Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Harvoni 33.75 mg/150 mg coated granules in sachet.
Harvoni 45 mg/200 mg coated granules in sachet.
| Pharmaceutical Form |
|---|
|
Coated granules in sachet. Orange, coated granules in sachet. |
Each sachet contains 33.75 mg ledipasvir and 150 mg sofosbuvir.
Excipients with known effect: Each sachet contains 220 mg of lactose (as monohydrate).
Each sachet contains 45 mg ledipasvir and 200 mg sofosbuvir.
Excipients with known effect: Each sachet contains 295 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Sofosbuvir and Ledipasvir |
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Ledipasvir is a HCV inhibitor targeting the HCV NS5A protein, which is essential for both RNA replication and the assembly of HCV virions. |
| List of Excipients |
|---|
|
Granule cores: Copovidone Film-coating: Hypromellose |
Harvoni 33.75 mg/150 mg and 45 mg/200 mg coated granules are supplied in polyester/aluminium/polyethylene film sachets in cartons. Each carton contains 28 sachets.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/14/958/004
EU/1/14/958/005
Date of first authorisation: 17 November 2014
Date of latest renewal: 01 August 2019
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