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5. Risk Management Plans<br />
5.1. Medicines in the pre-authorisation phase<br />
The PRAC provided advice to the CHMP on the proposed RMPs for a number of products (identified by<br />
active substance below) that are under evaluation for initial marketing authorisation. Information on<br />
the PRAC advice will be available in the European Public Assessment Reports (EPARs) to be published<br />
at the end of the evaluation procedure.<br />
Please refer to the CHMP pages for upcoming information (http://www.ema.europa.eu/ Home>About<br />
Us>Committees>CHMP Meetings<br />
5.1.1. Bazedoxifene, estrogens conjugated<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/002314<br />
Intended indication: Treatment of oestrogen deficiency and osteoporosis<br />
5.1.2. Dolutegravir, abacavir, lamivudine<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/002754<br />
Intended indication: Treatment of human immunodeficiency virus (HIV) infection in adults and<br />
adolescents from 12 years of age who are antiretroviral treatment-naïve or are infected with HIV<br />
without documented or clinically suspected resistance to any of the three antiretroviral agents in<br />
Triumeq<br />
5.1.3. Dulaglutide<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/002825<br />
Intended indication: Treatment of adults with type 2 diabetes mellitus<br />
5.1.4. Ibrutinib<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/003791, Orphan<br />
Intended indication: Treatment of mantle cell lymphoma, chronic lymphocytic leukaemia, small<br />
lymphocytic lymphoma<br />
5.1.5. Idelalisib<br />
<br />
Evaluation of an RMP in the context of an initial marketing authorisation application procedure<br />
Administrative details:<br />
Product number(s): EMEA/H/C/003843<br />
Intended indication: Treatment of patients with relapsed chronic lymphocytic leukaemia (CLL) and<br />
refractory indolent non-Hodgkin lymphoma (iNHL)<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/438418/2014 Page 24/75
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