FOI release

Pharmacovigilance activities for Levocarnitine Paediatric 30% Orla Solution

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 FOI2026/00808

Received 22 July 2026

Published 9 September 2026

Request

Following the recent MHRA communication regarding PLPI licences, we understand that a Risk Management Plan (RMP) is available for Levocarnitine Paediatric 30% Oral Solution (PL 48053/0005), as referenced in the attached document, "List of Cancelled UK MAs Cross-Referenced to a PLPI Licence & RMP - July 2026 v2." As the holder of the corresponding PLPI licence, OPD Laboratories Limited would be grateful if you could provide a copy of the RMP for PL 48053/0005 - Levocarnitine Paediatric 30% Oral Solution for our reference and to support our ongoing pharmacovigilance activities.

Response

See attached

Documents

• FOI2026_00808 (redacted).pdf (595.0 KB)
• L-carnitine_RMP_2_23Oct2017_Redacted.pdf (1.1 MB)

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