WC500185968
WC500185968
WC500185968
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Administrative details:<br />
Procedure number(s): EMEA/H/C/000909/II/0039<br />
Procedure scope: Extension of indication to include treatment of diabetic patients with peripheral<br />
neuropathic pain based on the results of studies E05-CL-3004 (STEP) and E05-CL-3002 (PACE). As a<br />
consequence, SmPC sections 4.1, 4.4 and 4.8 have been updated, and Annex II (additional risk<br />
minimisation measures) and the package leaflet have been updated accordingly. In addition, the MAH<br />
took the opportunity to implement minor editorial changes in the SmPC, Annex II, labelling and<br />
package leaflet<br />
MAH(s): Astellas Pharma Europe B.V.<br />
14.1.26. Dolutegravir, abacavir, lamivudine – TRIUMEQ (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Regulatory details:<br />
PRAC Rapporteur: Julie Williams (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002754/II/0005 (with RMP)<br />
Procedure scope: In compliance with the agreed RMP (MEA 02, category 3 study), submission of in<br />
vitro study report to assess the affinity of dolutegravir for melanocortin receptors<br />
MAH(s): ViiV Healthcare UK Limited<br />
14.1.27. Dolutegravir, abacavir, lamivudine – TRIUMEQ (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Regulatory details:<br />
PRAC Rapporteur: Julie Williams (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002754/II/0006 (with RMP)<br />
Procedure scope: In compliance with the agreed RMP (MEA 03, category 3 study), submission of in<br />
vitro study report to assess the affinity of dolutegravir<br />
MAH(s): ViiV Healthcare UK Limited<br />
14.1.28. Dolutegravir, abacavir, lamivudine – TRIUMEQ (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Regulatory details:<br />
PRAC Rapporteur: Julie Williams (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002754/II/0004/G<br />
Procedure scope: Grouped variations to update: 1) SmPC section 5.2 following the results of an in vitro<br />
study to investigate whether dolutegravir might be a substrate for the hepatic uptake transporters<br />
OATP1B1 and OATP1B3; 2) SmPC section 4.5 on the basis of pharmacokinetic analyses from the<br />
dolutegravir-boceprevir interaction study ING115697; 3) SmPC section 4.5 and 5.2 on the potential for<br />
interaction with midazolam/CYP3A4<br />
MAH(s): ViiV Healthcare UK Limited<br />
14.1.29. Eltrombopag – REVOLADE (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Regulatory details:<br />
PRAC Rapporteur: Dolores Montero Corominas (ES)<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/257790/2015 Page 67/89