A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Daiichi Sankyo Europe GmbH
85276 Pfaffenhofen, Bayern
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.
- Lixiana - edoxaban tosylate
Prescription drugs listed. Substance: "Edoxaban tosylate"
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 Roteas in each Member State, the Marketing Authorisation Holder (MAH) must agree 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 at mitigating the risk of serious bleeds or haemorrhage in patients treated with Roteas by ensuring prescriber awareness and providing guidance on appropriate patient selection, correct dosing as well as management of the risk.
The programme is also aimed at ensuring that the healthcare professionals who intend to prescribe Roteas are aware of the Patient alert card and that the card is to be given to and reviewed with all patients treated with Roteas.
The MAH shall ensure that in each Member State where Roteas is marketed, all healthcare professionals who are expected to use Roteas are provided with the following educational material:
•The Summary of Product Characteristics
•Prescriber Guide for healthcare professionals
•Patient alert card
The Prescriber Guide for healthcare professionals shall contain the following key elements:
•Relevant information on the risk of bleeding
•Details of the population potentially at higher risk of bleeding
•Recommendations for dose adjustment in at risk populations, including patients with renal or hepatic impairment, low body weight and concomitant use of some
•Guidance on switching from or to Roteas treatment
•Guidance regarding surgery or invasive procedure, and temporary discontinuation
•Management of overdose situations and haemorrhage
•Use of coagulation tests and their interpretation
•That all patients should be provided with a Patient alert card and be counselled about:
The signs or symptoms of bleeding and when to seek attention from a healthcare provider
Importance of treatment compliance
Necessity to carry the Patient alert card with them at all times
The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure
The Patient alert card should contain the following key safety messages:
•The signs or symptoms of bleeding and when to seek attention
•Importance of treatment compliance
•Necessity to carry the Patient alert card with them at all times
•The need to inform Health Care Professionals that they are taking Roteas if they need to have any surgery or invasive procedure