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SYCREST Sublingual tablet (2018)

Active ingredients: Asenapine

Product Name and Form

Sycrest 5 mg sublingual tablets.

Pharmaceutical form

Sublingual tablet.

Round, white to off-white, sublingual tablets debossed with “5” on one side.

Qualitative and Quantitative Composition

Each sublingual tablet contains 5 mg asenapine (as maleate).

For the full list of excipients, see section 6.1.

Chemical substance
Description
Asenapine

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
Mannitol (E421)

Pack sizes and Marketing

Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands

Date of first authorisation: 01 September 2010
Date of latest renewal: 05 May 2015

Marketing authorization number:

EU/1/10/640/001
EU/1/10/640/002
EU/1/10/640/003