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INVOKANA Film-coated tablets (2018)

Active ingredients: Canagliflozin

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.

Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free.

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.

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.

Chemical substance
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
Authorization dates

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

Date of first authorisation: 15 November 2013

Date of latest renewal: 26 July 2018

Marketing authorization number:

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)