219 results
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2019, EC decision date: 09/09/2019, Last updated: 16/09/2019 -
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Orphan designation: Lenvatinib for: Treatment of hepatocellular carcinoma
Date of designation: 19/03/2015, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of papillary thyroid cancer
Date of designation: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of follicular thyroid cancer
Date of designation: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Paediatric investigation plans: Templates, forms and submission dates (updated)
Last updated: 09/06/2023 -
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Q&A: Good clinical practice (GCP) (updated)
Last updated: 08/06/2023 -
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PRIME: priority medicines (updated)
Last updated: 06/06/2023 -
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EudraVigilance training and support (updated)
Last updated: 01/06/2023 -
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Mutual recognition agreements (MRA) (updated)
Last updated: 31/05/2023 -
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Big data (updated)
Last updated: 26/05/2023 -
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Modelling and simulation: questions and answers (updated)
Last updated: 24/05/2023 -
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Plasma master file certificates (updated)
Last updated: 17/05/2023 -
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CHMP opinions on consultation procedures (updated)
Last updated: 16/05/2023 -
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Opinions and letters of support on the qualification of novel methodologies for medicine development
Last updated: 11/05/2023 -
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Cancer Medicines Forum: kick-off meeting
Online, 08:30 - 12:30 Amsterdam time (CEST), 31/03/2022, Last updated: 24/03/2023 -
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Cancer Medicines Forum: December 2022
Online, 20/12/2022, Last updated: 24/03/2023 -
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Cancer Medicines Forum: June 2022
Online, 28/06/2022, Last updated: 24/03/2023 -
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Innovation in medicines
Last updated: 17/03/2023 -
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Ninth industry stakeholder platform on research and development support
Online, 05/12/2022, Last updated: 08/03/2023 -
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Regulatory and scientific virtual conference on RNA-based medicines
Online, 09:00 - 16:30 Amsterdam time (CET), 02/02/2023, Last updated: 24/02/2023 -
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Submission deadlines for orphan designations
Last updated: 17/02/2023 -
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ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline
Last updated: 16/02/2023 -
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Joint EMA-FDA workshop: Efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants
Online, 13:00 - 17:00 Amsterdam time (CET), 15/12/2022, Last updated: 10/02/2023 -
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Quality: non-immunologicals
Last updated: 03/02/2023 -
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Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
Last updated: 01/02/2023