Committee for medicinal products for human use (CHMP)

the first line therapy in patients with Stage IV
metastatic squamous non-small cell lung cancer
(NSCLC). This variation leads to amendments of
the Product Information: sections 4.4 and 5.1 of
the SmPC were updated to reflect the findings of
the study submitted. The update is being
reflected in the PL.”
Request for Supplementary Information adopted
on 21.07.2016.
Rotarix - human rotavirus, live attenuated -
EMEA/H/C/000639/II/0089
MAH: GlaxoSmithKline Biologicals S.A.,
Rapporteur: Bart Van der Schueren, “Update of
section 5.1 to introduce effectiveness data
following completion of ecological observational
study EPI-ROTA-025 VE AU DB (114910) - An
ecological study to assess impact of rotavirus
vaccination on hospitalisations for rotavirus
gastroenteritis (RV GE) in children