English (EN) (81.94 KB - PDF) First published: 07/07/2015Last updated: 21/06/2024
This public webinar aims to explain how pack sizes should be submitted to XEVMPD to support the European Shortages Monitoring Platform (ESMP) and how they will be incorporated into Product Management Service (PMS), providing an overview of the entire …
EMA will host a public online training session, following the go-live of the Product Management Service (PMS) Application Programming Interface (API) on 1st week of July for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs …
On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Daxocox. The marketing …
On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a marketing authorisation for the veterinary medicinal product Divence IBR Marker Live, lyophilisate and solvent for emulsion …
On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a group of variations to the terms of the marketing authorisation for the veterinary medicinal product Suvaxyn PRRS MLV. The …
On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Rabitec. The marketing …
On 19 June 2024, the Committee for Veterinary Medicinal Products (CVMP) adopted a positive opinion1, recommending the granting of a variation to the terms of the marketing authorisation for the veterinary medicinal product Stronghold Plus. The marketing …
VeterinaryProduct information
EMA is hosting the twelfth industry stakeholder platform on the operation of the centralised procedure for human medicines on 19 June 2024. This will be the twelfth in a series of regular meetings between regulators and representatives of industry …
This guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical pharmacokinetic drug-drug interaction (DDI) studies during the development of a …
The most common side effects with Cubicin (which may affect between 1 and 10 patients in 100) are infections caused by fungi (moulds and yeasts), urinary tract infections (infection of the structures that carry urine), Candida infection (a fungal infection …
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) are organising a multi-stakeholder hybrid workshop on Pharmacogenomics at EMA in Amsterdam. The objectives of the workshop are to: identify priority …
Bretaris Genuair is available as an inhalation powder in a portable inhaler device. Each inhalation provides 375 micrograms of aclidinium bromide equivalent to 322 micrograms of aclidinium. The recommended dose of Bretaris Genuair is one inhalation twice a …
The guideline aims to help with defining study populations and designing study protocols. It provides guidance on data collection, data quality management and data analysis to achieve higher quality evidence. It focuses on studies involving disease …
Primary hypercholesterolaemia or mixed dyslipidaemia Two studies showed that bempedoic acid and ezetimibe (the active substances of Nustendi) effectively reduced LDL cholesterol levels in patients with hypercholesterolaemia and heart disease or who were at …
Primary hypercholesterolaemia or mixed dyslipidaemia Nilemdo effectively reduced LDL cholesterol levels in four main studies involving adults with hypercholesterolaemia or mixed dyslipidaemia, in which Nilemdo was compared with placebo (a dummy treatment). …
Atosiban SUN can only be obtained with a prescription. Treatment with Atosiban SUN should be carried out by a doctor who has experience in the treatment of pre-term labour. Treatment should be started as soon as possible after diagnosis of pre-term labour. …
This webinar 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 were launched. The webinar will also highlight the benefits of the pilots, …
Alecensa has been shown to be effective in treating ALK-positive NSCLC. Advanced NSCLC Two main studies involved a total of 225 patients with advanced ALK-positive NSCLC in whom the disease progressed despite previous treatment with Xalkori (crizotinib), …
07 days 00:50:29
