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Approvals
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TGA
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MYOZYME alglucosidase alfa-rch 50 mg / 10 mL powder for concentrate for solution for infusion
Approved
STANDARD
MYOZYME alglucosidase alfa-rch 50 mg / 10 mL powder for concentrate for solution for infusion
Sanofi-Aventis Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
519342912e0c334f
Company
Sanofi-Aventis Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
519342912e0c334f
Product Name
MYOZYME alglucosidase alfa-rch 50 mg / 10 mL powder for concentrate for solution for infusion
Artg Id
136005
Artg Name
MYOZYME alglucosidase alfa-rch 50 mg / 10 mL powder for concentrate for solution for infusion
Sponsor
Sanofi-Aventis Australia Pty Ltd
Company Detail Path
/organization/sanofi-aventis-australia-pty-ltd
Artg Date
2008-03-14
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2011-CMI-01774-3
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-07179-3
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
519342912e0c334f
Type
Standard
Back to TGA Approvals
MYOZYME alglucosidase alfa-rch 50 mg / 10 mL powder for concentrate for solution for infusion - TGA Drug Approval Details