Periodic safety update reports

This format is a legal requirement for both nationally authorised products and centrally authorised products. Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report. Adopted First published: 25/06/2012 Last updated: 12/12/2013 Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: …

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Domestic Family Trust Planning. Domestic/Offshore Marriage/ Inheritance. Foreign Exchange Compliance for Family Enterprises and Family Members. Global Asset Planning for Family Enterprises and Family Members. Offshore Family Trust Planning. Overall Planning for Family Wealth Security and Inheritance. Planning of Family Enterprise …

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Medicines | European Medicines Agency

Our Medicine finder above helps you find information on medicines authorised for human or veterinary use. You can find these by including the medicine's name or its active …

Homepage | European Medicines Agency

EMA has recommended granting a marketing authorisation in the European Union (EU) for Voydeya, the first oral treatment for patients with paroxysmal nocturnal haemoglobinuria (PNH) who continue to have haemolytic anaemia (low levels of red blood cells) despite treatment with a C5 complement inhibitor (eculizumab or ravulizumab). 23 February 2024.

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Biosimilar medicines: Overview | European Medicines Agency

Biosimilar medicines: Overview. A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The European Medicines Agency (EMA) is ...

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EMA

Education that empowers the professional of the future. Ecole de Management Applique (EMA), founded in 2004, is a renowned institution offering a wide range of academic degrees, including undergraduate, postgraduate, MBA, DBA, and Ph.D. programmes in Applied Management. Our specialisations encompass Finance, Law, Economics, and Arts.

Pathology Outlines

Epithelial membrane antigen (EMA) is a transmembrane protein normally expressed in glandular or luminal epithelial cells and hematopoietic cells and absent in …

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The top tier international law firm, from Asia, for the world. A firm born in Asia, underpinned by world class capability. With over 3000 lawyers in 29 global locations, we draw from our Western and Eastern perspectives to deliver incisive counsel. We are focused on our clients – people and organisations with distinctive ambitions and challenges.

EMA: Q&A on Nitrosamines Updated to Rev. 18

The EMA Q&A on nitrosamine impurities has been updated on 2 October 2023 and is now available as Revision 18. The update concerns Q&A 3 regarding the "call of review" and how to report steps 1 and 2 to the competent authorities. The update highlights the responsibilities of MAH (s) to control, report, and mitigate the detection of ...

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EMA Recommends Seven Medicines for Approval in October

The European Medicines Agency (EMA) announced on Oct. 13, 2023 that the agency's Committee for Medicinal Products for Human Use (CHMP) has recommended seven new medicines for the treatment of a variety of conditions, including Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive …

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Procedural timetables | European Medicines Agency

Procedural timetables. This page lists the timetables for the submission, start and finish dates of procedures, as well as other interim dates and milestones that occur during the various procedures. Timetables are categorised according to the type of procedure (e.g. full applications, extensions and variations, as well as response timetables).

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The Future of Money: Around the World in Central Bank Digital Currencies. From Australia's pilot projects to Jamaica's JAM-DEX, the UK's budding Britcoin and China's ever-expanding e-CNY, there is significant movement in central bank digital currencies (CBDCs) globally. Here, we take a journey around the world in CBDCs.

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Ema Blanche Profiles | Facebook

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