EMEA-001499-PIP01-13 - paediatric investigation plan

Odanacatib

colecalciferol

Key facts

• Active Substance:
  • Odanacatib
  • colecalciferol
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0301/2013
• PIP number:
  EMEA-001499-PIP01-13
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of osteoporosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

  Tel. [phone]; Email: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  29/11/2013

Decision

P/0301/2013: EMA decision of 29 November 2013 on the granting of a product specific waiver for odanacatib / colecalciferol (EMEA-001499-PIP01-13)

AdoptedReference Number: EMA/659494/2013