XOLREMDI Hard capsule Ref.[116582] Active ingredients: Mavorixafor

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: X4 Pharmaceuticals (Austria) GmbH, Hohenstaufengasse 9/DG, 1010 Vienna, Austria

Product name and form

Xolremdi 100 mg hard capsules.

Pharmaceutical Form

Hard capsule (capsule).

Size 1 opaque hard gelatine capsules (length approx. 19.4 mm) with white body and light blue cap. The white capsule body is imprinted with "100 mg" in black ink, and the light blue capsule cap is imprinted with "MX4" in black ink.

Qualitative and quantitative composition

Each hard capsule contains 100 mg of mavorixafor.

For the full list of excipients, see section 6.1.

Active Ingredient

Mavorixafor is a CXC Chemokine Receptor 4 (CXCR4) antagonist that blocks the binding of the CXCR4 ligand, stromal-derived factor-1α (SDF-1α)/CXC Chemokine Ligand 12 (CXCL12). SDF-1/CXCR4 plays a role in trafficking and homing of leukocytes to and from the bone marrow compartment. Treatment with mavorixafor results in increased mobilisation of neutrophils and lymphocytes and monocytes from the bone marrow into peripheral circulation.
List of Excipients

Capsule content:

Silica, colloidal anhydrous (E551)
Croscarmellose sodium (E468)
Calcium hydrogen phosphate dihydrate (E3431(ii))
Cellulose, microcrystalline (E460(i))
Sodium laurilsulfate
Sodium stearyl fumarate

Capsule shell:

Indigotine (E132)
Gelatine (E441)
Titanium dioxide (E171)

Printing ink:

Ammonia solution, concentrated (E527)
Black iron oxide (E172)
Isopropyl alcohol
n-butyl alcohol
Propylene glycol (E1520)
Shellac glaze in ethanol (E904)

Pack sizes and marketing

High density polyethylene round white bottle with 38 mm child-resistant screw cap with label. Each bottle contains one desiccant positioned between the rayon coil and cap.

Pack sizes of 60, 90 or 120 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

X4 Pharmaceuticals (Austria) GmbH, Hohenstaufengasse 9/DG, 1010 Vienna, Austria

Marketing authorization dates and numbers

EU/1/26/2017/001
EU/1/26/2017/002
EU/1/26/2017/003

Drugs

Drug Countries
XOLREMDI Lithuania, United States
 
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