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KALYDECO 75 MG COMPRIMIDOS RECUBIERTOS CON PELICULA - CIMA-AEMPS Drug Approval Details
Approvals
/
CIMA-AEMPS
/
KALYDECO 75 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Approved
STANDARD
KALYDECO 75 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Vertex Pharmaceuticals (Ireland) Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Jan 20, 2021
Approval ID
8f19f1da0cedfbc9
Company
Vertex Pharmaceuticals (Ireland) Limited
Type
Standard
Approval Details
Approval Id
8f19f1da0cedfbc9
Drug Cima Aemps Name
KALYDECO 75 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Register Number
112782007
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
2021-01-20
Dosage Form
COMPRIMIDO RECUBIERTO CON PELÍCULA
Dose
75 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
Name En
Vertex Pharmaceuticals (Ireland) Limited
Country Name
Ireland
City Name
dublin,country_ie
Address
Unit F2, 49 Block
Active Ingredients
IVACAFTOR
93,75 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Jan 20, 2021
Approval ID
8f19f1da0cedfbc9
Type
Standard
Back to CIMA-AEMPS Approvals