PUBBLICATO IL RAPPORTO MENSILE DEL PHARMACOVIGILANCE WORKING PARTY



EMEA, PHARMACOVIGILANCE WORKING PARTY (PHVWP) MONTHLY REPORT
Fonte: EMA. Luglio 2011



E' disponibile il rapporto mensile del Pharmacovigilance Working Party pubblicato sul sito web dell'EMA.
Tale rapporto riassume gli argomenti discussi nella riunione plenaria del PhVWP del 18-20 luglio 2011.

Sono riportate le seguenti tematiche:

DISCUSSIONS ON SAFETY CONCERNS
• Antipsychotics – Risk of extrapyramidal effects and withdrawal symptoms in newborns after exposure during pregnancy
• Fusidic acid – Risk of rhabdomyolysis due to interaction with HMG-CoA reductase inhibitors
• Plantago ovata (syn.: P. isphagula) – Risk of allergic reactions after prolonged occupational exposure
• Reboxetine – Confirmation of positive benefit-risk balance
• PERFALGAN (paracetamol) 10 mg/ml solution for infusion – Risk of dosing errors in infants resulting in overdose with serious outcome
• Serotonergic antidepressants – Risk of persistent pulmonary hypertension of the newborn
• YASMIN/YIRA (ethinylestradiol 30µg + drospirenone) – Risk of venous thromboembolism
GUIDELINES AND GENERAL MATTERS
• EudraVigilance Access Policy for Medicines for Human Use