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EVRYSDI risdiplam 0.75 mg/mL powder for oral solution bottle - TGA Drug Approval Details
Approvals
/
TGA
/
EVRYSDI risdiplam 0.75 mg/mL powder for oral solution bottle
Approved
STANDARD
EVRYSDI risdiplam 0.75 mg/mL powder for oral solution bottle
Roche Products Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
May 30, 2025
Approval ID
f1efdaeb7b8f406f
Company
Roche Products Pty Ltd
Type
Standard
Approval Details
Approval Id
f1efdaeb7b8f406f
Product Name
EVRYSDI risdiplam 0.75 mg/mL powder for oral solution bottle
Artg Id
340350
Artg Name
EVRYSDI risdiplam 0.75 mg/mL powder for oral solution bottle
Sponsor
Roche Products Pty Ltd
Company Detail Path
/organization/roche-products-pty-ltd
Artg Date
2021-06-02
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/ab7b44d74c17342ea5843ec2d57a02e5.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/511071b3cef237ec2831e6bc5223c6fc.pdf
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
May 30, 2025
Approval ID
f1efdaeb7b8f406f
Type
Standard
Back to TGA Approvals