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Regulatory details: PRAC Rapporteur: Brigitte Keller-Stanislawski (DE) Administrative details: Procedure number(s): EMEA/H/C/000674/PSUV/0069 MAH(s): Sanofi Pasteur MSD, SNC Background Zostavax is a shingles (herpes zoster) vaccine (live) indicated for the prevention of herpes zoster (“zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN). Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Zostavax, a centrally authorised shingles vaccine, 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 Zostavax (shingles (herpes zoster) vaccine (live)) in the approved indication(s) remains favourable. The current terms of the marketing authorisation(s) should be maintained. In the next PSUR, the MAH should provide a more detailed analysis of zoster cases in relation to time to onset after vaccination. The MAH should provide also a revised RMP concerning herpes zoster/herpes zoster-like and varicella/varicella-like rash as an important identified risk. In addition, the MAH should amend its proposed passive surveillance and should provide a more active analysis of the quantitative risk of zoster development and its characterization caused by vaccination. 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. 6.1.10. Toremifene – FARESTON (CAP), NAP Evaluation of a PSUSA 28 procedure Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) Administrative details: Procedure number(s): EMEA/H/C/PSUSA/00002999/201309 MAH(s): Orion Corporation Background Toremifene is a nonsteroidal triphenylethylene derivative indicated as a first line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients. Based on the assessment of the individual PSURs part of the PSUR single assessment procedure (PSUSA), the PRAC reviewed the benefit-risk balance of toremifene-containing products and issued a recommendation on their marketing authorisation(s). 28 PSUR single assessment, referring to CAP, NAP Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 36/75
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
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