EMEA-000463-PIP02-10 - paediatric investigation plan

imatinib mesilate

Key facts

• Invented name:
  Glivec
• Active substance:
  imatinib mesilate
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/85/2011
• PIP number:
  EMEA-000463-PIP02-10
• Pharmaceutical form(s):
  • Film-coated tablet
  • Capsule, hard
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of pulmonary arterial hypertension
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/04/2011
• Compliance check done:
  Não

Decision

P/85/2011: EMA decision of 8 April 2011 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for imatinib (mesilate) (Glivec) (EMEA-000463-PIP02-10)

Adopted Reference Number: EMA/254705/2011