FOI release

Request for Risk Management Plan for PLPI Product-SEVIKAR

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 FOI2026/00809

Received 22 July 2026

Published 9 September 2026

Request

OPD Laboratories Limited has decided to maintain the following Product Licence of Parallel Import (PLPI) as an active licence, despite the corresponding UK reference marketing authorisation having been cancelled: * PLPI 15814/2087 - SEVIKAR(r) 20 mg/5 mg film-coated tablets OPD Laboratories Limited will continue to fulfil all pharmacovigilance obligations for this PLPI in accordance with the current UK pharmacovigilance requirements and intends to continue marketing the product in the UK. We would be grateful if you could provide a copy of the Risk Management Plan (RMP) and/or details of any additional risk minimisation measures that were applicable to the cancelled UK reference marketing authorisation PL 08265/0026, for our reference and to support our ongoing pharmacovigilance activities.

Response

See attached

Documents

• FOI2026_00809 (redacted).pdf (611.4 KB)
• Sevikar risk-management-system_redacted.pdf (4.3 MB)

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