Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
INTELENCE 25 mg tablets.
INTELENCE 100 mg tablets.
INTELENCE 200 mg tablets.
| Pharmaceutical Form |
|---|
INTELENCE 25 mg tabletsTablet. White to off-white, oval, scored tablet, debossed with “TMC” on one side. The tablet can be divided into two equal doses. INTELENCE 100 mg tabletsTablet. White to off-white, oval tablet debossed with “T125” on one side and “100” on the other side. INTELENCE 200 mg tabletsTablet. White to off-white, biconvex, oblong tablet debossed with “T200” on one side. |
INTELENCE 25 mg tablets: Each tablet contains 25 mg of etravirine.
Excipient with known effect:
Each tablet contains 40 mg lactose (as monohydrate).
Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
INTELENCE 100 mg tablets: Each tablet contains 100 mg of etravirine.
Excipient with known effect:
Each tablet contains 160 mg lactose (as monohydrate).
Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
INTELENCE 200 mg tablets: Each tablet contains 200 mg of etravirine.
Excipient with known effect:
Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Etravirine |
Etravirine is an non-nucleoside reverse transcriptase inhibitors (NNRTI) of human immunodeficiency virus type 1 (HIV-1). Etravirine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme’s catalytic site. |
| List of Excipients |
|---|
|
INTELENCE 25 mg tablets: Hypromellose INTELENCE 100 mg tablets: Hypromellose INTELENCE 200 mg tablets: Hypromellose |
INTELENCE 25 mg tablets: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 2 desiccant pouches, fitted with a polypropylene (PP) child resistant closure. Each carton contains one bottle.
INTELENCE 100 mg tablets: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure. Each carton contains one bottle.
INTELENCE 200 mg tablets: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 60 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure. Each carton contains one bottle.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
25 mg: EU/1/08/468/003
100 mg: EU/1/08/468/001
200 mg: EU/1/08/468/002
Date of first authorisation: 28 August 2008
Date of latest renewal: 23 August 2018
| Drug | Countries | |
|---|---|---|
| INTELENCE | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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