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KAFTRIO 75 MG/50 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA - CIMA-AEMPS Drug Approval Details
Approvals
/
CIMA-AEMPS
/
KAFTRIO 75 MG/50 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Approved
STANDARD
KAFTRIO 75 MG/50 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Vertex Pharmaceuticals (Ireland) Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Oct 23, 2020
Approval ID
7bad20fcf107a0a2
Company
Vertex Pharmaceuticals (Ireland) Limited
Type
Standard
Approval Details
Approval Id
7bad20fcf107a0a2
Drug Cima Aemps Name
KAFTRIO 75 MG/50 MG/100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Register Number
1201468001
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
2020-10-23
Dosage Form
COMPRIMIDO RECUBIERTO CON PELÍCULA
Dose
75 mg/50 mg/100 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
TEZACAFTOR
50 mg
IVACAFTOR
75 mg
ELEXACAFTOR
100 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Oct 23, 2020
Approval ID
7bad20fcf107a0a2
Type
Standard
Back to CIMA-AEMPS Approvals