XOFLUZA Film-coated tablet

Active ingredients: Baloxavir marboxil

Product name and form

Xofluza 20 mg film-coated tablets.

Xofluza 40 mg film-coated tablets.

Pharmaceutical Form

Xofluza 20 mg

White to light yellow, oblong shaped film-coated tablets approximately 8.6 mm in length, debossed with “772” on one side and “20” on the other side.

Xofluza 40 mg

White to light yellow, oblong shaped film-coated tablets approximately 11.1 mm in length, debossed on one side with “BXM40”.

Qualitative and quantitative composition

Xofluza 20 mg

Each tablet contains 20 mg baloxavir marboxil.

Excipient(s) with known effect: Each tablet contains 77.9 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Xofluza 40 mg

Each tablet contains 40 mg baloxavir marboxil.

Excipient(s) with known effect: Each tablet contains 155.8 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Baloxavir marboxil is a prodrug that is converted by hydrolysis to baloxavir, the active form that exerts anti-influenza activity. Baloxavir acts on the cap-dependent endonuclease (CEN), an influenza virus-specific enzyme in the polymerase acidic (PA) subunit of the viral RNA polymerase complex and thereby inhibits the transcription of influenza virus genomes resulting in inhibition of influenza virus replication.

List of Excipients

Tablet core:

Lactose monohydrate
Croscarmellose sodium (E468)
Povidone (K25)
Microcrystalline cellulose (E460)
Sodium stearyl fumarate

Film-coating:

Hypromellose
Talc (E553b)
Titanium dioxide (E171)

Pack sizes and marketing

Blister pack (OPA/Aluminum foil/PVC, sealed with aluminium foil).

Pack of 2 tablets.

Marketing authorization holder

Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Marketing authorization dates and numbers

EU/1/20/1500/001
EU/1/20/1500/002

Drugs

Drug
Countries
Austria, Finland, Hong Kong, Ireland, Lithuania, New Zealand, Poland, Singapore, United States