Crixivan

indinavir

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This is a summary of the European public assessment report (EPAR) for Crixivan. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Crixivan.

What is Crixivan and what is it used for?

Crixivan is an antiviral medicine for treating adults infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).

Crixivan is used in combination with other antiviral medicines and contains the active substance indinavir.

How is Crixivan used?

Crixivan is available as capsules (200 and 400 mg) and is taken by mouth one hour before or two hours after a meal with water or a light low-fat meal. The standard dose is 800 mg every eight hours, but Crixivan can also be taken at a dose of 400 mg twice a day if each dose is taken with 100 mg ritonavir (another antiviral medicine). To avoid the risk of developing kidney stones, patients should drink plenty of liquids (at least 1.5 litres every day for adults).

Crixivan should only be prescribed by doctors with experience in treating HIV and can only be obtained by prescription.

How does Crixivan work?

The active substance in Crixivan, indinavir, is a protease inhibitor. It blocks an enzyme called protease, which is involved in the reproduction of HIV. By blocking this enzyme, indinavir stops the virus from reproducing normally and thereby slows down the spread of infection.

Crixivan does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.

Ritonavir, another protease inhibitor, is sometimes used with Crixivan as a ‘booster’. It slows down the rate at which indinavir is broken down, helping to increase levels of indinavir in the blood.

What benefits of Crixivan have been shown in studies?

Studies have shown that Crixivan in combination with other antiviral medicines is effective at reducing the level of HIV in the blood (viral load). In one study, 90% of those taking Crixivan in combination with zidovudine and lamivudine had viral loads below 500 copies/ml after 24 weeks of treatment, compared with 43% of those taking Crixivan alone and none (0%) of those taking zidovudine and lamivudine without Crixivan.

What are the risks associated with Crixivan?

The most common side effects with Crixivan (seen in more than 1 patient in 10) are increases in size of red blood cells, decreases in neutrophils (a type of white blood cell), headache, dizziness, nausea (feeling sick), vomiting, diarrhoea, heartburn, instances of high blood bilirubin levels that do not cause any symptoms, increased levels of liver enzymes (alanine and aspartate transaminases), rash, dry skin, blood in the urine, protein in the urine, crystals in the urine, weakness or tiredness, an altered sense of taste and abdominal pain (stomach ache). For the full list of side effects reported with Crixivan, see the package leaflet.

Crixivan must not be taken with certain other medicines because of the possibility of harmful interactions. For the full list of restrictions, see the package leaflet.

Why is Crixivan been approved?

The CHMP decided that Crixivan’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

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

Other information about Crixivan

The European Commission granted a marketing authorisation valid throughout the European Union for Crixivan on 4 October 1996.

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

Name Language First published Last updated
Crixivan : EPAR - Summary for the public BG = bălgarski 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public ES = español 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public CS = čeština 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public DA = dansk 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public DE = Deutsch 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public ET = eesti keel 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public EL = elliniká 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public EN = English 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public FR = français 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public IT = italiano 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public LV = latviešu valoda 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public LT = lietuvių kalba 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public HU = magyar 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public MT = Malti 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public NL = Nederlands 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public PL = polski 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public PT = português 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public RO = română 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public SK = slovenčina 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public SL = slovenščina 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public FI = suomi 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public SV = svenska 2008-11-12 2017-01-12
Crixivan : EPAR - Summary for the public HR = Hrvatski 2008-11-12 2017-01-12

This EPAR was last updated on 12/01/2017 .

Authorisation details

Product details

Product details for Crixivan
NameCrixivan
Agency product numberEMEA/H/C/000128
Active substance

indinavir sulphate

International non-proprietary name (INN) or common name

indinavir

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AE02

Publication details

Publication details for Crixivan
Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Revision37
Date of issue of marketing authorisation valid throughout the European Union04/10/1996

Contact address:

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

06/01/2016  Crixivan -EMEA/H/C/000128 -IB/0101

Name Language First published Last updated
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05
Crixivan : EPAR - Product Information HR = Hrvatski 2009-07-23 2016-02-05

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
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05
Crixivan : EPAR - All Authorised presentations HR = Hrvatski 2009-02-27 2016-02-05

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Crixivan : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2005-10-21  
Crixivan : EPAR - Scientific Discussion HR = Hrvatski 2005-10-21