A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Novartis Pharma 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 marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 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.
Additional risk minimisation measures
Prior to launch of Farydak in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
The educational programme is aimed to address the risk of medication error.
The MAH shall ensure that in each Member State where Farydak is marketed, all patients/carers who are expected to use Farydak have access to/are provided with the following educational package:
Patient information pack
The patient information pack should contain: o Patient information leaflet
oA patient compliance card
The patient compliance card shall contain instructions on the following key messages: o How to become familiar with the compliance card: this section provides a general
overview of the compliance card and its purpose.
o How to use the compliance card: this section provides a general overview on how to use the compliance card.
o How to take medication according to the prescription: this section provides guidance on how to fill in the compliance card.
o Recommendation to bring compliance card to each visit: this section reminds the patient to bring the compliance card to the HCP at each visit.
o A table describing the treatment regimen for each day of the cycle with space for the patient to note what medication they took.