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.

KETOSTERIL COMPRIMIDOS RECUBIERTOS CON PELICULA EFG - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/KETOSTERIL COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

Approved

STANDARD

KETOSTERIL COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

Fresenius Kabi España, S.A.U.🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Mar 10, 2021
Approval ID: b0d527947d06491f
Company: Fresenius Kabi España, S.A.U.
Type: Standard

Approval Details

Approval Id: b0d527947d06491f
Drug Cima Aemps Name: KETOSTERIL COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Register Number: 85837
Holder Company Name: Fresenius Kabi España, S.A.U.
Marketing Company Name: Fresenius Kabi España, S.A.U.
Authorization Date: 2021-03-10
Dosage Form: COMPRIMIDO RECUBIERTO CON PELÍCULA
Dose: Not applicable as several active substances
Route Of Administration: VÍA ORAL
Prescription Type: Medicamento Sujeto A Prescripción Médica
Commercialized: No
Company Name: Fresenius Kabi España, S.A.U.

Active Ingredients

HIDROXIMETIONINA CALCICA

59 mg

CETO ISOLEUCINA CALCICA

67 mg

CETO LEUCINA CALCICA

101 mg

CETO FENILALANINA CALCICA

68 mg

CETO VALINA CALCICA

86 mg

HISTIDINA

38 mg

LISINA ACETATO

105 mg

TREONINA

53 mg

TRIPTOFANO

23 mg

TIROSINA

30 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Mar 10, 2021

Approval ID

b0d527947d06491f

Type

Standard

Back to CIMA-AEMPS Approvals