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Approvals
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CIMA-AEMPS
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SUBOXONE 8 MG/2 MG PELICULA SUBLINGUAL
Approved
STANDARD
SUBOXONE 8 MG/2 MG PELICULA SUBLINGUAL
Indivior Europe Limited
🇪🇸 Spanish Agency of Medicines and Medical Devices
Approval Date
Oct 29, 2020
Approval ID
17fc009fb79d6ce5
Company
Indivior Europe Limited
Type
Standard
Approval Details
Approval Id
17fc009fb79d6ce5
Drug Cima Aemps Name
SUBOXONE 8 MG/2 MG PELICULA SUBLINGUAL
Register Number
106359013
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
8 mg/2 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
8,64 mg
NALOXONA HIDROCLORURO DIHIDRATO
2,44 mg
Approved
Quick Info
Agency
CIMA-AEMPS
Country
🇪🇸
Approval Date
Oct 29, 2020
Approval ID
17fc009fb79d6ce5
Type
Standard
Back to CIMA-AEMPS Approvals
SUBOXONE 8 MG/2 MG PELICULA SUBLINGUAL - CIMA-AEMPS Drug Approval Details