MYQORZO Film-coated tablet Ref.[116279] Active ingredients: Aficamten

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Cytokinetics (Ireland) Limited, 45 Mespil Rd., Dublin D04 W2F1, Ireland

Product name and form

MYQORZO 5 mg film-coated tablets.

MYQORZO 10 mg film-coated tablets.

MYQORZO 15 mg film-coated tablets.

MYQORZO 20 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

MYQORZO 5 mg film-coated tablets: Purple, round tablet debossed with "5" on one side and "CK" on the other side. Tablet size of approximately 4.84 mm in diameter.

MYQORZO 10 mg film-coated tablets: Purple, triangle tablet debossed with "10" on one side and "CK" on the other side. Tablet size of approximately 6.73 mm x 6.99 mm.

MYQORZO 15 mg film-coated tablets: Purple, pentagon tablet debossed with "15" on one side and "CK" on the other side. Tablet size of approximately 7.33 mm x 7.37 mm.

MYQORZO 20 mg film-coated tablets: Purple, oval tablet debossed with "20" on one side and "CK" on the other side. Tablet size of approximately 5.46 mm x 10.29 mm.

Qualitative and quantitative composition

MYQORZO 5 mg film-coated tablets: Each film-coated tablet contains 5 mg aficamten.

MYQORZO 10 mg film-coated tablets: Each film-coated tablet contains 10 mg aficamten.

MYQORZO 15 mg film-coated tablets: Each film-coated tablet contains 15 mg aficamten.

MYQORZO 20 mg film-coated tablets: Each film-coated tablet contains 20 mg aficamten.

For the full list of excipients, see section 6.1.

Active Ingredient

Aficamten is a reversible allosteric cardiac myosin inhibitor that binds directly to the motor domain of cardiac myosin and prevents it from entering the force-producing state. It is designed to reduce the hypercontractility in the cardiac sarcomere fundamental to the pathophysiology of hypertrophic cardiomyopathy (HCM). The consequent reduction in cardiac contractility reduces left ventricular outflow tract (LVOT) obstruction in HCM patients.
List of Excipients

Tablet core:

MicrocrystallinEcellulos (E460(i))
Mannitol (E421)
CroscarmellosEsodium (E468)
Hydroxypropylcellulos (E463)
Sodium laurilsulfate
Magnesium stearat (E470b)

Film coating:

Macrogol poly(vinyl alcohol) grafted copolymer (E1209)
Talc (E553b)
Titanium dioxid (E171)
Glycerol mono and dicaprylocaprat (E471)
Poly(vinyl alcohol) (E1203)
Indigo carminEaluminum lak (E132)
Carmin (E120)

Pack sizes and marketing

Polyvinylchloride (PVC)/Aluminium foil blister containing 14 film-coated tablets.

Pack size of 28 tablets.

Marketing authorization holder

Cytokinetics (Ireland) Limited, 45 Mespil Rd., Dublin D04 W2F1, Ireland

Marketing authorization dates and numbers

EU/1/25/2014/001
EU/1/25/2014/002
EU/1/25/2014/003
EU/1/25/2014/004

Drugs

Drug Countries
MYQORZO Lithuania, United States
 
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