What the EU Approves for Animals: 301 Centrally Authorised Veterinary Medicines Analyzed
Analysis of 301 EMA-authorised veterinary medicines: 39% are vaccines, antiparasitics and NSAIDs dominate pharmaceuticals, food-animal species lead, and 2024–2025 set consecutive approval records.
The European Medicines Agency (EMA) maintains a public register of every veterinary medicine authorised through the EU centralised procedure — the pathway that grants a marketing authorisation valid across all EU and EEA member states. These are the products that meet the highest evidence bar in European veterinary regulation.
This article analyzes 301 centrally authorised veterinary medicines in the EMA register (data extract: May 2026) to show what Europe approves for animals, how that mix is changing, and what the trend says about veterinary pharmaceutical innovation. Every number below is computed directly from the EMA veterinary medicines dataset (analysis run date: 2026-06-10).
Three things these numbers do not mean
Before the data, three important caveats:
- Centralised authorisations are a subset. The centralised procedure is mandatory for biotech-derived medicines and optional for others (though many vaccine manufacturers choose it for food-producing animals because a single EU-wide authorisation simplifies cross-border distribution). Many veterinary medicines in Europe are authorised nationally and never appear in this dataset.
- Product count does not equal market size. A single authorisation may cover multiple formulations, and a product with ten authorisations is not necessarily more widely used than one with a single entry.
- Date of first publication is a proxy, not exact. We use the EMA "first published" date as the closest available proxy for when a product entered the register. Actual marketing may have begun earlier or later.
Vaccines versus pharmaceuticals
The most striking split in the data is between two fundamentally different product classes:
| Class | Count | Share |
|---|---|---|
| Vaccines and immunologicals | 118 | 39.2% |
| Non-vaccine pharmaceuticals | 183 | 60.8% |
Nearly four in ten centrally authorised veterinary products are vaccines, bacterins, or other immunologicals. This is not surprising — the EU centralised procedure is the primary route for veterinary vaccines, particularly those for food-producing animals where cross-border trade makes harmonised authorisation essential.
What species the vaccines target
Among the 118 authorised vaccines, food-producing animal species dominate:
| Target species | Vaccines | Share |
|---|---|---|
| Avian / poultry | 39 | 33.1% |
| Swine | 22 | 18.6% |
| Cattle | 19 | 16.1% |
| Other / multi-species | 18 | 15.3% |
| Cats | 8 | 6.8% |
| Dogs | 6 | 5.1% |
| Horses | 5 | 4.2% |
| Sheep | 1 | 0.8% |
Avian vaccines alone account for one-third of all authorised immunologicals. The poultry sector's scale, rapid population turnover, and vulnerability to high-consequence diseases (avian influenza, Newcastle disease, infectious bursal disease) drive continuous vaccine demand. Swine and cattle vaccines together add another 35%.
Companion animals — dogs and cats — together represent only about 12% of authorised vaccines. This reflects both the smaller market size relative to livestock and the fact that many companion-animal vaccines are authorised nationally rather than centrally.
The pharmaceutical landscape
Among the 183 non-vaccine pharmaceuticals, antiparasitics and anti-inflammatories lead:
| Therapeutic class | Products | Share |
|---|---|---|
| Antiparasitics (ectoparasiticides, endectocides, anthelmintics) | 30 | 16.4% |
| Anti-inflammatories (NSAIDs, oxicams) | 21 | 11.5% |
| Corticosteroids | 15 | 8.2% |
| Anti-infectives (antibiotics) | 15 | 8.2% |
| Anesthetics and analgesics | 5 | 2.7% |
| GI and metabolism | 6 | 3.3% |
| Blood and hematopoietics | 4 | 2.2% |
| Otology | 1 | 0.5% |
| Other / unclassified | 86 | 47.0% |
The "other" category is large because many products have pharmacotherapeutic group descriptions that do not map cleanly to a single therapeutic class — combination products, novel modalities (monoclonal antibodies like bedinvetmab and izenivetmab for osteoarthritis pain), and products with multiple indications.
Top active substances (non-vaccine)
| Active substance | Authorised products |
|---|---|
| Meloxicam | 16 |
| Tulathromycin | 8 |
| Fluralaner | 6 |
| Lotilaner | 5 |
| Firocoxib | 5 |
| Moxidectin | 5 |
| Praziquantel | 5 |
| Hydrocortisone aceponate | 5 |
Meloxicam leads with 16 authorised products — a reflection of its long patent history, broad species coverage (dogs, cats, cattle, horses), and multiple generic entrants. The isoxazoline class (fluralaner, lotilaner) shows strong representation, reflecting the EU's centralised approval pathway for parasiticides targeting cross-border markets.
