EMEA-001425-PIP01-13-M05 - paediatric investigation plan

Cobimetinib

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/03/2021
• Compliance check done:
  Ja
• Compliance procedure number:
  EMEA-C-001425-PIP01-13-M05
• Compliance opinion date:
  25/06/2021
• 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)

Reference Number: EMA/93313/2021