Arzerra (ofatumumab) – Conditions or restrictions regarding supply and use - L01XC10

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

Name and address of the manufacturers of the biological active substance

Lonza Biologics plc 228 Bath Road

Slough, Berks SL1 4DX United Kingdom

Lonza Biologics, Inc.

101 International Drive

Portsmouth, NH 03801-2815

United States

Name and address of the manufacturers responsible for batch release

Glaxo Operations UK Ltd.

Harmire Road

Barnard Castle

Durham, DL12 8DT

United Kingdom

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley, Surrey GU16 7SR

United Kingdom

Novartis Pharma GmbH

Roonstrasse 25

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.