Status: Planned First registered on: 30/05/2018
Last updated on: 01/06/2018
1. Study identification
EU PAS Register NumberEUPAS24224
Official titlePATTERN OF USE AND SAFETY PROFILE OF BRANDED VS GENERIC ANTIEPILEPTIC DRUGS
Study title acronym
Study typeObservational study
Brief description of the study
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUADRM
Department/Research groupUnit of adverse drug reactions monitoring
Organisation/affiliationUniversity hospital of Pisa
Website/Homepagehttp://www.ao-pisa.toscana.it/index.php?option=com_content&view=article&id=2256%3Asez-dip-monitoraggio-reazioni-avverse-ai-farmaci&catid=383&Itemid=54; http://www.medmcs.unipi.it/laboratorio-pharmacovigilance-and-drug-safety.html
Details of (Primary) lead investigator
Title Dr
Last name Lucenteforte
First name Ersilia
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

UADRM
Pharmacovigilance Unit of Neurofarba Department
ARS
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/06/2018
Start date of data collection01/06/2018
Start date of data analysis11/06/2018
Date of interim report, if expected
Date of final study report28/09/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherUniversity of Florence100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lucenteforte
First name Ersilia
Address line 1via Savi 10
Address line 2 
Address line 3 
CityPisa 
Postcode56126 
CountryItaly
Phone number (incl. country code)39-050-2218285 
Alternative phone number 
Fax number (incl. country code) 
Email address ersilia.lucenteforte@unipi.it
Public Enquiries
Title Dr 
Last name Lucenteforte 
First name Ersilia 
Address line 1via Savi 10 
Address line 2 
Address line 3 
CityPisa 
Postcode56126 
CountryItaly 
Phone number (incl. country code)39-050-2218285 
Alternative phone number 
Fax number (incl. country code) 
Email address ersilia.lucenteforte@unipi.it 
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