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Taliglucerase alfa
Taliglucerase alfa, commercially known as Elelyso, is a biopharmaceutical drug developed by Protalix and Pfizer.〔http://clinicaltrials.gov/ct2/show/NCT00962260〕 The drug, a recombinant glucocerebrosidase used to treat Gaucher’s Disease, was the first plant-made pharmaceutical to win approval by the U.S. Food and Drug Administration.〔http://www.sciencemag.org/content/320/5875/473.summary〕〔Maxmen, Amy (2 may 2012) (First plant-made drug on the market ) Nature, Biology & Biotechnology, Industry, Retrieved 26 June 2012〕
==Approval history==
U.S. FDA New Drug Application (NDA) was granted approval in May 2012 for use in adults.〔http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022458s000ltr.pdf〕〔http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022458lbl.pdf〕 U.S. FDA Supplemental New Drug Application (sNDA) for pediatric use was granted approved in August 2014.〔http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022458Orig1s003,022458Orig1s006ltr.pdf〕 In Israel, the Israeli Ministry of Health granted approval in September 2012.〔http://www.old.health.gov.il/units/pharmacy/trufot/PerutTrufa.asp?Reg_Number=148%2067%2033413%2000&safa=e〕 In Brazil, the Brazilian Health Surveillance Agency (ANVISA) granted approval in March 2013. In Canada, Health Canada issued a Notice of Compliance in May 2014 for both adults and paediatric patients.〔http://www.hc-sc.gc.ca/dhp-mps/prodpharma/sbd-smd/drug-med/sbd_smd_2014_elelyso_140854-eng.php〕
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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