Overview

The marketing authorisation for Alpivab has been withdrawn at the request of the marketing-authorisation holder.

Alpivab : EPAR - Medicine overview

Reference Number: EMEA/H/C/004299

English (EN) (650.2 KB - PDF)

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български (BG) (1.27 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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español (ES) (1.2 MB - PDF)

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čeština (CS) (1.26 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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dansk (DA) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Deutsch (DE) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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eesti keel (ET) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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ελληνικά (EL) (1.28 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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français (FR) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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hrvatski (HR) (1.22 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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italiano (IT) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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latviešu valoda (LV) (1.26 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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lietuvių kalba (LT) (1.22 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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magyar (HU) (1.25 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Malti (MT) (1.26 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Nederlands (NL) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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polski (PL) (1.25 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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português (PT) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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română (RO) (1.22 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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slovenčina (SK) (1.26 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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slovenščina (SL) (1.25 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Suomi (FI) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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svenska (SV) (1.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Product information

Alpivab : EPAR - Product Information

English (EN) (1.57 MB - PDF)

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български (BG) (3.2 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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español (ES) (2.3 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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čeština (CS) (2.77 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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dansk (DA) (2.25 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Deutsch (DE) (2.3 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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eesti keel (ET) (2.23 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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ελληνικά (EL) (3.21 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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français (FR) (2.29 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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hrvatski (HR) (2.31 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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íslenska (IS) (2.25 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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italiano (IT) (2.28 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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latviešu valoda (LV) (2.89 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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lietuvių kalba (LT) (2.37 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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magyar (HU) (2.75 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Malti (MT) (2.78 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Nederlands (NL) (2.27 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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norsk (NO) (2.24 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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polski (PL) (2.84 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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português (PT) (2.28 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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română (RO) (2.4 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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slovenčina (SK) (2.76 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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slovenščina (SL) (2.71 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Suomi (FI) (2.25 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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svenska (SV) (2.26 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Latest procedure affecting product information: T/0004

20/11/2020

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Alpivab : EPAR - All Authorised presentations

English (EN) (581.31 KB - PDF)

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български (BG) (1.17 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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español (ES) (1.13 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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čeština (CS) (1.15 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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dansk (DA) (1.12 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Deutsch (DE) (1.12 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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eesti keel (ET) (1.12 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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ελληνικά (EL) (1.17 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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français (FR) (1.12 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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hrvatski (HR) (1.14 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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íslenska (IS) (1.13 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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italiano (IT) (1.12 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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latviešu valoda (LV) (1.16 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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lietuvių kalba (LT) (1.14 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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magyar (HU) (1.15 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Malti (MT) (1.16 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Nederlands (NL) (1.13 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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norsk (NO) (1.12 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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polski (PL) (1.16 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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português (PT) (1.13 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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română (RO) (1.14 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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slovenčina (SK) (1.16 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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slovenščina (SL) (1.15 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Suomi (FI) (1.12 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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svenska (SV) (1.13 MB - PDF)

First published: 25/04/2018Last updated: 09/12/2020
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Product details

Name of medicine
Alpivab
Active substance
Peramivir
International non-proprietary name (INN) or common name
peramivir
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J05AH03

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.

Authorisation details

EMA product number
EMEA/H/C/004299
Marketing authorisation holder
Biocryst

Biocryst
Atlantic Avenue
Westpark Business Campus
Shannon V14 YX01
Ireland

Marketing authorisation issued
13/04/2018
Revision
2

Assessment history

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

English (EN) (1.2 MB - PDF)

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Alpivab : EPAR - Public assessment report

Reference Number: EMA/CHMP/148367/2018

English (EN) (6.34 MB - PDF)

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CHMP summary of positive opinion for Alpivab

AdoptedReference Number: EMA/CHMP/97060/2018

English (EN) (623.37 KB - PDF)

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More information on Alpivab

Public statement on Alpivab: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/CHMP/148367/2018

English (EN) (129.27 KB - PDF)

First published:
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