WC500185968

Background
Nalmefene is an opioid system modulator indicated for the reduction of alcohol consumption in adult
patients with alcohol dependence under certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Selincro, a
centrally authorised medicine containing nalmefene, 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 Selincro
(nalmefene) in the approved indication(s) remains favourable.
Nevertheless, the product information should be updated to refine the wording of the current
contraindication in patients taking opioid analgesics and specify that this contraindication
applies to patients taking opioid agonists (e.g. methadone) and opioid partial agonists (e.g.
buprenorphine). Therefore the current terms of the marketing authorisation(s) should be
varied 14 .
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. The frequency
of submission of the subsequent PSURs should be changed from 6-monthly to yearly and the list of
Union reference dates (EURD list) will be updated accordingly.
6.1.7. Natalizumab – TYSABRI (CAP)
Evaluation of a PSUSA procedure
Regulatory details:
PRAC Rapporteur: Brigitte Keller-Stanislawski (DE)
Administrative details:
Procedure number(s): EMEA/H/C/000603/PSUSA/02127/201408
MAH(s): Biogen Idec Ltd
Background
Natalizumab is a selective immunosuppressive agent indicated for the treatment of highly active
relapsing remitting multiple sclerosis (MS) under certain conditions.
Based on the assessment of the PSUR, the PRAC reviewed the benefit-risk balance of Tysabri, a
centrally authorised medicine containing natalizumab, 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 Tysabri
(natalizumab) in the approved indication(s) remains favourable.
The current terms of the marketing authorisation(s) should be maintained.
14 Update of SmPC section 4.3. The PRAC AR and PRAC recommendation are transmitted to the CHMP for adoption of an
opinion
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/257790/2015 Page 38/89