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Defitelio (defibrotide) – Conditions or restrictions regarding supply and use - B01AX01

Updated on site: 06-Oct-2017

Medication nameDefitelio
ATC CodeB01AX01
Substancedefibrotide
ManufacturerGentium S.r.l.

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

Name and address of the manufacturer of the biological active substance

Gentium S.r.l.

Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italy

Name and address of the manufacturer responsible for batch release

Gentium S.r.l.

Piazza XX Settembre, 2 22079 Villa Guardia (Como) Italy

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal products subject to restricted medical prescription, reserved for use in certain specialised areas (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.

If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.

Additional risk minimisation measures

The MAH shall agree the following with the National Competent Authority in each member state from which patients will be enrolled:

The format and content of the Healthcare professional material that highlights the existence of the Registry as well as the means to enter patients into the registry.

E. SPECIFIC OBLIGATION TO COMPLETE

POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES

This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:

Description

Due date

Prior to launch, the Marketing Authorisation Holder (MAH) shall set up a

Annual

reports

patient registry to investigate the long term safety, health outcomes and patterns

of utilisation of defibrotide during normal use. It shall be a multi-centre,

within the

annual re-

multinational and prospective observational disease registry of patients

assessment

diagnosed with severe hepatic VOD following haematopoietic stem cell

 

plantation (HSCT) and enroll patients treated with defibrotide, other treatments

 

or supportive care. The MAH shall ensure that information regarding all safety

 

concerns identified in the most recent version of the Risk Management Plan is

 

being collected. The MAH shall also ensure that all health care professionals

 

who might prescribe defibrotide are provided with information on the

 

importance of, and how to enter patients in, the registry.

 

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