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Zavesca (miglustat) – Conditions or restrictions regarding supply and use - A16AX06

Updated on site: 11-Oct-2017

Medication nameZavesca
ATC CodeA16AX06
Substancemiglustat
ManufacturerActelion Ltd

A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer responsible for batch release Actelion Manufacturing GmbH

Emil-Barell-Strasse 7 79639 Grenzach-Wyhlen 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 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.

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 following measures:

Description

Due date

The MAH shall maintain the ongoing NP-C Registry in order to

Annual reports will be

allow continued generation of data on safety, long term disease

submitted with the PSUR.

course and clinical outcomes of the treatment of patients with

 

NP-C disease. The NP-C Registry is a multicentre, prospective,

 

observational, cohort study in patients diagnosed with Niemann-

 

Pick type C (NP-C) disease.

 

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