A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer of the biological active substance
Republic of Korea
CELLTRION, Inc. (Plant II, CLT2) 20,
Name and address of the manufacturer responsible for batch release
Biotec Services International Ltd.
Biotec House, Central Park, Western Avenue
Bridgend Industrial Estate
Bridgend, CF31 3RT
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
- Rituzena (tuxella) - Celltrion Healthcare Hungary Kft.
- Ritemvia - Celltrion Healthcare Hungary Kft.
- Blitzima - Celltrion Healthcare Hungary Kft.
- Truxima - Celltrion Healthcare Hungary Kft.
Prescription drugs listed. Manufacturer: "Celltrion Healthcare Hungary Kft."
•Periodic Safety Update Reports
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation. Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and 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:
•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.
If the submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
•Additional risk minimisation measures
The Marketing Authorisation Holder (MAH) shall conduct an educational programme to ensure that all physicians who are expected to prescribe/use Remsima are aware of:
•The risk of opportunistic infections and tuberculosis (TB) in patients treated with Remsima.
•The need to assess the risk of TB in patients prior to treating with Remsima.
•The risk of acute hypersensitivity reactions (including anaphylactic shock) and delayed hypersensitivity reactions.
•The risk of lymphoma, melanoma, Merkel cell carcinoma, and other malignancies.
•The risk of disseminated BCG infection after BCG vaccination of infants up to 6 months of age who were exposed in utero to infliximab.
•The patient alert card, which is to be given to patients using Remsima.
Prescribers of Remsima for paediatric Crohn’s disease and paediatric ulcerative colitis shall additionally be made aware:
•That children may be at increased risk of developing infections and that their immunisations need to be up to date.