WC500185968

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14. ANNEX I - Risk Management Plans Medicines in the pre-authorisation phase As per agreed criteria, the PRAC endorsed without further plenary discussion the conclusions of the Rapporteur on the assessment of the RMP for the below mentioned medicines under evaluation for initial marketing authorisation application. Information on the medicines containing the below listed active substance will be made available following the CHMP opinion on their marketing authorisation. 14.1.1. Allogenic human heterologous liver cells Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003750, Orphan Intended indication(s): Treatment of urea cycle disorders (UCD) Applicant: Cytonet GmbH&Co KG 14.1.2. Aripiprazole Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/004008, Generic, Hybrid Intended indication(s): Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder 14.1.3. Atazanavir, cobicistat Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003904 Intended indication(s): Treatment of HIV-1 infected patients 14.1.4. Dasiprotimut Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002772, Orphan Intended indication(s): Treatment of non-Hodgkin’s lymphoma (FL) Applicant: Biovest Europe Ltd For adoption: PRAC RMP AR, PRAC RMP assessment overview and advice 14.1.5. Docetaxel Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003925, Generic Intended indication(s): Treatment of breast cancer, non-small cell lung cancer, prostate cancer, metastatic gastric adenocarcinoma and head and neck cancer Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 62/89
14.1.6. Ferric citrate coordination complex Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003776 Intended indication(s): Treatment of hyperphosphataemia 14.1.7. Guanfacine Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003759 Intended indication(s): Treatment of attention deficit hyperactivity disorder (ADHD) 14.1.8. Human alfa1-proteinase inhibitor Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/002739 Intended indication(s): Maintenance treatment to slow the underlying destruction of lung tissue leading to emphysema in adults with alpha1-proteinase inhibitor deficiency with clinically evident lung disease 14.1.9. Lumacaftor, ivacaftor Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003954, Orphan Intended indication(s): Treatment of cystic fibrosis (CF) Applicant: Vertex Pharmaceuticals (U.K.) Ltd. 14.1.10. Mercaptamine Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/004038, Orphan Intended indication(s): Treatment of corneal cystine deposits Applicant: Lucane Pharma 14.1.11. Netupitant, palonosetron Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003728 Intended indication(s): Prevention of chemotherapy-induced nausea and vomiting (CINV) 14.1.12. Parathyroid hormone Evaluation of an RMP in the context of an initial marketing authorisation application procedure Administrative details: Product number(s): EMEA/H/C/003861, Orphan Intended indication(s): Treatment of hypoparathyroidism Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/257790/2015 Page 63/89
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10 April 2015 EMA/PRAC/257790/2015
Page 3 and 4:
Table of contents 1. Introduction .
Page 5 and 6:
6.2. Follow-up to PSUR procedures .
Page 7 and 8:
12.15. Contacts of the PRAC with ex
Page 9 and 10:
15.1.25. Pandemic influenza vaccine
Page 11 and 12: 1. Introduction 1.1. Welcome and de
Page 13 and 14: Regulatory details: PRAC Rapporteur
Page 15 and 16: 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: account the comments raised. The PR
Page 65 and 66: Procedure scope: Updated RMP (versi
Page 69 and 70: Procedure scope: Extension of indic
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 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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