BTVPUR AlSap 1

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Withdrawn

This medicine's authorisation has been withdrawn

bluetongue-virus serotype-1 antigen
MedicineVeterinaryWithdrawn

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

The marketing authorisation for BTVPUR AlSap 1 has been withdrawn at the request of the marketing-authorisation holder.

BTVPUR AlSap 1 : EPAR - Summary for the public

Reference Number: EMA/CVMP/622300/2010

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română (RO) (264.84 KB - PDF)

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Product information

BTVPUR AlSap 1 : EPAR - Product Information

Reference Number: EMA/CVMP/622300/2010

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български (BG) (1.59 MB - PDF)

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español (ES) (959.08 KB - PDF)

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čeština (CS) (1.31 MB - PDF)

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dansk (DA) (976.46 KB - PDF)

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Latest procedure affecting product information:R/0005
08/09/2015

BTVPUR AlSap 1 : EPAR - All Authorised presentations

Reference Number: EMA/CVMP/622300/2010

English (EN) (165.08 KB - PDF)

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български (BG) (237.24 KB - PDF)

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español (ES) (179.61 KB - PDF)

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čeština (CS) (214.8 KB - PDF)

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dansk (DA) (168.71 KB - PDF)

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Deutsch (DE) (181.32 KB - PDF)

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eesti (ET) (216.18 KB - PDF)

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ελληνικά (EL) (224.9 KB - PDF)

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français (FR) (168.45 KB - PDF)

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hrvatski (HR) (203.36 KB - PDF)

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italiano (IT) (166.05 KB - PDF)

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latviešu (LV) (222.44 KB - PDF)

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lietuvių (LT) (215.2 KB - PDF)

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magyar (HU) (208.44 KB - PDF)

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Malti (MT) (226.37 KB - PDF)

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Nederlands (NL) (169.29 KB - PDF)

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polski (PL) (215.44 KB - PDF)

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português (PT) (180.94 KB - PDF)

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română (RO) (212.26 KB - PDF)

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slovenčina (SK) (211.23 KB - PDF)

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slovenščina (SL) (210.68 KB - PDF)

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suomi (FI) (168.59 KB - PDF)

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svenska (SV) (168.12 KB - PDF)

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Íslenska (IS) (171.81 KB - PDF)

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norsk (NO) (166.89 KB - PDF)

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Product details

Name of medicine
BTVPUR AlSap 1
Active substance
bluetongue-virus serotype-1 antigen
International non-proprietary name (INN) or common name
bluetongue-virus serotype-1 antigen
Species
  • Sheep
  • Cattle
Anatomical therapeutic chemical veterinary (ATCvet) code
QI04AA02

Pharmacotherapeutic group

Immunologicals

Therapeutic indication

Active immunisation of sheep and cattle to prevent viraemia and to reduce clinical signs caused by bluetongue virus serotype 1.

Onset of immunity has been demonstrated three weeks after the primary vaccination course. The duration of immunity for cattle and sheep is one year after the primary vaccination course.

Authorisation details

EMA product number
EMEA/V/C/002230
Marketing authorisation holder
Merial

29 Avenue Tony Garnier
69007 Lyon
France

Marketing authorisation issued
17/12/2010
Revision
4

Assessment history

BTVPUR AlSap 1 : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (202.88 KB - PDF)

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BTVPUR AlSap 1-V-C-2230-S-02 : EPAR - Assessment Report - Annual re-assessment

Adopted Reference Number: EMA/136739/2013

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BTVPUR AlSap 1 : EPAR - Scientific Discussion

Reference Number: EMA/CVMP/622300/2010

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CVMP summary of positive opinion for BTVPUR AlSap 1

Adopted Reference Number: EMA/CVMP/343642/2010

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