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SPRAVATO esketamine (as hydrochloride) 28 mg per 2 actuations nasal spray solution - TGA Drug Approval Details
Approvals
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TGA
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SPRAVATO esketamine (as hydrochloride) 28 mg per 2 actuations nasal spray solution
Approved
STANDARD
SPRAVATO esketamine (as hydrochloride) 28 mg per 2 actuations nasal spray solution
Janssen-Cilag Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
bc96b65b43e4a524
Company
Janssen-Cilag Pty Ltd
Type
Standard
Approval Details
Approval Id
bc96b65b43e4a524
Product Name
SPRAVATO esketamine (as hydrochloride) 28 mg per 2 actuations nasal spray solution
Artg Id
311827
Artg Name
SPRAVATO esketamine (as hydrochloride) 28 mg per 2 actuations nasal spray solution
Sponsor
Janssen-Cilag Pty Ltd
Company Detail Path
/organization/janssen-cilag-pty-ltd
Artg Date
2021-03-09
Registration Type
Medicine
Therapeutic Good Type
Medicine
Licence Status
A
Licence Category
RE
Consumer Medicine Info
https://medical-cdn.nocode.com/drug_tga/effe1927676a80364ae20240fb6f475b.pdf
Product Information
https://medical-cdn.nocode.com/drug_tga/16b3cf744f282c206fa3bfe08dd3bc45.pdf
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
bc96b65b43e4a524
Type
Standard
Back to TGA Approvals