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MAH(s): Roche Registration Ltd 14.1.25. Cetuximab – ERBITUX (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Ulla Wändel Liminga (SE) Administrative details: Procedure number(s): EMEA/H/C/000558/II/0066 Procedure scope: Update of SmPC section 5.1 with efficacy data by RAS (KRAS and NRAS) tumour status from the CRYSTAL (EMR 62 202-013) and FIRE3 studies MAH(s): Merck KGaA 14.1.26. Darunavir – PREZISTA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/000707/II/0063 Procedure scope: Update of SmPC section 4.1 for the 100mg/ml oral suspension and the 400mg, 800mg film-coated tablets with information on the use of darunavir with cobicistat as pharmacokinetic enhancer MAH(s): Janssen-Cilag International N.V. 14.1.27. Dexamethasone – OZURDEX (CAP) Evaluation of an RMP in the context of a variation, extension of indication Regulatory details: PRAC Rapporteur: Julie Williams (UK) Administrative details: Procedure number(s): EMEA/H/C/001140/II/0015 Procedure scope: Update of SmPC section 4.1 to add a new indication for treatment of adult patients with diabetic macular oedema. Consequential updates were proposed for SmPC sections 4.2, 4.4, 4.8, 5.1 and 5.2. In addition, the MAH proposed to reduce and consolidate the current HCP leaflet, which is provided as tear off section after the package leaflet MAH(s): Allergan Pharmaceuticals Ireland 14.1.28. Eslicarbazepine – ZEBINIX (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Martin Huber (DE) Administrative details: Procedure number(s): EMEA/H/C/000988/II/0044 Procedure scope: Update of the SmPC sections 4.2 and 5.1 with the information from concluded safety and efficacy study in the elderly MAH(s): Bial - Portela & Cª, S.A. 14.1.29. Etanercept – ENBREL (CAP) Evaluation of an RMP in the context of a variation, extension of indication Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 54/75
Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/000262/II/0167 Procedure scope: Extension of indication to treatment of adults with severe non-radiographic axial spondyloarthritis (nr-AxSpA) MAH(s): Pfizer Limited 14.1.30. Fidaxomicin – DIFICLIR (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Qun-Ying Yue (SE) Administrative details: Procedure number(s): EMEA/H/C/002087/II/0016 Procedure scope: Update of SmPC sections 4.5 and 5.2 with results from study 2819-CL-2003, assessing the effect of multiple doses of fidaxomicin on the pharmacokinetics of a single dose of rosuvastatin in healthy male subjects. With respect to missing information on the impact of fidaxomicin on intestinal efflux transporters (BCRP, MRP2, OAP2B1), a corresponding deletion from the RMP is proposed MAH(s): Astellas Pharma Europe B.V. 14.1.31. Ivacaftor – KALYDECO (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Miguel-Angel Macia (ES) Administrative details: Procedure number(s): EMEA/H/C/002494/II/0009 Procedure scope: Update of SmPC sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 to extend the indication of Kalydeco in the treatment of cystic fibrosis to patients aged 6 years and older who have other gating (class III) mutation in the CFTR gene than G551D MAH(s): Vertex Pharmaceuticals (U.K.) Ltd. 14.1.32. Leflunomide – ARAVA (CAP), LEFLUNOMIDE WINTHROP (CAP) Evaluation of an RMP in the context of a variation, worksharing procedure Regulatory details: PRAC Rapporteur: Sabine Straus (NL) Administrative details: Procedure number(s): EMEA/H/C/000235/WS0560/0062/G, EMEA/H/C/001129/WS0560/0019/G Procedure scope: Worksharing variation procedure: 1) Update of SmPC sections 4.3 and 4.4 contraindicating and including a warning on teriflunamide the active metabolite of leflunomide, 2) Update of SmPC section 4.5 for leflunomide related to the study reports HWA486/1032/001 (interaction cimetidine) and -HWA486/2F0.1 (interaction with methotrexate), 3) Update of SmPC section 4.5 for teriflunomide related to the following Study reports INT11697-INT11720-INT12503- INT12500-INT10564-INT6040. Furthermore the MAH took the opportunity of this worksharing procedure to include DRESS syndrome in the RMP as requested by PRAC MAH(s): Sanofi-aventis Deutschland 14.1.33. Lixisenatide – LYXUMIA (CAP) Evaluation of an RMP in the context of a variation Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 55/75
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10 July 2014 EMA/PRAC/438418/2014 P
Page 3 and 4: More detailed information on the ab
Page 5 and 6: 5.1.6. Insulin degludec, liraglutid
Page 7 and 8: 12.8.1. Post-Authorisation Safety S
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
Page 21 and 22: Summary of recommendation(s) The M
Page 23 and 24: The MAHs of nationally authorised m
Page 25 and 26: 5.1.6. Insulin degludec, liraglutid
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
Page 49 and 50: 14. ANNEX I Risk Management Plans M
Page 51 and 52: MAH(s): AbbVie Ltd. 14.1.12. Dabiga
Page 53: 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
Page 61 and 62: Administrative details: Procedure n
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
Page 75: Additional European experts partici
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