EMEA-000733-PIP02-12 - paediatric investigation plan

strontium succinate

Key facts

• Invented name:
  • • Protelos
    • Osseor
  • • Osseor
    • Protelos
• Active substance:
  strontium succinate
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0022/2013
• PIP number:
  EMEA-000733-PIP02-12
• Pharmaceutical form(s):
  • Granules for oral suspension
  • Tablet
• Condition(s) / indication(s):
  Treatment of osteoporosis
• Route(s) of administration:
  Oral use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  25/02/2013
• Compliance check done:
  No

Decision

P/0022/2013: EMA decision of 25 February 2013 on the granting of a product specific waiver for strontium (succinate) (Protelos, Osseor), (EMEA-000733-PIP02-12)

Adopted Reference Number: EMA/51547/2013