Lucentis (ranibizumab) – Conditions or restrictions regarding supply and use - S01LA04

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

Name and address of the manufacturers of the biological active substance

Genentech, Inc.

1 DNA Way

South San Francisco, CA 94080-4990

USA

Roche Singapore Technical Operations Pte. Ltd.

10 Tuas Bay Link

Singapore 637394

Singapore

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 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 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 in each Member State the MAH shall agree the final educational material with the National Competent Authority.

The MAH shall ensure that, following discussions and agreements with the National Competent Authorities in each Member State where Lucentis is marketed, at launch and after launch all ophthalmological clinics where Lucentis is expected to be used are provided with an up-to-date physician information pack containing the following elements:

Physician information

Intravitreal injection procedure video

Intravitreal injection procedure pictogram

Patient information packs

The physician information should contain the following key elements:

The Summary of Product Characteristics

Sterile techniques, including periocular and ocular disinfection, to minimise risk of infection

Use of povidone iodine or equivalent

The need to expel excess volume of the pre-filled syringe before injecting Lucentis to avoid overdose

Techniques for the intravitreal injection

Patient monitoring after IVT injection

Key signs and symptoms of IVT injection related adverse events including increased intraocular pressure, traumatic cataract and endophthalmitis

Management of IVT injection related adverse events

The patient information pack should be provided in both the form of patient information booklets and an audio-CD that contain following key elements:

Patient information leaflet

How to prepare for Lucentis treatment

What are the steps following treatment with Lucentis

Key signs and symptoms of serious adverse events including increased intraocular pressure, traumatic cataract and endophthalmitis

When to seek urgent attention from the health care provider