EMEA-001689-PIP01-14 - paediatric investigation plan

zoledronic acid monohydrate

Key facts

• Active Substance:
  zoledronic acid monohydrate
• Therapeutic area:
  Oncology
• Decision number:
  P/0324/2014
• PIP number:
  EMEA-001689-PIP01-14
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of skeletal related events in patients with advanced malignancies involving bone
• Route(s) of administration:
  Intravenous 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:
  19/12/2014

Decision

P/0324/2014: EMA decision of 19 December 2014 on the granting of a product specific waiver for zoledronic acid (monohydrate) (in combination with calcium (carbonate) / cholecalciferol) (EMEA-001689-PIP01-14)

AdoptedReference Number: EMA/759442/2014