European Medicines Agency Press Releases - EIN Presswire

Published on June 28, 2024 - 12:53 GMT

Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension

EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with other specific PAH therapies, to improve exercise capacity …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:53 GMT

EMA recommends revoking conditional marketing authorisation for Ocaliva

EMA’s human medicines committee (CHMP) has concluded its review of the medicine Ocaliva (obeticholic acid) and has recommended that the medicine’s marketing authorisation be revoked, because its benefits are no longer considered to outweigh its risks. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:53 GMT

First nasal adrenaline spray for emergency treatment against allergic reactions

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the nose for the emergency treatment of allergic reactions (anaphylaxis). …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:53 GMT

Summary of opinion: Imcivree, 27/06/2024 Positive

On 27 June 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Imcivree. The marketing authorisation holder for this …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:53 GMT

Summary of opinion: Betmiga, 27/06/2024 Positive

On 27 June 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Betmiga. The marketing authorisation holder for this medicinal …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:53 GMT

Summary of opinion: Beyfortus, 30/05/2024 Positive

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Beyfortus. The marketing authorisation holder for this …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:53 GMT

Summary of opinion: Tepkinly, 27/06/2024 Positive

On 27 June 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Tepkinly. The marketing authorisation holder for this …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:53 GMT

Summary of opinion: Vabysmo, 27/06/2024 Positive

On 27 June 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Vabysmo. The marketing authorisation holder for this medicinal …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:52 GMT

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting. The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult patients with unresectable or …

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Published on June 28, 2024 - 12:52 GMT

Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guideline

This document provide guidance on the statistical principles to be considered in the design, conduct, analysis and evaluation of clinical trials to demonstrate efficacy and/or safety of an investigational veterinary pharmaceutical product in animals. …

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Published on June 28, 2024 - 12:52 GMT

Conduct of efficacy studies for intramammary products for use in cattle - Scientific guideline

This document provides guidance on the conduct of efficacy studies and their evaluation for veterinary medicinal products that are administered via the teat canal to cattle. Keywords: Intramammary preparations, milk, udder, mastitis, somatic cell counts, …

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Published on June 28, 2024 - 12:52 GMT

Human medicines European public assessment report (EPAR): Aranesp, darbepoetin alfa, Date of authorisation: 08/06/2001, Revision: ...

Aranesp can only be obtained with a prescription and treatment should be started by a doctor who has experience in treating the types of anaemia mentioned above. Aranesp is available in a vial, a pre-filled syringe or a pre-filled pen. It is provided in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:52 GMT

Human medicines European public assessment report (EPAR): Repatha, evolocumab, Date of authorisation: 17/07/2015, Revision: 25, ...

Hypercholesterolaemia and mixed dyslipidaemia In primary hypercholesterolaemia and mixed dyslipidaemia, Repatha was studied in nine main studies involving around 7,400 adult patients, including patients with heterozygous familial disease. Some of the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:52 GMT

Referral: Lorazepam Macure 4 mg/ml, solution for injection, lorazepam Article 13 referrals CHMP opinion, 27/06/2024

Lorazepam Macure, a medicine of the benzodiazepine class, is used in several EU countries as a sedative before surgery or extensive physical examinations. It is also used to relieve severe fear or tension in people who cannot swallow tablets. Lorazepam …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 28, 2024 - 12:52 GMT

Clinical investigation of recombinant and human plasma-derived factor IX products - Scientific guideline

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use in the treatment and prevention of bleeding in patients with haemophilia …

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Published on June 28, 2024 - 12:52 GMT

Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific ...

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are indicated for use in the treatment and prophylaxis of bleeding in …

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Published on June 28, 2024 - 12:50 GMT

EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy. Translarna is used in patients whose disease is caused …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2024 - 15:47 GMT

Business hours and holidays

Business hours Business hours are Monday to Friday, 08:30 to 18:00. Switchboard is open Monday to Friday, 07:30 to 18:00. EMA's working hours follow Central European Time (CET). European Medicines Agency holidays 2025 1 January Wednesday, New Year' …

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Published on June 27, 2024 - 15:47 GMT

eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course - November 2024, Online, from 18 November 2024 to 20 ...

The training focuses on: Explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on authorised and unauthorised (referred to in the XEVMPD as 'development') medicinal products; …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 27, 2024 - 15:47 GMT

Extended EudraVigilance medicinal product dictionary (XEVMPD) training course for sponsors - October 2024, Online, from 10 October ...

This training focuses on: Explaining the guidance and data elements necessary for the electronic submission of information on unauthorised medicinal products (referred to in the XEVMPD as 'development' products). Applying the format of the …

Distribution channels: Healthcare & Pharmaceuticals Industry