EMEA-001480-PIP01-13 - paediatric investigation plan

calcium (citrate)

colecalciferol

Key facts

• Active substance:
  • calcium (citrate)
  • colecalciferol
• Therapeutic area:
  Other
• Decision number:
  P/0242/2013
• PIP number:
  EMEA-001480-PIP01-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  • Treatment of calcium and vitamin D3 deficiency
  • Prevention of calcium and vitamin D3 deficiency
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  24/09/2013
• Compliance check done:
  No

Decision

P/0242/2013: EMA decision of 24 September 2013 on the granting of a product specific waiver for calcium (citrate) / colecalciferol (EMEA-001480-PIP01-13)

Adopted Reference Number: EMA/496911/2013