EMA/PE/0000241614 - paediatric investigation plan

calcium carbonate

cholecalciferol

risedronate sodium

Key facts

• Active substance:
  • calcium carbonate
  • cholecalciferol
  • risedronate sodium
• Therapeutic area:
  Musculoskeletal and connective tissue disorders
• Decision number:
  EMA/PE/0000241614
• PIP number:
  EMA/PE/0000241614
• Pharmaceutical form(s):
  • Granules
  • Film-coated 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:
  15/05/2025
• Compliance check done:
  Nej

Decision

EMA/PE/0000241614 : EMA decision of 15 May 2025 on the granting of a product specific waiver for calcium carbonate / cholecalciferol + risedronate sodium

Adopted Reference Number: EMADOC-1700519818-2115989