HEPCLUDEX Powder for solution for injection Ref.[11023] Active ingredients: Bulevirtide

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Product name and form

HEPCLUDEX 2 mg powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection (powder for injection).

The powder is white to off-white.

After reconstitution, solution with a pH of approximately 9.0 and osmolality of approximately 300 mOsm/kg.

Qualitative and quantitative composition

Each vial contains bulevirtide acetate equivalent to 2 mg bulevirtide.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bulevirtide

Bulevirtide blocks the entry of HBV and HDV into hepatocytes by binding to and inactivating NTCP, a bile salt liver transporter serving as essential HBV/HDV entry receptor.

List of Excipients

Sodium carbonate anhydrous
Sodium hydrogen carbonate
Mannitol
Hydrochloric acid (for pH adjustment)
Sodium hydroxide (for pH adjustment)

Pack sizes and marketing

Colourless glass vial with bromobutyl rubber stopper, sealed with a flip off cap (aluminium with plastic disc).

Pack-size of 30 vials.

Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

Marketing authorization dates and numbers

EU/1/20/1446/001

Date of first authorisation: 31 July 2020
Date of latest renewal: 02 August 2021

Drugs

Drug Countries
HEPCLUDEX Austria, Estonia, France, Ireland, Lithuania, Poland, Romania

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