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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 toremifenecontaining
products in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to refine the current warning on
haematological disorders and to add anaemia, leukopenia and thrombocytopenia as
undesirable effects with a frequency unknown. Therefore the current terms of the marketing
authorisation should be varied 29 .
In the next PSURs for all toremifene-containing products, MAHs should provide further data, in
particular, detailed reviews of cases of hepatobiliary disorders, cases of cerebrovascular
disorders and cases of interstitial lung disease. MAHs should also comment on the risk for
clinically relevant drug-drug interaction with toremifene as an enzyme inhibitor, based on the
in vitro data compared with clinical exposure data as well as clinical experience.
The frequency of PSUR submission should be revised from three-yearly to yearly and the next PSUR
should be submitted to the EMA within 70 days of the data lock point. The list of Union reference dates
(EURD list) provided for under Article 107c(7) of Directive 2001/83/EC is updated accordingly.
6.2. Follow-up to PSUR procedures 30
6.2.1. Aclidinium bromide – BRETARIS GENUAIR (CAP), EKLIRA GENUAIR (CAP)
Evaluation of a follow-up to a PSUR procedure
Regulatory details:
PRAC Rapporteur: Julie Williams (UK)
Administrative details:
Procedure number(s): EMEA/H/C/002211/LEG 006.1, EMEA/H/C/002706/LEG 006.1
Procedure scope: MAH’s response to LEG 006 adopted in January 2014
MAH(s): Almirall S.A.
Background
Following the evaluation of the most recently submitted PSUR-related discussion for the above
mentioned medicines, the PRAC requested the MAH to submit further data (see PRAC Minutes
September 2013 and PRAC Minutes January 2014). The responses were assessed by the Rapporteur
for further PRAC advice.
Summary of recommendation(s) and conclusions
Based on the conclusion of the PRAC rapporteur, the PRAC considered that the outstanding issues were
resolved and the RMP was satisfactorily updated to include more information on product quality issues
to date and the distribution of demo kits. The MAH should submit to EMA a revised version of the
follow-up questionnaire for all reports of medication errors and/or use of device errors.
See also 5.2.1.
29 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.
30 Follow up as per the conclusions of the previous PSUR procedure, assessed outside next PSUR procedure.
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 37/75