Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
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. |
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 |
Colourless glass vial with bromobutyl rubber stopper, sealed with a flip off cap (aluminium with plastic disc).
Pack-size of 30 vials.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/20/1446/001
Date of first authorisation: 31 July 2020
Date of latest renewal: 02 August 2021
| Drug | Countries | |
|---|---|---|
| HEPCLUDEX | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania |
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