P/149/2011

Key facts

Invented name
RotaTeq
Active substance
17 rotavirus type G1/rotavirus type G2/rotavirus type G3/rotavirus type G4/rotavirus type P1A[8] /03/2011
Therapeutic area
Vaccines
Decision number
P/149/2011
PIP number
P/149/2011
Pharmaceutical form(s)
Oral solution
Condition(s) / indication(s)
Prevention of rotaviral enteritis
Route(s) of administration
Oral use
Contact for public enquiries
Sanofi Pasteur MSD SNC
piplan@spmsd.com
France
Phone: +33 437284000
Decision type
PM: decision on the application for modification of an agreed PIP
Compliance procedure number
EMEA-C-000967-PIP01-10-M01
Compliance opinion date
21/07/2011
Compliance outcome
positive

Decision

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