What is Nevirapine Teva?
Nevirapine Teva is a medicine that contains the active substance nevirapine. It is available in 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 HIV-1 infected patients (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 should be administered 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. Since the medicine can cause severe skin reactions, the 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. It is advisable not to increase the dose before the complete disappearance of any rash. If the patient cannot switch to the twice daily dose within four weeks of receiving Nevirapine Teva, alternative treatments should be sought.
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 and reproduce. By blocking 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 may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
What studies have been performed on Nevirapine Teva?
Because Nevirapine Teva is a generic medicine, studies have been limited to tests to show that it is bioequivalent to the reference medicine, Viramune. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Nevirapine Teva?
Because Nevirapine Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are supposed to be the same as the latter.
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 opinion of the CHMP that, as in the case of Viramune, the benefits outweigh the risks identified. The Committee recommended the granting of the marketing authorization for Nevirapine Teva.
More information on Nevirapina Teva
On 30 November 2009, the European Commission issued a marketing authorization valid throughout the European Union for Nevirapina Teva to Teva Pharma BV. The marketing authorization is valid for five years, after which it can be renewed.
The full EPAR for Nevirapine Teva can be found here.
The full EPAR of the reference medicine is also found on the Agency's website.
Last update of this summary: 10-2009.
