EMEA-000145-PIP01-07-M09

Key facts

Invented name
  • Prolia
  • Xgeva
  • Xgeva; Prolia
Active substance
denosumab
Therapeutic area
Endocrinology, -gynacology-fertility-metabolism
Decision number
P/0098/2018
PIP number
EMEA-000145-PIP01-07-M09
Pharmaceutical form(s)
Solution for injection
Condition(s) / indication(s)
  • Treatment of hypercalcemia of malignancy
  • Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
  • Treatment of giant cell tumour of bone
  • Prevention of skeletal related events in patients with bone metastases
  • Treatment of bone loss associated with sex hormone ablative therapy
Route(s) of administration
Subcutaneous use
Contact for public enquiries
Amgen Europe B.V.
Tel. +44 (0)1223 420305
E-mail: pipenquiry@amgen.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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