Skip to main content

MedPath Trial Home

Organizations News Research

Data Sources:ClinicalTrials.govEU CTRFDAEMANMPATGAHealth CanadaWHO ICTRP

MedPath Trial Home

Search trials. Track pipelines. Understand approvals. With AI-powered intelligence for clinical research.

Product

Clinical Trials
Drug Intelligence
Global Approvals
AI Research
Pricing

Resources

FAQ
Search

Company

News
About
Contact

Legal

Privacy Policy
Terms of Service

Disclaimer: This website provides information retrieval and data analysis services. The content does not constitute medical advice. Eligibility assessments are for reference only and should not replace consultation with qualified healthcare professionals. Data is sourced from public registries and regulatory agencies; MedPath does not guarantee completeness or accuracy. Always verify information with primary sources.

© 2026 MedPath Trial. All rights reserved.

We value your privacy

We use cookies to analyze site traffic and improve your experience. See our Privacy Policy.

DABIGATRAN ETEXILATO KRKA 110 MG CAPSULAS DURAS EFG - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/DABIGATRAN ETEXILATO KRKA 110 MG CAPSULAS DURAS EFG

Approved

STANDARD

DABIGATRAN ETEXILATO KRKA 110 MG CAPSULAS DURAS EFG

Krka D.D. Novo Mesto🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Feb 9, 2024
Approval ID: ecc4209f6d94b06d
Company: Krka D.D. Novo Mesto
Type: Standard

Approval Details

Approval Id: ecc4209f6d94b06d
Drug Cima Aemps Name: DABIGATRAN ETEXILATO KRKA 110 MG CAPSULAS DURAS EFG
Register Number: 89309
Holder Company Name: Krka D.D. Novo Mesto
Marketing Company Name: Krka Farmaceutica S.L.
Authorization Date: 2024-02-09
Dosage Form: CÁPSULA DURA
Dose: 110 mg
Route Of Administration: VÍA ORAL
Prescription Type: Medicamento Sujeto A Prescripción Médica
Commercialized: Yes
Company Name: Krka D.D. Novo Mesto

Active Ingredients

DABIGATRAN ETEXILATO MESILATO

126,87 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Feb 9, 2024

Approval ID

ecc4209f6d94b06d

Type

Standard

Back to CIMA-AEMPS Approvals