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Approvals
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CIMA-AEMPS
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AKYNZEO 300 MG/0,5 MG SUSPENSION ORAL EN SOBRE
Approved
STANDARD
AKYNZEO 300 MG/0,5 MG SUSPENSION ORAL EN SOBRE
Helsinn Birex Pharmaceuticals Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Sep 8, 2026
Approval ID
06d160beccccd325
Company
Helsinn Birex Pharmaceuticals Limited
Type
Standard
Approval Details
Approval Id
06d160beccccd325
Drug Cima Aemps Name
AKYNZEO 300 MG/0,5 MG SUSPENSION ORAL EN SOBRE
Register Number
1151001005
Holder Company Name
Helsinn Birex Pharmaceuticals Limited
Marketing Company Name
Immedica Pharma Ab
Holder Company Detail Path
/organization/helsinn-birex-pharmaceuticals-limited
Marketing Company Detail Path
/organization/immedica-pharma-ab
Authorization Date
2026-09-08
Dosage Form
SUSPENSIÓN ORAL
Dose
300 mg/ 0,5 mg
Route Of Administration
VÍA ORAL
Prescription Type
Uso Hospitalario
Commercialized
No
Company Name
Helsinn Birex Pharmaceuticals Limited
Company Detail Path
/organization/helsinn-birex-pharmaceuticals-limited
Company Information
Pharmaceutical Company Name
HELSINN BIREX PHARMACEUTICALS LIMITED
Country Name
Ireland
City Name
dublin,country_ie
Address
Damastown
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Sep 8, 2026
Approval ID
06d160beccccd325
Type
Standard
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