ongoing

Applicant: MYLAN S.A.S, treatment of
pulmonary arterial hypertension (PAH), Generic,
Generic of Adcirca, Cialis, Generic application
(Article 10(1) of Directive No 2001/83/EC)
Terrosa - teriparatide - EMEA/H/C/003916
Applicant: Gedeon Richter Plc., treatment of
osteoporosis, Similar biological application
(Article 10(4) of Directive No 2001/83/EC)
Vemlidy - tenofovir alafenamide -
EMEA/H/C/004169
Applicant: Gilead Sciences International Ltd,
treatment of chronic hepatitis B, New active
substance (Article 8(3) of Directive No
2001/83/EC)
Zinplava - bezlotoxumab -
EMEA/H/C/004136
Applicant: Merck Sharp & Dohme Limited,
indicated for the prevention of Clostridium
difficile infection (CDI) recurrence, New active
substance (Article 8(3) of Directive No
2001/83/EC)
B.5. TYPE II VARIATION, WORKSHARING PROCEDURE OUTCOMES
Disclosure of scopes related to Chemistry, Manufacturing, and Controls cannot be released at present
time as these contain commercially confidential information.
B.5.1. CHMP assessed procedures scope: Pharmaceutical aspects
Aflunov - prepandemic influenza vaccine
(H5N1) (surface antigen, inactivated,
adjuvanted) -
EMEA/H/C/002094/II/0026/G
MAH: Seqirus S.r.l, Rapporteur: Daniela
Melchiorri
Request for Supplementary Information adopted
on 21.07.2016, 03.03.2016, 03.12.2015.
BeneFIX - nonacog alfa -
EMEA/H/C/000139/II/0138
MAH: Pfizer Limited, Rapporteur: Jan Mueller-
Berghaus
Request for Supplementary Information adopted
on 06.10.2016.
Colobreathe - colistimethate sodium -
EMEA/H/C/001225/II/0023
MAH: Forest Laboratories UK Limited,
Rapporteur: Nithyanandan Nagercoil
Request for Supplementary Information adopted
Weekly start timetable.
Weekly start timetable.
Weekly start timetable. The Committee
adopted a Request for Supplementary
information together with a specific timetable.
Annex to December 2016 CHMP Agenda
EMA/CHMP/819197/2016 Page 10/55