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Rapporteurs, and to coordinate the regulatory approach consisting of a number of synchronised postauthorisation
measures. A list of questions for the various MAHs will be discussed in July 2014.
10.3.2. Dabigatran - PRADAXA (CAP)
PRAC consultation on post-authorisation measures, upon CHMP request
Regulatory details:
PRAC Rapporteur: Torbjörn Callréus (DK)
Administrative details:
Procedure number(s): EMEA/H/C/000829/LEG 0042.1
Procedure scope: Assessment of MAH’s response to request for supplementary information (RSI)
adopted by the CHMP in April 2014
MAH(s): Boehringer Ingelheim International GmbH
Background
The CHMP is evaluating the choice of the fatal bleeding events definition from the RE-LY study and
assessing a targeted re-analysis of selected RE-LY data. This re-analysis was performed to determine
whether there were any previously uncategorized major bleeding events and how they were
distributed. Following an initial assessment, further data and analysis had been requested to the MAH.
The MAH had fulfilled this request, provided re-calculated results and the advice of the PRAC was
requested on the interpretation of the findings.
Summary of recommendation(s) and conclusions
The PRAC agreed with the interpretation of the definitions of the major bleeding events used in the RE-
LY trial and emphasised on alternative resources such as registries (e.g. GLORIA-AF) or health care
databases as more appropriate means of monitoring of post-marketing rates of adverse drug reactions.
In addition, in relation to the targeted review of selected RE-LY data, the PRAC indicated that the
product information may needed to be updated in line with the re-calculated results.
However, whilst updated frequency estimates and hazard ratios will reflect more precisely the dataset,
PRAC agreed that they overall did not change the current understanding of the risk of bleeding.
Management of the communication of these changes to the scientific community was considered
important and should be enhanced to facilitate appropriate interpretation, providing a full background
and rationale for the changes.
11. Other Safety issues for discussion requested by the
Member States
11.1. Safety related variations of the marketing authorisation
11.1.1. Aceclofenac (NAP)
PRAC consultation on a variation procedure, upon Spain’s request
Regulatory details:
Lead member: Dolores Montero Corominas (ES)
Administrative details:
Procedure number(s): ES/H/XXXX/WS/001
Procedure scope: Update the product information of systemic aceclofenac-containing medicinal
products in accordance with the outcome of the referral procedure for diclofenac, DHPC
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 42/75