EMEA-000092-PIP02-11 - paediatric investigation plan

Recombinant salmon calcitonin

Key facts

• Active Substance:
  Recombinant salmon calcitonin
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/194/2011
• PIP number:
  EMEA-000092-PIP02-11
• Pharmaceutical form(s):
  Tablet
• Condition(s) / indication(s):
  Treatment of bone metabolism disorders
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Novartis Europharm Ltd

  [e-mail]; United Kingdom; Phone: [phone]; Fax: [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  03/08/2011

Decision

P/194/2011: EMA decision of 3 August 2011 on the granting of a product specific waiver for recombinant salmon calcitonin (EMEA-000092-PIP02-11)

AdoptedReference Number: EMA/593331/2011