跳至主要内容
MedPath Trial Home
临床试验
产品
机构
资讯
AI 研究
价格
Search
EN
登录
我们重视您的隐私
我们使用 Cookie 分析网站流量并改善您的体验。请参阅我们的
隐私政策
。
拒绝
接受
XYNTHA moroctocog alfa (rch) 2000IU powder for injection plus pre-filled diluent syringe - TGA Drug Approval Details
Approvals
/
TGA
/
XYNTHA moroctocog alfa (rch) 2000IU powder for injection plus pre-filled diluent syringe
Approved
STANDARD
XYNTHA moroctocog alfa (rch) 2000IU powder for injection plus pre-filled diluent syringe
Pfizer Australia Pty Ltd
🇦🇺 Therapeutic Goods Administration
Approval Date
Dec 9, 2025
Approval ID
cd4612c7edff3d5e
Company
Pfizer Australia Pty Ltd
Type
Standard
Approval Details
Approval Id
cd4612c7edff3d5e
Product Name
XYNTHA moroctocog alfa (rch) 2000IU powder for injection plus pre-filled diluent syringe
Artg Id
161717
Artg Name
XYNTHA moroctocog alfa (rch) 2000IU powder for injection plus diluent syringe
Sponsor
Pfizer Australia Pty Ltd
Company Detail Path
/organization/pfizer-australia-pty-ltd
Artg Date
2009-06-26
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-2010-CMI-06727-3
Product Information
http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2010-PI-06728-3
Approved
Quick Info
Agency
TGA
Country
🇦🇺
Approval Date
Dec 9, 2025
Approval ID
cd4612c7edff3d5e
Type
Standard
Back to TGA Approvals