Tilmovet® 90 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Tilmovet® 90

Active ingredient

Tilmicosin

Application type

ANADA

Sponsor

Huvepharma EOOD

Applications on record

1

First published

November 10, 2018

Adverse event reports

Source: openFDA VeDDRA

495

Reports mentioning this ingredient

February 2, 2007 – March 17, 2026

212

Classified serious

per reporter assessment

49

Lack of expected efficacy

resistance signal

121

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “TILMICOSIN”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Death	120
Accidental exposure	118
Injection site bleeding	38
Injection site swelling	31
Injection site pain	26
Containers, Leaking	25
Bad taste	23
Lack of efficacy - NOS	22
Anaphylaxis	16
Feeling anxious	16
High blood pressure	16
Increased heart rate	15
Dizziness	15
Recumbency	11
Tingling sensation	11
Bottles, Damaged	11
NT - Abnormal necropsy finding NOS	10
Chest discomfort NOS	10
Respiratory tract disorder NOS	9
Localised pain NOS (see other 'SOCs' for specific pain)	9

Species affected

Source: openFDA VeDDRA

Human 195 Cattle 177 Pig 32 Sheep 3 Horse 1 Dog 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient