WC500185968

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Administrative details: Procedure number(s): EMEA/H/C/001110/II/0019 Procedure scope: Update of SmPC section 4.8 to include ‘thrombotic microangiopathy (TMA) with acute renal failure’. The package leaflet is updated accordingly. In addition, the MAH took the opportunity to make a minor change to SmPC section 4.8 clarifying that the safety data included are derived both from studies and from post-marketing reports MAH(s): GlaxoSmithKline Trading Services 14.1.30. Epoetin beta – NEORECORMON (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Valerie Strassmann (DE) Administrative details: Procedure number(s): EMEA/H/C/000116/II/0083 Procedure scope: Update of the product information to implement the outcome of the PSUR (covering the period 2007-2010) concerning the increased risk of retinopathy of prematurity (RoP) MAH(s): Roche Registration Ltd See under 10.1.1. 14.1.31. Golimumab – SIMPONI (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/000992/II/0063 Procedure scope: Update of SmPC sections 4.2 and 5.1 to reflect the data from a multicentre, placebocontrolled, double-blind, randomised-withdrawal, parallel group study (GO KIDS) in children (2 to 17 years of age) with active polyarticular juvenile idiopathic arthritis (pJIA). The package leaflet is updated accordingly MAH(s): Janssen Biologics B.V. 14.1.32. Insulin degludec, liraglutide – XULTOPHY (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/002647/II/0001/G MAH(s): Novo Nordisk A/S 14.1.33. Insulin degludec, liraglutide – XULTOPHY (CAP) Evaluation of an RMP in the context of a variation, extension of indication Regulatory details: PRAC Rapporteur: Menno van der Elst (NL) Administrative details: Procedure number(s): EMEA/H/C/002647/II/0002 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 68/89
Procedure scope: Extension of indication to include the transfer of patients from glucagon-like peptide- 1 (GLP1) receptor agonist (RA) treatment to Xultophy. Consequently, SmPC sections 4.1, 4.2, 4.4, and 5.1 as well as the package leaflet are updated accordingly MAH(s): Novo Nordisk A/S 14.1.34. Maraviroc – CELSENTRI (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/000811/II/0041 Procedure scope: Update of SmPC sections 4.4 and 5.1 further to the 48-week time-point results of study A4001098 conducted to evaluate the safety of Maraviroc in combination with other antiretroviral agents in HIV-1-infected subjects co-infected with hepatitis C and/or hepatitis B virus (MEA 010.3) MAH(s): ViiV Healthcare UK Limited 14.1.35. Methylnaltrexone bromide – RELISTOR (CAP) Evaluation of an RMP in the context of a variation, extension of indication Regulatory details: PRAC Rapporteur: Valerie Strassmann (DE) Administrative details: Procedure number(s): EMEA/H/C/000870/II/0030 Procedure scope: Extension of indication for the treatment of opioid induced constipation in adult non cancer pain patients. Consequently, the MAH proposed the update of SmPC sections 4.1, 4.2, 4.4 and 5.1. The package leaflet is updated accordingly MAH(s): TMC Pharma Services Ltd 14.1.36. Perampanel – FYCOMPA (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/002434/II/0016 Procedure scope: Extension of indication as adjunctive treatment of primary generalised tonic-clonic seizures in patients with epilepsy aged 12 years and older. SmPC sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 5.2 and the package leaflet are updated accordingly MAH(s): Eisai Europe Ltd 14.1.37. Ponatinib – ICLUSIG (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Rafe Suvarna (UK) Administrative details: Procedure number(s): EMEA/H/C/002695/II/0017 Procedure scope: Update of SmPC sections 4.8 and 5.1 to update the safety information and to update pharmacology information after the availability of the updated Clinical Study report for Study AP24534- Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 69/89
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10 April 2015 EMA/PRAC/257790/2015
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Table of contents 1. Introduction .
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6.2. Follow-up to PSUR procedures .
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12.15. Contacts of the PRAC with ex
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15.1.25. Pandemic influenza vaccine
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1. Introduction 1.1. Welcome and de
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Regulatory details: PRAC Rapporteur
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mainly reported in the published li
Page 17 and 18: During routine signal detection act
Page 19 and 20: Taking into account this first repo
Page 21 and 22: During routine signal detection act
Page 23 and 24: Summary of recommendation(s) The M
Page 25 and 26: 4.3.5. Sodium containing formulatio
Page 27 and 28: Intended indication(s): Treatment i
Page 29 and 30: Procedure scope: Proposal for a new
Page 31 and 32: association of lenalidomide and sec
Page 33 and 34: 6. Periodic Safety Update Reports (
Page 35 and 36: The next PSUR should be submitted i
Page 37 and 38: 6.1.5. Mecasermin - INCRELEX (CAP)
Page 39 and 40: In the next PSUR, the MAH should pr
Page 41 and 42: The next PSUR should be submitted i
Page 43 and 44: Summary of recommendation(s) and co
Page 45 and 46: 6.1.14. Zoledronic acid - ACLASTA (
Page 47 and 48: Administrative details: Procedure n
Page 49 and 50: Although the PRAC recognised the re
Page 51 and 52: 10.3. Other requests 10.3.1. Antire
Page 53 and 54: 11. Other Safety issues for discuss
Page 55 and 56: 12.2.2. Pharmacovigilance Inspectio
Page 57 and 58: EudraVigilance data analysis system
Page 59 and 60: pharmacovigilance referrals, prepar
Page 61 and 62: account the comments raised. The PR
Page 63 and 64: 14.1.6. Ferric citrate coordination
Page 65 and 66: Procedure scope: Updated RMP (versi
Page 67: Administrative details: Procedure n
Page 71 and 72: Procedure scope: Grouped variation
Page 73 and 74: 15.1.7. Dabrafenib - TAFINLAR (CAP)
Page 75 and 76: 15.1.17. Influenza vaccine (split v
Page 77 and 78: 15.1.27. Pyronaridine, artesunate -
Page 79 and 80: 16.1.3. Sodium, magnesium, potassiu
Page 81 and 82: Administrative details: Procedure n
Page 83 and 84: MAH(s): Novartis Europharm Ltd 16.1
Page 85 and 86: 17. ANNEX I - Renewals of the Marke
Page 87 and 88: Name Role Member state or affiliati
Page 89: Name Role Member state or affiliati
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WC500185968

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