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APO-PRAMIPEXOLE pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack - TGA Drug Approval Details
Approvals
/
TGA
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APO-PRAMIPEXOLE pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack
Approved
STANDARD
APO-PRAMIPEXOLE pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack
Southern Cross Pharma Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
642846d690a2df56
Company
Southern Cross Pharma Pty Ltd
Type
Standard
Approval Details
Approval Id
642846d690a2df56
Product Name
APO-PRAMIPEXOLE pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack
Artg Id
227666
Artg Name
APO-PRAMIPEXOLE pramipexole dihydrochloride monohydrate 0.125 mg tablet blister pack
Sponsor
Southern Cross Pharma Pty Ltd
Company Detail Path
/organization/southern-cross-pharma-pty-ltd
Artg Date
2015-11-17
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-2018-CMI-01996-1
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2015-PI-02750-1
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
642846d690a2df56
Type
Standard
Back to TGA Approvals