Strontium ranelate - paediatric investigation plan

strontium ranelate

Key facts

• Invented name:
  • Protelos
  • Protelos
• Active substance:
  strontium ranelate
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/23/2010
• PIP number:
  Strontium ranelate
• Pharmaceutical form(s):
  Granules for oral suspension
• Condition(s) / indication(s):
  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:
  02/03/2010
• Compliance check done:
  Nē

Decision

P/23/2010: European Medicines Agency decision of 15 March 2010 on the granting of a product specific waiver for strontium ranelate (Protelos) (EMEA-000732-PIP01-09) in accordance with Regulation (EC) No 1901/2006 of the ...

Reference Number: EMA/164721/2010