Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Mirtazapine 15 mg orodispersible tablets.
| Pharmaceutical Form |
|---|
|
Orodispersible tablet. The tablets are white or almost white, 8 mm round, biconvex, uncoated tablets and marked M1. |
Each tablet contains 15 mg of mirtazapine.
Excipient(s): 6 mg of Aspartame (E951).
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Mirtazapine |
Mirtazapine is a centrally active presynaptic α2-antagonist, which increases central noradrenergic and serotonergic neurotransmission. The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine. Both enantiomers of mirtazapine are presumed to contribute to the antidepressant activity, the S(+) enantiomer by blocking α2 and 5-HT2 receptors and the R(-) enantiomer by blocking 5-HT3 receptors. |
| List of Excipients |
|---|
|
Mannitol DC |
Al/Al Blister, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.
Al/Al Blister with peel off foil, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.
PP securitainers, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.
HDPE containers with LDPE caps, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets.
Not all pack sizes or types may be marketed.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
PL 20075/0695
Date of first authorisation: 13/07/2011
Date of latest renewal: 23/07/2012
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