Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Xofluza 20 mg film-coated tablets.
Xofluza 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
Xofluza 20 mgWhite 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 mgWhite to light yellow, oblong shaped film-coated tablets approximately 11.1 mm in length, debossed on one side with “BXM40”. |
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.
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 |
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 Film-coating: Hypromellose |
Blister pack (OPA/Aluminum foil/PVC, sealed with aluminium foil).
Pack of 2 tablets.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
EU/1/20/1500/001
EU/1/20/1500/002
| 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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