EMEA-000145-PIP01-07-M09

Adopted

First published: 07/06/2018
Last updated: 07/06/2018
EMA/107500/2018

Invented name	Prolia Xgeva Xgeva; Prolia
Active substance	denosumab
Therapeutic area	Endocrinology-Gynaecology-Fertility-Metabolism
Decision number	P/0098/2018
PIP number	EMEA-000145-PIP01-07-M09
Pharmaceutical form(s)	Solution for injection
Condition(s) / indication(s)	Prevention of skeletal related events in patients with bone metastases Treatment of bone loss associated with sex hormone ablative therapy Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis) Treatment of giant cell tumour of bone Treatment of hypercalcemia of malignancy
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
Compliance procedure number	EMEA-C-000145-PIP01-07-M09
Compliance opinion date	01/03/2019
Compliance outcome	positive