Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Sebivo 600 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. White to slightly yellowish, oval film-coated tablet, imprinted with “LDT” on one side. |
Each film-coated tablet contains 600 mg telbivudine.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Telbivudine |
Telbivudine is a synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase. It is efficiently phosphorylated by cellular kinases to the active triphosphate form. Incorporation of telbivudine-5'-triphosphate into viral DNA causes DNA chain termination, resulting in inhibition of HBV replication. |
| List of Excipients |
|---|
|
Tablet core: Cellulose microcrystalline Tablet film coat: Titanium dioxide (E171) |
PVC/aluminium blisters.
Pack sizes: 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
EU/1/07/388/001
EU/1/07/388/002
Date of first authorisation: 24 April 2007
Date of latest renewal: 16 December 2016
| Drug | Countries | |
|---|---|---|
| SEBIVO | Estonia, Hong Kong, Lithuania, Poland, Romania, Singapore |
© 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.
