Overview
Aftovaxpur DOE has been withdrawn at the request of the marketing authorisation holder.
Aftovaxpur DOE : EPAR - Summary for the public
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Product information
Aftovaxpur DOE : EPAR - Product Information
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Latest procedure affecting product information: IG/1204/G
20/03/2020
Aftovaxpur DOE : EPAR - All Authorised presentations
English (EN) (973.05 KB - PDF)
български (BG) (807.49 KB - PDF)
español (ES) (1.28 MB - PDF)
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lietuvių kalba (LT) (615.74 KB - PDF)
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svenska (SV) (647.06 KB - PDF)
Product details
- Name of medicine
- Aftovaxpur DOE
- Active substance
- Maximum three of the following purified, inactivated foot-and-mouth disease virus strains: O1 Manisa ≥ 6 PD50*; O1 BFS ≥ 6 PD50*; O Taiwan 3/97 ≥ 6 PD50*; A22 Iraq ≥ 6 PD50*; A24 Cruzeiro ≥ 6 PD50*; A Turkey 14/98 ≥ 6 PD50*; Asia 1 Shamir ≥ 6 PD50*; SAT2 Saudi Arabia ≥ 6 PD50*; * PD50 – 50% protective dose in cattle as described in Ph. Eur. monograph 0063.
- International non-proprietary name (INN) or common name
- inactivated vaccine against foot-and-mouth disease
- Species
- Pigs
- Cattle
- Sheep
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QI02AA04
Pharmacotherapeutic group
ImmunologicalsTherapeutic indication
Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.
Authorisation details
- EMA product number
- EMEA/V/C/002292
- Marketing authorisation holder
- Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim am Rhein
Germany - Marketing authorisation issued
- 15/07/2013
- Revision
- 8
Assessment history
Aftovaxpur DOE : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (326.66 KB - PDF)
Aftovaxpur DOE-V-C-2292-II-0009 : EPAR - Assessment Report - Variation
English (EN) (372.92 KB - PDF)
Aftovaxpur DOE-V-C-2292-II-0001 : EPAR - Assessment Report - Variation
English (EN) (388.69 KB - PDF)
CVMP post-authorisation summary of positive opinion for Aftovaxpur DOE
English (EN) (106.9 KB - PDF)
Aftovaxpur DOE : EPAR - Public assessment report
English (EN) (978.05 KB - PDF)
CVMP summary of positive opinion for Aftovaxpur DOE
English (EN) (122.22 KB - PDF)