EMCITATE Dispersible tablet Ref.[114870] Active ingredients: Tiratricol

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Rare Thyroid Therapeutics International AB, Klara Norra Kyrkogata 26, 111 22, Stockholm, Sweden

Product name and form

Emcitate 350 microgram dispersible tablets.

Pharmaceutical Form

Dispersible tablet.

White, oblong tablet (size: 10 mm long, 5 mm wide) with score lines on both sides.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 350 micrograms tiratricol.

Excipient with known effect:

Each tablet contains 19 mg of lactose (corresponding to 20 mg of lactose monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tiratricol

Tiratricol (3,3',5-triiodothyroacetic acid) is a naturally circulating metabolite of active thyroid hormone (T3) with a high degree of structural similarity and follows the same downward degradation pathway (deiodination and conjugation) and elimination via bile and urine. Tiratricol has been demonstrated to be able to enter MCT8 dependent cells without a functioning MCT8 transporter unlike T3 and T4. Tiratricol can thereby replace T3 in MCT8 dependent tissues and restore normal thyroid hormone activity across tissues.

List of Excipients

Lactose monohydrate
Calcium hydrogen phosphate
Maize starch
Magnesium stearate

Pack sizes and marketing

PVC/Aluminium blister.

Pack size of 60 dispersible tablets.

Marketing authorization holder

Rare Thyroid Therapeutics International AB, Klara Norra Kyrkogata 26, 111 22, Stockholm, Sweden

Marketing authorization dates and numbers

EU/1/24/1897/001

Drugs

Drug Countries
EMCITATE Estonia, Lithuania

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