TA-46 has completed Phase 1 andhas received Orphan Drug Designation from the European Medicines Agency(EMA) and the U.S. Food and Drug Administration(FDA).
欧州医薬品庁、2013年上半期で44のヒト用医薬品および6の動物用医薬品の承認を推奨。
European Medicines Agency recommends approval of 44 medicines for human use and six medicines for veterinary use in first half 2013.
年2月にALUNBRIGの市販承認申請(MAA)が欧州医薬品庁(EMA)に提出されました。
A Marketing Authorization Application(MAA) for ALUNBRIG was submitted to the European Medicines Agency(EMA) in February 2017.
数年前、カモミールの利用を欧州医薬品庁(EMA)が承認しました。
The European Medicine Agency(EMA) approved the use of chamomile a few years ago.
欧州医薬品庁(EMA)のオランダ移転によって、今後起こりうるビジネス環境やエコシステムの変化とは?
What will happen to the business environment andecosystem changes in the future as a result of the European Medicines Agency(EMA) relocation in the Netherlands?
The European Medicines Agency's Committee for Medicinal Products for Human Use(CHMP) recently recommended granting marketing authorization for IDELVION in the European Union.
欧州においては、欧州医薬品庁(EMA)により、2016年11月に承認されました。
It was submitted to the European Medicines Agency(EMA) in September 2016.
年8月、aducanumabは欧州医薬品庁(EMA)のPRIMEプログラムとして認定されました。
In August 2016 aducanumab was accepted into the European Medicines Agency's PRIME program.
The U.S. Food and Drug Administration(FDA) and the European Medicines Agency(EMA) are currently reviewing marketing authorization applications for EVENITY and interactions with the agencies are ongoing.
According to the European Medicines Agency, there are between 5000 and 8000 distinct rare diseases in the EU, affecting between 27 and 36 million people.
Beginning in 2018, the European Medicines Agency(EMA) will require biopharmaceutical companies to submit data on medicines in accordance with the International Organization for Standardization(ISO) IDMP standards.
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