A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer of the biological active substance
SICOR Biotech UAB Molėtų pl. 5
08409 Vilnius Lithuania
Name and address of the manufacturer responsible for batch release
Merckle Biotec GmbH
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLYauthorisedAND 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
safety update reports for this product in
The marketing authorisation holder shall submit periodicno
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
The MAH shall performMedicinalthe required pharmacovigilance activities and interventions detailed in the
Risk Managem nt Plan (RMP)
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.