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.

SKYCLARYS 50 MG CAPSULAS DURAS - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/SKYCLARYS 50 MG CAPSULAS DURAS

Approved

STANDARD

SKYCLARYS 50 MG CAPSULAS DURAS

Biogen Netherlands B.V.🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Feb 29, 2024
Approval ID: baa5f80de9fe9791
Company: Biogen Netherlands B.V.
Type: Standard

Approval Details

Approval Id: baa5f80de9fe9791
Drug Cima Aemps Name: SKYCLARYS 50 MG CAPSULAS DURAS
Register Number: 1231786001
Holder Company Name: Biogen Netherlands B.V.
Marketing Company Name: Biogen Spain S.L.
Holder Company Detail Path: /organization/biogen-netherlands-bv
Authorization Date: 2024-02-29
Dosage Form: CÁPSULA DURA
Dose: 50 mg
Route Of Administration: VÍA ORAL
Prescription Type: Uso Hospitalario
Commercialized: No
Company Name: Biogen Netherlands B.V.
Company Detail Path: /organization/biogen-netherlands-bv

Company Information

Pharmaceutical Company Name: Biogen Netherlands BV
Country Name: Netherlands
Website: http://www.biogen.nl

Active Ingredients

OMAVELOXOLONA

50 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Feb 29, 2024

Approval ID

baa5f80de9fe9791

Type

Standard

Back to CIMA-AEMPS Approvals