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KAFTRIO 37,5 MG/25 MG/50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA - CIMA-AEMPS Drug Approval Details
Approvals
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CIMA-AEMPS
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KAFTRIO 37,5 MG/25 MG/50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Approved
STANDARD
KAFTRIO 37,5 MG/25 MG/50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Vertex Pharmaceuticals (Ireland) Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Feb 11, 2022
Approval ID
1da35447b53614bb
Company
Vertex Pharmaceuticals (Ireland) Limited
Type
Standard
Approval Details
Approval Id
1da35447b53614bb
Drug Cima Aemps Name
KAFTRIO 37,5 MG/25 MG/50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
Register Number
1201468002
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
2022-02-11
Dosage Form
COMPRIMIDO RECUBIERTO CON PELÍCULA
Dose
37,5 MG/25 MG/50 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
37,5 mg
TEZACAFTOR
25 mg
ELEXACAFTOR
50 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Feb 11, 2022
Approval ID
1da35447b53614bb
Type
Standard
Back to CIMA-AEMPS Approvals