Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
SIRTURO 20 mg tablets.
SIRTURO 100 mg tablets.
| Pharmaceutical Form |
|---|
|
SIRTURO 20 mg tablets: Tablet. Uncoated, white to almost white oblong tablet (12.0 mm long x 5.7 mm wide), with score line on both sides, debossed with “2” and “0” on one side and plain on other side. The tablet can be divided into equal doses. SIRTURO 100 mg tablets: Tablet. Uncoated, white to almost white round biconvex tablet, 11 mm in diameter, with debossing of “T” over “207” on one side and “100” on the other side. |
SIRTURO 20 mg tablets: Each tablet contains bedaquiline fumarate equivalent to 20 mg of bedaquiline.
SIRTURO 100 mg tablets: Each tablet contains bedaquiline fumarate equivalent to 100 mg of bedaquiline.
Excipient with known effect: Each tablet contains 145 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Bedaquiline |
Bedaquiline is a diarylquinoline. Bedaquiline specifically inhibits mycobacterial ATP (adenosine 5'-triphosphate) synthase, an essential enzyme for the generation of energy in Mycobacterium tuberculosis. The inhibition of ATP synthase leads to bactericidal effects for both replicating and non-replicating tubercle bacilli. |
| List of Excipients |
|---|
|
SIRTURO 20 mg tablet: Microcrystalline cellulose SIRTURO 100 mg tablet: Lactose monohydrate |
SIRTURO 20 mg tablets: White, opaque, high-density polyethylene (HDPE) bottle with child-resistant polypropylene (PP) closure with aluminium induction seal liner. Each bottle contains 60 tablets and silica gel desiccant.
SIRTURO 100 mg tablets: White HDPE bottle with child-resistant PP closure with aluminium induction seal liner containing 188 tablets.
Carton containing 4 push-through blister strips (containing 6 tablets per strip). Tablets are packaged in aluminium/aluminium foil blisters.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
EU/1/13/901/001
EU/1/13/901/002
EU/1/13/901/003
Date of first authorisation: 5 March 2014
Date of latest renewal: 11 January 2021
| Drug | Countries | |
|---|---|---|
| SIRTURO | Austria, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Turkey, United Kingdom, United States, South Africa |
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