Section D Biologics

D1

Label (Mock-up) for Immediate Container
Please refer:

Appendix 9: 9.1.1 LABEL (MOCK-UP) FOR IMMEDIATE CONTAINER AND OUTER CARTON

D2

Label (Mock-up) for Outer Carton
Please refer:

Appendix 9: 9.1.1 LABEL (MOCK-UP) FOR IMMEDIATE CONTAINER AND OUTER CARTON

D3

Proposed Package Insert
Please refer:
Appendix 9: 9.1.2 PROPOSED PACKAGE INSERT

D4

Patient Information Leaflet (PIL) / RisalahMaklumat Ubat Pesakit (RiMUP)
Please refer:

1. DirektifPenguatkuasaanKeperluanMengemukakanRisalahMaklumat Ubat untukPengguna (RiMUP) Bil. 5 Year 2011 Bil (15) dlm BPFK/PPP/01/03 Jld 1
2. Garispanduan Pelaksanaan Risalah Maklumat Ubat untukPengguna (RiMUP)

D5

Label (Mock-up) for Diluent
Please provide label (mock-up) for diluent.