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 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.
Additional risk minimisation measures
The MAH shall ensure that prior to launch, all doctors who intend to prescribe the medicinal product, and all pharmacists who may dispense the medicinal product, are provided with a healthcare professional information pack containing the following:
Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Key elements to be included in the educational brochure
Brief background on Tasigna, its authorised indication and posology
Information on the cardiac risks associated with the use of Tasigna
oThat Tasigna can cause prolongation of the QT interval and that Tasigna should be used with caution in patients who have or who are at significant risk of developing prolongation of QTc. Concomitant use of Tasigna with
medicinal products that may prolong the QT interval should be undertaken with caution
oCaution in prescribing to patients with a history of or risk factors for coronary heart disease
oThat Tasigna may cause fluid retention, cardiac failure and pulmonary oedema
That Tasigna is metabolised by CYP3A4 and that strong inhibitors or inducers of this enzyme may significantly affect exposure to Tasigna.
oThat inhibitors may increase the potential for adverse drug reactions in particular QT interval prolongation.
oTo warn patients about OTC medicines in particular St John’s Wort
The need to inform patients about the effects of food on Tasigna
oNot to eat within two hours before and one hour after taking Tasigna
o The need to avoid foods such as grapefruit juice which inhibit CYP3A4 enzymes