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Regulatory details: PRAC Rapporteur: Qun-Ying Yue (SE) Administrative details: Procedure number(s): EMEA/H/C/002445/II/0003 Procedure scope: Update of SmPC section 4.4 in order to implement the recommendations of the recent Article 5(3) procedure on GLP-1-based therapies and pancreatic safety MAH(s): Sanofi-Aventis Groupe 14.1.34. Ibandronic acid – IBANDRONIC ACID ACCORD (CAP) Evaluation of an RMP in the context of a variation, line extension Regulatory details: PRAC Rapporteur: Doris Stenver (DK) Administrative details: Procedure number(s): EMEA/H/C/002638/X/0006 Procedure scope: Addition of a new strength/potency and a new pharmaceutical form 3 mg solution for injection MAH(s): Accord Healthcare Limited 14.1.35. Methylnaltrexone – 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 MAH(s): TMC Pharma Services Ltd 14.1.36. Nilotinib – TASIGNA (CAP) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Doris Stenver (DK) Administrative details: Procedure number(s): EMEA/H/C/000798/II/0067 Procedure scope: Update of SmPC sections 4.2, 4.4, 4.8 and 5.1 further to 60 month data analysis from the phase III multicentre, open-label, randomised study CAMN107A2303 of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia in chronic phase (CML-CP) (ANX 40.3) MAH(s): Novartis Europharm Ltd 14.1.37. Palivizumab – SYNAGIS (CAP) Evaluation of an RMP in the context of a variation, line extension Regulatory details: PRAC Rapporteur: Torbjörn Callréus (DK) Administrative details: Product number(s): EMEA/H/C/000257/X/0095 Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 56/75
Procedure scope: Introduction of a new pharmaceutical form: 100 mg/ml solution for injection presented in vials containing 0.5 ml and 1 ml MAH(s): AbbVie Ltd. 14.1.38. Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) – ADJUPANRIX (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/001206/II/0034 Procedure scope: Update of SmPC section 4.4 to include a statement regarding the observed increased risk of narcolepsy following vaccination with Pandemrix, the MAH's ASO3 adjuvanted H1N1 influenza vaccine, based on a review of epidemiologic or post-marketing surveillance MAH(s): GlaxoSmithKline Biologicals S.A. 14.1.39. Pneumococcal polysaccharide conjugate vaccine (adsorbed) – SYNFLORIX (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/000973/II/0079 Procedure scope: Update of SmPC section 5.1 to reflect the results of the phase III/IV clinical trial (Finnish Invasive Pneumococcal disease vaccine) to evaluate the effectiveness of Synflorix (against reduction of hospital-diagnosed pneumonia, and impact on tympanostomy tube placements and outpatient antimicrobial prescriptions) to address a post-authorisation measure MAH(s): GlaxoSmithKline Biologicals S.A. 14.1.40. Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) – PREPANDRIX (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/000822/II/0051 Procedure scope: Update of SmPC to include a statement regarding the observed increased risk of narcolepsy following vaccination with Pandemrix, the MAH's ASO3 adjuvanted H1N1 influenza vaccine, based on a review of epidemiologic or post-marketing surveillance MAH(s): GlaxoSmithKline Biologicals S.A. 14.1.41. Pyronaridine, artesunate – PYRAMAX (Art 58) Evaluation of an RMP in the context of a variation Regulatory details: PRAC Rapporteur: Isabelle Robine (FR) Administrative details: Procedure number(s): EMEA/H/W/002319/II/0002 Procedure scope: Changes to SmPC section 4.1 to remove restrictions on repeated course of treatment in any individual and use only in areas of low transmission with evidence of artesmisinin resistance, based on further clinical experience. Consequent changes in SmPC sections 4.2, 4.4, 4.8. Change is Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/438418/2014 Page 57/75
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10 July 2014 EMA/PRAC/438418/2014 P
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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 and 54: RMP in the context of a variation -
Page 55: Regulatory details: PRAC Rapporteur
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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
Page 75: Additional European experts partici
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