Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Indivior UK Limited, The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY, United Kingdom
Temgesic 200 microgram Sublingual Tablets.
Temgesic 400 microgram Sublingual Tablets.
| Pharmaceutical Form |
|---|
|
Sublingual tablet. Temgesic 200 microgram Sublingual Tablets: White to creamy white, circular, biconvex tablets, embossed on one side with “L”. Temgesic 400 microgram Sublingual Tablets: White to creamy white, circular, biconvex tablets, embossed on one side with “H”. |
Buprenorphine hydrochloride 216 µg/tablet, equivalent to 200 µg buprenorphine base.
Excipient(s) with known effect: lactose.
For the full list of excipients, see section 6.1.
Buprenorphine hydrochloride 432 µg/tablet, equivalent to 400 µg buprenorphine base.
Excipient(s) with known effect: lactose.
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 μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence. |
| List of Excipients |
|---|
|
Lactose |
Nylon/aluminium/uPVC blister strips of 10 tablets each, packed in cartons of 50 tablets.
HDPE bottle consisting of 50 tablets.
Indivior UK Limited, The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY, United Kingdom
Temgesic 200 microgram Sublingual Tablets: PL 36699/0004
Temgesic 400 microgram Sublingual Tablets: PL 36699/0005
11/11/1980 / 17/05/2002
| Drug | Countries | |
|---|---|---|
| TEMGESIC | Austria, Germany, Finland, France, Hong Kong, Ireland, Mexico, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, South Africa |
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