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Viramune (nevirapine)

Region

🇪🇺 EU

Active substance

nevirapine

Company

Boehringer Ingelheim International GmbH

Status

Authorised

Therapeutic area

HIV Infections

CHMP opinion

Wed 22 Oct 1997

EU approval

Wed 04 Feb 1998

Application

EMEA/H/C/000183

ATC

J05AG01

Official record

www.ema.europa.eu

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).

Regulatory milestones

No milestones recorded in the last year.

Same substance in other markets

• 🇪🇺 Nevirapine Teva Withdrawn · Teva B.V.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.