Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
Sycrest 5 mg sublingual tablets.
| Pharmaceutical Form |
|---|
|
Sublingual tablet. Round, white to off-white, sublingual tablets debossed with “5” on one side. |
Each sublingual tablet contains 5 mg asenapine (as maleate).
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
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The mechanism of action of asenapine is not fully understood. However, based on its receptor pharmacology, it is proposed that the efficacy of asenapine is mediated through a combination of antagonist activity at D2 and 5-HT2A receptors. Actions at other receptors e.g. 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, and a2-adrenergic receptors, may also contribute to the clinical effects of asenapine. |
| List of Excipients |
|---|
|
Gelatin |
Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Not all pack sizes may be marketed.
N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
EU/1/10/640/001
EU/1/10/640/002
EU/1/10/640/003
Date of first authorisation: 01 September 2010
Date of latest renewal: 05 May 2015
| Drug | Countries | |
|---|---|---|
| SYCREST | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Japan, Lithuania, Poland, Romania, United Kingdom |
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