EMEA-000057-PIP01-07-M07 - paediatric investigation plan

zoledronic acid

Key facts

• Invented name:
  Aclasta
• Active substance:
  zoledronic acid
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0028/2020
• PIP number:
  EMEA-000057-PIP01-07-M07
• Pharmaceutical form(s):
  Solution for infusion
• Condition(s) / indication(s):
  • Treatment of osteoporosis
  • Treatment of Paget’s disease of the bone
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  17/01/2020
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000057-PIP01-07-M07
• Compliance opinion date:
  30/04/2020
• Compliance outcome:
  Positive

Decision

P/0028/2020: EMA decision of 17 January 2020 on the acceptance of a modification of an agreed paediatric investigation plan for zoledronic acid (Aclasta), (EMEA-000057-PIP01-07-M07)

Adopted Reference Number: EMA/12235/2020