WC500165698

Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Xalkori, a
centrally authorised medicine containing crizotinib, 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 Xalkori
(crizotinib) in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to include gastrointestinal
perforations as a warning and as an undesirable effect with an uncommon frequency.
Therefore the current terms of the marketing authorisation should be varied 17 .
In the next PSUR, the MAH should closely monitor cases of renal dysfunction and thrombosis.
In addition, the MAH should provide a detailed analysis of cases of vision disorders.
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.
6.1.4. Peginterferon alfa-2b – PEGINTRON (CAP), VIRAFERONPEG (CAP)
Evaluation of a PSUR procedure
Status: for discussion and agreement of recommendation to CHMP
Regulatory details:
PRAC Rapporteur: Qun-Ying Yue (SE)
Administrative details:
Procedure number(s): EMEA/H/C/000280/PSU 084 (PegIntron), EMEA/H/C/000329/PSU 081
(ViraferonPeg)
MAH(s): Merck Sharp & Dohme Limited
Documents:
For adoption: PRAC PSUR AR, PRAC recommendation
Background
Peginterferon alfa-2b is a recombinant interferon alfa-2b covalently conjugated with monomethoxy
polyethylene glycol indicated for the treatment of chronic hepatitis C genotype 1 infection in
monotherapy or combination under certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of PegIntron and
ViraferonPeg, centrally authorised medicines containing peginterferon alfa-2b, and issued a
recommendation on their marketing authorisations.
Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of PegIntron
and ViraferonPeg (peginterferon alfa-2b) in the approved indication(s) remains favourable.
The product information should be updated to include tongue pigmentation as an undesirable
effect with an unknown frequency. Therefore the current terms of the marketing authorisations
should be varied 18 .
17 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/253432/2014 Page 30/64