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SPEXOTRAS 0,05 MG/ML POLVO PARA SOLUCION ORAL - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/SPEXOTRAS 0,05 MG/ML POLVO PARA SOLUCION ORAL

Approved

STANDARD

SPEXOTRAS 0,05 MG/ML POLVO PARA SOLUCION ORAL

Novartis Europharm Limited🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Apr 10, 2024
Approval ID: 3f5616675faf5d73
Company: Novartis Europharm Limited
Type: Standard

Approval Details

Approval Id: 3f5616675faf5d73
Drug Cima Aemps Name: SPEXOTRAS 0,05 MG/ML POLVO PARA SOLUCION ORAL
Register Number: 1231781001
Holder Company Name: Novartis Europharm Limited
Marketing Company Name: Novartis Farmaceutica S.A.
Holder Company Detail Path: /organization/novartis-europharm-limited
Authorization Date: 2024-04-10
Dosage Form: POLVO PARA SOLUCIÓN ORAL
Dose: 4,7 mg
Route Of Administration: VÍA ORAL
Prescription Type: Diagnóstico Hospitalario
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

TRAMETINIB DIMETIL SULFOXIDO

5,3 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Apr 10, 2024

Approval ID

3f5616675faf5d73

Type

Standard

Back to CIMA-AEMPS Approvals