FOI release

Information on Variations for Product Lentus

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 FOI2026/00865

Received 6 August 2026

Published 18 September 2026

Request

Dear Madam or Sir, I would like to request the following information under the Freedom of Information Act (FOIA): Could you please kindly provide me with the information on whether the variations presented in the attached document have been approved by the MHRA for the following drug products: Lantus 100 units/ml solution for injection in a vial (PLGB 04425/0814) Lantus 100 units/ml solution for injection in a cartridge (PLGB 04425/0815) Lantus SoloStar 100 units/ml solution for injection in a prefilled pen (PLGB 04425/0816) MAH of the drug products is Aventis Pharma Limited (trading as Sanofi). The approval dates for EU drug product Lantus (EMEA/H/C/000284) from the EMA homepage are provided to give an approximative understanding of the timelines.

Response

See attached

Documents

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