DARUNAVIR KRKA 600 mg Film-coated tablet Ref.[51263] 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 600 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Orangish brown, oval, biconvex film-coated tablets, engraved with a mark S2 on one side. Tablet dimension: 19.5 × 10 mm.

Qualitative and quantitative composition

Each film-coated tablet contains 600 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)
Iron oxide, red (E172)

Pack sizes and marketing

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.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

30 film-coated tablets: EU/1/17/1249/005
60 film-coated tablets: EU/1/17/1249/006
90 film-coated tablets: EU/1/17/1249/007
180 film-coated tablets: EU/1/17/1249/008

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

 
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