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Rituzena (Tuxella) (rituximab) – Conditions or restrictions regarding supply and use - L01XC02

Updated on site: 10-Oct-2017

Medication nameRituzena (Tuxella)
ATC CodeL01XC02
Substancerituximab
ManufacturerCelltrion Healthcare Hungary Kft.

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer of the biological active substance

CELLTRION Inc.,

20 Academy–ro 51 beon-gil

Yeonsu-gu, Incheon, 22014, Republic of Korea

Name and address of the manufacturers responsible for batch release

Biotec Services International Ltd.

Biotec House, Central Park, Western Avenue

Bridgend Industrial Estate

Bridgend, CF31 3RT, UK

Units 2100, 2110, 2010, 2120 and 2130

Phase 18, Central Park

Bridgend Industrial Estate

Bridgend, CF31 3TY, UK

The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.

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 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

Non-oncology indications:

The MAH must ensure that all physicians who are expected to prescribe Tuxella are provided with the following:

Product information Physician information Patient information Patient Alert card

The Physician information about Tuxella should contain the following key elements:

The need for close supervision during administration in an environment where full resuscitation facilities are immediately available

The need to check, prior to Tuxella treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination

The need to monitor patients for infections, especially PML, during and after Tuxella treatment

Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML

The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.

The need to provide patients with the Patient Alert Card with each infusion

The Patient information about Tuxella should contain the following key elements:

Detailed information on the risk of infections and PML

Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any

The importance of sharing this information with their partner or caregiver

Information on the Patient Alert Card

The Patient Alert Card for Tuxella in non-oncology indications should contain the following key elements:

The need to carry the card at all times and to show the card to all treating health care professionals

Warning on the risk of infections and PML, including the symptoms

The need for patients to contact their health care professional if symptoms occur

Oncology indications:

The MAH must ensure that all physicians who are expected to prescribe Tuxella are provided with the following:

Product information Physician information

The Physician information about Tuxella should contain the following key elements:

Information that the product should be administered as IV only to avoid administration route errors.

The Physician information and Patient information must be agreed with the National Competent Authorities prior to distribution and Patient Alert Card should be included as part of inner packaging.

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