Pagina blog
France assessing risk-benefit profile of bromocriptine
The French regulator ANSM has reassessed the risk/benefit profile of bromocriptine on behalf of the EMA. The active substance is indicated to inhibit lactation after delivery.
Antibiotic resistance, NICE proposes prescription surveillance
The National Institute for Health and Care Excellence (NICE) has brought some stir in the British healthcare system by proposing some measures to tackle resistance to antibiotics.
BfArM informs on further developments on stolen Italian drugs
The German Medicine Agency BfArM announced new developments on the investigations regarding the theft of medicines occurred in Italy at the beginning of 2014.
Pediatric Committee, new recommendations
The Pediatric Committee (PDCO) of the European Medicine Agency has published some recommendations issued during their meeting in January.
EMA to translate product information changes into all EU languages
The European Medicines Agency (EMA) will translate its recommendations into all the official languages of the European Union, as well as into Norwegian and Icelandic; these will…
MD sector growing
Good news also for medical devices; the Italian market data are also very encouraging.
Cosmetics, internal market reduced but exportations increase
The new sale data on cosmetic products in Italy are encouraging. On one side, the internal demand is slightly reduced, with sale proceeds decreasing of 1% compared…
Mapping the risks in GMP inspections
The Italian Medicine Agency (AIFA) informed all manufacturing sites and importers of active substances that the API Inspection Unit is mapping the risks in the frame of…
Changes to the National Network of Pharmacovigilance
The Italian Medicine Agency informed all concerned parties that some changes have been introduced to the National Network of Pharmacovigilance (RFN) allowing the registration of reports of suspected adverse reactions occurred on…
New monitoring registers
Starting from February 23th 2015 a new web sheet regarding the medicinal product containing the active substance simeprevir has been made available on the web platform of…
