Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Italfarmaco S.p.A., Viale F. Testi, 330, 20126 Milano, Italy, Tel: +39 02 64431, info@italfarmacogroup.com
Duvyzat 8.86 mg/ml oral suspension.
| Pharmaceutical Form |
|---|
|
Oral suspension. White to off-white or faintly pink, homogenous suspension when mixed. |
Each ml contains 8.86 mg givinostat (as hydrochloride monohydrate).
Excipient(s) with known effect:
Each ml contains 4.4 mg of sodium benzoate (E211).
Each ml contains 400 mg of sorbitol (E420).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Givinostat is a class I and II histone deacetylase (HDAC) inhibitor that modulates the uncontrolled HDAC activity in dystrophic muscles, which contributes to the pathology of Duchenne muscular dystrophy (DMD). Givinostat HDAC inhibition has been shown to reduce muscle fiber damage, chronic muscular inflammation, fibrosis, fat deposition, and to promote mitochondrial biogenesis. |
| List of Excipients |
|---|
|
Polysorbate 20 (E432) |
Amber polyethylene terephthalate bottle containing 140 ml oral suspension closed with a high-density polyethylene child-resistant closure with low-density polyethylene syringe adapter.
Each pack contains one bottle and one graduated oral syringe of 5 ml.
The syringe of 5 ml is graduated from 1 to 5 ml by increments of 0.5 ml.
Italfarmaco S.p.A., Viale F. Testi, 330, 20126 Milano, Italy, Tel: +39 02 64431, info@italfarmacogroup.com
EU/1/25/1930/001
| Drug | Countries | |
|---|---|---|
| DUVYZAT | Lithuania, United States |
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