ongoing

Rapporteur: Simona Kudeliene
Scope: “Extension application to introduce a new pharmaceutical form (Gastro-resistant
capsule, hard)”
Action: For adoption
List of Questions adopted on 10.11.2016.
4.1.3. Pergoveris - follitropin alfa / lutropin alfa - EMEA/H/C/000714/X/0047
Merck Serono Europe Limited
Rapporteur: Nithyanandan Nagercoil, PRAC Rapporteur: Julie Williams
Scope: “Extension application to introduce a new pharmaceutical form (solution for
injection) associated with 3 strengths of (300 IU + 150 IU)/ 0.48 ml, (450 IU + 225 IU)/
0.72 ml and (900 IU + 450 IU)/ 1.44 ml.”
Action: For adoption
List of Questions adopted on 10.11.2016.
4.2. Extension of marketing authorisation according to Annex I of
Commission Regulation (EC) No 1234/2008; Day 180 list of
outstanding issues
4.2.1. Celsentri - maraviroc - EMEA/H/C/000811/X/0046/G
ViiV Healthcare UK Limited
Rapporteur: Filip Josephson, Co-Rapporteur: Bruno Sepodes, PRAC Rapporteur: Qun-Ying
Yue
Scope: “Extension application to introduce new pharmaceutical form (20mg/ml oral
solution) and 2 new strenghts of film-coated tablets (25mg and 75mg) to the currently
approved presentations for Celsentri, grouped with extension of indication to include
paediatric use (2 to 18 years).
As a consequence, sections 4.2 and 4.4 of the SmPC are updated to detail posology in
paediatric patients and to update the safety information, respectively.
The Package Leaflet and Labelling are updated in accordance.
Furthermore, the PI is brought in line with the latest QRD template version 10.”
Action: For adoption
List of Questions adopted on 13.10.2016.
Committee for medicinal products for human use (CHMP)
EMA/CHMP/117089/2017 Page 18/39