Committee for medicinal products for human use (CHMP)

Action: For adoption
Participation of patients’ representatives
See 2.3.1
9.1.3. Tyverb - lapatinib - EMEA/H/C/000795/II/0048/G
Novartis Europharm Ltd
Rapporteur: Filip Josephson, Co-Rapporteur: Bruno Sepodes, PRAC Rapporteur: Rapporteur:
Ulla Wändel Liminga
Scope: “1) C.I.4 (type II): Update of sections 4.4, 4.8, and 5.1 of the SmPC in order to add a
warning on QTc prolongation and update safety information following the submission of study
report EGF114271 (A Phase IV placebo controlled single sequence crossover study to evaluate
the effect of repeat oral doses of lapatinib on cardiac repolarization in patients with advanced
cancer). The Package Leaflet is updated accordingly.
2) C.I.4 (type II): Update of section 4.8 of the SmPC in order to further elaborate on the
undesirable effect ‘serious cutaneous reactions’ based on the review of the Novartis safety
database. The Package Leaflet is updated accordingly”
Action: For adoption
10. Referral procedures
10.1. Procedure for Centrally Authorised products under Article 20 Council
Regulation (EC) No 726/2004
10.1.1. Direct-acting antivirals (DAAV) indicated for the treatment of hepatitis C (interferon
free): Daklinza - daclatasvir; Exviera - dasabuvir ; Viekirax - ombitasvir, paritaprevir,
ritonavir ; Olysio – simeprevir; Sovaldi - sofosbuvir sofosbuvir, Harvoni - ledipasvir –
EMEA/H/A-20/1438
Applicant: Bristol-Myers Squibb Pharma EEIG (Daklinza); AbbVie Ltd (Exviera, Viekirax);
Janssen-Cilag International N.V. (Olysio); Gilead Sciences International Ltd (Harvoni, Sovaldi)
CHMP Rapporteurs: Rapporteur: Filip Josephson, Co-Rapporteur: Robert James Hemmings
(Daklinza), Rapporteur: Filip Josephson, Co-Rapporteur: Johann Lodewijk Hillege (Exviera,
Viekirax), Rapporteur: Arantxa Sancho-Lopez, Co-Rapporteur: Daniela Melchiorri (Olysio);
Rapporteur: Filip Josephson, Co-Rapporteur: Alar Irs (Sovaldi), Rapporteur: Filip Josephson,
Co-Rapporteur: Joseph Emmerich (Harvoni)
PRAC Rapporteur: Margarida Guimarães; PRAC Co-rapporteur: Dolores Montero Corominas
Scope: Minutes of the SAG HIV/Viral diseases meeting
Review of the benefit-risk balance of DAAV following notification by the European Commission
of a referral under Article 20 of Regulation (EC) No 726/2004 based on pharmacovigilance data
Action: For information
Committee for medicinal products for human use (CHMP)
EMA/CHMP/682760/2016 Page 21/30