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KAFTRIO 60 MG/40 MG/80 MG GRANULADO EN SOBRE - CIMA-AEMPS Drug Approval Details
Approvals
/
CIMA-AEMPS
/
KAFTRIO 60 MG/40 MG/80 MG GRANULADO EN SOBRE
Approved
STANDARD
KAFTRIO 60 MG/40 MG/80 MG GRANULADO EN SOBRE
Vertex Pharmaceuticals (Ireland) Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Dec 14, 2023
Approval ID
45620b67c4cf0ce4
Company
Vertex Pharmaceuticals (Ireland) Limited
Type
Standard
Approval Details
Approval Id
45620b67c4cf0ce4
Drug Cima Aemps Name
KAFTRIO 60 MG/40 MG/80 MG GRANULADO EN SOBRE
Register Number
1201468003
Holder Company Name
Vertex Pharmaceuticals (Ireland) Limited
Marketing Company Name
Vertex Pharmaceuticals (Spain) S.L.
Holder Company Detail Path
/organization/vertex-pharmaceuticals-ireland-limited
Authorization Date
2023-12-14
Dosage Form
GRANULADO EN SOBRE
Dose
60 MG/40 MG/80 MG
Route Of Administration
VÍA ORAL
Prescription Type
Uso Hospitalario
Commercialized
Yes
Company Name
Vertex Pharmaceuticals (Ireland) Limited
Company Detail Path
/organization/vertex-pharmaceuticals-ireland-limited
Company Information
Pharmaceutical Company Name
VERTEX PHARMACEUTICALS (IRELAND) LIMITED
Country Name
Ireland
City Name
dublin,country_ie
Address
Unit F2, 49 Block
Active Ingredients
IVACAFTOR
60 mg
TEZACAFTOR
40 mg
ELEXACAFTOR
80 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Dec 14, 2023
Approval ID
45620b67c4cf0ce4
Type
Standard
Back to CIMA-AEMPS Approvals