EMEA-001266-PIP02-14 - paediatric investigation plan

Masitinib mesilate

Key facts

• Active Substance:
  Masitinib mesilate
• Therapeutic area:
  Other
• Decision number:
  P/0093/2015
• PIP number:
  EMEA-001266-PIP02-14
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Treatment of mastocytosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  AB Science

  France; [e-mail] ; [phone]; [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  08/05/2015

Decision

P/0093/2015: EMA decision of 8 May 2015 on the refusal of a paediatric investigation plan and on the granting of a waiver for masitinib (mesylate) (EMEA-001266-PIP02-14)

Reference Number: EMA/215125/2015