FOI2026/00677 - Further information on Fipronil and Fipronil Combo products
Published 13 July 2026
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This publication is available at https://www.gov.uk/government/publications/vmd-foieir-requests-april-2026/foi202600677-further-information-on-fipronil-and-fipronil-combo-products
1. Your request
- How many Fipronil and Fipronil Combo products are licenced for the UK at this moment?
- Who are the Marketing Authorisation Holders ( MAH ) for ItchFlea? ( ItchFlea containing Fipronil and Methoprene ). www.itchpet.com ; Chanelle Pharmaceuticals Manufacturing Ltd and who else?
- Can you supply the User Risk Assessments for ItchFlea please.
- Can you supply the pharmacovigilance for ItchFlea for the years 2023, 2024 and 2025 please.
If too voluminous for all MHAs then at least the ones for Chanelle Pharmaceuticals Manufacturing Ltd.
2. Our reply
For requests relating to information about authorised products, I refer you to our response to FOI2026/00235, sent to you on 10/02/2026, which explains how you can access this information on our Product Information Database.
When considering your request for yearly reports about pharmacovigilance, also known as Benefit Risk Review Reports (BRRs) (which superseded Periodic Safety Update Reports (PSURs) in 2024), we are able to release suspected Adverse Event Reports (AERs), as these contain information reported by the public.
However, we are withholding certain other information relevant to post‑authorisation safety monitoring, such as commentary, analysis, and supporting material contained within PSURs and BRRs, and your request for User-Risk Assessments under Section 41(1) of the Freedom of Information Act 2000. This exemption applies because:
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The information was supplied to the VMD by Marketing Authorisation Holders (MAHs) or other third parties and was not created by the VMD.
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It possesses the necessary quality of confidence, as it contains detailed, non‑public technical, scientific, and commercial material provided as part of regulatory submissions.
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There is a reasonable and explicit expectation from MAHs that such information will remain confidential, given its sensitive nature and its role in regulatory oversight.
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Disclosure would be likely to harm the commercial interests of the affected party, undermine trust between regulators and industry, and affect willingness to share essential data with the VMD.
Because these criteria are met, releasing this material would constitute an actionable breach of confidence, and Section 41 therefore applies. As an absolute exemption, no Public Interest Test is required.
Accordingly, the VMD is releasing the adverse event data that can be disclosed, but the interpretive or evaluative content contained within PSURs and BRRs is withheld under Section 41(1).
Our Product Information Database also contains Public Assessment Reports which provides a summary of the scientific assessment carried out when granting a Marketing Authorisation (MA).
The additional information you have requested in response to our clarification request extends beyond the scope of your initial FOI request. If you would like us to consider this further information, please submit it as a separate FOI request and we will be happy to consider it.
We can confirm that there are currently:
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273 products containing fipronil alone or in combination with another active substance currently authorised in Great Britain or in Great Britain and Northern Ireland
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222 products containing fipronil alone or in combination with another active substance currently authorised solely in Northern Ireland.
Itch Flea Spot-on Solution is a range of veterinary medicinal products used for the treatment of cats and dogs against infestations with fleas, alone or in association with ticks and/or biting lice. The product has 2 active ingredients: Fipronil and (S)-Methoprene. There are 5 different strengths: small dogs, medium dogs, large dogs, extra large dogs and cats.
| Product name | Fipronil (mg) | (S)-Methoprene |
|---|---|---|
| (mg) | ||
| ITCH FLEA 67 mg/60.3 mg Spot-on Solution for Small Dogs | 67 | 60.3 |
| ITCH FLEA 134 mg/120.6 mg Spot-on Solution for Medium Dogs | 134 | 120.6 |
| ITCH FLEA 268 mg/241.2 mg Spot-on Solution for Large Dogs | 268 | 241.2 |
| ITCH FLEA 402 mg/361.8 mg Spot-on Solution for Extra Large Dogs | 402 | 361.8 |
| ITCH FLEA 50 mg/60 mg Spot-on Solution for Cats | 50 | 60 |
Please be aware that the data we have provided below are not subject to independent verification and the Veterinary Medicines Directorate (VMD) does not guarantee their accuracy.
We have included all adverse event reports. This includes reports where more than one product was used (including events which may have occurred before one or more products were administered), reports when the product was used off-label, that is using a medicine in a way that is not specified on the product’s label, or reports where, on further evaluation, there may have been other reasons for the adverse event occurring. Evaluation is dependent on the accuracy and quality of data received from veterinary professionals and animal owners, and reporting frequency can vary over time (reporting frequency may be affected by a product being new to the market or social media interest, for example).
The number of adverse events alone cannot be used to determine the likelihood of an event occurring. This is because the numbers need to be put into context considering other factors such as differing sales volumes.
