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
Route(s) of administration
Oral use
Contact for public enquiries

Roche Registration GmbH

E-mail: global.eu_regulatory_office@roche.com
Tel. +49 7624142892

Decision type
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

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