What is Nevirapine Teva?
Nevirapine Teva is a medicine that contains the active substance nevirapine. It is available as white oval tablets (200 mg).
Nevirapine Teva is a 'generic medicine', which means that Nevirapine Teva is similar to a 'reference medicine' already authorized in the European Union (EU) called Viramune.
What is Nevirapine Teva used for?
Nevirapine Teva is an antiviral medicine used in combination with other antiviral medicines to treat patients infected with HIV-1 (human immunodeficiency virus type 1), a virus that causes AIDS (acquired immunodeficiency syndrome).
The medicine can only be obtained with a prescription.
How is Nevirapine Teva used?
Nevirapine Teva must be given by a doctor who has experience in the treatment of HIV infection.
Neravina Teva is never taken alone, but with at least two other antiviral medicines. As the medicine can cause severe skin reactions, treatment should start with a dose of 200 mg once a day for two weeks, then increased to the standard dose of 200 mg twice a day. The dose should not be increased before any rash has completely disappeared. If the patient cannot switch to the twice daily dose within four weeks of first taking Nevirapine Teva, alternative treatments should be found.
How does Nevirapine Teva work?
The active substance in Nevirapine Teva, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by the HIV-1 virus that allows it to infect the body's cells and reproduce. By inhibiting this enzyme, Nevirapine Teva taken in combination with another antiviral drug reduces the amount of HIV-1 in the blood, keeping it at a low level. Nevirapine Teva does not cure HIV infection or AIDS, but it can delay damage to the immune system and the development of AIDS-associated infections and diseases.
How has Nevirapine Teva been studied?
As Nevirapine Teva is a generic medicine, the studies were limited to evidence to show that the medicine is bioequivalent to the reference medicine Viramune. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
What are the benefits and risks of Nevirapine Teva?
Since Nevirapine Teva is a generic medicine and is bioequivalent to the reference medicine, the benefits and risks are assumed to be the same as the reference medicine.
Why has Nevirapine Teva been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Nevirapine Teva has been shown to have comparable quality and to be bioequivalent to Viramune. It is therefore the CHMP's view that, as in the case of Viramune, the benefits outweigh the identified risks. The Committee recommended that Nevirapine Teva be given a Marketing Authorization.
Other information about Nevirapine Teva
On 30 November 2009, the European Commission issued Teva Pharma B.V. a "marketing authorization" for Nevirapine Teva, valid throughout the European Union. The "marketing authorization" is valid for five years, after which it can be renewed.
The full version of the EPAR for Nevirapine Teva can be found here.
The full EPAR version of the reference medicine can also be found on the Agency's website.
Last update of this summary: 10-2009.
The information on Nevirapine Teva published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
