Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: BRISTOL-MYERS SQUIBB PHARMA EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
Baraclude 0.5 mg film-coated tablets.
Baraclude 1 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Baraclude 0.5 mg film-coated tablets: White to off-white and triangular-shaped tablet with “BMS” debossed on one side and “1611” on the other. Baraclude 1 mg film-coated tablets: Pink and triangular-shaped tablet with “BMS” debossed on one side and “1612” on the other. |
Baraclude 0.5 mg film-coated tablets: Each tablet contains 0.5 mg entecavir (as monohydrate).
Baraclude 1 mg film-coated tablets: Each tablet contains 1 mg entecavir (as monohydrate).
Excipients with known effect:
Each 0.5 mg film-coated tablet contains 120.5 mg lactose.
Each 1 mg film-coated tablet contains 241 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Entecavir |
Entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA. |
| List of Excipients |
|---|
|
Baraclude 0.5 mg film-coated tablets: Tablet core: Crospovidone Tablet coating: Titanium dioxide Baraclude 1 mg film-coated tablets: Tablet core: Crospovidone Tablet coating: Titanium dioxide |
Each carton contains either:
High-density polyethylene (HDPE) bottle with child resistant polypropylene closure containing 30 film-coated tablets. Each carton contains one bottle.
Not all pack sizes and container types may be marketed.
BRISTOL-MYERS SQUIBB PHARMA EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom
Baraclude 0.5 mg film-coated tablets:
Blister packs:
EU/1/06/343/003
EU/1/06/343/006
Bottle packs:
EU/1/06/343/001
Baraclude 1 mg film-coated tablets:
Blister packs:
EU/1/06/343/004
EU/1/06/343/007
Bottle packs:
EU/1/06/343/002
Date of first authorisation: 26 June 2006
Date of latest renewal: 26 June 2011
| Drug | Countries | |
|---|---|---|
| BARACLUDE | Austria, Brazil, Canada, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Ireland, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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