Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Evrenzo 20 mg film-coated tablets.
Evrenzo 50 mg film-coated tablets.
Evrenzo 70 mg film-coated tablets.
Evrenzo 100 mg film-coated tablets.
Evrenzo 150 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablets (tablets). Evrenzo 20 mg tablets: Red, oval tablets (approximately 8 mm × 4 mm) with ‘20’ debossed on one side. Evrenzo 50 mg tablets: Red, oval tablets (approximately 11 mm × 6 mm) with ‘50’ debossed on one side. Evrenzo 70 mg tablets: Red, round tablets (approximately 9 mm) with ‘70’ debossed on one side. Evrenzo 100 mg tablets: Red, oval tablets (approximately 14 mm × 7 mm) with ‘100’ debossed on one side. Evrenzo 150 mg tablets: Red, almond-shaped tablets (approximately 14 mm × 9 mm) with ‘150’ debossed on one side. |
Evrenzo 20 mg film-coated tablets: Each tablet contains 20 mg of roxadustat.
Evrenzo 50 mg film-coated tablets: Each tablet contains 50 mg of roxadustat.
Evrenzo 70 mg film-coated tablets: Each tablet contains 70 mg of roxadustat.
Evrenzo 100 mg film-coated tablets: Each tablet contains 100 mg of roxadustat.
Evrenzo 150 mg film-coated tablets: Each tablet contains 150 mg of roxadustat.
Excipient(s) with known effect:
Each 20 mg film-coated tablet contains 40.5 mg of lactose, 0.9 mg of Allura Red AC aluminium lake and 0.21 mg soya lecithin.
Each 50 mg film-coated tablet contains 101.2 mg of lactose, 1.7 mg of Allura Red AC aluminium lake and 0.39 mg soya lecithin.
Each 70 mg film-coated tablet contains 141.6 mg of lactose, 2.1 mg of Allura Red AC aluminium lake and 0.47 mg soya lecithin.
Each 100 mg film-coated tablet contains 202.4 mg of lactose, 2.8 mg of Allura Red AC aluminium lake and 0.63 mg soya lecithin.
Each 150 mg film-coated tablet contains 303.5 mg of lactose, 3.7 mg of Allura Red AC aluminium lake and 0.84 mg soya lecithin.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Roxadustat |
Roxadustat is a hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI). The activity of HIF-PH enzymes controls intracellular levels of HIF, a transcription factor that regulates the expression of genes involved in erythropoiesis. Activation of the HIF pathway is important in the adaptative response to hypoxia to increase red blood cell production. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coating: Poly(vinyl alcohol) (E1203) |
PVC/aluminium perforated unit dose blisters in a carton containing 12 × 1 film-coated tablets.
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
EU/1/21/1574/001
EU/1/21/1574/002
EU/1/21/1574/003
EU/1/21/1574/004
EU/1/21/1574/005
| Drug | Countries | |
|---|---|---|
| EVRENZO | Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, South Africa |
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