Vihuma

simoctocog alfa

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This is a summary of the European public assessment report (EPAR) for Vihuma. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vihuma.

For practical information about using Vihuma, patients should read the package leaflet or contact their doctor or pharmacist.

What is Vihuma and what is it used for?

Vihuma is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance simoctocog alfa.

This medicine is the same as Nuwiq, which is already authorised in the European Union (EU). The company that makes Nuwiq has agreed that its scientific data can be used for Vihuma (‘informed consent’).

How is Vihuma used?

Vihuma can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.

Vihuma is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the seriousness of the haemophilia, the extent and location of the bleeding and the patient’s condition and bodyweight. For further information, see the summary of product characteristics (also part of the EPAR).

Patients or their carers may be able to administer Vihuma themselves at home once they have been trained appropriately. For full details, see the package leaflet.

How does Vihuma work?

Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs. The active substance in Vihuma, simoctocog alfa, works in the body in the same way as human factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.

What benefits of Vihuma have been shown in studies?

Vihuma has been shown to be effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.

The first study involved 22 patients aged 12 years and above, who were given Vihuma for the treatment of bleeding episodes or to prevent bleeding during surgery. A total of 986 bleeding episodes were recorded, the majority of which resolved with one injection of Vihuma. The main measure of effectiveness was based on patients’ assessment of how well treatment worked. Treatment with Vihuma was rated as ‘excellent’ or ‘good’ for 94% of bleeding episodes. In the two surgeries that occurred during the study, Vihuma was rated as excellent in preventing bleeding episodes.

The second study involved 32 patients aged 12 years and above who were given Vihuma to prevent and treat bleeding events as well as to prevent bleeding during surgery. When used to prevent bleeding, an average of 0.19 bleeds per month was recorded for each patient. When used for the treatment of bleeding episodes, Vihuma was mainly rated as ‘excellent’ or ‘good’ at treating major bleeding episodes and most bleeding episodes resolved following one or more injections of Vihuma. In the five surgeries that occurred during the study, Vihuma was rated as excellent in preventing bleeding episodes for four surgeries and as moderate to prevent bleeding during one surgical intervention.

The third study involved 59 children aged two to 12 years. When Vihuma was used to prevent bleeding, an average of 0.34 bleeds per month was recorded for each child. When used for treatment bleeding episodes resolved in 81% of cases following one or two injections with Vihuma.

What are the risks associated with Vihuma?

Side effects with Vihuma have not been commonly reported (affecting between 1 and 10 in 1,000 people). They include paraesthesia (unusual sensations like pins and needles), headache, vertigo (a spinning sensation), dry mouth, back pain and inflammation and pain at the injection site.

Hypersensitivity (allergic) reactions although not seen so far with Vihuma, have been reported rarely with factor VIII products and may in some cases progress to severe allergic reactions. Following treatment with factor VIII products some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body’s immune system produces against factor VIII and which can cause the medicine to stop working, resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.

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

Why is Vihuma approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Vihuma’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Vihuma has been shown to be effective at treating and preventing the occurrence of bleeding in patients with haemophilia A. Vihuma was also effective in preventing and treating bleeding in relation to bleeding episodes after surgery, with effects similar to other factor VIII products. The safety profile of Vihuma was also considered similar to other factor VIII products.

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

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

Other information about Vihuma

The European Commission granted a marketing authorisation valid throughout the European Union for Vihuma on 13 February 2017.

For more information about treatment with Vihuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Vihuma : EPAR - Summary for the public BG = bălgarski 2017-04-12  
Vihuma : EPAR - Summary for the public ES = español 2017-04-12  
Vihuma : EPAR - Summary for the public CS = čeština 2017-04-12  
Vihuma : EPAR - Summary for the public DA = dansk 2017-04-12  
Vihuma : EPAR - Summary for the public DE = Deutsch 2017-04-12  
Vihuma : EPAR - Summary for the public ET = eesti keel 2017-04-12  
Vihuma : EPAR - Summary for the public EL = elliniká 2017-04-12  
Vihuma : EPAR - Summary for the public EN = English 2017-04-12  
Vihuma : EPAR - Summary for the public FR = français 2017-04-12  
Vihuma : EPAR - Summary for the public IT = italiano 2017-04-12  
Vihuma : EPAR - Summary for the public LV = latviešu valoda 2017-04-12  
Vihuma : EPAR - Summary for the public LT = lietuvių kalba 2017-04-12  
Vihuma : EPAR - Summary for the public HU = magyar 2017-04-12  
Vihuma : EPAR - Summary for the public MT = Malti 2017-04-12  
Vihuma : EPAR - Summary for the public NL = Nederlands 2017-04-12  
Vihuma : EPAR - Summary for the public PL = polski 2017-04-12  
Vihuma : EPAR - Summary for the public PT = português 2017-04-12  
Vihuma : EPAR - Summary for the public RO = română 2017-04-12  
Vihuma : EPAR - Summary for the public SK = slovenčina 2017-04-12  
Vihuma : EPAR - Summary for the public SL = slovenščina 2017-04-12  
Vihuma : EPAR - Summary for the public FI = suomi 2017-04-12  
Vihuma : EPAR - Summary for the public SV = svenska 2017-04-12  
Vihuma : EPAR - Summary for the public HR = Hrvatski 2017-04-12  

This EPAR was last updated on 12/04/2017 .

Authorisation details

Product details

Product details for Vihuma
NameVihuma
Agency product numberEMEA/H/C/004459
Active substance

simoctocog alfa

International non-proprietary name (INN) or common name

simoctocog alfa

Therapeutic area Hemophilia A
Anatomical therapeutic chemical (ATC) code B02BD02
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 Vihuma
Marketing-authorisation holder

Octapharma AB

Revision0
Date of issue of marketing authorisation valid throughout the European Union13/02/2017

Contact address:

Octapharma AB
Lars Forssells gata 
23 112 75 Stockholm 
Sweden

Product information

Product information

13/02/2017  Vihuma -EMEA/H/C/004459 --

Name Language First published Last updated
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  
Vihuma : EPAR - Product Information HR = Hrvatski 2017-04-12  

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
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  
Vihuma : EPAR - All Authorised presentations HR = Hrvatski 2017-04-12  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Vihuma can be used for all age groups.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Vihuma : EPAR - Public assessment report HR = Hrvatski 2017-04-12  
CHMP summary of positive opinion for Vihuma HR = Hrvatski 2016-12-16  

Authorised

This medicine is approved for use in the European Union