恩瑞格(地拉罗司)上市了没?
Thalassemia is a rare genetic disease. In addition to iron removal and blood transfusion, most patients in China use oral dispersible tablets (deferasirox) for treatment. Oral Enriga (deferasirox) treatment is far safer and more convenient than blood transfusion, and the side effects are smaller.
So, has Enrig (deferasirox) been launched?
Enrig (deferasirox) was researched and developed by Novartis and is already on the market!
The first oral iron chelator approved by the FDA in 2005 for routine use, the FDA granted Enrig (deferasirox) orphan drug status for the treatment of iron overload in non-transfusion-dependent thalassemia. It is currently on the market in more than 80 countries. The oral suspension and dispersible tablets marketed in the United States are approved for the treatment of chronic iron overload due to transfusion in adult and pediatric patients 2 years and older and chronic iron overload in patients 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndrome.
In 2010, Enrig (deferasirox) dispersible tablets were approved for marketing in China, and were approved for the treatment of chronic iron overload caused by frequent blood transfusions in beta-thalassemia patients aged 2 years and above and chronic iron overload in patients with non-transfusion-dependent thalassemia (NTDT) syndrome aged 10 years and above.
In 2012, Enrig (deferasirox) was approved in the EU for the treatment of chronic iron overload thalassemia in patients aged 6 years and older due to frequent blood transfusions (hematocrit ≥7ml/kg/month). It was also approved for the treatment of chronic iron overload caused by blood transfusions when deferoxamine treatment is contraindicated or insufficient. In Japan, this product is approved for the treatment of iron overload caused by blood transfusion.
On January 23, 2013, the FDA approved a new indication (deferasirox) for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia (NTDT) aged 10 years and above.
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