Variables [Abhayrab [Speeda WaxiRabN Registration number IBR-629 [BR-669 BRP-O71 Generic name [Purified Vero Cell Rabies Vaccine Purified Rabies Vaccine (vero Cell) [Rabies Vaccine for Human Use (Purified IChick Embryo Cell) LTO (establishment) holder \Vizcarra pharmaceutical, inc, Manila Zydus Healtheare ippines, BGC, Taguig period [2019-01-26 [2018-10-23 Dosage strength & form [> 25 1U/0.5mL FD for [> 2.5 1U/0.5mL FD for injection (IMI 1D) injection (IM/ ID) [Glass vial [Glass ampoule [Glass ampoule single dose single dose [sodium chloride (0.9% wiv) _|water for injection lwater for injection. Semone @28c 36 months @ 2-86 [24 months @ 2-8 C Human Biologicals Instute, [Tamil Nadu, India Liaoning Cheng Da Biotechnology Co., LTD |(CDBIO), Shenyang, Liaoning, China |Cadila Healthcare Ltd, India [2018-02-21 2019-02-03 [2019-10-28 IP Biotech, Inc, BGC, Taguig Pharma-Surrey Int Inc., [Zydus Healtheare Philippines |Quezon City IP Biotech, Inc, BGC, Taguig |Pharma-Surrey Int Inc., |Zydus Healthcare Philippines |Quezon City FDA requirement 1 [Subject to lot release certification certification FDA requirement 2 [subject to submission ofF sample of first batch of importation! manufacture/ [packing / repacking [subject to submission of sample of first batch of importation’ manufacture! packing / repacking [subject to submission of sample of first batch of importation! manufacture packing / repacking=e [Control Organization CDSCO |(WHO-certified) [China CFDA (2011, 2014 I Drugs Standard Control certified) [Organization CDSCO (WHO-certified) }>300 million doses since {2005 }* 20 countries incl. India, Thailand, Vero cell Vero cell ~|L- Pasteur 2061/Vero Rabies Strain IL. Pasteur 2061/Vero Rabies [Strain beta-propiolactone lbeta-propiolactone [Chromatography [thiomerosal 0.01% why thiomerosal < 0.04 mg [Maltose; Hu.Serum Albumin Dextran-40 (18 mg);Hu.Serum Albumin (>5 mg) Neomycin; Kanamycin; Polymixin B sulphate >2.51U after heating for 4 weeks at 37 C[Abhayrab [Speoda [VaxiRab-N [0.1 mL one-site only on d lor7a21/28 lupdated TRC ID regimen [0.5 mL on site only ond lor7a21/28 -dose /every 1-3 years l0-7 mi C0510), WHO Recommendation on updated [Thai Red Cross (2-2-2-0-2; d __|o/3/7828/30) [0.5 mL-5 injections ond losi7/4i28. Magpantay et al (CHD; |4(1) 2010; 61-7 Expert Rev Vaccines, 2074, 1-9 ISCR d14 (GMC 3.3 1Uimi) & 128 (GMC 4.37 IU/ml) lupdate TRC ID regimen: D14 In=30 GMT 12.69 IU/mL vs. VeroRab N=31 8.97 IU/mL. SCR di4 (GMC 3.7 1Uimi) & 1d28 (GMC 4.8 IU/ml) mild only [dossier - 30 min local and systemic reactions [Clinical stuy report (dossier) VeroRab (Sanofi) as active [comparator i vs n=33 [SCR at d14 both 100% GMT at di4 45 vs 56, 19> 0.05,