Alpivab

RSS
Withdrawn

This medicine's authorisation has been withdrawn

peramivir
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 20 November 2020, the European Commission withdrew the marketing authorisation for Alpivab (peramivir) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, BioCryst Ireland Limited, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Alpivab was granted a marketing authorisation in the EU on 13 April 2018 for the treatment of uncomplicated influenza in adults and children from the age of 2 years. The marketing authorisation was valid for a 5-year period. The product had not been marketed in the EU. 

The European Public Assessment Report (EPAR) for Alpivab is updated to indicate that the marketing authorisation is no longer valid.

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)

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

First published: Last updated:
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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
View

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)

First published: Last updated:
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български (BG) (1.17 MB - PDF)

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

español (ES) (1.13 MB - PDF)

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

čeština (CS) (1.15 MB - PDF)

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

dansk (DA) (1.12 MB - PDF)

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

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
View

français (FR) (1.12 MB - PDF)

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

hrvatski (HR) (1.14 MB - PDF)

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

íslenska (IS) (1.13 MB - PDF)

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

italiano (IT) (1.12 MB - PDF)

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

latviešu valoda (LV) (1.16 MB - PDF)

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

lietuvių kalba (LT) (1.14 MB - PDF)

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

magyar (HU) (1.15 MB - PDF)

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

Malti (MT) (1.16 MB - PDF)

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

Nederlands (NL) (1.13 MB - PDF)

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

norsk (NO) (1.12 MB - PDF)

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

polski (PL) (1.16 MB - PDF)

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

português (PT) (1.13 MB - PDF)

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

română (RO) (1.14 MB - PDF)

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

slovenčina (SK) (1.16 MB - PDF)

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

slovenščina (SL) (1.15 MB - PDF)

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

Suomi (FI) (1.12 MB - PDF)

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

svenska (SV) (1.13 MB - PDF)

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

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)

First published: Last updated:
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Alpivab : EPAR - Public assessment report

Reference Number: EMA/CHMP/148367/2018

English (EN) (6.34 MB - PDF)

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

AdoptedReference Number: EMA/CHMP/97060/2018

English (EN) (623.37 KB - PDF)

First published: Last updated:
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