STOCRIN Film-coated tablet

Active ingredients: Efavirenz

Product name and form

STOCRIN 600 mg film-coated tablets.

STOCRIN 50 mg film-coated tablets.

STOCRIN 200 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

STOCRIN 600 mg film-coated tablets: Dark yellow, capsule-shaped, debossed with “225” on one side.

STOCRIN 50 mg film-coated tablets: Yellow, round, debossed with “113” on one side.

STOCRIN 200 mg film-coated tablets: Yellow, round, debossed with “223” on one side.

Qualitative and quantitative composition

STOCRIN 600 mg film-coated tablets

Each film-coated tablet contains 600 mg of efavirenz.

Excipient with known effect: Each film-coated tablet contains 249.6 mg of lactose (as monohydrate).

STOCRIN 50 mg film-coated tablets

Each film-coated tablet contains 50 mg of efavirenz.

Excipient with known effect: Each film-coated tablet contains 20.8 mg of lactose (as monohydrate).

STOCRIN 200 mg film-coated tablets

Each film-coated tablet contains 200 mg of efavirenz.

Excipient with known effect: Each film-coated tablet contains 83.2 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Efavirenz is a NNRTI of HIV-1. Efavirenz is a non-competitive inhibitor of HIV-1 reverse transcriptase (RT) and does not significantly inhibit HIV-2 RT or cellular DNA polymerases (α, β, γ or δ).

List of Excipients

STOCRIN 600 mg film-coated tablets

Tablet core: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate, Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate

Film coating: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Yellow iron oxide (E172), Carnauba wax

STOCRIN 50 mg film-coated tablets

Tablet core: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate, Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate

Film coating: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Yellow iron oxide (E172), Carnauba wax

STOCRIN 200 mg film-coated tablets

Tablet core: Croscarmellose sodium, Microcrystalline cellulose, Sodium laurilsulfate, Hydroxypropylcellulose, Lactose monohydrate, Magnesium stearate

Film coating: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Yellow iron oxide (E172), Carnauba wax

Pack sizes and marketing

STOCRIN 600 mg film-coated tablets: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle of 30 film-coated tablets.

STOCRIN 50 mg film-coated tablets: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle of 30 film-coated tablets.

STOCRIN 200 mg film-coated tablets: HDPE bottles with a child-resistant polypropylene closure. Each carton contains 1 bottle of 90 film-coated tablets.

Marketing authorization holder

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

Marketing authorization dates and numbers

EU/1/99/111/008
EU/1/99/111/010
EU/1/99/111/011

Date of first authorisation: 28 May 1999
Date of latest renewal: 23 April 2014

Drugs

Drug
Countries
Austria, Australia, Cyprus, Germany, Estonia, Spain, Ireland, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, South Africa
Austria, Canada, Germany, Estonia, Spain, France, Ireland, Lithuania, Poland, United States