INVOKANA Film-coated tablet Ref.[6483] Active ingredients: Canagliflozin

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Product name and form

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.

Qualitative and quantitative composition

Invokana 100 mg film-coated tablets

Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.

Excipient(s) with known effect: Each tablet contains 39.2 mg lactose.

Invokana 300 mg film-coated tablets

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
Microcrystalline cellulose
Hydroxypropylcellulose
Croscarmellose sodium
Magnesium stearate

Film-coating:

Invokana 100 mg film-coated tablets:

Poly (vinylalcohol)
Titanium dioxide (E171)
Macrogol 3350
Talc
Iron oxide yellow (E172)

Invokana 300 mg film-coated tablets:

Poly (vinylalcohol)
Titanium dioxide (E171)
Macrogol 3350
Talc

Pack sizes and marketing

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.

Marketing authorization holder

Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium

Marketing authorization dates and numbers

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

Drugs

Drug Countries
INVOKANA Austria, Brazil, Canada, Cyprus, Estonia, Spain, Finland, Hong Kong, Ireland, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

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