EMEA-001407-PIP01-12-M03 - paediatric investigation plan

nivolumab
PIPHuman

Key facts

Invented name
Opdivo
Active Substance
nivolumab
Therapeutic area
Oncology
Decision number
P/0432/2020
PIP number
EMEA-001407-PIP01-12-M03
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except nervous system, haematopoietic and lymphoid tissue)
Route(s) of administration
Intravenous use
Contact for public enquiries

Bristol-Myers Squibb Pharma EEIG 
E-mail: medical.information@bms.com 
Tel. +44 (0)1423 533610

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001407-PIP01-12-M03
Compliance opinion date
Compliance outcome
Positive

Decision

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