WC500169468

1.2.19. Ofatumumab – ARZERRA (CAP)
Evaluation of an RMP in the context of a variation, extension of indication
Regulatory details:
PRAC Rapporteur: Doris Stenver (DK)
Administrative details:
Procedure number(s): EMEA/H/C/001131/II/0023, Orphan
Procedure scope: Extension of indication to the first line treatment of chronic lymphocytic leukaemia in
combination with alkylator-based regimens in patients not eligible for fludarabine-based therapy. As a
result, SmPC sections 2, 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 6.6 are updated
MAH(s): Glaxo Group Ltd
1.2.20. Ponatinib – ICLUSIG (CAP)
Evaluation of an RMP in the context of a variation
Regulatory details:
PRAC Rapporteur: Rafe Suvarna (UK)
Administrative details:
Procedure number(s): EMEA/H/C/002695/II/0005/G
Procedure scope: Grouped variations: 1) Update of SmPC section 4.5 to reflect the results from study
AP24534-12-107 (open-label, non-randomized, inpatient/outpatient clinical study to assess the effect
of rifampicin on the pharmacokinetics of ponatinib, when qdministered concomitantly in healthy
subjects; 2) Update of SmPC sections 4.4, 4.5, 5.2 to reflect the results from study AP24534-12-108
(clinical study to evaluate the effect of multiple doses of lansoprazole on the pharmacokinetics of
ponatinib when administered concomitantly to healthy subjects; 3) Update of SmPC sections 4.2, 4.4,
4.5 and 5.2 to reflect the results from study AP24534-12- 109 (evaluation of pharmacokinetics and
safety of ponatinib in patients with chronic hepatic impairment and matched healthy subjects; 4)
Update of SmPC sections 4.5 to reflect the results from study ARI-001A (simcyp physiologically-based
PBPK modelling to determine the impact of different ketoconazole dosing regimens (400 mg QD versus
200 mg BID; pre-dosing with ketoconazole for multiple days versus a single day prior to coadministration
of ponatinib) on the pharmacokinetics of ponatinib due to CYP3A4 inhibition); 5)
Update of SmPC section 5.2 to reflect the results from study ARP350 ( in vitro study to determine
whether co-administered drugs that are highly bound to human plasma proteins can displace ponatinib
from its binding sites); Submit the results of study ARP395 - a follow up study in which plasma
samples from post 24 hr collections were analyzed to determine metabolite profile; Submit the results
of study XT133050 - Study on the potential for ponatinib (at concentrations up to 10 μM) to induce
cytochrome P450 (CYP) enzymes in cultured human hepatocytes. In addition, the RMP is submitted to
reflect the data submitted and to reflect changes requested as part of variation
EMEA/H/C/002695/II/002
MAH(s): Ariad Pharma Ltd
1.2.21. Posaconazole – NOXAFIL (CAP)
Evaluation of an RMP in the context of a variation, line extension
Regulatory details:
PRAC Rapporteur: Rafe Suvarna (UK)
Administrative details:
Product number(s): EMEA/H/C/000610/X/0033
Intended indication: Line extension to Noxafil 18mg/ml concentrate for solution for infusion
1.2.22. Ranibizumab – LUCENTIS (CAP)
Evaluation of an RMP in the context of a variation
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/324055/2014 Page 57/73