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Table of contents 1. Introduction .......................................................................................... 11 1.1. Welcome and declarations of interest of members, alternates and experts ................. 11 1.2. Adoption of agenda of the meeting on 10-13 June 2014 .......................................... 11 1.3. Minutes of the previous PRAC meeting on 5-8 May 2014 ......................................... 11 2. EU Referral Procedures for Safety Reasons: Urgent EU Procedures .................. 11 2.1. Newly triggered procedures ................................................................................. 11 2.2. Ongoing Procedures ............................................................................................ 11 2.2.1. Methadone medicinal products for oral use containing povidone (NAP) ................... 11 2.3. Procedures for finalisation ................................................................................... 12 3. EU Referral Procedures for Safety Reasons: Other EU Referral Procedures ....... 12 3.1. Newly triggered Procedures ................................................................................. 12 3.1.1. Ibuprofen (NAP) .............................................................................................. 12 3.2. Ongoing Procedures ............................................................................................ 13 3.2.1. Bromocriptine (NAP) ........................................................................................ 13 3.2.2. Hydroxyzine (NAP) .......................................................................................... 14 3.3. Procedures for finalisation ................................................................................... 14 3.4. Article 5(3) of Regulation (EC) No 726/2004 as amended: PRAC advice on CHMP request .................................................................................................................... 14 3.5. Others .............................................................................................................. 14 3.5.1. Diacerein (NAP) ............................................................................................... 14 4. Signals assessment and prioritisation ............................................................... 15 4.1. New signals detected from EU spontaneous reporting systems ................................. 15 4.1.1. Vildagliptin – GALVUS (CAP), JALRA (CAP), XILIARX (CAP) Vildagliptin, metformin - EUCREAS (CAP), ICANDRA (CAP), ZOMARIST (CAP) ...................................................... 15 4.2. New signals detected from other sources ............................................................... 16 4.2.1. Chlorhexidine (NAP) ......................................................................................... 16 4.2.2. Ipilimumab – YERVOY (CAP) ............................................................................. 17 4.3. Signals follow-up and prioritisation ....................................................................... 18 4.3.1. Dexmedetomidine – DEXDOR (CAP) ................................................................... 18 4.3.2. Enzalutamide - XTANDI (CAP) ........................................................................... 19 4.3.3. Fluoroquinolones: ciprofloxacin (NAP), enoxacin (NAP), flumequine (NAP), lomefloxacin (NAP), levofloxacin (NAP), moxifloxacin (NAP), norfloxacin (NAP), ofloxacin (NAP), pefloxacin (NAP), prulifloxacin (NAP), rufloxacin (NAP) ........................................ 20 4.3.4. Lansoprazole (NAP) ......................................................................................... 21 4.3.5. Mycophenolate mofetil - CELLCEPT (CAP) ........................................................... 21 4.3.6. Vildagliptin – GALVUS (CAP), JALRA (CAP), XILIARX (CAP) Vildagliptin, metformin – EUCREAS (CAP), ICANDRA (CAP), ZOMARIST (CAP) ...................................................... 23 5. Risk Management Plans .................................................................................... 24 5.1. Medicines in the pre-authorisation phase ............................................................... 24 5.1.1. Bazedoxifene, estrogens conjugated .................................................................. 24 5.1.2. Dolutegravir, abacavir, lamivudine ..................................................................... 24 5.1.3. Dulaglutide ..................................................................................................... 24 5.1.4. Ibrutinib ......................................................................................................... 24 5.1.5. Idelalisib ........................................................................................................ 24 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 4/75
5.1.6. Insulin degludec, liraglutide .............................................................................. 25 5.1.7. Insulin glargine ............................................................................................... 25 5.1.8. Ketoconazole .................................................................................................. 25 5.1.9. Olaparib ......................................................................................................... 25 5.1.10. Oritavancin ................................................................................................... 25 5.2. Medicines already authorised ............................................................................... 25 RMP in the context of a variation – PRAC-led procedure ................................................. 25 5.2.1. Aclidinium bromide – BRETARIS GENUAIR (CAP), EKLIRA GENUAIR (CAP) .............. 25 RMP in the context of a variation – CHMP-led procedure ................................................ 26 5.2.2. Ferumoxytol – RIENSO (CAP) ............................................................................ 26 5.2.3. Influenza vaccine (split virion, inactivated) – IDFLU (CAP), INTANZA (CAP) ............ 27 5.2.4. Influenza vaccine (surface antigen, inactivated, prepared in cell cultures) – OPTAFLU (CAP) ...................................................................................................................... 27 5.2.5. Nitric oxide – INOMAX (CAP) ............................................................................. 28 5.2.6. Ofatumumab – ARZERRA (CAP) ......................................................................... 28 RMP evaluated in the context of a PSUR procedure ....................................................... 29 RMP evaluated in the context of PASS results ............................................................... 29 RMP evaluated in the context of a renewal of the marketing authorisation, conditional renewal or annual reassessment ................................................................................. 29 RMP evaluated in the context of a stand-alone RMP procedure ........................................ 29 6. Periodic Safety Update Reports (PSURs) ............................................... 29 6.1. Evaluation of PSUR procedures ............................................................................ 29 6.1.1. Aflibercept – EYLEA (CAP) ................................................................................. 29 6.1.2. Anagrelide – XAGRID (CAP), NAP ...................................................................... 30 6.1.3. Boceprevir – VICTRELIS (CAP) .......................................................................... 31 6.1.4. Deferasirox – EXJADE (CAP) ............................................................................. 32 6.1.5. Ferumoxytol – RIENSO (CAP) ............................................................................ 33 6.1.6. Ivabradine – CORLENTOR (CAP), PROCORALAN (CAP) .......................................... 33 6.1.7. Modified vaccinia ankara virus – IMVANEX (CAP) ................................................. 34 6.1.8. Pixantrone – PIXUVRI (CAP) ............................................................................. 35 6.1.9. Shingles (herpes zoster) vaccine (live) – ZOSTAVAX (CAP) ................................... 35 6.1.10. Toremifene – FARESTON (CAP), NAP ................................................................ 36 6.2. Follow-up to PSUR procedures ............................................................................. 37 6.2.1. Aclidinium bromide – BRETARIS GENUAIR (CAP), EKLIRA GENUAIR (CAP) .............. 37 7. Post-authorisation Safety Studies (PASS) ............................................. 38 7.1. Protocols of PASS imposed in the marketing authorisation(s) ................................... 38 7.1.1. Ethinylestradiol, gestodene transdermal patch (NAP) ........................................... 38 7.1.2. Sodium, magnesium, potassium sulphates for bowel preparation (NAP) ................. 38 7.2. Protocols of PASS non-imposed in the marketing authorisation(s) ............................ 39 7.3. Results of PASS imposed in the marketing authorisation(s) ..................................... 39 7.4. Results of PASS non-imposed in the marketing authorisation(s) ............................... 39 7.5. Interim results of imposed and non-imposed PASS and results of non-imposed PASS submitted before the entry into force of the revised variations regulation ........................ 39 7.5.1. Rufinamide – INOVELON (CAP) .......................................................................... 39 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 5/75
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PRAC member PRAC alternate Country
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Additional European experts partici
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