SEBIVO Film-coated tablet Ref.[8658] Active ingredients: Telbivudine

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

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.

Qualitative and quantitative composition

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
Povidone
Sodium starch glycolate
Silica, colloidal anhydrous
Magnesium stearate

Tablet film coat:

Titanium dioxide (E171)
Macrogol
Talc
Hypromellose

Pack sizes and marketing

PVC/aluminium blisters.

Pack sizes: 28 or 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EU/1/07/388/001

EU/1/07/388/002

Date of first authorisation: 24 April 2007

Date of latest renewal: 16 December 2016

Drugs

Drug Countries
SEBIVO Estonia, Hong Kong, Lithuania, Poland, Romania, Singapore

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