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ZIMBUS BREEZHALER 114 microgramos/46 microgramos/136 microgramos POLVO PARA INHALACION (CAPSULA DURA) - CIMA-AEMPS Drug Approval Details
Approvals
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CIMA-AEMPS
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ZIMBUS BREEZHALER 114 microgramos/46 microgramos/136 microgramos POLVO PARA INHALACION (CAPSULA DURA)
Approved
STANDARD
ZIMBUS BREEZHALER 114 microgramos/46 microgramos/136 microgramos POLVO PARA INHALACION (CAPSULA DURA)
Novartis Europharm Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Dec 15, 2020
Approval ID
6c4a95f5ea45e8c8
Company
Novartis Europharm Limited
Type
Standard
Approval Details
Approval Id
6c4a95f5ea45e8c8
Drug Cima Aemps Name
ZIMBUS BREEZHALER 114 microgramos/46 microgramos/136 microgramos POLVO PARA INHALACION (CAPSULA DURA)
Register Number
1201440002
Holder Company Name
Novartis Europharm Limited
Marketing Company Name
Laboratorios Gebro Pharma S.A.
Holder Company Detail Path
/organization/novartis-europharm-limited
Authorization Date
2020-12-15
Dosage Form
POLVO PARA INHALACIÓN (CÁPSULA DURA)
Dose
114 microgramos/46 microgramos/136 microgramos
Route Of Administration
VÍA INHALATORIA
Prescription Type
Medicamento Sujeto A Prescripción Médica
Commercialized
Yes
Company Name
Novartis Europharm Limited
Company Detail Path
/organization/novartis-europharm-limited
Company Information
Pharmaceutical Company Name
NOVARTIS EUROPHARM LIMITED
Country Name
United Kingdom
City Name
camberley,country_gb
Address
200 Frimley Business Park
Active Ingredients
INDACATEROL ACETATO
0,173 mg
GLICOPIRRONIO BROMURO
0,063 mg
MOMETASONA FUROATO
0,1600 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Dec 15, 2020
Approval ID
6c4a95f5ea45e8c8
Type
Standard
Back to CIMA-AEMPS Approvals