NEVIRAPINE TEVA Tablet Ref.[8787] Active ingredients: Nevirapine

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

Product name and form

Nevirapine Teva 200 mg tablets.

Pharmaceutical Form

Tablet.

White, oval, biconvex tablets. One side is debossed with “N”, a scoreline and “200”. The opposite side is debossed with a scoreline. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 200 mg of nevirapine (as anhydrous).

Excipient with known effect: Each tablet contains 168 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1

Active Ingredient Description
Nevirapine

Nevirapine is a NNRTI of HIV-1. Nevirapine is a non-competitive inhibitor of the HIV-1 reverse transcriptase, but it does not have a biologically significant inhibitory effect on the HIV-2 reverse transcriptase or on eukaryotic DNA polymerases α, β, γ, or δ.

List of Excipients

Microcrystalline cellulose
Lactose (as monohydrate)
Povidone K25
Sodium starch glycolate (Type A)
Colloidal silicon dioxide
Magnesium stearate

Pack sizes and marketing

Treatment initiation pack: White opaque PVC/PE/PVdC – Aluminium blisters or OPA/Alu/PVC – Aluminium blisters. Cartons containing 14 tablets (Calendar Pack).

Maintenance packs: White opaque PVC/PE/PVdC – Aluminium blisters or OPA/Alu/PVC – Aluminium blisters. Cartons containing 60 or 120 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Teva B.V., Swensweg 5, 2031GA Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/09/598/001-006

Date of first authorisation: 30 November 2009
Date of latest renewal: 26 August 2014

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