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There were 1,920 press releases posted in the last 24 hours and 355,559 in the last 365 days.

European Medicines Agency Press Releases

3,984 Press Releases

Published on June 5, 2024 - 14:50 GMT

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance ...

EudraVigilance is the EU's system for managing and analysing information on adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area (EEA) and supports the reporting and analysis of …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 5, 2024 - 14:50 GMT

Human medicines European public assessment report (EPAR): Erbitux, cetuximab, Date of authorisation: 29/06/2004, Revision: 30, ...

The most common side effects with Erbitux (seen in more than 1 patient in 10) are skin reactions such as rash, hypomagnesaemia (low blood magnesium levels), mild or moderate reactions linked to the infusion (such as fever, chills, dizziness and difficulty …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 4, 2024 - 09:58 GMT

Referral: Kexxtone 32.4 g continuous-release intraruminal device for cattle, monensin Article 130(4) European Commission final ...

The veterinary medicine Kexxtone suspended across the European Union On 23 April 2024, the EMA’s veterinary medicines committee, CVMP, completed a review recommending the suspension of the marketing authorisation of Kexxtone in the European Union. This …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 4, 2024 - 00:22 GMT

Veterinary medicines European public assessment report (EPAR): Credelio, lotilaner, Status: Authorised

Credelio : EPAR - Medicine overview Reference Number: EMA/122474/2017

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Veterinary medicines European public assessment report (EPAR): Bravecto, fluralaner, Status: Authorised

CVMP post-authorisation summary of positive opinion for Bravecto (II/0033/G, II/0036) AdoptedReference Number: EMA/CVMP/465180/2019

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Recommendations on medication errors

In the European Union (EU), national competent authorities and the European Medicines Agency (EMA) play a key role in identifying and reducing the risk of medication errors before and after the authorisation of a medicine. EMA applies a consistent approach …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Veterinary medicines European public assessment report (EPAR): Circovac, adjuvanted inactivated vaccine against porcine circovirus ...

Circovac : EPAR - Summary for the public Reference Number: EMA/286116/2007

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Human medicines European public assessment report (EPAR): Sunitinib Accord, sunitinib, Date of authorisation: 11/02/2021, Revision:...

Sunitinib Accord can only be obtained with a prescription and treatment should be started by doctors who have experience in the use of cancer medicines. Sunitinib Accord is available as capsules of various strengths to be taken by mouth. For GIST and …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

EMEA-003371-PIP01-22

P/0154/2023 : EMA decision of 12 May 2023 on the granting of a product specific waiver for N-(4-(4-amino-5-(3-fluoro-4-((4-methylpyrimidin-2- yl)oxy)phenyl)...(EMEA-003371-PIP01-22) Reference Number: EMA/170256/2023

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Human medicines European public assessment report (EPAR): Dacogen, decitabine, Date of authorisation: 20/09/2012, Revision: 17, ...

The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count). The most common serious side effects (seen in more than 20% of patients) include …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Paediatric medicines: applications and procedures

As of 4 June 2024, applicants should use the IRIS platform for the following types of procedure: Initial paediatric investigation plan (PIP) Modification of an agreed PIP Product-specific waiver Compliance check Annual report on paediatric deferred …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Paediatric medicines: Research and development

If you need to contact EMA about an ongoing paediatric procedure in IRIS, send your message as a reply to the latest email received from IRIS relating to that procedure. Please make sure not to change the subject field when replying so your message is …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Paediatric investigation plans: Templates and forms

The forms and templates should be downloaded and saved first before being completed. To report any technical issues with the form, please use the EMA Service Desk portal. It is mandatory to use the latest published version of all templates and forms unless …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Paediatric investigation plans: questions and answers

EMA is running a pilot for a 'stepwise PIP' agreement which would introduce a partial development programme supporting the authorisation of innovative medicines for children. This programme would be conditional on the development of a full PIP once …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Annual report on deferrals

Marketing-authorisation holders that have received a deferral on a PIP are obliged to submit annual reports to the Agency. These reports should provide an update on progress with paediatric studies in accordance with the decision of the Agency agreeing the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 14:38 GMT

Class waivers

Androgen receptor modulator, of oestrogen receptor modulator, of growth and sex hormone as well as their releasing or inhibiting factors, and of sex hormone-metabolism modulator medicinal products Breast malignant neoplasms, prostate malignant neoplasms …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 09:50 GMT

Removing an orphan designation

Sponsors need to use EMA's IRIS system to submit all post-designation activities. EMA will not be able to process any submissions outside of IRIS. including removal of an orphan designation from the EC register. For information and guidance on using …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on June 3, 2024 - 09:50 GMT

Human medicines European public assessment report (EPAR): Hizentra, human normal immunoglobulin (SCIg), Date of authorisation: 14/...

As human normal immunoglobulin has been used to treat these diseases for many years, in accordance with current guidelines, two small studies and an analysis of scientific literature were needed to establish the effectiveness and safety of Hizentra in …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 31, 2024 - 19:23 GMT

Q&A clinic on Product Management Service (PMS) Product User Interface - 6 June 2024, Online, European Medicines Agency, Amsterdam, ...

Following the go-live of Product Management Service (PMS) Product User Interface on 31 May 2024, the PMS team is available to answer your questions on PUI use during weekly 30-minute sessions.

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on May 31, 2024 - 19:23 GMT

Q&A clinic on Product Management Service (PMS) Product User Interface - 27 June 2024, Online, European Medicines Agency, Amsterdam,...

Following the go-live of Product Management Service (PMS) Product User Interface on 31 May 2024, the PMS team is available to answer your questions on PUI use during weekly 30-minute sessions.

Distribution channels: Healthcare & Pharmaceuticals Industry

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