P/0341/2014 - paediatric investigation plan

cholecalciferol

calcium carbonate

Key facts

• Active Substance:
  • cholecalciferol
  • calcium carbonate
• Therapeutic area:
  Other
• Decision number:
  P/0341/2014
• PIP number:
  P/0341/2014
• Pharmaceutical form(s):
  Film-coated tablet
• Condition(s) / indication(s):
  Combination treatment of osteoporosis
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Gedeon Richter Plc.

  Hungary ; E-mail: [e-mail] ; Tel. [phone] ; Fax [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  22/12/2014

Decision

P/0341/2014: EMA decision of 22 December 2014 on the granting of a product specific waiver for calcium (carbonate) / cholecalciferol (in combination with ibandronic acid) (EMEA-001670-PIP01-14)

AdoptedReference Number: EMA/713537/2014