ongoing

of giant cell arteritis for the subcutaneous
formulation of RoActemra. As a consequence,
sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 5.2 of
the SmPC are updated to reflect information
relevant to this indication. The Package Leaflet
is updated in accordance.”
B.6.8. CHMP assessed procedures scope: Pharmaceutical aspects
HBVAXPRO - hepatitis B vaccine (rDNA) -
EMEA/H/C/000373/II/0055
MAH: Sanofi Pasteur MSD SNC, Rapporteur: Jan
Mueller-Berghaus
Lantus - insulin glargine -
EMEA/H/C/000284/II/0107/G
MAH: Sanofi-aventis Deutschland GmbH,
Rapporteur: Johann Lodewijk Hillege
Nimenrix - meningococcal group A, C,
W135 and Y conjugate vaccine -
EMEA/H/C/002226/II/0062
MAH: Pfizer Limited, Rapporteur: Greg Markey
Orencia - abatacept -
EMEA/H/C/000701/II/0106/G
MAH: Bristol-Myers Squibb Pharma EEIG,
Rapporteur: Outi Mäki-Ikola
Privigen - human normal immunoglobulin -
EMEA/H/C/000831/II/0111
MAH: CSL Behring GmbH, Rapporteur: Jan
Mueller-Berghaus
B.6.9. CHMP assessed procedures scope: Non-Clinical and Clinical aspects
GONAL-f - follitropin alfa -
EMEA/H/C/000071/II/0136
MAH: Merck Serono Europe Limited,
Rapporteur: Nithyanandan Nagercoil, “Update of
the SmPC sections 4.4 and 4.8 to revise the
frequency of thromboembolic events from 'very
rare' to 'rare'. In addition, the Marketing
authorisation holder (MAH) took the opportunity
to update the list of local representatives in the
Package Leaflet. Furthermore, the PI is brought
in line with the latest QRD template version
10.0.”
Simponi - golimumab -
EMEA/H/C/000992/II/0072
MAH: Janssen Biologics B.V., Rapporteur:
Kristina Dunder, “Update of section 4.4 of the
Annex to December 2016 CHMP Agenda
EMA/CHMP/819197/2016 Page 50/55