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5. Risk Management Plans 5.1. Medicines in the pre-authorisation phase The PRAC provided advice to the CHMP on the proposed RMPs for a number of products (identified by active substance below) that are under evaluation for initial marketing authorisation. Information on the PRAC advice will be available in the European Public Assessment Reports (EPARs) to be published at the end of the evaluation procedure. Please refer to the CHMP pages for upcoming information (http://www.ema.europa.eu/ Home>About Us>Committees>CHMP Meetings 5.1.1. Bazedoxifene, estrogens conjugated Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002314 Intended indication: Treatment of oestrogen deficiency and osteoporosis 5.1.2. Dolutegravir, abacavir, lamivudine Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002754 Intended indication: Treatment of human immunodeficiency virus (HIV) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents in Triumeq 5.1.3. Dulaglutide Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002825 Intended indication: Treatment of adults with type 2 diabetes mellitus 5.1.4. Ibrutinib Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003791, Orphan Intended indication: Treatment of mantle cell lymphoma, chronic lymphocytic leukaemia, small lymphocytic lymphoma 5.1.5. Idelalisib Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003843 Intended indication: Treatment of patients with relapsed chronic lymphocytic leukaemia (CLL) and refractory indolent non-Hodgkin lymphoma (iNHL) Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 24/75
5.1.6. Insulin degludec, liraglutide Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002647 Intended indication: Treatment of type 2 diabetes mellitus 5.1.7. Insulin glargine Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002835, Biosimilar Intended indication: Treatment of diabetes mellitus 5.1.8. Ketoconazole Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003906, Orphan Intended indication: Treatment of Cushing’s syndrome 5.1.9. Olaparib Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003726, Orphan Intended indication: Treatment of ovarian cancer 5.1.10. Oritavancin Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003785 Intended indication: Treatment of complicated skin and soft tissue infections (cSSTI) 5.2. Medicines already authorised RMP in the context of a variation 18 – PRAC-led procedure 5.2.1. Aclidinium bromide – BRETARIS GENUAIR (CAP), EKLIRA GENUAIR (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/002706/II/0012, EMEA/H/C/002211/II/0012 Procedure scope: Update of the RMP (version 4.0) MAH(s): Almirall S.A 18 In line with the revised variation regulation for submissions as of 4 August 2013 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 25/75
Page 1 and 2: 10 July 2014 EMA/PRAC/438418/2014 P
Page 3 and 4: More detailed information on the ab
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Page 9 and 10: 15.1.12. Human normal immunoglobuli
Page 11 and 12: 1. Introduction 1.1. Welcome and de
Page 13 and 14: Discussion The PRAC noted the notif
Page 15 and 16: The CMDh position on diacerein (see
Page 17 and 18: provides the best antimicrobial act
Page 19 and 20: Summary of recommendation(s) The M
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Page 23: The MAHs of nationally authorised m
Page 27 and 28: 5.2.3. Influenza vaccine (split vir
Page 29 and 30: Regulatory details: PRAC Rapporteur
Page 31 and 32: Summary of recommendation(s) and co
Page 33 and 34: effects with frequencies unknown, a
Page 39 and 40: 7.2. Protocols of PASS non-imposed
Page 43 and 44: MAH(s): Almirall, S.A., Temis Farma
Page 45 and 46: 12. Organisational, regulatory and
Page 47 and 48: EMA secretariat also made a proposa
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Page 51 and 52: MAH(s): AbbVie Ltd. 14.1.12. Dabiga
Page 53 and 54: RMP in the context of a variation -
Page 57 and 58: Procedure scope: Introduction of a
Page 59 and 60: RMP evaluated in the context of a s
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Page 63 and 64: 15.1.16. Irbesartan, hydrochlorothi
Page 67 and 68: MAH(s): Janssen-Cilag International
Page 71 and 72: Administrative details: Procedure n
Page 73 and 74: PRAC member PRAC alternate Country
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Additional European experts partici
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