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Wakix (pitolisant) – Conditions or restrictions regarding supply and use - N07XX11

Updated on site: 10-Oct-2017

Medication nameWakix
ATC CodeN07XX11
Substancepitolisant
ManufacturerBioprojet Pharma

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

Rottendorf

ZI N°2 de Prouvy Rouvignies

1 rue de Nungesser

59121 Prouvy France

Patheon

40 Boulevard de Champaret

38300 Bourgoin-Jallieu France

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.

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

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

Obligation to conduct post-authorisation measures

The MAH shall complete, within the stated timeframe, the below measures:

Description

Due date

Non-interventional post-authorisation safety study (PASS):

Final report: 3Q 2023

A multi-center, observational post-authorization safety study to

 

document the drug utilisation of Wakix and to collect information on

 

the safety of Wakix when used in routine medical practice

 

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