Date: 2011-10-12
Type of information: Granting of a Market Authorisation in Japan
Product name: Mircera®
Compound: epoetin beta pegol
Therapeutic area: Renal diseases
Action mechanism: long-acting erythropoiesis stimulating agent
Company: Chugai (Japan) Roche (Switzerland)
Disease: renal anemia
Latest news: On April 22, 2011, Chugai Pharmaceutical announced that it has obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare , for a long-acting erythropoiesis stimulating agent (ESA), with indication for use in the treatment of renal anemia. The drug was approved in Europe in 2007, and is currently being launched in more than 100 countries around the world.
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Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
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Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
