WC500169468

Background
Buprenorphine/naloxone used in combination is indicated for the substitution treatment for opioid drug
dependence under certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Suboxone, a
centrally authorised medicine containing buprenorphine/naloxone, 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 Suboxone
(buprenorphine/naloxone) in the approved indication(s) remains favourable.
The current terms of the marketing authorisation(s) should be maintained.
The MAH should submit to EMA within 60 days a detailed review on the need to upgrade the
current warning on drug-drug interaction with naloxone to a contraindication, taking into
account that the product information already recommends against this concomitant use, to
avoid severe withdrawal syndromes associated with buprenorphine. The MAH should also
include a proposal for an update of the product information, taking into consideration the
existing labelling in the product information for naltrexone- and nalmefene-containing products
as well as the ongoing variation procedure for buprenorphine (Subutex (FR/H/1047/1-
3/II/038)). In addition, the MAH should provide a detailed analysis of cases of misuse and
abuse associated with buprenorphine/naloxone, including information on the used route of
administration. Finally, the MAH should provide a detailed analysis of EU cases of medication
errors and propose risk minimisation measures as warranted.
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. Decitabine – DACOGEN (CAP)
Evaluation of a PSUR procedure
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure number(s): EMEA/H/C/002221/PSUV/0011 (with RMP version 3.0)
MAH(s): Janssen-Cilag International N.V.
Background
Decitabine is a cytidine deoxynucleoside analogue indicated for the treatment of adult patients aged 65
years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML) under
certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Dacogen, a
centrally authorised medicine containing decitabine, and issued a recommendation on its marketing
authorisation(s).
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 34/73