EMEA-003101-PIP01-21 - paediatric investigation plan

colchicine

Key facts

• Active Substance:
  colchicine
• Therapeutic area:
  Cardiovascular diseases
• Decision number:
  P/0028/2022
• PIP number:
  EMEA-003101-PIP01-21
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Prevention of cardiovascular events
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pharmascience International Limited

  [e-mail]

  [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  31/01/2022

Decision

P/0028/2022 : EMA decision of 31 January 2022 on the granting of a product specific waiver for colchicine (EMEA-003101-PIP01-21)

AdoptedReference Number: EMA/12322/2022