A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release
ZI N°2 de Prouvy Rouvignies
1 rue de Nungesser
59121 Prouvy France
40 Boulevard de Champaret
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
C.OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web- portal.
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
D.CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP)
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
An updated RMP should be submitted:
At the request of the European Medicines Agency;
Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Obligation to conduct
The MAH shall complete, within the stated timeframe, the below measures:
Final report: 3Q 2023
document the drug utilisation of Wakix and to collect information on
the safety of Wakix when used in routine medical practice