- A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) 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
- E. SPECIFIC OBLIGATION TO COMPLETE
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer(s) of the biological active substance(s) ImClone Systems LLC
33 ImClone Drive Branchburg
NJ 08876 UNITED STATES
Name and address of the manufacturer(s) responsible for batch release Lilly S.A.
Avda. de la Industria 30 Alcobendas
28108 Madrid SPAIN
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
The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
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.
•Additional risk minimisation measures
E. SPECIFIC OBLIGATION TO COMPLETE
This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
In order to further confirm the efficacy and safety of olaratumab in the
31 January 2020
treatment of patients with advanced soft tissue sarcoma, the MAH should
submit the clinical study report of the phase III study JGDJ comparing
doxorubicin plus olaratumab versus doxorubicin in patients with
advanced or metastatic STS (including exploratory biomarker data).
In addition, the MAH will submit the second interim safety analysis of the
31 December 2016
phase III study JGDJ.