DARUNAVIR KRKA 400 mg / 800 mg Film-coated tablet Ref.[8767] Active ingredients: Darunavir

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Product name and form

Darunavir Krka 400 mg film-coated tablets.

Darunavir Krka 800 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Darunavir Krka 400 mg film-coated tablets: Yellowish brown, oval, biconvex film-coated tablets, engraved with a mark S1 on one side. Tablet dimension: 17 × 8.5 mm.

Darunavir Krka 800 mg film-coated tablets: Brownish red, oval, biconvex film-coated tablets, engraved with a mark S3 on one side. Tablet dimension: 20 × 10 mm.

Qualitative and quantitative composition

Darunavir Krka 400 mg film-coated tablets: Each film-coated tablet contains 400 mg darunavir.

Darunavir Krka 800 mg film-coated tablets: Each film-coated tablet contains 800 mg darunavir.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Darunavir

Darunavir is an inhibitor of the dimerisation and of the catalytic activity of the HIV-1 protease (KD of 4.5 × 10-12 M). It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
List of Excipients

Tablet core:

Cellulose, microcrystalline
Crospovidone
Hydroxypropylcellulose
Silica, colloidal anhydrous
Silicified microcrystalline cellulose (Cellulose, microcrystalline; Silica, colloidal anhydrous)
Magnesium stearate (E470b)

Film coating:

Poly(vinyl alcohol)
Macrogol
Titanium dioxide (E171)
Talc (E553b)
Iron oxide, yellow (E172) – only for 400 mg film-coated tablets
Iron oxide, red (E172)

Pack sizes and marketing

400 mg film-coated tablets:

Bottle (HDPE), child resistant tamper evident PP closure with a desiccant:

  • 30 tablets: 1 bottle of 30 film-coated tablets,
  • 60 tablets: 2 bottles of 30 film-coated tablets,
  • 90 tablets: 3 bottles of 30 film-coated tablets,
  • 180 tablets: 6 bottles of 30 film-coated tablets.

800 mg film-coated tablets:

Bottle (HDPE), child resistant tamper evident PP closure with a desiccant:

  • 30 tablets: 1 bottle of 30 film-coated tablets,
  • 90 tablets. 3 bottles of 30 film-coated tablets.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Marketing authorization dates and numbers

400 mg film-coated tablets:

30 film-coated tablets: EU/1/17/1249/001
60 film-coated tablets: EU/1/17/1249/002
90 film-coated tablets: EU/1/17/1249/003
180 film-coated tablets: EU/1/17/1249/004

800 mg film-coated tablets:

30 film-coated tablets: EU/1/17/1249/009
90 film-coated tablets: EU/1/17/1249/010

Date of first authorisation: 26 January 2018
Date of latest renewal: 9 November 2022

 
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