AGOMAVAL Film-coated tablet Ref.[51171] Active ingredients: Agomelatine

Source: Medicines Authority (MT)  Revision Year: 2022  Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Product name and form

Agomaval 25 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (Tablet).

Yellow, oblong, biconvex film-coated tablets 9.0 mm long, 4.5 mm wide.

Qualitative and quantitative composition

Each film-coated tablet contains agomelatine-citric acid equivalent to 25 mg agomelatine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Agomelatine

Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist. In humans, agomelatine has positive phase shifting properties; it induces a phase advance of sleep, body temperature decline and melatonin onset.
List of Excipients

Tablet core:

Colloidal silicified dioxide
Cellulose, microcrystalline
Mannitol
Povidone 30
Silica, colloidal anhydrous
Crospovidone
Sodium stearyl fumarate
Magnesium stearate
Stearic acid

Film coating:

Hypromellose
Macrogol
Titanium dioxide (E171)
Talc
Iron oxide yellow (E172)

Pack sizes and marketing

Blister (OPA/Alu/PVC/Alu).

Pack size: 14, 28, 56, 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

Marketing authorization dates and numbers

MA982/03001

17.05.2021 / 15.12.2022

Drugs

Drug Countries
AGOMAVAL Germany, Malta
 
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