A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Avda de la Industria 30
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
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.
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.
•Additional risk minimisation measures
The MAH should provide educational material to all physicians who may be involved in treating patients with prasugrel. The format and means of dissemination, of this material should be discussed with the appropriate learned societies. The results of the discussion, and where appropriate the material, should be agreed with the national competent authority and be available prior to launch in each member state.
The educational material should include:
•A copy of the SPC
o Severe haemorrhagic events are more frequent in patients ≥ 75 years of age (including fatal events) or those weighing < 60 kg
o Treatment with prasugrel is generally not recommended for patients of ≥ 75 years of age.
o If, after a careful individual benefit/risk evaluation by the prescribing physician, treatment is deemed necessary in the ≥ 75 years age group then following a loading dose of 60 mg, a reduced maintenance dose of 5mg should be prescribed.
o Patients weighing < 60 kg should have a reduced maintenance dose of 5mg