FOI release
UK Ivermectin Tablet Authorisations and Reference Medicinal Products
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 FOI2026/00986
Received 2 September 2026
Published 9 October 2026
Request
I request the following recorded information under the Freedom of Information Act 2000 concerning oral ivermectin tablets for human use. 1. Historical UK authorisations Please provide details of any UK marketing authorisation (MA) or historic product licence for oral ivermectin tablets granted before PL 23218/0227 on 11 April 2023, including: * product name and strength; * licence number and holder; * date and legal basis of authorisation; and * current status or date of withdrawal. Please specifically confirm whether Stromectol 3 mg Tablets, Mectizan or any other oral ivermectin tablet was ever authorised in the UK before 11 April 2023. 2. Current UK reference medicinal product Please provide any record held by MHRA identifying a UK-authorised ivermectin 3 mg tablet currently eligible to be cited as the reference medicinal product (RMP) for a new UK-wide generic application under Regulation 51B. If MHRA does not designate or maintain a list of such products, please confirm whether MHRA records identify any currently eligible UK RMP for ivermectin 3 mg tablets. For each currently authorised generic or hybrid ivermectin tablet, please also provide: * the legal basis of the application; * the RMP cited; * its MA number, holder, country or UK territory and initial authorisation date; and * the identity and authorised market from which the bioequivalence (BE) comparator was sourced. Please distinguish between the legal RMP and the comparator used in the BE study. 3. PL 40546/0266 and PL 40546/0267 The published SmPCs identify the following products, held by Aristo Pharma GmbH, as first authorised on 5 August 2026: * Ivermectin 3 mg Tablets - PL 40546/0266; and * Ivermectin 6 mg Tablets - PL 40546/0267. For each product, please provide: * the legal basis and application type; * the regulatory procedure or assessment route; * the original submission and validation dates; * whether any transitional arrangements relating to applications submitted by 31 December 2024 applied; * the cited RMP and BE comparator, if it was a generic or hybrid application; * whether it was an informed-consent or duplicate application and, if so, the product name and PL number of the source or parent authorisation; and * whether the 6 mg strength was supported by a separate BE study or an additional-strength biowaiver. Please also provide the Public Assessment Reports for these two authorisations or confirm when they are expected to be published. I am not requesting commercially confidential dossier contents. Where information is withheld, please provide the remaining non-exempt information and identify the applicable exemption. If necessary to remain within the cost limit, please prioritise section 3, followed by confirmation of whether any oral ivermectin tablet was authorised in the UK before 11 April 2023.
Response
See attached
Documents
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