Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Vokanamet 50 mg/850 mg film-coated tablets.
Vokanamet 50 mg/1,000 mg film-coated tablets.
Vokanamet 150 mg/850 mg film-coated tablets.
Vokanamet 150 mg/1,000 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Vokanamet 50 mg/850 mg film-coated tablets: The tablet is pink, capsule-shaped, 20 mm in length, film-coated, and debossed with “CM” on one side and “358” on the other side. Vokanamet 50 mg/1,000 mg film-coated tablets: The tablet is beige, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “551” on the other side. Vokanamet 150 mg/850 mg film-coated tablets: The tablet is light yellow, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “418” on the other side. Vokanamet 150 mg/1,000 mg film-coated tablets: The tablet is purple, capsule-shaped, 22 mm in length, film-coated, and debossed with “CM” on one side and “611” on the other side. |
Vokanamet 50 mg/850 mg film-coated tablets: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Vokanamet 50 mg/1,000 mg film-coated tablets: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 1,000 mg of metformin hydrochloride.
Vokanamet 150 mg/850 mg film-coated tablets: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Vokanamet 150 mg/1,000 mg film-coated tablets: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 1,000 mg of metformin hydrochloride.
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). |
|
| Metformin |
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia. |
|
| Metformin and Canagliflozin |
Combination of two oral glucose-lowering medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: canagliflozin, an inhibitor of SGLT2 transporter, and metformin hydrochloride, a member of the biguanide class. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose Film-coating: Vokanamet 50 mg/850 mg film-coated tablets: Macrogol (3350) Vokanamet 50 mg/1,000 mg film-coated tablets: Macrogol (3350) Vokanamet 150 mg/850 mg film-coated tablets: Macrogol (3350) Vokanamet 150 mg/1,000 mg film-coated tablets: Macrogol (3350) |
HDPE bottle with child-resistant closure, induction seal, and desiccant.
The bottles contain 20 or 60 film-coated tablets.
Pack sizes:
1 × 20 film-coated tablets
1 × 60 film-coated tablets
Multipack containing 180 (3 × 60) film-coated tablets.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Vokanamet 50 mg/850 mg film-coated tablets:
EU/1/14/918/001 (20 film-coated tablets)
EU/1/14/918/002 (60 film-coated tablets)
EU/1/14/918/003 (180 film-coated tablets)
Vokanamet 50 mg/1,000 mg film-coated tablets:
EU/1/14/918/004 (20 film-coated tablets)
EU/1/14/918/005 (60 film-coated tablets)
EU/1/14/918/006 (180 film-coated tablets)
Vokanamet 150 mg/850 mg film-coated tablets:
EU/1/14/918/007 (20 film-coated tablets)
EU/1/14/918/008 (60 film-coated tablets)
EU/1/14/918/009 (180 film-coated tablets)
Vokanamet 150 mg/1,000 mg film-coated tablets:
EU/1/14/918/010 (20 film-coated tablets)
EU/1/14/918/011 (60 film-coated tablets)
EU/1/14/918/012 (180 film-coated tablets)
Date of first authorisation: 23 April 2014
Date of latest renewal: 18 December 2018
| Drug | Countries | |
|---|---|---|
| VOKANAMET | Austria, Cyprus, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, Singapore, United Kingdom |
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