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LIBMELDY 2-10 X 10^6 CELULAS/ML DISPERSION PARA PERFUSION - CIMA-AEMPS Drug Approval Details
Approvals
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CIMA-AEMPS
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LIBMELDY 2-10 X 10^6 CELULAS/ML DISPERSION PARA PERFUSION
Approved
STANDARD
LIBMELDY 2-10 X 10^6 CELULAS/ML DISPERSION PARA PERFUSION
Orchard Therapeutics (Netherlands) B.V.
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Oct 19, 2021
Approval ID
2218d77860725072
Company
Orchard Therapeutics (Netherlands) B.V.
Type
Standard
Approval Details
Approval Id
2218d77860725072
Drug Cima Aemps Name
LIBMELDY 2-10 X 10^6 CELULAS/ML DISPERSION PARA PERFUSION
Register Number
1201493001
Holder Company Name
Orchard Therapeutics (Netherlands) B.V.
Marketing Company Name
Orchard Therapeutics (Netherlands) B.V.
Holder Company Detail Path
/organization/orchard-therapeutics-netherlands-b-v
Marketing Company Detail Path
/organization/orchard-therapeutics-netherlands-b-v
Authorization Date
2021-10-19
Dosage Form
DISPERSION PARA PERFUSION
Dose
2-10 million cells/ml
Route Of Administration
VÍA INTRAVENOSA
Prescription Type
Uso Hospitalario
Commercialized
Yes
Company Name
Orchard Therapeutics (Netherlands) B.V.
Company Detail Path
/organization/orchard-therapeutics-netherlands-b-v
Company Information
Pharmaceutical Company Name
Orchard Therapeutics (Netherlands) B.V.
Country Name
Netherlands
City Name
amsterdam,noord-holland,country_nl
Address
Basisweg 10
Active Ingredients
ATIDARSAGEN AUTOTEMCEL
2-10 million células/ml
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Oct 19, 2021
Approval ID
2218d77860725072
Type
Standard
Back to CIMA-AEMPS Approvals