We are able to provide the number of adverse event reports for all strengths of Itch Flea Spot-on Solution coded to Preferred Term (PT) level as per VeDDRA (VeDDRA (Veterinary Dictionary for Drug Regulatory Activities)) for the years 2023, 2024 and 2025.
All adverse events submitted to the VMD directly or from Marketing Authorisation Holders have their clinical signs coded using this standardised approach. Specifics of adverse events submitted are provided within a narrative section of the submission and the codes used may not exactly correlate verbatim with the detail provided in the narrative. Further information regarding VeDDRA can be located on the European Medicines Agency website, including the VeDDRA list of clinical terms for reporting suspected adverse events and the Guidance notes on the use of VeDDRA terminology.
Please note that no adverse events have been received involving people who have had contact with the products or animals treated with these products.
| Preferred Term | 2023 | 2024 | 2025 |
|---|---|---|---|
| Application site hair change | 23 | 38 | 19 |
| Application site lesion | 20 | 21 | 8 |
| Application site erythema | 14 | 21 | 5 |
| Behavioural disorder NOS | 8 | 7 | 3 |
| Application site pruritus | 7 | 5 | 4 |
| Lethargy | 6 | 3 | 4 |
| Pruritus | 6 | 3 | 2 |
| Anxiety | 5 | 4 | 2 |
| Vocalisation | 5 | 0 | 1 |
| Hyperactivity | 4 | 2 | 0 |
| Anorexia | 4 | 1 | 3 |
| Emesis | 4 | 3 | 2 |
| Discomfort NOS | 4 | 2 | 1 |
| Application site haemorrhage | 3 | 3 | 1 |
| Diarrhoea | 3 | 0 | 2 |
| Skin disorders NOS | 3 | 5 | 0 |
| Application site serosanguinous discharge | 3 | 3 | 0 |
| Hypersalivation | 3 | 5 | 0 |
| Alopecia | 2 | 6 | 2 |
| Tachypnoea | 2 | 2 | 0 |
| Application site reaction NOS | 2 | 9 | 4 |
| Convulsion | 2 | 0 | 0 |
| Urticaria | 2 | 1 | 0 |
| Malaise | 2 | 1 | 1 |
| Application site mucopurulent discharge | 2 | 2 | 0 |
| Periorbital oedema | 1 | 0 | 0 |
| Aggression | 1 | 1 | 1 |
| Application site pain | 1 | 1 | 1 |
| Dyspepsia | 1 | 0 | 0 |
| Musculoskeletal disorder NOS | 1 | 0 | 0 |
| Application site burn | 1 | 5 | 1 |
| Rhinitis | 1 | 0 | 0 |
| Erythema | 1 | 3 | 1 |
| Somnolence | 1 | 1 | 0 |
| Eye redness | 1 | 0 | 0 |
| Abnormal reflex test | 1 | 0 | 0 |
| General pain | 1 | 0 | 0 |
| Paralysis | 1 | 0 | 0 |
| Weight loss | 1 | 0 | 0 |
| Blepharospasm | 1 | 0 | 0 |
| Allergic oedema | 1 | 0 | 0 |
| Self-mutilation | 1 | 0 | 0 |
| Application site skin change | 1 | 4 | 1 |
| Skin oedema | 1 | 0 | 0 |
| Impaired consciousness | 1 | 0 | 0 |
| Cranial nerve disorder | 1 | 0 | 0 |
| Inappropriate defecation | 1 | 0 | 0 |
| Adipsia | 1 | 0 | 1 |
| Ataxia | 1 | 2 | 0 |
| Application site blister | 1 | 2 | 1 |
| Grooming disorder | 1 | 1 | 0 |
| Lack of efficacy | 0 | 2 | 0 |
| Application site inflammation | 0 | 2 | 1 |
| Application site self trauma | 0 | 1 | 0 |
| Muscle weakness | 0 | 1 | 0 |
| Disorientation | 0 | 1 | 0 |
| Nystagmus | 0 | 1 | 0 |
| Eye irritation | 0 | 1 | 0 |
| Mydriasis | 0 | 1 | 0 |
| Application site mass NOS | 0 | 1 | 0 |
| Pinnal irritation | 0 | 1 | 0 |
| Hypersensitivity reaction | 0 | 1 | 0 |
| Involuntary defecation | 0 | 1 | 0 |
| Stomatitis | 0 | 1 | 0 |
| Bradycardia | 0 | 1 | 0 |
| Trauma NOS | 0 | 1 | 0 |
| Death | 0 | 1 | 0 |
| Difficulty eating NOS | 0 | 1 | 0 |
| Application site discharge NOS | 0 | 0 | 2 |
| Tremor | 0 | 0 | 1 |
| Intestinal stasis | 0 | 0 | 1 |
| Grand total | 165 | 186 | 76 |