ATTROGY Film-coated tablet Ref.[115596] Active ingredients: Diflunisal

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Purpose Pharma International AB, Grev Turegatan 13b, 114 46 Stockholm, Sweden

Product name and form

Attrogy 250 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Light orange, capsule shape, biconvex coated tablet, engraved “D250” on one side and plain on the other side. The tablet is 6.35 mm in width and 14.29 mm in length.

Qualitative and quantitative composition

Each film-coated tablet contains 250 mg diflunisal.

Excipient(s) with known effect: Each tablet contains 60 micrograms sunset yellow (E110).

For the full list of excipients, see section 6.1.

Active Ingredient

Diflunisal is a potent stabiliser of tetrameric transthyretin (TTR), which effectively stabilises the tetramer against dissociation to the TTR monomers which are responsible for amyloidosis pathology.

List of Excipients

Microcrystalline cellulose (E460) (PH 101)
Pre-gelatinised starch (E1422)
Croscarmellose sodium (E468)
Silica, hydrophobic colloidal (E551)
Magnesium stearate
Hydroxypropyl methylcellulose (E464) 2910 E5/Hypromellose
Macrogol 3350 (E1521)
Titanium dioxide (E171)
Sunset Yellow Aluminium Lake (E110)
Purified water

Pack sizes and marketing

HDPE bottle with polypropylene child-resistant tamper-evident screw cap with a liner. Pack size of 100 film-coated tablets.

Marketing authorization holder

Purpose Pharma International AB, Grev Turegatan 13b, 114 46 Stockholm, Sweden

Marketing authorization dates and numbers

EU/1/25/1929/001

Drugs

Drug Countries
ATTROGY Austria, Estonia, Lithuania

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