20262 results
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Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - February 2023 (new)
Online, 09:00 - 13:00 Amsterdam time (CET), from 16/02/2023 to 17/02/2023, Last updated: 12/12/2023 -
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Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for clinical trial sponsors - May 2023 (new)
Online, 14:00 - 18:00 Amsterdam time (CET), from 04/05/2023 to 05/05/2023, Last updated: 12/12/2023 -
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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,
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, Revision: 2, Authorised, Last updated: 30/11/2023
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ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline (updated)
Last updated: 06/10/2023 -
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Human medicine European public assessment report (EPAR): Mayzent (updated)
Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020,, Revision: 9, Authorised, Last updated: 31/01/2023
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Clinical Trials Information System (CTIS): Readiness for mandatory use of the Clinical Trials Regulation from 31 January 2023 (updated)
Online, 10:00 - 13:00 Amsterdam time (CET), 20/01/2023, Last updated: 31/01/2023 -
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,, 
, Revision: 3, Authorised, Last updated: 31/01/2023
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec) (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002571-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 14/08/2020, Last updated: 31/01/2023, Compliance check: X -
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EMA virtual workshop on myocarditis post COVID-19 vaccination (new)
Online, 16/01/2023, Last updated: 31/01/2023 -
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Committee for Herbal Medicinal Products (HMPC): 21-23 November 2022 (updated)
from 21/11/2022 to 23/11/2022, Last updated: 31/01/2023 -
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Human medicine European public assessment report (EPAR): Celdoxome pegylated liposomal (updated)
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms; Multiple Myeloma; Sarcoma, Kaposi
Date of authorisation: 15/09/2022, Authorised, Last updated: 31/01/2023 -
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Clinical trials in human medicines (updated)
Last updated: 31/01/2023 -
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Human medicine European public assessment report (EPAR): Efficib (updated)
sitagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/07/2008, Revision: 32, Authorised, Last updated: 31/01/2023 -
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Union Product Database: release notes (updated)
Last updated: 31/01/2023 -
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Human medicine European public assessment report (EPAR): Truxima (updated)
rituximab, Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
Date of authorisation: 17/02/2017,
, Revision: 19, Authorised, Last updated: 31/01/2023
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Clinical Trials Information System: training and support (updated)
Last updated: 31/01/2023 -
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Human medicine European public assessment report (EPAR): Xelevia (updated)
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 37, Authorised, Last updated: 31/01/2023 -
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Financial management and budgetary reporting (updated)
Last updated: 31/01/2023 -
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News: Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU (new)
Last updated: 31/01/2023 -
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Newsletters (updated)
Last updated: 31/01/2023 -
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Direct healthcare professional communication (DHPC): Lymphoseek (tilmanocept) 50 micrograms kit for radiopharmaceutical preparation: temporary extension of shelf life (new)
Active substance: tilmanocept, DHPC type: Medicine shortage, Last updated: 31/01/2023 -
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Substance and product data management services (updated)
Last updated: 30/01/2023 -
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Orphan designation: Allogeneic Epstein-Barr virus specific cytotoxic T lymphocytes (Tabelecleucel) for: Treatment of post-transplantation lymphoproliferative disorders (updated)
Date of designation: 21/03/2016, Positive, Last updated: 30/01/2023 -
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Orphan designation: Ex-vivo-expanded autologous keratinocytes transduced with retroviral vector containing the COL7A1 gene (prademagene zamikeracel) for: Treatment of epidermolysis bullosa (updated)
Date of designation: 27/02/2017, Positive, Last updated: 30/01/2023 -
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Medicine evaluation figures (updated)
Last updated: 30/01/2023