Anastrozole - paediatric investigation plan

Anastrozole

Key facts

• Invented name:
  Arimidex and associated names
• Active Substance:
  Anastrozole
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/20/2009
• PIP number:
  Anastrozole
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Gynaecomastia
  • McCune-Albright syndrome
  • Short stature due to Growth Hormone deficiency
  • Testotoxicosis
• 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:
  06/02/2009
• Compliance procedure number:
  EMEA-C-000283-PIP01-08
• Compliance opinion date:
  03/04/2009
• Compliance outcome:
  Positive

Decision

P/20/2009: European Medicines Agency decision of of 6 February 2009 on the agreement of a Paediatric Investigation Plan and on the granting of a waiver for anastrozole, Arimidex and associated names (EMEA-000283-PIP-01-0...

AdoptedReference Number: EMEA/64242/2009