WC500185968
WC500185968
WC500185968
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Procedure scope: Extension of indication to include the transfer of patients from glucagon-like peptide-<br />
1 (GLP1) receptor agonist (RA) treatment to Xultophy. Consequently, SmPC sections 4.1, 4.2, 4.4, and<br />
5.1 as well as the package leaflet are updated accordingly<br />
MAH(s): Novo Nordisk A/S<br />
14.1.34. Maraviroc – CELSENTRI (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/000811/II/0041<br />
Procedure scope: Update of SmPC sections 4.4 and 5.1 further to the 48-week time-point results of<br />
study A4001098 conducted to evaluate the safety of Maraviroc in combination with other antiretroviral<br />
agents in HIV-1-infected subjects co-infected with hepatitis C and/or hepatitis B virus (MEA 010.3)<br />
MAH(s): ViiV Healthcare UK Limited<br />
14.1.35. Methylnaltrexone bromide – RELISTOR (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation, extension of indication<br />
Regulatory details:<br />
PRAC Rapporteur: Valerie Strassmann (DE)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/000870/II/0030<br />
Procedure scope: Extension of indication for the treatment of opioid induced constipation in adult non<br />
cancer pain patients. Consequently, the MAH proposed the update of SmPC sections 4.1, 4.2, 4.4 and<br />
5.1. The package leaflet is updated accordingly<br />
MAH(s): TMC Pharma Services Ltd<br />
14.1.36. Perampanel – FYCOMPA (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation, extension of indication<br />
Regulatory details:<br />
PRAC Rapporteur: Julie Williams (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002434/II/0016<br />
Procedure scope: Extension of indication as adjunctive treatment of primary generalised tonic-clonic<br />
seizures in patients with epilepsy aged 12 years and older. SmPC sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1<br />
and 5.2 and the package leaflet are updated accordingly<br />
MAH(s): Eisai Europe Ltd<br />
14.1.37. Ponatinib – ICLUSIG (CAP)<br />
<br />
Evaluation of an RMP in the context of a variation<br />
Regulatory details:<br />
PRAC Rapporteur: Rafe Suvarna (UK)<br />
Administrative details:<br />
Procedure number(s): EMEA/H/C/002695/II/0017<br />
Procedure scope: Update of SmPC sections 4.8 and 5.1 to update the safety information and to update<br />
pharmacology information after the availability of the updated Clinical Study report for Study AP24534-<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/257790/2015 Page 69/89
Change language