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There were 1,839 press releases posted in the last 24 hours and 429,665 in the last 365 days.

European Medicines Agency Press Releases

3,984 Press Releases

Published on June 19, 2024 - 17:20 GMT

Human medicines European public assessment report (EPAR): Sondelbay, teriparatide, Date of authorisation: 24/03/2022, Revision: 1, ...

The safety of Sondelbay has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine Forsteo. The most common side effect with teriparatide (which …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 19, 2024 - 17:20 GMT

Human medicines European public assessment report (EPAR): Eviplera, emtricitabine,rilpivirine,tenofovir disoproxil, Date of ...

Eviplera has been studied in two main studies in patients with HIV-1 who had not received HIV treatment before. In the first main study involving 690 patients, Eviplera was compared with a similar combination that had efavirenz in place of rilpivirine. The …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 19, 2024 - 13:06 GMT

ACT EU consolidated advice pilots: information and training webinar for Applicants, European Medicines Agency, Amsterdam, the ...

This webinar, hosted by the Accelerating clinical trials in the EU (ACT EU) initiative, will provide information on the newly launched consolidated advice pilots (SAWP-CTCG and pre-CTA advice). It will inform on the background of the pilots and why they …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 19, 2024 - 12:00 GMT

Human medicines European public assessment report (EPAR): Firazyr, icatibant, Date of authorisation: 11/07/2008, Revision: 24, ...

Each pre-filled syringe of Firazyr contains 30 mg icatibant in 3 ml. The medicine is given by injecting it slowly under the skin, preferably in the abdomen (belly). The recommended dose of Firazyr in adults is one injection (3 ml). If symptoms continue or …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 15:41 GMT

Medicine shortages and availability issues: guidance for companies

Guidance is available for marketing authorisation holders for human and veterinary medicines on detecting and reporting medicine shortages, based on a harmonised definition of a shortage agreed upon by all national competent authorities and EMA. When a …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 15:41 GMT

EMEA-003372-PIP01-22

P/0157/2023: EMA decision of 12 May 2023 on the granting of a product-specific waiver for ramipril / indapamide (EMEA-003372-PIP01-22) Reference Number: EMA/170257/2023

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 15:41 GMT

EMEA-003373-PIP01-22

P/0158/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for atorvastatin / ezetimibe (EMEA-003373-PIP01-22) Reference Number: EMA/170258/2023

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 15:41 GMT

EMEA-003374-PIP01-22

P/0188/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for adeno-associated viral vector serotype 9 expressing codon-optimized human GRN gene (LY3884963) (EMEA-003374-PIP01-22) Reference Number: EMA/198966/2023

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 15:41 GMT

EMEA-003376-PIP01-22

P/0180/2023 : EMA decision of 15 May 2023 on the granting of a product specific waiver for recombinant humanized monoclonal antibody (immunoglobulin gamma-1 with kappa light chains, IgG1κ) ... (EMEA-003376-PIP01-22) Reference Number: EMA/176012/2023

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 15:41 GMT

Human medicines European public assessment report (EPAR): Memantine Mylan, memantine, Date of authorisation: 21/04/2013, Revision: ...

Memantine Mylan is available as 10-mg and 20-mg tablets and can only be obtained with a prescription. Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer’s disease. Treatment should only be …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 10:58 GMT

Faster access to clinical trial information in Europe

The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 10:28 GMT

Development of the Clinical Trials Information System

EMA continues to regularly engage with external stakeholders on CTIS development and change management matters, before and after go-live, under the stakeholder engagement model in place since 2019. Nominated experts representing national competent …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 10:28 GMT

Clinical Trials Information System

A joint controllership arrangement describes the processing of personal data in CTIS, in accordance with the General Data Protection Regulation and EU Data Protection Regulation. A range of actors may need to enter personal data into CTIS as part of …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 18, 2024 - 10:00 GMT

Human medicines European public assessment report (EPAR): Steqeyma, ustekinumab, Status: Opinion

On 27 June 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Steqeyma, intended for the treatment of adults and children with plaque …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 17, 2024 - 14:46 GMT

Small and medium-sized enterprises info day, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 18 October ...

The European Medicines Agency (EMA) is organising a hybrid SME (small and medium-sized enterprises) info day on 18 October 2024. The SME info day is a training event dedicated to small and medium-sized enterprises in the pharmaceutical sector. It …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 17, 2024 - 14:46 GMT

Veterinary medicines European public assessment report (EPAR): Bovilis Blue-8, bluetongue virus vaccine (inactivated) serotype 8, ...

English (EN) (81.94 KB - PDF) First published: 08/12/2017Last updated: 17/06/2024

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 17, 2024 - 14:46 GMT

Veterinary medicines European public assessment report (EPAR): Activyl, indoxacarb, Status: Withdrawn

English (EN) (81.94 KB - PDF) First published: 28/02/2011Last updated: 17/06/2024

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 17, 2024 - 14:46 GMT

Veterinary medicines European public assessment report (EPAR): Forceris, toltrazuril,iron (III) ion, Status: Authorised

English (EN) (81.94 KB - PDF) First published: 16/05/2019Last updated: 17/06/2024

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 14, 2024 - 19:20 GMT

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024

Review of painkiller metamizole started Review will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to minimise it. EMA has started a review of medicines containing the painkiller …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 14, 2024 - 19:20 GMT

Review of painkiller metamizole started

EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be effective enough. Metamizole-containing medicines are authorised in a number …

Distribution channels: Healthcare & Pharmaceuticals Industry

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