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STOCRIN Film-coated tablet (2020)

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.

Chemical substance
Description
Efavirenz

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
Authorization dates

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

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

Marketing authorization number:

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