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5.2. Update on on-going Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 5.2.1. BeneFIX - nonacog alfa - EMEA/H/C/000139/II/0141 MAH: Pfizer Limited Rapporteur: Jan Mueller-Berghaus Scope: “Update of section 5.2 of the SmPC in order to update the information based on PK data from study B1821048. This study reported PK from an extended collection time beyond the 72 hours previously used in all other BeneFIX studies, to 96 hours, after BeneFIX administration.” Letter dated 17.02.2017 informing about the withdrawal of the variation application. Action: For information 5.3. Re-examination of Type II variation; variation of therapeutic indication procedure according to Commission Regulation (EC) No 1234/2008 6. Ancillary medicinal substances in medical devices 6.1. Ancillary medicinal substances in medical devices; Opinions/ Day 180 list of outstanding issues / Day 120 list of questions 6.2. Update of Ancillary medicinal substances in medical devices 7. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use) 7.1. Procedure under Article 83(1) of Regulation (EC) 726/2004 (Compassionate Use) 8. Pre-submission issues 8.1. Pre-submission issue 8.2. Priority Medicines (PRIME) Disclosure of information related to priority medicines cannot be released at present time as Committee for medicinal products for human use (CHMP) EMA/CHMP/117089/2017 Page 24/39
these contain commercially confidential information 8.2.1. List of applications received Action: For information 8.2.2. Recommendation for PRIME eligibility Action: For adoption 9. Post-authorisation issues 9.1. Post-authorisation issues 9.1.1. Vectibix - panitumumab - EMEA/H/C/000741/II/0080 MAH: Amgen Europe B.V. Rapporteur: Robert James Hemmings, PRAC Rapporteur: Julie Williams Scope: “Update of Annex II in order to provide the results of biomarker analyses from the Vectibix clinical programme including Study 20080763 (according to Supplementary Statistical Analysis Plan dated 20 September 2013), Study 20070820 and Study 20060447. The data submitted are in fulfilment of Annex II obligation ANX017. The Risk Management Plan (version 21.0) has been updated accordingly. The requested variation proposed amendments to Annex II and the Risk Management Plan.” Request for Supplementary Information adopted on 10.11.2016. Action: For adoption 9.1.2. Tagrisso - osimertinib - EMEA/H/C/004124/II/0009/G MAH: AstraZeneca AB Rapporteur: Aranzazu Sancho-Lopez, PRAC Rapporteur: Sabine Straus Scope: “Update of SmPC sections 4.2, 4.4, 4.8, 5.1 and 5.2 based on the results from study D5160C00003 (AURA3) and the updated CSRs for studies D5160C00001 (AURAex) and D5160C00002 (AURA2). The Package Leaflet has been updated accordingly. In addition, the MAH took the opportunity to make editorial changes in the SmPC and Package Leaflet. The application included an updated RMP version 6.0. The provision of the CSR from study AURA3 addresses the Specific Obligation for Tagrisso and hence the MAH requests the conversion from a Conditional Marketing Authorisation to a Marketing Authorisation not subject to Specific Obligations.” Request for Supplementary Information adopted on 15.12.2016. Committee for medicinal products for human use (CHMP) EMA/CHMP/117089/2017 Page 25/39
Page 1 and 2: 20 February 2017 EMA/CHMP/117089/20
Page 3 and 4: 3.2.11. - sarilumab - EMEA/H/C/0042
Page 5 and 6: 8.2.2. Recommendation for PRIME eli
Page 7 and 8: 14.3.12. Safety Working Party (SWP)
Page 9 and 10: 2.1.3. - pentosan polysulfate sodiu
Page 11 and 12: Scope: Opinion Action: For adoption
Page 13 and 14: 3.2.9. - febuxostat - EMEA/H/C/0043
Page 15 and 16: Scope: Day 120 list of questions Ac
Page 17 and 18: List of Questions adopted on 13.10.
Page 19 and 20: 4.3. Extension of marketing authori
Page 21 and 22: accordance. In addition, the Market
Page 23: Rapporteur: Greg Markey, Co-Rapport
Page 27 and 28: An increased risk has not been seen
Page 29 and 30: 10.6. Community Interests - Referra
Page 31 and 32: 13.2. Innovation Task Force briefin
Page 33 and 34: 14.2.3. Committee for Herbal Medici
Page 35 and 36: 14.3.8. Rheumatology/Immunology Wor
Page 37 and 38: 16. Explanatory notes The notes bel
Page 39 and 40: particular medicine or class of med
Page 41 and 42: B.6.7. Type II Variations scope of
Page 43 and 44: MAH: Baxalta Innovations GmbH, Rapp
Page 45 and 46: MAH: Janssen-Cilag International NV
Page 47 and 48: amino acids and vitamins, acts as a
Page 49 and 50: EMEA/H/C/004137/II/0001 MAH: Zentiv
Page 51 and 52: MAH: Pfizer Limited, Rapporteur: Kr
Page 53 and 54: on 16.02.2017. BeneFIX - nonacog al
Page 55 and 56: local representatives in the Packag
Page 57 and 58: evise the instructions for handling
Page 59 and 60: subcutaneous doses of alirocumab on
Page 61 and 62: adverse drug reaction (hepatic enzy
Page 63 and 64: ALT due to treatment with the HCV c
Page 65 and 66: the implementation of the use of co
Page 67 and 68: Epclusa - sofosbuvir / velpatasvir
Page 69 and 70: Imbruvica - ibrutinib - EMEA/H/C/00
Page 71 and 72: TRYPHAENA study( BO22280) A randomi
Page 73 and 74: SmPC under the sub-heading 'Tabulat
Page 75 and 76:
on 26.01.2017. Zykadia - ceritinib
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important identified risk.” Reque
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term Safety of Infliximab Study C01
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MAH: Amgen Europe B.V., Rapporteur:
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Rapporteur: Hanne Lomholt Larsen WS
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EMEA/H/C/003825/WS1119/0007/G MAH:
Page 87 and 88:
Constella - linaclotide - EMEA/H/C/
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The Package Leaflet and Risk Manage
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B.6.8. CHMP assessed procedures sco
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B.6.9. CHMP assessed procedures sco
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Weight and Cardiovascular Risk Fact
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Rapporteur: Hanne Lomholt Larsen, P
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EMEA/H/C/004156/WS1133/0011/G Strib
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in a type II variation (Procedure N
Page 103 and 104:
Exelon, Lead Rapporteur: Alexandre
Page 105:
G.3.1. List of procedures concludin
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