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SPIKEVAX BIVALENTE ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMOS/50 MICROGRAMOS)/ML DISPERSION INYECTABLE - CIMA-AEMPS Drug Approval Details
Approvals
/
CIMA-AEMPS
/
SPIKEVAX BIVALENTE ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMOS/50 MICROGRAMOS)/ML DISPERSION INYECTABLE
Approved
STANDARD
SPIKEVAX BIVALENTE ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMOS/50 MICROGRAMOS)/ML DISPERSION INYECTABLE
Moderna Biotech Spain S.L.
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Oct 26, 2022
Approval ID
883be06b48a74e4f
Company
Moderna Biotech Spain S.L.
Type
Standard
Approval Details
Approval Id
883be06b48a74e4f
Drug Cima Aemps Name
SPIKEVAX BIVALENTE ORIGINAL/OMICRON BA.4-5 (50 MICROGRAMOS/50 MICROGRAMOS)/ML DISPERSION INYECTABLE
Register Number
1201507006
Holder Company Name
Moderna Biotech Spain S.L.
Marketing Company Name
Moderna Biotech Spain S.L.
Authorization Date
2022-10-26
Dosage Form
DISPERSIÓN INYECTABLE
Dose
50 MICROGRAMOS/50 MICROGRAMOS
Route Of Administration
VÍA INTRAMUSCULAR
Prescription Type
Medicamento Sujeto A Prescripción Médica
Commercialized
No
Company Name
Moderna Biotech Spain S.L.
Active Ingredients
ELASOMERAN
0,05 mg
DAVESOMERAN
0,05 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Oct 26, 2022
Approval ID
883be06b48a74e4f
Type
Standard
Back to CIMA-AEMPS Approvals