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Farydak (panobinostat lactate anhydrous) – Conditions or restrictions regarding supply and use - L01XX42

Updated on site: 06-Oct-2017

Medication nameFarydak
ATC CodeL01XX42
Substancepanobinostat lactate anhydrous
ManufacturerNovartis Europharm Ltd

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

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 marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 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 Farydak in each Member State the Marketing Authorisation Holder (MAH) must agree about 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 to address the risk of medication error.

The MAH shall ensure that in each Member State where Farydak is marketed, all patients/carers who are expected to use Farydak have access to/are provided with the following educational package:

Patient information pack

The patient information pack should contain: o Patient information leaflet

oA patient compliance card

The patient compliance card shall contain instructions on the following key messages: o How to become familiar with the compliance card: this section provides a general

overview of the compliance card and its purpose.

o How to use the compliance card: this section provides a general overview on how to use the compliance card.

o How to take medication according to the prescription: this section provides guidance on how to fill in the compliance card.

o Recommendation to bring compliance card to each visit: this section reminds the patient to bring the compliance card to the HCP at each visit.

o A table describing the treatment regimen for each day of the cycle with space for the patient to note what medication they took.

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