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Summary of recommendation(s) and conclusions
Based on the review of the data on safety and efficacy, the risk-benefit balance of anagrelidecontaining
products in the approved indication(s) remains favourable.
With regard to Thromboreductin, the product information should be updated to refine the
current warning on monitoring, to add the need to closely supervise the level of electrolytes
(potassium, magnesium and calcium) and to add a new warning on cardiovascular risks. In
addition, torsades de pointe and tubulointerstitial nephritis should be added as undesirable
effects with a frequency unknown. Finally, information on effects on heart rate and QTc interval
should be added to the product information under pharmacodynamic properties. Therefore the
current terms of the marketing authorisation(s) should be varied 22 .
With regard to Xagrid, the current terms of the marketing authorisation(s) should be
maintained.
With regard to Xagrid, the MAH should submit to EMA within 90 days a variation to update the
product information in sections dedicated to fertility, pregnancy and lactation and preclinical
safety data with newly available non-clinical data. With regard to Thromboreductin, revisions of
the product information will have to be considered at the national level where the medicinal
product is authorised, once the variation procedure for Xagrid is finalised.
In the next PSURs for all anagrelide-containing products, MAHs should closely monitor cardiac
events in young patients (aged 50 years and under), cardiac events related to QTc
prolongation and torsade de pointes, thrombohaemorrhagic events, benign or malignant
neoplasms including myelofibrosis, pulmonary adverse events from the interstitial lung disease
and cases of exposure during pregnancy.
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.
6.1.3. Boceprevir – VICTRELIS (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure number(s): EMEA/H/C/002332/PSUV/0028
MAH(s): Merck Sharp & Dohme Limited
Background
Boceprevir is an inhibitor of the hepatitis C virus (HCV) non-structural protein 3 (NS3) indicated for the
treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and
ribavirin, in adult patients with compensated liver disease who are previously untreated or who have
failed previous therapy.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Victrelis, a
centrally authorised medicine containing boceprevir, and issued a recommendation on its marketing
authorisation(s).
22 Update of SmPC sections 4.4, 4.8 and 5.1. 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 31/75