WC500165698

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10.1.2. Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) – PANDEMRIX (CAP) PRAC consultation on a safety-related variation, upon CHMP request Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/000832/II/0069 Procedure scope: Restriction of the indication to adults 18 years of age and older in an officially declared pandemic situation caused by A (H1N1)v 2009 virus and to update sections 4.2, 4.4, 4.8 and 5.1 of the SmPC to reflect the totality of the data on the risk of narcolepsy and an updated benefit-risk assessment of Pandemrix, based on the data currently available to the MAH on H1N1 influenza disease burden, effectiveness and safety of Pandemrix and available epidemiology data on narcolepsy. MAH(s): GlaxoSmithKline Biologicals Background Pandemrix is an pandemic influenza vaccine (H1N1) currently indicated for the prophylaxis of influenza caused by A (H1N1)v 2009 virus. In persons under 20 years of age, Pandemrix should only be used if the recommended annual seasonal trivalent influenza vaccine is not available and if immunisation against (H1N1)v is considered necessary. However, Pandemrix is not in use in any EU Member State. PRAC advice was requested by CHMP on a variation to restrict the indication to adults 18 years of age and older in an officially declared pandemic situation caused by A (H1N1)v 2009 virus, and to make related changes in other parts of the product information including an updated warning on the risk of narcolepsy and removal of all information relating to use in those aged less than 18 years. Summary of advice Based on the review of the submitted data, including the MAH’s assessment of epidemiological studies investigating Pandemrix and narcolepsy and an exploratory quantitative benefit-risk assessment focused on narcolepsy, the PRAC acknowledged that possible bias and confoundings in the studies were unlikely to have fully accounted for the observed risk following vaccination and that the totality of evidence supports a role of Pandemrix in the development of narcolepsy. The PRAC agreed that, at least in theory, in its currently authorised indication (and if it were still available), Pandemrix could still offer potential benefits to individuals (e.g. elderly, immunocompromised) in a seasonal context, therefore the proposed restricted indication to adults 18 years and older and only in an officially declared pandemic situation was not considered appropriate based on the MAH’s benefit-risk assessment. Moreover on the basis that no new data on benefits and risks have been presented, there was little basis to alter the conclusion on the indication and updated narcolepsy paragraph for section 4.4 of the SmPC, as previously reached by PRAC (see, PRAC minutes 10-13 June 2013). However, the PRAC agreed with the MAH’s proposal to include the range of absolute risk estimates for narcolepsy in the SmPC. Further information will be requested to the MAH to clarify some remaining aspects. See also under 5.2.2. 10.2. Timing and message content in relation to MS safety announcements None Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 36/64
10.3. Other requests None 11. Other Safety issues for discussion requested by the Member States 11.1. Safety related variations of the marketing authorisation None 11.2. Renewals of the Marketing Authorisation None 11.3. Other requests 11.3.1. Antidiabetics (CAP, NAP) PRAC consultation on national review of the safety of insulins in patients with type 2 diabetes mellitus, on Member State’s request Status: for discussion and agreement of advice to Member States Regulatory details: Lead PRAC member: Julie Williams (UK) Administrative details: Procedure scope: UK’s review of the safety of insulins used in the treatment of type 2 diabetic patients. MAH(s): Eli Lilly Nederland B.V. (Humalog, Liprolog) Novo Nordisk A/S (Actrapid, Actraphane, Insulatard, Levemir, Novorapid, Novomix, Tresiba), Sanofi-aventis Deutschland GmbH (Apidra, Insuman, Insulin human Withrop, Lantus), various Background In 2011 and 2012 following various publications from Currie et al. including recently published research 25 , the Pharmacovigilance Working Party (PhVWP) discussed a signal of possible increased risk of common diabetes-related complications and all-cause mortality in people with type 2 diabetes treated with insulin. The results of such studies showed significantly increased risks of all outcomes for patients receiving insulin, when compared with metformin monotherapy, with hazard ratios (HRs) of 1.4 for cancer, 1.8 for major adverse cardiovascular events (MACE) and 2.2 for all-cause mortality. Following an assessment by the UK, the PhVWP concluded that the ongoing European Commissionfunded projects which might be suitable to incorporate some of the research questions arising from the review, should be identified with a view to confirming or refuting the signal. The Cancer Risk and Insulin Analogues (CARING) project and the Safety Evaluation of Adverse Reactions in Diabetes (SAFEGUARD) project were subsequently explored and were considered to be a source of further data. In 2012, the MHRA convened a national Expert Working Group to investigate the signal in more detail which had been kept under ongoing monitoring. The UK requested the PRAC advice on the latest position reached by the now finalised national in-depth review. 25 J Clin Endocrinol Metab. Feb 2013; 98(2): 668–677. Published online Jan 31, 2013. doi: 10.1210/jc.2012-3042PMCID: PMC3612791Mortality and Other Important Diabetes-Related Outcomes With Insulin vs Other Antihyperglycemic Therapies in Type 2 Diabetes- Craig J. Currie, Chris D. Poole, Marc Evans, John R. Peters, and Christopher Ll. Morgan Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/253432/2014 Page 37/64
Page 1 and 2: 10 April 2014 EMA/PRAC/253432/2014
Page 3 and 4: Table of contents Note on access to
Page 5 and 6: 10.2. Timing and message content in
Page 7 and 8: 15.1.8. Dronedarone - MULTAQ (CAP)
Page 9 and 10: 1. Introduction 1.1. Welcome and de
Page 11 and 12: 3.2.2. Bromocriptine (NAP) Review
Page 13 and 14: Discussion The PRAC discussed the e
Page 15 and 16: Background Cefepime is a cephalospo
Page 17 and 18: Summary of recommendation(s) The M
Page 19 and 20: conducted in the US Veterans Affair
Page 21 and 22: Taken together, the available evide
Page 23 and 24: eported in 38.5% of the cases. Amon
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Page 27 and 28: Summary of advice The RMP version
Page 29 and 30: Background Colistimethate sodium is
Page 31 and 32: The next PSUR should be submitted i
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Page 35: Summary of advice Based on the revi
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Page 43 and 44: 14. ANNEX I Risk Management Plans 1
Page 45 and 46: 14.1.13. Tobramycin Evaluation of
Page 47 and 48: 14.2.8. Amifampridine - FIRDAPSE (C
Page 49 and 50: Procedure scope: Grouping of three
Page 57 and 58: 16.2. Protocols of PASS non-imposed
Page 59 and 60: Procedure scope: Evaluation of fina
Page 63 and 64: PRAC members and alternates Country

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