Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
AQUIPTA 10 mg tablets.
AQUIPTA 60 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. AQUIPTA 10 mg tablets: White to off-white, round biconvex tablet, diameter 6 mm, and debossed with “A” and “10” on one side. AQUIPTA 60 mg tablets: White to off-white, oval biconvex tablet, 16 mm x 9 mm, and debossed with “A60” on one side. |
AQUIPTA 10 mg tablets: Each tablet contains 10 mg of atogepant.
AQUIPTA 60 mg tablets: Each tablet contains 60 mg of atogepant.
Excipient with known effect: Each 60 mg tablet contains 31.5 mg sodium.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Atogepant |
Atogepant is indicated for prophylaxis of migraine. Atogepant shows affinity to several receptors of the calcitonin/CGRP-receptor family. In view of the clinically relevant free plasma concentrations of atogepant and the fact that CGRP and amylin-1 receptors are considered to be involved in the pathophysiology of migraine, inhibitory effects of atogepant at these receptors could be of clinical relevance. However, the precise mechanism of action of atogepant in the prophylaxis of migraine remains to be established. |
| List of Excipients |
|---|
|
Polyvinylpyrrolidone/Vinyl acetate copolymer |
AQUIPTA 10 mg tablets: Aluminium foil and PVC/PE/PCTFE blisters, each containing 7 tablets. Packs containing 28 or 98 tablets.
AQUIPTA 60 mg tablets: Aluminium foil and PVC/PE/PCTFE blisters, each containing 7 tablets. Packs containing 28 or 98 tablets.
Not all pack sizes may be marketed.
AbbVie Deutschland GmbH & Co. KG, Knollstrasse, 67061 Ludwigshafen, Germany
EU/1/23/1750/001
EU/1/23/1750/002
EU/1/23/1750/003
EU/1/23/1750/004
| Drug | Countries | |
|---|---|---|
| AQUIPTA | Croatia, Ireland, Lithuania, United Kingdom |
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