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Tafinlar (dabrafenib mesylate) – Conditions or restrictions regarding supply and use - L01XE23

Updated on site: 10-Oct-2017

Medication nameTafinlar
ATC CodeL01XE23
Substancedabrafenib mesylate
ManufacturerNovartis Europharm Limited

A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturers responsible for batch release

GLAXO WELLCOME, S.A.

Avda. Extremadura, 3, Pol. Ind. Allendeduero 09400, Aranda de Duero (Burgos)

Spain

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley, Surrey GU16 7SR

United Kingdom

Novartis Pharma GmbH

Roonstraße 25

D-90429 Nuremberg

Germany

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

Not applicable.

Obligation to conduct post-authorisation measures

Not applicable.

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