Alpivab

RSS

peramivir

Authorised
This medicine is authorised for use in the European Union.

Overview

An overview of Alpivab and why it is authorised in the EU

Alpivab is an antiviral medicine that contains the active substance peramivir. It is used to treat uncomplicated influenza (flu) in adults and children over 2 years. Uncomplicated means that the flu has typical features (such as fever, aches, cough, sore throat and runny nose) and is not made worse by other conditions.

This EPAR was last updated on 25/04/2018

Authorisation details

Product details
Name
Alpivab
Agency product number
EMEA/H/C/004299
Active substance
Peramivir
International non-proprietary name (INN) or common name
peramivir
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J05AH03
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Biocryst UK Limited
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
13/04/2018
Contact address
c/o Morgan Lewis Bockius Condor House
5-10 St. Paul's Churchyard
London EC4M 8AL
United Kingdom

Product information

13/04/2018 Alpivab - EMEA/H/C/004299 - -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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 (see sections 4.4 and 5.1)

Assessment history

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