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Roteas (edoxaban tosylate) – Conditions or restrictions regarding supply and use - B01AF03

Updated on site: 10-Oct-2017

Medication nameRoteas
ATC CodeB01AF03
Substanceedoxaban tosylate
ManufacturerDaiichi Sankyo Europe GmbH

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Daiichi Sankyo Europe GmbH

Luitpoldstrasse 1

85276 Pfaffenhofen, Bayern

Germany

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.

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

Contraindications

Recommendations for dose adjustment in at risk populations, including patients with renal or hepatic impairment, low body weight and concomitant use of some P-gp inhibitors

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

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