Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Forxiga 5 mg film-coated tablets.
Forxiga 10 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Forxiga 5 mg film-coated tablets: Yellow, biconvex, 0.7 cm diameter round, film-coated tablets with “5” engraved on one side and “1427” engraved on the other side. Forxiga 10 mg film-coated tablets: Yellow, biconvex, approximately 1.1 × 0.8 cm diagonally diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side. |
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Excipient with known effect: Each 5 mg tablet contains 25 mg of lactose.
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Excipient with known effect: Each 10 mg tablet contains 50 mg of lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Dapagliflozin |
Dapagliflozin is a highly potent, selective and reversible inhibitor of SGLT2. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460i) Film-coating: Polyvinyl alcohol (E1203) |
Alu/Alu blister
Forxiga 5 mg film-coated tablets:
Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters.
Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Forxiga 10 mg film-coated tablets:
Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters.
Pack sizes of 10x1, 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
AstraZeneca AB, SE-151 85 Södertälje, Sweden
Forxiga 5 mg film-coated tablets:
EU/1/12/795/001 14 film-coated tablets
EU/1/12/795/002 28 film-coated tablets
EU/1/12/795/003 98 film-coated tablets
EU/1/12/795/004 30 × 1 (unit dose) film-coated tablets
EU/1/12/795/005 90 × 1 (unit dose) film-coated tablets
Forxiga 10 mg film-coated tablets:
EU/1/12/795/006 14 film-coated tablets
EU/1/12/795/007 28 film-coated tablets
EU/1/12/795/008 98 film-coated tablets
EU/1/12/795/009 30 × 1 (unit dose) film-coated tablets
EU/1/12/795/010 90 × 1 (unit dose) film-coated tablets
EU/1/12/795/011 10 × 1 (unit dose) film-coated tablets
Date of first authorisation: 12 November 2012
Date of latest renewal: 28 August 2017
| Drug | Countries | |
|---|---|---|
| FORXIGA | Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa |
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