Alpivab

peramivir

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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.

How is Alpivab used?

Alpivab is available as a solution to be diluted for infusion (drip) into a vein. The medicine can only be obtained with a prescription. Alpivab is given as an infusion lasting 15 to 30 minutes. The dose depends on age and body weight and should be reduced in adults and adolescents over 13 years of age with reduced kidney function. It is given once only, within 48 hours after symptoms start.

For more information about using Alpivab, see the package leaflet or contact your doctor or pharmacist.

How does Alpivab work?

The active substance in Alpivab, peramivir, prevents the flu virus from spreading further by blocking the activity of enzymes (proteins) on the surface of the virus called neuraminidases. Peramivir works on neuraminidases of both influenza-A (the most common type) and influenza-B viruses.

What benefits of Alpivab have been shown in studies?

Alpivab was shown to reduce the length of time symptoms lasted in patients with influenza.

Alpivab was compared with placebo (a dummy treatment) in one main study of 296 adults with influenza (mostly influenza A) treated within 48 hours of symptoms appearing. The main measure of effectiveness was the length of time before symptoms (cough, sore throat, headache, blocked nose, feverishness or chills, aches or pains of the muscle or joints and tiredness) got better. Symptoms took around 2 and a half days (59 hours) to get better in patients taking Alpivab in comparison with just under 3 and a half days (82 hours) in patients taking placebo.

What are the risks associated with Alpivab?

The most common side effects with Alpivab (which may affect up to around 3 in 100 people) are a decrease in the levels of neutrophils (a type of white blood cell) and nausea (feeling sick). Serious side effects with Alpivab are anaphylaxis (a severe allergic reaction) and skin reactions, including erythema multiforme (an allergic skin reaction) and Stevens-Johnson Syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).

For the full list of side effects and restrictions with Alpivab, see the package leaflet.

Why is Alpivab authorised in the EU?

Alpivab reduces the length of time flu symptoms last by one day on average. Although this difference is not large, it may benefit some patients. There is a risk of severe allergic reactions, and although it is not known exactly how often these reactions occur, they appear to be rare. The European Medicines Agency decided that Alpivab’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Alpivab?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Alpivab have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Alpivab are continuously monitored. Side effects reported with Alpivab are carefully evaluated and any necessary action taken to protect patients.

Other information about Alpivab

Alpivab received a marketing authorisation valid throughout the EU on 13 April 2018.

Further information on Alpivab can be found on the Agency’s website. 

Name Language First published Last updated
Alpivab : EPAR - Medicine overview BG = bălgarski 2018-04-25  
Alpivab : EPAR - Medicine overview ES = español 2018-04-25  
Alpivab : EPAR - Medicine overview CS = čeština 2018-04-25  
Alpivab : EPAR - Medicine overview DA = dansk 2018-04-25  
Alpivab : EPAR - Medicine overview DE = Deutsch 2018-04-25  
Alpivab : EPAR - Medicine overview ET = eesti keel 2018-04-25  
Alpivab : EPAR - Medicine overview EL = elliniká 2018-04-25  
Alpivab : EPAR - Medicine overview EN = English 2018-04-25  
Alpivab : EPAR - Medicine overview FR = français 2018-04-25  
Alpivab : EPAR - Medicine overview IT = italiano 2018-04-25  
Alpivab : EPAR - Medicine overview LV = latviešu valoda 2018-04-25  
Alpivab : EPAR - Medicine overview LT = lietuvių kalba 2018-04-25  
Alpivab : EPAR - Medicine overview HU = magyar 2018-04-25  
Alpivab : EPAR - Medicine overview MT = Malti 2018-04-25  
Alpivab : EPAR - Medicine overview NL = Nederlands 2018-04-25  
Alpivab : EPAR - Medicine overview PL = polski 2018-04-25  
Alpivab : EPAR - Medicine overview PT = português 2018-04-25  
Alpivab : EPAR - Medicine overview RO = română 2018-04-25  
Alpivab : EPAR - Medicine overview SK = slovenčina 2018-04-25  
Alpivab : EPAR - Medicine overview SL = slovenščina 2018-04-25  
Alpivab : EPAR - Medicine overview FI = suomi 2018-04-25  
Alpivab : EPAR - Medicine overview SV = svenska 2018-04-25  
Alpivab : EPAR - Medicine overview HR = Hrvatski 2018-04-25  

This EPAR was last updated on 25/04/2018 .

Authorisation details

Product details

Product details for Alpivab
NameAlpivab
Agency product numberEMEA/H/C/004299
Active substance

peramivir

International non-proprietary name (INN) or common name

peramivir

Therapeutic area Influenza, Human
Anatomical therapeutic chemical (ATC) code J05AH03
Additional monitoring

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

Publication details

Publication details for Alpivab
Marketing-authorisation holder

Biocryst UK Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union13/04/2018

Contact address:

c/o Morgan Lewis & Bockius Condor House
5-10 St. Paul's Churchyard
London EC4M 8AL
United Kingdom

Product information

Product information

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

Name Language First published Last updated
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  
Alpivab : EPAR - Product Information HR = Hrvatski 2018-04-25  

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.


Name Language First published Last updated
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  
Alpivab : EPAR - All Authorised presentations HR = Hrvatski 2018-04-25  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Alpivab : EPAR - Public assessment report HR = Hrvatski 2018-04-25  
CHMP summary of positive opinion for Alpivab HR = Hrvatski 2018-02-23  

Authorised

This medicine is approved for use in the European Union