Article Contents
- A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
- B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
- C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
- D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
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
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
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:
- Sprimeo hct - Novartis Europharm Ltd.
- Arzerra - Novartis Europharm Ltd
- Rasilamlo - Novartis Europharm Ltd
- Copalia hct - Novartis Europharm Ltd.
- Farydak - Novartis Europharm Ltd
- Tekturna - Novartis Europharm Ltd.
Prescription drugs listed. Manufacturer: "Novartis Europharm Ltd"
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
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
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
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
- Irbesartan hydrochlorothiazide bms
- Actelsar hct
- Olazax disperzi
- Twinrix paediatric
- Arzerra
- Lantus
Prescription drugs listed:
When to seek urgent attention from the health care provider
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