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6.1.38. Prucalopride – RESOLOR (CAP) - PSUSA/00002568/201510 (with RMP)<br />
Applicant: Shire Pharmaceuticals Ireland Ltd.<br />
PRAC Rapporteur: Rafe Suvarna<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.39. Ramucirumab – CYRAMZA (CAP) - PSUSA/00010323/201510 (with RMP)<br />
Applicant: Eli Lilly Nederland B.V.<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.40. Siltuximab – SYLVANT (CAP) - PSUSA/00010254/201510<br />
Applicant: Janssen-Cilag International NV<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.41. Thalidomide – THALIDOMIDE CELGENE (CAP) - PSUSA/00002919/201510<br />
Applicant: Celgene Europe Limited<br />
PRAC Rapporteur: Isabelle Robine<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.42. Tocilizumab – ROACTEMRA (CAP) - PSUSA/00002980/201510<br />
Applicant: Roche Registration Limited<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.43. Turoctocog alfa – NOVOEIGHT (CAP) - PSUSA/00010138/201510<br />
Applicant: Novo Nordisk A/S<br />
PRAC Rapporteur: Brigitte Keller-Stanislawski<br />
Scope: Evaluation of a PSUSA procedure<br />
Action: Adoption of recommendation to CHMP<br />
6.1.44. Umeclidinium bromide – INCRUSE (CAP) - PSUSA/00010263/201510<br />
Applicant: Glaxo Group Ltd<br />
PRAC Rapporteur: Carmela Macchiarulo<br />
Pharmacovigilance Risk Assessment Committee (PRAC)<br />
EMA/PRAC/325452/2016 Page 32/52
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