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OYONE 20/10 oxycodone hydrochloride 20 mg / naloxone hydrochloride 10 mg modified release tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
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OYONE 20/10 oxycodone hydrochloride 20 mg / naloxone hydrochloride 10 mg modified release tablet blister pack
Approved
STANDARD
OYONE 20/10 oxycodone hydrochloride 20 mg / naloxone hydrochloride 10 mg modified release tablet blister pack
Maple Healthcare Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Oct 21, 2025
Approval ID
31ac8122d124d9bd
Company
Maple Healthcare Pty Ltd
Type
Standard
Approval Details
Approval Id
31ac8122d124d9bd
Product Name
OYONE 20/10 oxycodone hydrochloride 20 mg / naloxone hydrochloride 10 mg modified release tablet blister pack
Artg Id
462785
Artg Name
OYONE 20/10 oxycodone hydrochloride 20 mg / naloxone hydrochloride 10 mg modified release tablet blister pack
Sponsor
Maple Healthcare Pty Ltd
Company Detail Path
/organization/maple-healthcare-pty-ltd
Artg Date
2025-10-20
Registration Type
Medicine
Therapeutic Good Type
Medicines
Licence Status
A
Licence Category
RE
Active Ingredients
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Oct 21, 2025
Approval ID
31ac8122d124d9bd
Type
Standard
Back to TGA Approvals