VOYDEYA Film-coated tablet Ref.[110089] Active ingredients: Danicopan

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Alexion Europe SAS, 103-105 rue Anatole France, 92300 Levallois-Perret, FRANCE

Product name and form

Voydeya 50 mg film-coated tablets.

Voydeya 100 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Voydeya 50 mg film-coated tablets: White to off-white, round film-coated tablets, “DCN” above “50” debossed on one side, plain on the other side. Each tablet is approximately 8 mm.

Voydeya 100 mg film-coated tablets: White to off-white, round film-coated tablets, “DCN” above “100” debossed on one side, plain on the other side. Each tablet is approximately 10.3 mm.

Qualitative and quantitative composition

Voydeya 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of danicopan.

Voydeya 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of danicopan.

Excipient with known effect:

Each 50 mg tablet contains 57.5 mg of lactose monohydrate.

Each 100 mg tablet contains 115 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Danicopan

Danicopan binds reversibly to complement factor D (FD) and acts as a selective inhibitor of FD function. By inhibiting FD, danicopan selectively blocks the activation of complement alternative pathway (AP), leading to prevention of the production of multiple effectors, that include C3 fragments, after AP activation. The 2 other complement pathways (classical and lectin) remain active. Danicopan’s inhibitory effect on AP activation inhibits the deposition of C3 fragments on PNH red blood cells; such deposition is a key cause of the EVH which can become clinically significant in a small subset of patients with PNH on a C5 inhibitor. Maintenance of C5 inhibition controls the lifethreatening pathophysiological consequences of terminal complement activation underlying PNH.
List of Excipients

Tablet core:

Lactose monohydrate
Cellulose, microcrystalline
Croscarmellose sodium
Sodium laurilsulfate
Magnesium stearate
Silica, hydrophobic colloidal
Hypromellose acetate succinate

Film-coating:

Polyvinyl alcohol
Titanium dioxide (E171)
Macrogol 4000
Talc

Pack sizes and marketing

Bottle

HDPE bottles containing 90 film-coated tablets with desiccant and child resistant seal. Each pack contains 180 film-coated tablets.

The following pack sizes are available:

  • Packs containing 1 bottle of 90 × 50 mg film-coated tablets and 1 bottle of 90 × 100 mg film-coated tablets.
  • Packs containing 2 bottles of 90 × 100 mg film-coated tablets.

Blister

PVC/PCTFE/PVC blister. Each pack contains 168 film-coated tablets.

The following pack sizes are available:

  • Pack containing 4 blister wallet cards (child resistant), each containing 21 × 50 mg film-coated tablets and 21 × 100 mg film-coated tablets.
  • Pack containing 4 blister wallet cards (child resistant), each containing 42 × 100 mg film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Alexion Europe SAS, 103-105 rue Anatole France, 92300 Levallois-Perret, FRANCE

Marketing authorization dates and numbers

EU/1/24/1792/001
EU/1/24/1792/002
EU/1/24/1792/003
EU/1/24/1792/004

Drugs

Drug Countries
VOYDEYA Estonia, Lithuania, Romania
 
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