194 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Date of first decision: 19/03/2015, Withdrawn, Last updated: 22/10/2018 -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Date of first decision: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -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Date of first decision: 26/04/2013, Withdrawn, Last updated: 22/10/2018 -
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Big data (updated)
Last updated: 23/10/2020 -
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PRIME: priority medicines (updated)
Last updated: 22/10/2020 -
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Qualification of novel methodologies for medicine development (updated)
Last updated: 19/10/2020 -
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Scientific advice (updated)
Last updated: 19/10/2020 -
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Requesting scientific advice or protocol assistance from EMA (updated)
Last updated: 19/10/2020 -
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EudraVigilance training and support (updated)
Last updated: 12/10/2020 -
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Clinical Trial Regulation (updated)
Last updated: 05/10/2020 -
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Submitting annual reports on medicine development (updated)
Last updated: 02/10/2020 -
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Changing the name or address of a sponsor (updated)
Last updated: 02/10/2020 -
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ICH Q3D Elemental impurities (updated)
Last updated: 01/10/2020 -
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Orphans: Regulatory and procedural guidance and forms (updated)
Last updated: 28/09/2020 -
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Plasma master file certificates (updated)
Last updated: 25/09/2020 -
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Parallel consultation with regulators and health technology assessment bodies
Last updated: 17/09/2020 -
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Guidance for medicine developers and other stakeholders on COVID-19
Last updated: 27/07/2020 -
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Q&A: Good clinical practice (GCP)
Last updated: 24/07/2020 -
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Classifications as minor-use-minor-species and limited-market
Last updated: 08/07/2020 -
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Good clinical practice (GCP) inspection procedures
Last updated: 10/06/2020 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 05/06/2020 -
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European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meeting
Virtual meeting, 02/06/2020, Last updated: 05/06/2020 -
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Innovation in medicines
Last updated: 18/05/2020 -
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Compassionate use
Last updated: 11/05/2020