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COFACT 500 IU POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE - CIMA-AEMPS Drug Approval Details
Approvals
/
CIMA-AEMPS
/
COFACT 500 IU POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
Approved
STANDARD
COFACT 500 IU POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
Prothya Biosolutions Netherlands B.V.
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Jan 4, 2023
Approval ID
dfd1aa2970d90533
Company
Prothya Biosolutions Netherlands B.V.
Type
Standard
Approval Details
Approval Id
dfd1aa2970d90533
Drug Cima Aemps Name
COFACT 500 IU POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
Register Number
86490
Holder Company Name
Prothya Biosolutions Netherlands B.V.
Marketing Company Name
Accord Healthcare S.L.U.
Holder Company Detail Path
/organization/prothya-biosolutions-netherlands-b-v
Marketing Company Detail Path
/organization/accord-healthcare-sl
Authorization Date
2023-01-04
Dosage Form
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Dose
500 UI
Route Of Administration
VÍA INTRAVENOSA
Prescription Type
Uso Hospitalario
Commercialized
No
Company Name
Prothya Biosolutions Netherlands B.V.
Company Detail Path
/organization/prothya-biosolutions-netherlands-b-v
Company Information
Pharmaceutical Company Name
Prothya Biosolutions Netherlands B.V.
Country Name
Belgium
City Name
unknown,country_be
Address
Unknown Belgian address 0
Website
http://www.prothya.com
Active Ingredients
FACTOR II
14 - 35 UI/ml
FACTOR VII
7 - 20 UI/ml
FACTOR IX
25 UI/ml
FACTOR X
14 - 35 UI/ml
PROTEINA C
11-39 mmol/ml
PROTEINA S
1-8 mmol/ml
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Jan 4, 2023
Approval ID
dfd1aa2970d90533
Type
Standard
Back to CIMA-AEMPS Approvals