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Approvals/CIMA-AEMPS/SUBOXONE 12 MG/3 MG PELICULA SUBLINGUAL

Approved

STANDARD

SUBOXONE 12 MG/3 MG PELICULA SUBLINGUAL

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

Approval Date: Oct 29, 2020
Approval ID: f895a6de90c668c7
Company: Indivior Europe Limited
Type: Standard

Approval Details

Approval Id: f895a6de90c668c7
Drug Cima Aemps Name: SUBOXONE 12 MG/3 MG PELICULA SUBLINGUAL
Register Number: 106359016
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: 2020-10-29
Dosage Form: PELICULA SUBLINGUAL
Dose: 12 mg/3 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

12,96 mg

NALOXONA HIDROCLORURO DIHIDRATO

3,66 mg

Approved

Quick Info

Agency

CIMA-AEMPS

Country

🇪🇸

Approval Date

Oct 29, 2020

Approval ID

f895a6de90c668c7

Type

Standard

Back to CIMA-AEMPS Approvals

SUBOXONE 12 MG/3 MG PELICULA SUBLINGUAL - CIMA-AEMPS Drug Approval Details