- 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
Names and addresses of the manufacturers of the biological active substance
1000 New Horizons Way
Vacaville, CA 95688
1 Antibody Way
Oceanside, CA 92056 5802
300, Songdo Bio Way (Daero)
Name and address of the manufacturer responsible for batch release
Roche Pharma AG
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 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 webportal.
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 pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed and 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 dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Additional risk minimisation measures
The MAH must ensure that all physicians who are expected to prescribe MabThera are provided with the following:
Patient Alert card
The Physician information about MabThera should contain the following key elements:
The need for close supervision during administration in an environment where full resuscitation facilities are immediately available
The need to check, prior to MabThera treatment, for infections, for immunosuppression, for prior/current medication affecting the immune system and recent history of, or planned, vaccination
The need to monitor patients for infections, especially PML, during and after MabThera treatment
Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML
The need to advise patients on the risk of infections and PML, including the symptoms to be aware of and the need to contact their doctor immediately if they experience any.
The need to provide patients with the Patient Alert Card with each infusion
The Patient information about MabThera should contain the following key elements:
Detailed information on the risk of infections and PML
Information on the signs and symptoms of infections, especially PML, and the need to contact their doctor immediately if they experience any
The importance of sharing this information with their partner or caregiver
Information on the Patient Alert Card
The Patient Alert Card for MabThera in
The need to carry the card at all times and to show the card to all treating health care professionals
Warning on the risk of infections and PML, including the symptoms
The need for patients to contact their health care professional if symptoms occur
The Physician information, Patient information and Patient Alert Card must be agreed with the National Competent Authorities prior to distribution.
All healthcare professionals administering MabThera subcutaneous formulation will be provided with an Educational Material (« step by step guide » and « comparison card ») to minimise the risk of off label use and administration route error.
Obligation to conduct
The MAH shall complete, within the stated timeframe, the below measures:
Submission of clinical study reports from the clinical trials BO22334 and BO25341 including reports on
Final CSR BO22334a (both stages)
Final CSR BO25341a (both parts)
a To report analysis of primary endpoint (Ctrough
Immunogenicity data from BO22334/SABRINA and
B025341/SAWYER will be reviewed on an ongoing manner.
An Immunogenicity report from both stages of BO22334/SABRINA
by end of Q4/2016
and from B025341/SAWYER to be submitted by Q4 2016 and as
planneda by Q3/2018 and Q4/2018 respectively.
by Q3 and Q4/2018 (see