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30/11/2018 Human medicines European public assessment report (EPAR): Irbesartan/Hydrochlorothiazide Teva, irbesartan, hydrochlorothiazide, Hypertension, 26/11/2009, Generic, 14, Authorised
30/11/2018 Human medicines European public assessment report (EPAR): Kiovig, human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic, Bone Marrow Transplantation, Immunologic Deficiency Syndromes, Guillain-Barre Syndrome, Mucocutaneous Lymph Node Syndrome, 18/01/2006, 20, Authorised
30/11/2018 Agenda: Agenda - COMP agenda of the 4-6 December 2018 meeting
30/11/2018 Human medicines European public assessment report (EPAR): Topotecan Hospira, topotecan, Uterine Cervical Neoplasms, Small Cell Lung Carcinoma, 09/06/2010, 13, Authorised
30/11/2018 Other: Opinion of the Committee for Medicinal Products for Veterinary Use pursuant to Article 30(3) of Regulation (EC) No 726/2004
30/11/2018 Other: CVMP assessment report regarding the request for an opinion under Article 30(3) of Regulation (EC) No. 726/2004
30/11/2018 Human medicines European public assessment report (EPAR): Cystadrops, mercaptamine hydrochloride, Cystinosis, 18/01/2017, Orphan, 3, Authorised
30/11/2018 Other: EudraVigilance registration documents
30/11/2018 Other: Change of qualified person for pharmacovigilance and responsible person for EudraVigilance
30/11/2018 Regulatory and procedural guideline: Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)