Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AKEBIA EUROPE Limited, 70 Sir John Rogersons Quay, Dublin 2, Co. Dublin, D02 R296, Ireland
Vafseo 150 mg film-coated tablets.
Vafseo 300 mg film-coated tablets.
Vafseo 450 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. Vafseo 150 mg film-coated tablets: Round, white tablets 8 mm in diameter, debossed with “VDT” on one side and “150” on the other side. Vafseo 300 mg film-coated tablets: Oval, yellow tablets 8 mm in width, 13 mm in length, debossed with “VDT” on one side and “300” on the other side. Vafseo 450 mg film-coated tablets: Oval, pink tablets 9 mm in width, 15 mm in length debossed with “VDT” on one side and “450” on the other side. |
Vafseo 150 mg film-coated tablets: Each 150 mg film-coated tablet contains 150 mg of vadadustat.
Vafseo 300 mg film-coated tablets: Each 300 mg film-coated tablet contains 300 mg of vadadustat.
Vafseo 450 mg film-coated tablets: Each 450 mg film-coated tablet contains 450 mg of vadadustat.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vadadustat |
Vadadustat is a hypoxia-inducible factor prolyl-hydroxylase inhibitor which leads to increased cellular levels of hypoxia-inducible factor thereby stimulating endogenous erythropoietin (EPO) production, increasing iron mobilization and red blood cell production, resulting in gradual rate of rise in Hb. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Tablet coating: Polyvinyl alcohol (E1203) |
Vafseo 150 mg film-coated tablets:
28 tablets in 2 PVC/aluminium foil blisters with 14 × 150 mg film-coated tablets
98 tablets in 7 PVC/aluminium foil blisters with 14 × 150 mg film-coated tablets
Vafseo 300 mg film-coated tablets:
28 tablets in 2 PVC/aluminium foil blisters with 14 × 300 mg film-coated tablets
98 tablets in 7 PVC/aluminium foil blisters with 14 × 300 mg film-coated tablets
Vafseo 450 mg film-coated tablets:
28 tablets in 2 PVC/aluminium foil blisters with 14 × 450 mg film-coated tablets
98 tablets in 7 PVC/aluminium foil blisters with 14 × 450 mg film-coated tablets
Not all pack sizes may be marketed.
AKEBIA EUROPE Limited, 70 Sir John Rogerson’s Quay, Dublin 2, Co. Dublin, D02 R296, Ireland
EU/1/23/1725/001
EU/1/23/1725/002
EU/1/23/1725/003
EU/1/23/1725/004
EU/1/23/1725/005
EU/1/23/1725/006
| Drug | Countries | |
|---|---|---|
| VAFSEO | Austria, Estonia, Croatia, Ireland, Italy, Japan, Lithuania |
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