198 results
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Haemophilus influenzae / Klebsiella pneumoniae / Moraxella catarrhalis / Staphylococcus aureus / Streptococcus mitis / S. pneumoniae / S. pyogenes, H. influenzae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes, S. pneumoniae / S. agalactiae / Staphylococcus aureus / H. influenzae, H. influenzae / K. ozaenae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes / S. viridans, H. influenzae / membrane fraction of K. pneumoniae / ribosomal fractions of K. pneumoniae / S. pneumoniae / S. pyogenes, Escherichia coli / K. pneumoniae / S. aureus / S. epidermidis / S. salivarius / S. pneumoniae / S. pyogenes / H. influenzae / Corynebacterium pseudodiphtheriticum / M. catarrhalis, 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Date of first decision: 19/03/2015, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of papillary thyroid cancer
Date of first decision: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Orphan designation: Lenvatinib for: Treatment of follicular thyroid cancer
Date of first decision: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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CHMP opinions on consultation procedures (updated)
Last updated: 04/03/2021 -
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Plasma master file certificates (updated)
Last updated: 01/03/2021 -
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European Medicines Agency / AnimalhealthEurope veterinary medicines info day 2021 (updated)
Virtual meeting, 25/03/2021, Last updated: 01/03/2021 -
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Q&A: Good clinical practice (GCP) (updated)
Last updated: 16/02/2021 -
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Changing the name or address of a sponsor (updated)
Last updated: 16/02/2021 -
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COVID-19 vaccines: research and development (updated)
Last updated: 05/02/2021 -
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COVID-19 treatments: research and development (updated)
Last updated: 05/02/2021 -
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Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
Last updated: 02/02/2021 -
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PRIME: priority medicines
Last updated: 02/02/2021 -
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Clinical Trial Regulation
Last updated: 01/02/2021 -
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Big data
Last updated: 01/02/2021 -
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Immunologicals: general
Last updated: 29/01/2021 -
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ICH Q3D Elemental impurities
Last updated: 29/01/2021 -
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Fifth industry stakeholder platform on research and development support
Virtual meeting, 16/11/2020, Last updated: 21/01/2021 -
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EudraVigilance training and support
Last updated: 17/12/2020 -
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Guidance on good manufacturing practice and good distribution practice: Questions and answers
Last updated: 16/12/2020 -
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Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
Last updated: 14/12/2020 -
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Guidance for medicine developers and other stakeholders on COVID-19
Last updated: 27/11/2020 -
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GMP/GDP Inspectors Working Group
Last updated: 23/11/2020 -
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Multidisciplinary: vaccines
Last updated: 19/11/2020 -
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Paediatric investigation plans: questions and answers
Last updated: 13/11/2020