Comunicazione EMA sull'uso obbligatorio dello PSUR repository (13/02/2016)
L'Agenzia Italiana del Farmaco rende disponibile un documento di domande
e risposte per i titolari di AIC sull’uso dello PSUR repository.
Italiano
L'Agenzia Italiana del Farmaco rende disponibile un documento di domande
e risposte per i titolari di AIC sull’uso dello PSUR repository.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Si ricorda ai Responsabili di Farmacovigilanza che l'utilizzo dello PSUR repository per la
presentazione degli PSUR nell'Unione Europea diventerà obbligatorio il 13 giugno 2016.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Majority of reported problems occurred in individuals intentionally misusing and abusing high doses of loperamide in attempts to self-treat opioid withdrawal symptoms or to achieve a feeling of euphoria.
Risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products.
Reports of severe redness, pain, skin discoloration, blistering, and cracked skin.
There may be a higher risk of patient infection associated with surgeries that introduced a prosthetic product/material [e.g., heart valve, graft, LVAD], or heart transplants when the 3T was used.
Over-65 diabetics represent about half of the patients visiting general practitioners.
Manufacturing defect causes an increase in temperature within battery that may cause a fire.
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