A.MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) responsible for batch release
Pfizer Manufacturing Deutschland GmbH
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 intervetions detailed in the agreedRMP 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 Medicine Agency;
•Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
•Additional risk minimisation measure
The Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the National Competent Authority. The final wording used on the educational material should be in line with the approved product information.
The MAH should ensure that, at launch and thereafter, all Healthcare Professionals who are expected to use and/or prescribe XALKORI are provided with an educational pack.
The educational pack should contain the following:
1.Summary of Product Characteristics and Package Leaflet.
2.Patient brochure including a Patient Alert Card (text as agreed by the CHMP).