EMEA-001123-PIP01-11-M03 - paediatric investigation plan

Odanacatib

Key facts

• Active Substance:
  Odanacatib
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0307/2015
• PIP number:
  EMEA-001123-PIP01-11-M03
• 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.

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/12/2015

Decision

P/0307/2015: EMA decision of 21 December 2015 on the acceptance of a modification of an agreed paediatric investigation plan for odanacatib (EMEA-001123-PIP01-11-M03)

AdoptedReference Number: EMA/761887/2015