Innovax-ND-IBD

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Authorised

This medicine is authorised for use in the European Union

Newcastle disease / infectious bursal disease / Marek's disease vaccine (live recombinant)
MedicineVeterinaryAuthorised

Romanian is available via eTranslation, the European Commission's machine translation service.

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  • 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.

Innovax-ND-IBD : EPAR - Medicine overview

Reference Number: EMA/391280/2017

English (EN) (81.94 KB - PDF)

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български (BG) (93.36 KB - PDF)

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Deutsch (DE) (82.76 KB - PDF)

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eesti (ET) (82.18 KB - PDF)

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magyar (HU) (94.15 KB - PDF)

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Malti (MT) (95.95 KB - PDF)

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Nederlands (NL) (82.05 KB - PDF)

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polski (PL) (95.62 KB - PDF)

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português (PT) (83.01 KB - PDF)

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română (RO) (94.17 KB - PDF)

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slovenčina (SK) (94.08 KB - PDF)

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slovenščina (SL) (82.27 KB - PDF)

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suomi (FI) (81.54 KB - PDF)

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svenska (SV) (82.05 KB - PDF)

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Íslenska (IS) (83.29 KB - PDF)

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norsk (NO) (82 KB - PDF)

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Product information

Innovax-ND-IBD : EPAR - Product Information

English (EN) (81.49 KB - PDF)

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български (BG) (91.78 KB - PDF)

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español (ES) (81.51 KB - PDF)

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čeština (CS) (92.48 KB - PDF)

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dansk (DA) (82.05 KB - PDF)

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Deutsch (DE) (81.72 KB - PDF)

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eesti (ET) (81.22 KB - PDF)

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ελληνικά (EL) (91.79 KB - PDF)

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français (FR) (81.63 KB - PDF)

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Gaeilge (GA) (81.36 KB - PDF)

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hrvatski (HR) (91.56 KB - PDF)

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italiano (IT) (81.76 KB - PDF)

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latviešu (LV) (92.14 KB - PDF)

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lietuvių (LT) (92.19 KB - PDF)

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magyar (HU) (92.76 KB - PDF)

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Malti (MT) (93.86 KB - PDF)

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Nederlands (NL) (81.15 KB - PDF)

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polski (PL) (93.22 KB - PDF)

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português (PT) (82.53 KB - PDF)

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română (RO) (91.73 KB - PDF)

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slovenčina (SK) (81.75 KB - PDF)

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slovenščina (SL) (81.76 KB - PDF)

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suomi (FI) (81.11 KB - PDF)

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svenska (SV) (81.47 KB - PDF)

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Íslenska (IS) (81.52 KB - PDF)

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norsk (NO) (81.52 KB - PDF)

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Latest procedure affecting product information:WS2102/G

Innovax-ND-IBD : EPAR - All Authorised presentations

English (EN) (81.94 KB - PDF)

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български (BG) (93.36 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

español (ES) (81.97 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

čeština (CS) (93.99 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

dansk (DA) (83.34 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

Deutsch (DE) (82.76 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

eesti (ET) (82.18 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

ελληνικά (EL) (93.76 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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français (FR) (82.44 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

Gaeilge (GA) (83.57 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

hrvatski (HR) (92.27 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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italiano (IT) (82.29 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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latviešu (LV) (94.29 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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lietuvių (LT) (94.03 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

magyar (HU) (94.15 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
Vizualizare

Malti (MT) (95.95 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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Nederlands (NL) (82.05 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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polski (PL) (95.62 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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português (PT) (83.01 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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română (RO) (94.17 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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slovenčina (SK) (94.08 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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slovenščina (SL) (82.27 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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suomi (FI) (81.54 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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svenska (SV) (82.05 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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Íslenska (IS) (83.29 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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norsk (NO) (82 KB - PDF)

Prima publicare: 21/09/2017 Cea mai recent: 04/11/2021
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Product details

Name of medicine
Innovax-ND-IBD
Active substance
cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of ND virus and the VP2 protein of IBD virus
International non-proprietary name (INN) or common name
  • Newcastle disease
  • infectious bursal disease
  • Marek's disease vaccine (live recombinant)

Pharmacotherapeutic group

  • Immunologicals for aves
  • Domestic fowl
  • Live viral vaccines

Authorisation details

EMA product number
EMEA/V/C/004422

Assessment history

Innovax-ND-IBD : EPAR - Procedural steps taken and scientific information after the authorisation

English (EN) (81.94 KB - PDF)

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Innovax-ND-IBD-V-C-4422-II-0004 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/193705/2019

English (EN) (81.49 KB - PDF)

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CVMP post-authorisation summary of positive opinion for Innovax-ND-IBD (II/0004)

Adopted Reference Number: EMA/CVMP/507630/2020

English (EN) (129.06 KB - PDF)

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Innovax-ND-IBD-V-C-4422-X-0001 : EPAR - Assessment report - Extension

Adopted Reference Number: EMA/193705/2019

English (EN) (81.49 KB - PDF)

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CVMP post-authorisation summary of positive opinion for Innovax-ND-IBD (X-001)

Adopted Reference Number: EMA/CVMP/153784/201

English (EN) (68.25 KB - PDF)

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Innovax-ND-IBD : EPAR - Public assessment report

Reference Number: EMA/377164/2017

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CVMP summary of positive opinion for Innovax-ND-IBD

Adopted Reference Number: EMA/CVMP/290079/2017

English (EN) (68.61 KB - PDF)

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