1u7kf0g

Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of Imvanex
(modified vaccinia Ankara virus) in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to add angioedema with a frequency
rare. Therefore the current terms of the marketing authorisation(s) should be varied 26 .
The next PSUR should be submitted in accordance with the requirements set out in the list of Union
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC.
6.1.8. Pixantrone – PIXUVRI (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Rafe Suvarna (UK)
Administrative details:
Procedure number(s): EMEA/H/C/002055/PSUV/0015 (with RMP version 6.0)
MAH(s): CTI Life Sciences Limited
Background
Pixantrone is a cytotoxic aza-anthracenedione indicated as monotherapy for the treatment of adult
patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell Lymphomas (NHL).
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Pixuvri, a
centrally authorised medicine containing pixantrone, and issued a recommendation on its marketing
authorisation(s).
Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of Pixuvri
(pixantrone) in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to refine the current warning on the
risk of development of secondary malignancies (specifically acute myeloid leukaemia (AML) and
myelodysplastic syndrome (MDS)). In addition, secondary malignancy should be added to the
product information as an undesirable effect with a frequency uncommon. Therefore the
current terms of the marketing authorisation(s) should be varied 27 .
In the next PSUR, the MAH should provide an update on the invalidated case of tumour lysis
syndrome which is subject to ongoing follow-up and should continue to closely monitor cases
of cardiotoxic events.
The next PSUR should be submitted in accordance with the requirements set out in the list of Union
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC.
6.1.9. Shingles (herpes zoster) vaccine (live) – ZOSTAVAX (CAP)
Evaluation of a PSUR procedure
26 Update of SmPC section 4.8. The package leaflet is updated accordingly. The PRAC AR and PRAC recommendation are
transmitted to the CHMP for adoption of an opinion.
27 Update of SmPC sections 4.4 and 4.8. The package leaflet is updated accordingly. The PRAC AR and PRAC
recommendation are transmitted to the CHMP for adoption of an opinion.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 35/75