Who holds the authorisations
Marketing authorisation holder (MAH) data in the centralised register is partially populated — only 75 of 388 total records carry a named MAH. Among those that do, concentration is high:
| MAH | Authorised products (including withdrawn) |
|---|---|
| Intervet International BV (Merck Animal Health) | 13 |
| Merial (now part of Boehringer Ingelheim) | 7 |
| Zoetis Belgium SA | 6 |
| Pfizer Limited (legacy Zoetis) | 6 |
| Eli Lilly and Company (legacy Elanco) | 3 |
| Others (22 companies) | 22 |
The top four holders — representing Merck/MSD Animal Health, Boehringer Ingelheim, and Zoetis — account for approximately 69% of named authorisations. This mirrors the broader concentration in the global animal health industry, where the top ten companies control a majority of the market.
The approval trend
The most important trend in the data is the acceleration of centralised veterinary authorisations:
| Year | New authorisations | Vaccines | Pharmaceuticals |
|---|---|---|---|
| 2013 | 4 | 1 | 3 |
| 2014 | 10 | 7 | 3 |
| 2015 | 12 | 5 | 7 |
| 2016 | 25 | 6 | 19 |
| 2017 | 62 | 26 | 36 |
| 2018 | 55 | 13 | 42 |
| 2019 | 14 | 5 | 9 |
| 2020 | 13 | 3 | 10 |
| 2021 | 21 | 9 | 12 |
| 2022 | 4 | 1 | 3 |
| 2023 | 9 | 4 | 5 |
| 2024 | 37 | 20 | 17 |
| 2025 | 30 | 16 | 14 |
| 2026 (partial) | 4 | 2 | 2 |
Two observations stand out:
2017 was a watershed year. The peak of 62 new authorisations coincides with the transition period ahead of the new Veterinary Medicines Regulation (Regulation EU 2019/6), which took effect in January 2022. Many companies submitted applications before the regulatory framework changed.
2024–2025 set consecutive records. EMA confirmed that 2024 saw 25 new recommendations (the highest ever at the time) and 2025 raised that to 30 — the second consecutive record year. EMA attributes this to sustained innovation and the positive impact of the Veterinary Medicines Regulation in fostering product development. The vaccine share is notable: 16 of the 30 recommendations in 2025 were vaccines, including seven authorised under exceptional circumstances for animal health emergencies (avian influenza, bluetongue, epizootic hemorrhagic disease).
Withdrawn products
The register also records 56 products that have been withdrawn, expired, lapsed, or had authorisation revoked. Withdrawal does not necessarily indicate a safety problem — products may be withdrawn for commercial reasons, superseded by improved formulations, or consolidated under a different legal entity. The rate of withdrawal is a normal feature of any mature pharmaceutical market.
What this means for veterinary practice
Several patterns in the data are practically relevant:
The vaccine pipeline for livestock is active. Avian influenza, bluetongue, African swine fever, and epizootic hemorrhagic disease are driving vaccine innovation, with conditional and emergency authorisations becoming more common. Veterinarians in food-animal practice should expect continued introductions.
Companion-animal pharmaceuticals are diversifying. The arrival of monoclonal antibodies (bedinvetmab, izenivetmab, relfovetmab for OA pain), new isoxazoline combinations, and novel antiemetics reflects a market where pet-owner willingness to pay for chronic-disease management is pulling new molecular entities into veterinary medicine.
Generic competition is growing. Meloxicam's 16 products, multiple firocoxib entrants, and the spread of isoxazoline generics mean veterinarians have increasing choice — and need to evaluate whether a newer product's marginal benefit justifies its price premium over established generics.
Sources
- European Medicines Agency (EMA). Veterinary medicines data — centrally authorised products. https://www.ema.europa.eu/en/medicines/veterinary
- EMA. "Veterinary medicines in 2025." January 2026. https://www.ema.europa.eu/en/news/veterinary-medicines-2025
- EMA. "Veterinary medicines in 2024." January 2025. https://www.ema.europa.eu/en/news/veterinary-medicines-2024
- EMA. Marketing authorisation for veterinary medicines — overview. https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines
- Regulation (EU) 2019/6 on veterinary medicinal products. https://eur-lex.europa.eu/eli/reg/2019/6/oj
- FDA Center for Veterinary Medicine. How FDA's animal drug regulation compares internationally. https://www.fda.gov/animal-veterinary
