Human medicines European public assessment report (EPAR): Viramune, nevirapine, Date of authorisation: 04/02/1998, Revision: 46, Status: Authorised

Viramune RSS Authorised This medicine is authorised for use in the European Union nevirapine Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Viramune is an antiviral medicine used to treat people infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). It is used in combination with at least two other antiviral medicines. Viramune contains the active substance nevirapine. Expand section Collapse section How is Viramune used? Viramune can only be obtained with a prescription and treatment should be given by a doctor who has experience in the treatment of HIV infection. Viramune is available as tablets and as a liquid to be taken by mouth. Because the medicine can cause serious rash, treatment should be started at low doses. For more information about using Viramune, see the package leaflet or contact your doctor or pharmacist. How does Viramune work? The active substance in Viramune, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to reproduce itself in the cells it has infected. By blocking this enzyme, Viramune, taken in combination with other antiviral medicines, reduces the amount of HIV-1 in the blood and keeps it at a low level. Viramune does not cure HIV-1 infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS. What benefit of Viramune have been shown in studies? Viramune has been studied in five studies involving a total of 1,956 adults. The main measures of effectiveness were the reduction in the amount of HIV in the blood (viral load), the rise in CD4 T-cells in the blood (CD4 cell count), and the number of patients whose disease got worse or who died. CD4 T-cells are white blood cells that are involved in fighting infections but which are reduced by HIV. Viramune, taken in combination with two other antiviral medicines, was more effective than combinations of two medicines. In 398 adults who had taken treatment for HIV infection before, Viramune in combination with the antiviral medicines zidovudine and lamivudine led to a 38% fall in viral load after 48 weeks, compared with a 28% rise in those taking zidovudine and lamivudine without Viramune. In 151 patients who had not taken treatment for HIV-1 infection before, viral load fell by 99% in the three-medicine group, compared with 96% in the two-medicine group after 40 to 52 weeks. In adults taking three medicines the rise in CD4 cell counts was greater, and fewer patients got worse or died. Two studies involved 478 children with HIV-1 taking Viramune alone or in combination with one or two other antiviral medicines. The results in children were similar to those in adults. What are the risks associated with Viramune? For the full list of side effects and restrictions with Viramune, see the package leaflet. The most common side effects with Viramune (which may affect up to 1 and 10 people) include rash, allergic reactions, hepatitis (inflammation of the liver), blood tests showing liver changes, nausea (feeling sick), vomiting, diarrhoea, abdominal (belly) pain, tiredness, fever, headache and muscle pain. The most serious side effects are Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening allergic reactions affecting the skin and mucous membranes), serious hepatitis and liver failure, and serious allergic reactions affecting several parts of the body. The first 18 weeks of treatment are a critical period which requires close monitoring of patients for possible severe and life-threatening skin reactions and serious liver failure. Patients developing signs or symptoms of hepatitis, severe skin reaction or hypersensitivity reactions must stop taking Viramune and immediately consult a healthcare professional. Viramune must not be used in patients who have severe problems with their liver or have signs of liver problems, or who are taking St John’s wort (a herbal remedy used to treat depression). Treatment with Viramune must not be started again in patients who have had to stop taking the medicine in the past because of rash, allergic reactions or hepatitis, or who had signs of liver problems while they were taking Viramune that returned when the medicine was started again. Why is Viramune authorised in the EU? The European Medicines Agency decided that Viramune’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 Viramune? Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Viramune have been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Viramune are continuously monitored. Suspected side effects reported with Viramune are carefully evaluated and any necessary action taken to protect patients. Other information about Viramune Viramune received a marketing authorisation valid throughout the EU on 5 February 1998. Viramune : EPAR - Medicine overview Reference Number: EMA/48208/2025 English (EN) (133.18 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View Other languages (22) български (BG) (158.36 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View español (ES) (133.59 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View čeština (CS) (157.19 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View dansk (DA) (133.76 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View Deutsch (DE) (137.09 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View eesti keel (ET) (131.13 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View ελληνικά (EL) (159.78 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View français (FR) (134.29 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View hrvatski (HR) (155.66 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View italiano (IT) (132.53 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View latviešu valoda (LV) (172.14 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View lietuvių kalba (LT) (155.04 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View magyar (HU) (156.97 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View Malti (MT) (173.65 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View Nederlands (NL) (134.73 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View polski (PL) (161.46 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View português (PT) (134.57 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View română (RO) (151.87 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View slovenčina (SK) (157.77 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View slovenščina (SL) (155.14 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View Suomi (FI) (130.41 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View