Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: BridgeBio Europe B.V., Weerdestein 97, Amsterdam, 1083 GG, The Netherlands
BEYONTTRA 356 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). White, oval film-coated tablets approximately 15 mm × 7.5 mm with the BridgeBio company logo followed by “ACOR” in black ink on one side. |
Each film-coated tablet contains acoramidis hydrochloride equivalent to 356 mg acoramidis.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Acoramidis |
Transthyretin amyloid cardiomyopathy is initiated by the dissociation of the transthyretin (TTR) tetramer into its constituent monomers. Acoramidis is a specific stabiliser of TTR. Acoramidis was designed to mimic the disease protective genetic variant (T119M), through the formation of hydrogen bonds with adjacent serine residues within both thyroxine binding sites of the tetramer. |
| List of Excipients |
|---|
|
Tablet core: Microcrystalline cellulose (E460) Film-coat: Macrogol poly(vinyl alcohol) grafted copolymer (E1209) Printing ink: Iron oxide black (E172) |
Blister packs – Thermoformed dual-cavity blisters of PVC/PCTFE with aluminium foil lidding.
Pack sizes: 120 tablets in 6 blister strips, each with 10 cavities (2 tablets per cavity).
BridgeBio Europe B.V., Weerdestein 97, Amsterdam, 1083 GG, The Netherlands
EU/1/24/1906/001
| Drug | Countries | |
|---|---|---|
| BEYONTTRA | France, Lithuania |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.