Europe – Review of pholcodine medicines started
The European Medicines Agency (EMA) has started a review of medicines that contain pholcodine following concerns that their use may put people at risk...
Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde...
Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) recommande de nouvelles mesures pour réduire les risques d’insuffisance respiratoire et de sepsis...
UK – NHS fast tracks life-extending prostate cancer drug to patients
Around 9,000 men with one of the most advanced forms of prostate cancer will be eligible for a new life-extending treatment thanks to a...
Europe – Human medicines: highlights of 2022
In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 41 had a new active substance which had never been authorised in the European Union (EU)...
Europe – Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling...
EMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the...
Europe – EMA medical terms simplifier
This compilation gives plain-language descriptions of medical terms commonly used in information about medicines. Communication specialists at EMA use these descriptions for materials prepared...
Italy – The New Italian Sunshine Act: What Companies Should Know And How To...
On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act. The Sunshine Act entered into force on 26...
UK – NICE rejects AstraZeneca and MSD’s Lynparza as NHS prostate cancer treatment
NICE has said it is unable to recommend NHS use of AstraZeneca’s Lynparza for some patients with prostate cancer, after failing to reach an...
Europe – Guidance on the anonymisation of protected personal data and assessment of commercially...
This document aims at giving general guidance to companies on the retention/removal of Protected Personal Data (PPD) and identification of Commercially Confidential Information (CCI)....
Europe – Facilitating Decentralised Clinical Trials in the EU
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs)...
