Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Indivior Europe Limited, 27 Windsor Place, Dublin 2, D02 DK44, Ireland
Suboxone 2 mg/0.5 mg sublingual tablets.
Suboxone 8 mg/2 mg sublingual tablets.
Suboxone 16 mg/4 mg sublingual tablets.
| Pharmaceutical Form |
|---|
|
Sublingual tablet. Suboxone 2 mg/0.5 mg sublingual tablets: White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on one side. Suboxone 8 mg/2 mg sublingual tablets: White hexagonal biconvex tablets of 11 mm with “N8” debossed on one side. Suboxone 16 mg/4 mg sublingual tablets: White round biconvex tablets of 10.5 mm with “N16” debossed on one side. |
Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride) and 0.5 mg naloxone (as hydrochloride dihydrate).
Excipients with known effect: Each sublingual tablet contains 42 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.
Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride) and 2 mg naloxone (as hydrochloride dihydrate).
Excipients with known effect: Each sublingual tablet contains 168 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.
Each sublingual tablet contains 16 mg buprenorphine (as hydrochloride) and 4 mg naloxone (as hydrochloride dihydrate).
Excipients with known effect: Each sublingual tablet contains 156.64 mg lactose (as monohydrate). For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Buprenorphine |
Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the ÎŒ (mu) and Îș (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the ÎŒ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence. |
|
| Naloxone |
Naloxone hydrochloride, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors. It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists, such as pentazocine, for example, but also nalorphine. |
| List of Excipients |
|---|
|
Lactose monohydrate |
7 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC.
28 tablets in blister packs Paper/Aluminium/Nylon/Aluminium/PVC.
Not all pack sizes may be marketed.
Indivior Europe Limited, 27 Windsor Place, Dublin 2, D02 DK44, Ireland
Suboxone 2 mg/0.5 mg sublingual tablets:
EU/1/06/359/001
EU/1/06/359/002
Suboxone 8 mg/2 mg sublingual tablets:
EU/1/06/359/003
EU/1/06/359/004
Suboxone 16 mg/4 mg sublingual tablets:
EU/1/06/359/005
EU/1/06/359/006
Date of first authorisation: 26 September 2006
Date of latest renewal: 16 September 2011
| Drug | Countries | |
|---|---|---|
| SUBOXONE | Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, United States, South Africa |
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