FOI release

Request for documents related to XGEVA 120mg PFS, PLGB 13832/0091

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2025/00101

Received 6 February 2025

Published 25 April 2025

Request

We would like to request the following documents related to XGEVA 120 mg solution for injection in pre-filled syringe (PLGB 13832/0091) approved by MHRA under the International Recognition Procedure. 1) Assessment report of reference regulator EMA for this product under the procedure number EMEA/H/C/002173/II/0082/G. 2) Clinical study report [including all its appendix(ces)] of clinical study conducted by the Sponsor/Applicant to support assessment and approval of XGEVA 120 mg/mL solution for injection in pre-filled syringe.

Response

see attached

Documents

• FOI2025_00101 redacted for publication.pdf (185.8 KB)

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