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Where can I access EMA product information and summaries of product characteristics (SmPC) for veterinary ivermectin?
Executive summary
For European veterinary ivermectin product information and SmPCs, the European Medicines Agency (EMA) points users to its own referral and MRL documents on ivermectin and to national medicine registers that host authorised medicines and links to SmPCs (see EMA referral page and national registers) [1] [2]. National databases (for example, the UK electronic medicines compendium) and specialised EMA documents such as Maximum Residue Limit (MRL) summary reports and referral annexes contain product lists, withdrawal-period details and technical SmPC material [3] [4].
1. Where EMA publishes central ivermectin material — referrals and MRL reports
EMA maintains a dedicated ivermectin referral page summarising the Article 35 referral concerning injectable ivermectin in cattle and links to opinions, questions and stakeholder calls; that page is a starting point for central EMA materials on veterinary ivermectin [1]. EMA also issues MRL (maximum residue limit) summary reports and other technical documents that discuss residue limits, withdrawal periods and assessment conclusions relevant to veterinary ivermectin [3] [5].
2. National registers hold the actual SmPCs for authorised veterinary products
EMA’s website explains that national medicine registers in EU/EEA member states contain information on medicines authorised locally — including direct links to summaries of product characteristics (SmPCs) and package leaflets — and that these national registers complement EMA-published information because EMA’s pages only include medicines the agency evaluates itself [2]. In practice, therefore, you should use EMA’s national-registers gateway to jump to the specific country database that hosts the SmPC for a given veterinary ivermectin product [2].
3. Where to find product-level lists and product identities
For lists of specific veterinary ivermectin products, EMA’s referral annexes include detailed product listings (names, strengths, routes, authorisation countries) — useful if you need the manufacturer, formulation or indicated dose for a given brand or national authorisation [4]. Those annexes were produced as part of the Article 35 referral because of concerns such as differing withdrawal periods across Member States [1] [4].
4. Practical route to an SmPC: EMA → national register → product SmPC
Journalistic takeaway: start at EMA’s national-registers page to identify the member state register that covers the product you care about, then open that national register to retrieve the product entry and its SmPC or package leaflet link [2]. If you prefer central EMA material first, check the ivermectin referral page and associated annexes or MRL reports for links or product names you can then look up in national registers [1] [3] [4].
5. Context on why multiple documents matter — residues, withdrawal periods and safety
EMA’s referral and MRL materials exist because national marketing authorisations for injectable ivermectin in cattle were granted under varying procedures and legal bases across Member States; differences in withdrawal periods prompted an Article 35 referral due to potential human-health concerns from residues [1]. MRL summary reports and residue-assessment documents therefore contain the technical residue and withdrawal information that SmPC users (veterinarians, farmers, regulators) often need [3] [5].
6. Alternative sources and related documentation referenced in coverage
Beyond EMA and national registers, product SmPC-style information is routinely published in national formularies and compendia (for example, UK electronic medicines compendium entries for ivermectin tablet SmPCs), and scientific reviews or chromatography/environmental studies cite SmPC guidance when discussing environmental residues or approved uses [6] [7]. Use those national compendia when you need a specific marketed product’s SmPC text [6].
7. Limitations, disagreements and what’s not covered in current reporting
Available sources do not mention a single consolidated “EMA SmPC database” that hosts every veterinary SmPC centrally; instead, EMA points to national registers for authorised product SmPCs [2]. If you want a specific product SmPC and cannot find it through the national register route described by EMA, the sources here do not provide an alternate central repository — you must consult the named national register or national compendium [2] [6].
8. How to proceed right now (practical checklist)
1) Open EMA’s national registers page to identify which country authorised your product; 2) follow the country’s register entry to the product page and download the SmPC or leaflet link; 3) if you need residue/withdrawal guidance or regulatory background, consult EMA’s ivermectin referral page and the MRL summary reports and annexes for technical detail [2] [1] [3].