Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
EDRONAX 4 mg Tablets.
| Pharmaceutical Form |
|---|
|
Tablet. White, round, convex tablet with a breakline on one side. A ‘P’ is marked on the left side of the breakline. A ‘U’ is marked on the right side of the breakline. The side opposite the breakline is marked ‘7671’. The tablet can be divided into equal halves. |
One tablet contains 4 mg of reboxetine.
For full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Reboxetine |
Reboxetine is a highly selective and potent inhibitor of noradrenaline reuptake. Noradrenaline reuptake inhibition and the consequent increase of noradrenaline availability in the synaptic cleft and modification of noradrenergic transmission, reportedly is among the most relevant mechanisms of action of known antidepressant drugs. |
| List of Excipients |
|---|
|
Cellulose microcrystalline |
The tablets are contained either in amber glass, type III, bottle, closed with an aluminium pilfer-proof screw cap equipped with a polyethylene undercap or in aluminium-PVDC/PVC-PVDC opaque blisters.
Each pack contains: 10, 20, 50, 60, 100, 120, and 180 tablets in blisters; and 60 tablets in glass bottles.
Multipacks of 3x60, 5x60 and 10x60 tablets in blisters; and 3x60, 5x60 and 10x60 tablets in glass bottles.
Not all pack sizes may be marketed.
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
PL 00057/0972
Date of first authorisation: 10 April 1997
Date of last renewal: 10 April 2007
| Drug | Countries | |
|---|---|---|
| EDRONAX | Austria, Australia, Estonia, Croatia, Ireland, Israel, New Zealand, Poland, Turkey, United Kingdom, South Africa |
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