Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Invokana 100 mg film-coated tablets.
Invokana 300 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Invokana 100 mg film-coated tablets: The tablet is yellow, capsule-shaped, approximately 11 mm in length, immediate-release and film-coated, with “CFZ” on one side and “100” on the other side. Invokana 300 mg film-coated tablets: The tablet is white, capsule-shaped, approximately 17 mm in length, immediate-release and film-coated, with “CFZ” on one side and “300” on the other side. |
Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Excipient(s) with known effect: Each tablet contains 39.2 mg lactose.
Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Excipient(s) with known effect: Each tablet contains 117.78 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Canagliflozin |
Canagliflozin is an orally-active inhibitor of SGLT2. The SGLT2 transporter, expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. By inhibiting SGLT2, canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for glucose (RTG). |
| List of Excipients |
|---|
|
Tablet core: Lactose Film-coating: Invokana 100 mg film-coated tablets: Poly (vinylalcohol) Invokana 300 mg film-coated tablets: Poly (vinylalcohol) |
Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.
Pack sizes of 10 × 1, 30 × 1, 90 × 1, and 100 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Invokana 100 mg film-coated tablets:
EU/1/13/884/001 (10 film-coated tablets)
EU/1/13/884/002 (30 film-coated tablets)
EU/1/13/884/003 (90 film-coated tablets)
EU/1/13/884/004 (100 film-coated tablets)
Invokana 300 mg film-coated tablets:
EU/1/13/884/005 (10 film-coated tablets)
EU/1/13/884/006 (30 film-coated tablets)
EU/1/13/884/007 (90 film-coated tablets)
EU/1/13/884/008 (100 film-coated tablets)
Date of first authorisation: 15 November 2013
Date of latest renewal: 26 July 2018
| Drug | Countries | |
|---|---|---|
| INVOKANA | Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States |
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