Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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. |
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).
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).
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 |
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 tabletsTablet 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 tabletsTablet 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 tabletsTablet 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 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.
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
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
| Drug | Countries | |
|---|---|---|
| STOCRIN | Austria, Australia, Cyprus, Germany, Estonia, Spain, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, South Africa | |
| SUSTIVA | Austria, Canada, Germany, Estonia, Spain, France, Ireland, Lithuania, Poland, United Kingdom, United States |
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