A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturers responsible for batch release Synthon Hispania, S.L.
C/ Castello, nº1, Pol. Las Salinas, Sant Boi de Llobregat
08830 Barcelona, Spain
Synthon, s.r.o. Brněnská 32/čp. 597 Blansko
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.
- Capecitabine medac - medac Gesellschaft für klinische Spezialpräparate mbH
- Leflunomide medac - medac Gesellschaft für klinische Spezialpräparate mbH
- Zoledronic acid medac - medac Gesellschaft für klinische Spezialpräparate mbH
- Temomedac - medac Gesellschaft für klinische Spezialpräparate mbH
Prescription drugs listed. Manufacturer: "Medac Gesellschaft fur klinische Spezialpraparate mbH"
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
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.