AUGTYRO Capsule, hard Ref.[114562] Active ingredients: Repotrectinib

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Product name and form

AUGTYRO 40 mg hard capsules.

AUGTYRO 160 mg hard capsules.

Pharmaceutical Form

Capsule, hard (capsule).

AUGTYRO 40 mg hard capsules: Size 0 (21.7 mm in length), hard gelatin capsule with white opaque body and cap, and “REP 40” printed in blue ink on the cap.

AUGTYRO 160 mg hard capsules: Size 0 (21.7 mm in length), hard gelatin capsule with blue opaque body and cap, and “REP 160” printed in white ink on the cap.

Qualitative and quantitative composition

AUGTYRO 40 mg hard capsules: Each hard capsule contains 40 mg repotrectinib.

AUGTYRO 160 mg hard capsules: Each hard capsule contains 160 mg repotrectinib.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Repotrectinib

Repotrectinib is an inhibitor of proto-oncogene tyrosine-protein kinase ROS1, the tropomyosin receptor tyrosine kinases (TRK) TRKA, TRKB, TRKC, and anaplastic lymphoma kinase (ALK). Repotrectinib has demonstrated in vitro and in vivo inhibition of cell lines expressing the targeted fusion oncogenes ROS1, TRKA, TRKB, TRKC, and corresponding mutations (ROS1G2032R, ROS1D2033N, TRKAG595R, TRKBG639R, TRKCG623R).
List of Excipients

Capsule content:

Microcrystalline cellulose
Sodium lauryl sulphate
Croscarmellose sodium
Silica colloidal anhydrous
Magnesium stearate (for 160 mg hard capsule only)

Capsule shell:

Gelatin
Titanium dioxide (E171)
Brilliant blue (E133 – for 160 mg hard capsule only)

Printing ink (40 mg hard capsule):

Shellac (E904)
Indigo carmine aluminium lake (E132)

Printing ink (160 mg hard capsule):

Shellac (E904)
Titanium dioxide (E171)

Pack sizes and marketing

AUGTYRO 40 mg hard capsules:

High-density polyethylene (HDPE) bottles with 2-piece child-resistant continuous thread (CRCT) polypropylene (PP) closures.

Each bottle contains 60 hard capsules packed in a cardboard carton.

Each bottle contains 120 hard capsules packed in a cardboard carton.

Each carton contains one bottle.

AUGTYRO 160 mg hard capsules:

PVC/polychlorotrifluoroethylene clear blister with push through aluminium foil lidding.

Packs of 20 or 60 hard capsules with 10 hard capsules in blister cards.

Not all pack sized may be marketed.

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Marketing authorization dates and numbers

Augtyro 40 mg hard capsules:

EU/1/24/1883/001 (60 capsules)
EU/1/24/1883/002 (120 capsules)

Augtyro 160 mg hard capsules:

EU/1/24/1883/003 (20 capsules)
EU/1/24/1883/004 (60 capsules)

Drugs

Drug Countries
AUGTYRO Lithuania, United States
 
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