Article Contents
- A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS 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 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
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
- Tobi podhaler - Novartis Europharm Ltd
- Xolair - Novartis Europharm Ltd
- Ultibro breezhaler - Novartis Europharm Ltd
- Lucentis - Novartis Europharm Ltd
- Enviage - Novartis Europharm Ltd.
- Hirobriz breezhaler - Novartis Europharm Ltd
Prescription drugs listed. Manufacturer: "Novartis Europharm Ltd"
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
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:
- Fexeric
- Fiasp
- Pemetrexed hospira uk limited
- Filgrastim hexal
- Jevtana
- Exjade
Prescription drugs listed:
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.
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