AUMSEQA Film-coated tablet Ref.[116271] Active ingredients: Aumolertinib

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Loerrach, Germany

Product name and form

Aumseqa 55 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Light yellow, 7 mm, round immediate release tablet debossed with "E1" on one side and plain on the reverse.

Qualitative and quantitative composition

Each film-coated tablet contains aumolertinib mesilate equivalent to 55 mg aumolertinib.

Excipients with known effect:

Each film-coated tablet contains 15.3 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient
List of Excipients

Tablet core:

Microcrystalline cellulose (E460)
Sodium starch glycolate (type a)
Lactose
Sodium stearyl fumarate (E485)
Magnesium stearate (E572)

Film-coating:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350
Talc (E553b)
Iron oxide yellow (E172)

Pack sizes and marketing

White, high density polyethylene (HDPE) bottle with an aluminium heat-induction sealed child-resistant closure, a silica gel desiccant cannister inside, and a white polypropylene (PP) cap.

Each bottle contains 60 film-coated tablets.

Each carton contains one bottle.

Marketing authorization holder

SFL Pharmaceuticals Deutschland GmbH, Marie-Curie-Strasse 8, 79539 Loerrach, Germany

Marketing authorization dates and numbers

EU/1/25/2006/001

Drugs

Drug Countries
AUMSEQA Lithuania, United Kingdom

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