Search Tag: EMA
2021 11 Mar
The European Medicines Agency’s (EMA) announced today that the single dose Covid-19 vaccine has been approved for use in individuals 18 years of age and older in the European Union. Developed by the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) in Belgium and the Netherlands, this vaccine is the fourth to be approved by the EMA....Read more
2015 04 Jul
The European Medicines Agency (EMA) has recommended the introduction of more effective educational material to promote appropriate use of adrenaline auto-injectors. The move came following concerns that currently available devices may deliver adrenaline under the skin instead of into a muscle, hence delaying response to treatment. Adrenaline auto-injectors...Read more
2015 18 Feb
The European Medicines Agency (EMA) has announced that physicians should take precautions when prescribing the antihistamine hydroxyzine as it can cause potentially fatal arrhythmias. Hydroxyzine is approved for the treatment of anxiety disorders, sleep disorders and pruritus. It is also used as a premedication before surgery and is used off...Read more
2015 30 Jan
A committee of the European Medicines Agency (EMA) has made recommendations that the sale of four dozen generic drugs should be suspended. These include generic medicines for diabetes, depression and hypertension. The recommendations have been made on the grounds that the approval of these drugs was based on flawed clinical studies that had been conducted...Read more
2015 12 Jan
The European Medical Agency (EMA) has shown its support for a record number of orphan medicines in 2014. Out of a total of 82 medicines for human use, 17 are indicated for the treatment of a rare disease. EMA has given positive opinions on 40 new non-orphan drugs, three biosimilars, one drug for paediatric use and 21 generic, hybrid and informed consent...Read more
2014 16 Jun
The European Medicines Agency (EMA) has come to an agreement about its policy pertaining to the publication of clinical trial data, which will allow the agency to proactively share study results that are submitted with applications for marketing authorisation. The policy will enable academic and non-commercial researchers to download, save and print...Read more
2013 11 Jul
The European Medicines Agency has established a formal Healthcare Professionals’ Working Party (HCPWP) to further involve this group of stakeholders in its range of activities. The role of the HCPWP is to provide recommendations to the Agency on all matters of interest to healthcare professionals in relation to medicines. The creation of this working...Read more