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OVALEAP 300IU/0.5mL follitropin alfa (rch) solution for injection, cartridge - TGA Drug Approval Details
Approvals
/
TGA
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OVALEAP 300IU/0.5mL follitropin alfa (rch) solution for injection, cartridge
Approved
STANDARD
OVALEAP 300IU/0.5mL follitropin alfa (rch) solution for injection, cartridge
Theramex Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
873acfdf7e032d1f
Company
Theramex Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
873acfdf7e032d1f
Product Name
OVALEAP 300IU/0.5mL follitropin alfa (rch) solution for injection, cartridge
Artg Id
328122
Artg Name
OVALEAP 300IU/0.5mL follitropin alfa (rch) solution for injection, cartridge
Sponsor
Theramex Australia Pty Ltd
Company Detail Path
/organization/theramex-australia-pty-ltd
Artg Date
2021-03-10
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-2022-CMI-01120-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2021-PI-01344-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
873acfdf7e032d1f
Type
Standard
Back to TGA Approvals