CHMP recommends approval of pharmaceutical besremi for the treatment of asymptomatic spleen enlargement and real erythrophaemia
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, PharmaceuticalPharmaceutical(http://limited sharescompany(http://(http:// announced that the human medicineproduct seine(http://Committee (CHMP) adopted a positive opinion, recommended approval of the treatment of asymptomatic spleen and large-scale red blood cell hypertrophy market authorizationBesremi's application company is AOP Orphan S AGabout Besremi can beBesremi can be used as an injection solution (250 micrograms/0.5 ml and 500 micrograms/0.5 ml)Besremi's active substance is a ropeginterferon alfa-2b manufactured in accordance with the PIC/S cGMP specification at the Taichung Science Park in TaiwanThe Science Park was certified gmp in January 2018 by the EuropeanMedicines(http:// Authority (EMA) Besremi has the advantage of being able to get a complete hematological response in patients with true erythroblastays The most common side effects of Besremi are reduced white blood cells, platelets, joint pain, fatigue, flu-like illness and muscle pain on Ropeglyon alfa-2b
Ropeglyn alfa-2b is a new long-acting type (-98%) mono-modified proline interferon (ATC L03AB15), with improved pharmacokinetic characteristics and unprecedented doses and resistance Injections every 2 weeks or every 4 weeks during long-term repairs are expected to be the first interferon in the world to be approved for the treatment of true red blood cell hyperplasia Ropegryon alfa-2b was discovered and produced by Pharmaceutical sinatior in Taiwan, which was GMP certified by the European Medicines Agency in January 2018 Ropeglyon alfa-2b is eligible for orphan medicine in the European Union, Switzerland and the United States for the treatment of true red blood cell hyperplasia
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