Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA)
ABBOTT LABORATORIES (M) SDN. BHD.
INACTIVATED,INFLUENZA VIRUS TYPE A (H1N1); INACTIVATED,INFLUENZA VIRUS TYPE A (H3N2); INACTIVATED,INFLUENZA VIRUS TYPE B (B/YAMAGATA); INACTIVATED,INFLUENZA VIRUS TYPE B (B/VICTORIA)
10 Pre-Filled Syringes; 1 Pre-Filled Syringes
Abbott Biologicals B.V
Not applicable Leggi il documento completo
PAGE 1 OF 1 MASCHERINA INVOLVED PLANT: PRODUCT NAME: CUTTING GUIDES / SIZE: AFFILIATE ORIGINATOR: COMMODITY CODE: COLORS: FONT STYLE / MINIMUM FONT SIZE FOR TEXT: NOTES: PHARMACODE: ORIGINATING FROM LCR / MKPR Number: Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Operator/Dev. Packaging & Label Management COMMODITY TYPE: Abbott - Established Pharmaceuticals Division Version Number: 1.0 Effective date: 05-SEP-2021 Approved date: 22-JUL-2021 QMForm051768/1 PLM.14.01.F01 Olst Influvac Influvac Tetra 0.5 ml Suspension for injection Malaysia Influvac LCR-19196-2023-DEV 1134744 LCS 120 43045 120x575mm fold to 120x23mm 91 Leaflet LTS 1-0-7 PROCESS BLACK ( I X X X I I ) Helvetica Neue / 7 pt X 18/04/2023 V. Peric 1134744_d1 PROCESS BLACK 1134744 1134744 FRONT 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus surface antigens (inactivated) (haemagglutinin and neuraminidase) of the following strains*: - A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) 15 micrograms HA ** - A/Darwin/9/2021 (H3N2)-like strain (A/Darwin/9/2021, SAN-010) 15 micrograms HA ** - B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) 15 micrograms HA ** - B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) 15 micrograms HA ** per 0.5 ml dose * propagated in fertilised hens’ eggs from healthy chicken flocks ** haemagglutinin. This vaccine complies with the World Health Organisation (WHO) recommendation (Northern hemisphere) and EU recommendation for the 2023/2024 season. For a full list of excipients see section 5.1. Influvac ® Tetra 2023/2024 may contain traces of eggs (such as ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin, which are used during the manufacturing process (see section 3.3). 2. PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe. A colourless clear Leggi il documento completo