Gumbohatch

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Authorised

This medicine is authorised for use in the European Union

avian infectious bursal disease vaccine (live)
Medicine Veterinary Authorised
  • Application under evaluation
  • CVMP opinion
  • European Commission decision

Overview

Up-to-date information on this veterinary medicinal product is available on the Veterinary Medicines Information website

Gumbohatch : EPAR - Medicine overview

Reference Number: EMA/494045/2019

English (EN) (81.94 KB - PDF)

First published: Last updated:
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български (BG) (93.36 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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español (ES) (81.97 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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čeština (CS) (93.99 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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dansk (DA) (83.34 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Deutsch (DE) (82.76 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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eesti keel (ET) (82.18 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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ελληνικά (EL) (93.76 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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français (FR) (82.44 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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hrvatski (HR) (92.27 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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íslenska (IS) (83.29 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Gaeilge (GA) (83.57 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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italiano (IT) (82.29 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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latviešu valoda (LV) (94.29 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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lietuvių kalba (LT) (94.03 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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magyar (HU) (94.15 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Malti (MT) (95.95 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Nederlands (NL) (82.05 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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norsk (NO) (82 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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polski (PL) (95.62 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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português (PT) (83.01 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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română (RO) (94.17 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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slovenčina (SK) (94.08 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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slovenščina (SL) (82.27 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Suomi (FI) (81.54 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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svenska (SV) (82.05 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Product information

Gumbohatch : EPAR - Product information

English (EN) (81.49 KB - PDF)

First published: Last updated:
View

български (BG) (91.78 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

español (ES) (81.51 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

čeština (CS) (92.48 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

dansk (DA) (82.05 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Deutsch (DE) (81.72 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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eesti keel (ET) (81.22 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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ελληνικά (EL) (91.79 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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français (FR) (81.63 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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hrvatski (HR) (91.56 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

íslenska (IS) (81.52 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Gaeilge (GA) (81.36 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

italiano (IT) (81.76 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

latviešu valoda (LV) (92.14 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

lietuvių kalba (LT) (92.19 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

magyar (HU) (92.76 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Malti (MT) (93.86 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Nederlands (NL) (81.15 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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norsk (NO) (81.52 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

polski (PL) (93.22 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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português (PT) (82.53 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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română (RO) (91.73 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

slovenčina (SK) (81.75 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

slovenščina (SL) (81.76 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Suomi (FI) (81.11 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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svenska (SV) (81.47 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
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Gumbohatch : EPAR - All authorised presentations

English (EN) (81.94 KB - PDF)

First published: Last updated:
View

български (BG) (93.36 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

español (ES) (81.97 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

čeština (CS) (93.99 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

dansk (DA) (83.34 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Deutsch (DE) (82.76 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

eesti keel (ET) (82.18 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

ελληνικά (EL) (93.76 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

français (FR) (82.44 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

hrvatski (HR) (92.27 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

íslenska (IS) (83.29 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Gaeilge (GA) (83.57 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

italiano (IT) (82.29 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

latviešu valoda (LV) (94.29 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

lietuvių kalba (LT) (94.03 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

magyar (HU) (94.15 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Malti (MT) (95.95 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Nederlands (NL) (82.05 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

norsk (NO) (82 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

polski (PL) (95.62 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

português (PT) (83.01 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

română (RO) (94.17 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

slovenčina (SK) (94.08 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

slovenščina (SL) (82.27 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Suomi (FI) (81.54 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

svenska (SV) (82.05 KB - PDF)

First published: 10/12/2019 Last updated: 15/02/2024
View

Product details

Name of medicine
Gumbohatch
Active substance
live attenuated infectious bursal disease virus (IBDV), strain 1052
International non-proprietary name (INN) or common name
avian infectious bursal disease vaccine (live)

Pharmacotherapeutic group

  • Immunologicals for aves
  • Domestic fowl
  • Live viral vaccines
  • avian infectious bursal disease virus (gumboro disease)

Authorisation details

EMA product number
EMEA/V/C/004967

Assessment history

Gumbohatch : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (81.94 KB - PDF)

First published: Last updated:
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CVMP post-authorisation summary of positive opinion for Gumbohatch (VRA-0009)

Adopted Reference Number: EMA/CVMP/163699/2023

English (EN) (137.67 KB - PDF)

First published:
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Gumbohatch : EPAR - Public assessment report

Adopted Reference Number: EMA/507480/2019

English (EN) (81.49 KB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Gumbohatch

Adopted Reference Number: EMA/CVMP/472052/2019

English (EN) (135.56 KB - PDF)

First published:
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