Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013

Granulomatosis with polyangiitis and microscopic polyangiitis

MabThera, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).

Hepatitis-B infection

Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adults with:

Viread 33 mg/g granules are indicated for the treatment of chronic hepatitis B in adults for whom a solid dosage form is not appropriate with:

- compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and / or fibrosis (see section 5.1);
- evidence of lamivudine-resistant hepatitis B virus (see sections 4.8 and 5.1);
- decompensated liver disease (see sections 4.4, 4.8 and 5.1).

Viread 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to 18 years of age with:

Viread 33 mg/g granules are also indicated for the treatment of chronic hepatitis B in adolescents 12 to 18 years of age for whom a solid dosage form is not appropriate with:

- compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and / or fibrosis (see sections 4.4, 4.8 and 5.1).

Xarelto 2.5 mg

- Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1).