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.

SUBOXONE 2 MG/0,5 MG PELICULA SUBLINGUAL - CIMA-AEMPS Drug Approval Details

Approvals/CIMA-AEMPS/SUBOXONE 2 MG/0,5 MG PELICULA SUBLINGUAL

Approved

STANDARD

SUBOXONE 2 MG/0,5 MG PELICULA SUBLINGUAL

Indivior Europe Limited🇪🇸 Spanish Agency of Medicines and Medical Devices

Approval Date: Oct 30, 2020
Approval ID: 4b831553d91cc09a
Company: Indivior Europe Limited
Type: Standard

Approval Details

Approval Id: 4b831553d91cc09a
Drug Cima Aemps Name: SUBOXONE 2 MG/0,5 MG PELICULA SUBLINGUAL
Register Number: 106359007
Holder Company Name: Indivior Europe Limited
Marketing Company Name: Indivior Europe Limited
Holder Company Detail Path: /organization/indivior-europe-ltd
Marketing Company Detail Path: /organization/indivior-europe-ltd
Authorization Date: 2020-10-30
Dosage Form: PELICULA SUBLINGUAL
Dose: 2/0.5 mg
Route Of Administration: Vía bucal (buccal use), VÍA SUBLINGUAL
Prescription Type: Diagnóstico Hospitalario
Commercialized: No
Company Name: Indivior Europe Limited
Company Detail Path: /organization/indivior-europe-ltd

Company Information

Pharmaceutical Company Name: Indivior Europe Limited
Name En: Indivior Europe Limited
Country Name: Ireland

Active Ingredients

BUPRENORFINA HIDROCLORURO

2,16 mg

NALOXONA HIDROCLORURO DIHIDRATO

0,61 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Oct 30, 2020

Approval ID

4b831553d91cc09a

Type

Standard

Back to CIMA-AEMPS Approvals