KONTAKTDATEN MEINES Kontakt-Vertretung: MEINE KONTAKTDATEN

Opdivo can be used on its own and, for some cancers, it can also be used together with ipilimumab and other cancer medicines Opdivo contains the active substance nivolumab How is Opdivo used? Treatment with Opdivo must be started and supervised by a doctor experienced in treating cancer The medicine can only be obtained with a prescription

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

The recommended dose of OPDIVO is either nivolumab 240 mg every 2 weeks or 480 mg every 4 weeks (see section 5 1) depending on the indication, as presented in Table 1 Table 1: Recommended dose and infusion time for intravenous administration of

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

OPDIVO 10 mg/mL concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 10 mg of nivolumab One vial of 4 mL contains 40 mg of nivolumab One vial of 10 mL contains 100 mg of nivolumab Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology

ANEXA I REZUMATUL CARACTERISTICILOR PRODUSULUI

OPDIVO 10 mg/ml concentrat pentru soluţie perfuzabilă 2 COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ Fiecare ml de concentrat conţine nivolumab 10 mg Un flacon a 4 ml conţine nivolumab 40 mg Un flacon a 10 ml conţine nivolumab 100 mg Nivolumab este produs în celule ovariene de hamster chinezesc prin tehnologia ADN-ului recombinant

BRISTOL-MYERS SQUIBB RESEARCH & DEVELOPMENT SUMMARY OF THE

OPDIVO® (nivolumab) 3 SUMMARY OF RISK MANAGEMENT PLANFOR OPDIVO®(NIVOLUMAB) This is a summary of the RMP for OPDIVO® The RMP details important risks associated with OPDIVO® treatment, how these risks can be minimized, and howadditionalinformation will be obtained about OPDIVO®'s risks and uncertainties (missing information)

Bristol-Myers Squibb Research and Development

SUMMARY OF RISK MANAGEMENT PLAN FOR OPDIVO (NIVOLUMAB) This is a summary of the risk management plan (RMP) for OPDIVO The RMP details important risks of OPDIVO, how these risks can be minimized, and how more information will be obtained about OPDIVO's risks and uncertainties (missing information)