XOFLUZA Film-coated tablet Ref.[49734] Active ingredients: Baloxavir marboxil

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany

Product name and form

Xofluza 20 mg film-coated tablets.

Xofluza 40 mg film-coated tablets.

Xofluza 80 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".

Xofluza 80 mg: White to light yellow, oblong shaped film-coated tablets approximately 16.1 mm in length, debossed on one side with "BXM80".

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.

Xofluza 80 mg

Each tablet contains 80 mg baloxavir marboxil.

Excipient(s) with known effect: Each tablet contains 311.6 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient

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) (E1201)
Microcrystalline cellulose (E460)
Sodium stearyl fumarate

Film-coating:

Hypromellose (E464)
Talc (E553b)
Titanium dioxide (E171)

Pack sizes and marketing

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

Pack sizes

Xofluza 20 mg film-coated tablets:

1 blister containing 2 film-coated tablets

Xofluza 40 mg film-coated tablets:

1 blister containing 1 film-coated tablet
1 blister containing 2 film-coated tablets

Xofluza 80 mg film-coated tablets:

1 blister containing 1 film-coated tablet

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
EU/1/20/1500/003
EU/1/20/1500/004

Date of first authorisation: 07 January 2021

Drugs

Drug Countries
XOFLUZA Austria, Ecuador, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, New Zealand, Poland, Romania, Singapore, Turkey, United States, South Africa
 
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