EMEA-000024-PIP01-07 - paediatric investigation plan

zoledronic acid

Key facts

• Invented name:
  • Zometa
  • Zometa
• Active Substance:
  zoledronic acid
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/32/2008
• PIP number:
  EMEA-000024-PIP01-07
• Pharmaceutical form(s):
  • Powder and solvent for solution for infusion
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  • Osteogenesis imperfecta
  • Prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors
  • Prevention of skeletal related events in patients with advanced malignancies involving bone
  • Tumour-induced hypercalcaemia
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  24/06/2008
• Compliance procedure number:
  EMEA-C-000024-PIP01-07
• Compliance opinion date:
  12/12/2008
• Compliance outcome:
  Positive

Decision

P/32/2008: European medicines agency decision of 24 June 2008 on the application for agreement of a Paediatric Investigation Plan for zoledronic acid (Zometa) EMEA-000024-PIP01-07 in accordance with Regulation (EC) No 19...

AdoptedReference Number: EMEA/310181/2008