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EMEA-001425-PIP01-13-M05 - paediatric investigation plan
Cobimetinib
PIPHuman
Key facts
Invented name
Cotellic
Active Substance
Cobimetinib
Therapeutic area
Oncology
Decision number
P/0119/2021
PIP number
EMEA-001425-PIP01-13-M05
Pharmaceutical form(s)
Film-coated tablet
Age-appropriate oral formulation
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except haematopoietic and lymphoid tissue) with Ras, Raf or MEK pathway activation
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001425-PIP01-13-M05
Compliance opinion date
Compliance outcome
Positive
Decision
P/0119/2021 : EMA decision of 17 March 2021 on the acceptance of a modification of an agreed paediatric investigation plan for cobimetinib (Cotellic) (EMEA-001425-PIP01-13-M05)