2:2.8×10^6感染单位;G3:2.2×10^6感染单位;G4:2.0×10^6感染单位;P1A[8]:2.3×10^6感染单位。

生物制品

March 20, 2023

March 19, 2028

Company Information

Applicant Company

Merck, Inc.

126 E. Lincoln Avenue, P.O. Box 2000, Rahway, NJ 07065, US

Manufacturing Company

Merck, Inc.

770 Sumneytown Pike, West Point, PA 19486, US

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