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ORKAMBI 75 MG/94 MG GRANULADO EN SOBRE - CIMA-AEMPS Drug Approval Details
Approvals
/
CIMA-AEMPS
/
ORKAMBI 75 MG/94 MG GRANULADO EN SOBRE
Approved
STANDARD
ORKAMBI 75 MG/94 MG GRANULADO EN SOBRE
Vertex Pharmaceuticals (Ireland) Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Jul 26, 2023
Approval ID
c48368ae65ee53a1
Company
Vertex Pharmaceuticals (Ireland) Limited
Type
Standard
Approval Details
Approval Id
c48368ae65ee53a1
Drug Cima Aemps Name
ORKAMBI 75 MG/94 MG GRANULADO EN SOBRE
Register Number
1151059008
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
2023-07-26
Dosage Form
GRANULADO
Dose
75 MG /94 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
LUMACAFTOR
75 mg
IVACAFTOR
94 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Jul 26, 2023
Approval ID
c48368ae65ee53a1
Type
Standard
Back to CIMA-AEMPS Approvals