Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Harvoni 90 mg/400 mg film-coated tablets.
Harvoni 45 mg/200 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Harvoni 90 mg/400 mg film-coated tablets: Orange, diamond-shaped, film-coated tablet of dimensions of approximately 19 mm x 10 mm, debossed with “GSI” on one side and “7985” on the other side. Harvoni 45 mg/200 mg film-coated tablets: White, capsule-shaped, film-coated tablet of dimensions of approximately 14 mm x 7 mm, debossed with “GSI” on one side and “HRV” on the other side. |
Each film-coated tablet contains 90 mg ledipasvir and 400 mg sofosbuvir.
Excipients with known effect: Each film-coated tablet contains 157 mg of lactose (as monohydrate) and 47 micrograms of sunset yellow FCF.
Each film-coated tablet contains 45 mg ledipasvir and 200 mg sofosbuvir.
Excipients with known effect: Each film-coated tablet contains 78 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ledipasvir |
|
|
| Sofosbuvir |
Sofosbuvir is a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. |
|
| 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 |
|---|
|
Tablet core: Copovidone Film-coating: Polyvinyl alcohol |
Harvoni tablets are supplied in high density polyethylene (HDPE) bottles with a polypropylene child-resistant closure containing 28 film-coated tablets with a silica gel desiccant and polyester coil.
The following pack sizes are available:
Not all pack sizes may be marketed.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/14/958/001
EU/1/14/958/002
EU/1/14/958/003
Date of first authorisation: 17 November 2014
Date of latest renewal: 01 August 2019
| Drug | Countries | |
|---|---|---|
| HARVONI | Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
