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Regulatory details:<br />
PRAC Rapporteur: Rafe Suvarna (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000262/II/0167<br />
Procedure scope: Extension of indication to treatment of adults with severe non-radiographic axial<br />
spondyloarthritis (nr-AxSpA)<br />
MAH(s): Pfizer Limited<br />
14.1.30. Fidaxomicin – DIFICLIR (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Regulatory details:<br />
PRAC Rapporteur: Qun-Ying Yue (SE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002087/II/0016<br />
Procedure scope: Update of SmPC sections 4.5 and 5.2 with results from study 2819-CL-2003,<br />
assessing the effect of multiple doses of fidaxomicin on the pharmacokinetics of a single dose of<br />
rosuvastatin in healthy male subjects. With respect to missing information on the impact of fidaxomicin<br />
on intestinal efflux transporters (BCRP, MRP2, OAP2B1), a corresponding deletion from the RMP is<br />
proposed<br />
MAH(s): Astellas Pharma Europe B.V.<br />
14.1.31. Ivacaftor – KALYDECO (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Regulatory details:<br />
PRAC Rapporteur: Miguel-Angel Macia (ES)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002494/II/0009<br />
Procedure scope: Update of SmPC sections 4.1, 4.2, 4.4, 4.8, 5.1 and 5.2 to extend the indication of<br />
Kalydeco in the treatment of cystic fibrosis to patients aged 6 years and older who have other gating<br />
(class III) mutation in the CFTR gene than G551D<br />
MAH(s): Vertex Pharmaceuticals (U.K.) Ltd.<br />
14.1.32. Leflunomide – ARAVA (CAP), LEFLUNOMIDE WINTHROP (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation, worksharing procedure<br />
Regulatory details:<br />
PRAC Rapporteur: Sabine Straus (NL)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000235/WS0560/0062/G, EMEA/H/C/001129/WS0560/0019/G<br />
Procedure scope: Worksharing variation procedure: 1) Update of SmPC sections 4.3 and 4.4<br />
contraindicating and including a warning on teriflunamide the active metabolite of leflunomide, 2)<br />
Update of SmPC section 4.5 for leflunomide related to the study reports HWA486/1032/001<br />
(interaction cimetidine) and -HWA486/2F0.1 (interaction with methotrexate), 3) Update of SmPC<br />
section 4.5 for teriflunomide related to the following Study reports INT11697-INT11720-INT12503-<br />
INT12500-INT10564-INT6040. Furthermore the MAH took the opportunity of this worksharing<br />
procedure to include DRESS syndrome in the RMP as requested by PRAC<br />
MAH(s): Sanofi-aventis Deutschland<br />
14.1.33. Lixisenatide – LYXUMIA (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/438418/2014 Page 55/75
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