svenska (SV) (131.44 KB - PDF) First published: 21/10/2009 Last updated: 04/03/2025 View Product information Viramune : EPAR - Product Information English (EN) (999.43 KB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View Other languages (24) български (BG) (1.11 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View español (ES) (1.03 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View čeština (CS) (1.09 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View dansk (DA) (972.39 KB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View Deutsch (DE) (1.17 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View eesti keel (ET) (991.17 KB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View ελληνικά (EL) (1.16 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View français (FR) (1.12 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View hrvatski (HR) (1.03 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View íslenska (IS) (1.06 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View italiano (IT) (1.08 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View latviešu valoda (LV) (1.02 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View lietuvių kalba (LT) (1.08 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View magyar (HU) (1.17 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View Malti (MT) (1.23 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View Nederlands (NL) (1.07 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View norsk (NO) (902.78 KB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View polski (PL) (1.08 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View português (PT) (1.02 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View română (RO) (1.34 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View slovenčina (SK) (1.2 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View slovenščina (SL) (1.06 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View Suomi (FI) (1.01 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View svenska (SV) (1.03 MB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View Latest procedure affecting product information: N/0000339673 07/04/2026 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). Viramune : EPAR - All Authorised presentations English (EN) (24.61 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View Other languages (24) български (BG) (27.64 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View español (ES) (32.04 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View čeština (CS) (26.3 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View dansk (DA) (26.2 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View Deutsch (DE) (26.5 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View eesti keel (ET) (24.19 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View ελληνικά (EL) (28.17 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View français (FR) (24.96 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View hrvatski (HR) (25.53 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View íslenska (IS) (26 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View italiano (IT) (25.21 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View latviešu valoda (LV) (25.34 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View lietuvių kalba (LT) (26.29 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View magyar (HU) (26.45 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View Malti (MT) (34.09 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View Nederlands (NL) (25.27 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View norsk (NO) (25.84 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View polski (PL) (26.39 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View português (PT) (25.12 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View română (RO) (24.91 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View slovenčina (SK) (26 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View slovenščina (SL) (25.64 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View Suomi (FI) (24.33 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View svenska (SV) (25.34 KB - PDF) First published: 12/03/2009 Last updated: 21/04/2023 View Product details Name of medicine Viramune Active substance nevirapine International non-proprietary name (INN) or common name nevirapine Therapeutic area (MeSH) HIV Infections Anatomical therapeutic chemical (ATC) code J05AG01 Pharmacotherapeutic group Antivirals for systemic use Therapeutic indication Viramune 50 mg/5 mL oral suspension and 200 mg tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age. Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing. Viramune 400 mg prolonged-release tablets Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children three years and above and able to swallow tablets (see section 4.2). Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used (see section 4.2). Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1). Authorisation details EMA product number EMEA/H/C/000183 Marketing authorisation holder Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany Opinion adopted 22/10/1997 Marketing authorisation issued 04/02/1998 Revision 46 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Viramune : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (143.2 KB - PDF) First published: 07/04/2026 View Viramune : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (332.75 KB - PDF) First published: 11/06/2009 Last updated: 07/04/2026 View Viramune-H-C-183-X-95 : EPAR - Assessment Report - Extension Adopted Reference Number: EMA/538380/2011 English (EN) (1.34 MB - PDF) First published: 27/10/2011 Last updated: 27/10/2011 View Viramune : EPAR - Steps taken after authorisation when a cutoff date has been used English (EN) (122.23 KB - PDF) First published: 21/10/2005 Last updated: 21/10/2005 View Initial marketing authorisation documents Viramune : EPAR - Procedural steps taken before authorisation English (EN) (82.6 KB - PDF) First published: 21/10/2005 Last updated: 21/10/2005 View Viramune : EPAR - Scientific Discussion English (EN) (291.54 KB - PDF) First published: 21/10/2005 Last updated: 21/10/2005 View News on Viramune Updated advice on body fat changes and lactic acidosis with HIV medicines 23/10/2015 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 October 2015 23/10/2015 More information on Viramune EMEA-000391-PIP01-08-M01 - paediatric investigation plan Topics Medicines This page was last updated on 07/04/2026 Share this page