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  1. www.ema.europa.eu › en › human-regulatory-overviewAvailability of medicines before and during crises | European...

    Hace 1 día · The European Medicines Agency (EMA) plays a key role in coordinating the European Union's (EU) response to medicine supply issues caused by crises such as major events or public health emergencies. EMA also has an important role in monitoring medicine shortages that cannot be resolved through measures taken at national level and that might lead ...

  2. www.ema.europa.eu › en › newsFirst vaccine to protect adults from Chikungunya | European...

    31 de may. de 2024 · EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against Chikungunya. It is given as a single dose.

  3. www.ema.europa.eu › en › ich-q2r2-validation-analytical-proceduresEuropean Medicines Agency - ICH Q2 (R2) Validation of analytical...

    14 de jun. de 2024 · This guideline presents a discussion of elements for consideration during the validation of analytical procedures included as part of registration applications submitted within the ICH member regulatory authorities.

  4. clinicaldata.ema.europa.euHome - Clinical Data Publication - clinicaldata.ema.europa.eu

    30 de may. de 2024 · This website contains clinical data published under the European Medicines Agency (EMA) policy on the publication of clinical data.

  5. ec.europa.eu › newsroom › emaEUROPEAN MEDICINES AGENCY - EU NTC 10-year anniversary event

    30 de may. de 2024 · In 2024, the EU NTC will mark the 10-year anniversary of its creation, as a strategic collaborative endeavour between EMA and HMA.

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  7. www.reuters.com › business › healthcare-pharmaceuticalsEU regulator backs use of Pfizer's gene therapy for rare bleeding...

    31 de may. de 2024 · The European Medicines Agency (EMA) has recommended the use of Pfizer's gene therapy for a rare bleeding disorder called hemophilia B, which typically requires regular infusions of a blood ...

  8. news.bms.com › news › detailsEuropean Medicines Agency Validates Bristol Myers Squibb’s ...

    Hace 6 días · PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated the extension application to introduce a new route of administration (subcutaneous use) for Opdivo ® (nivolumab) that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult ...