EMEA-001454-PIP05-18 - paediatric investigation plan

binimetinib

Key facts

• Invented name:
  Mektovi
• Active substance:
  binimetinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0037/2019
• PIP number:
  EMEA-001454-PIP05-18
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of colorectal carcinoma
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/01/2019
• Compliance check done:
  Ne

Decision

P/0037/2019: EMA decision of 29 January 2019 on the granting of a product specific waiver for binimetinib (Mektovi), (EMEA-001454-PIP05-18)

Reference Number: EMA/887187/2018