संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

seqirus, inc. - influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (formaldehyde inactivated) (unii: 2j002y0b0w) (influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:mz5g0f0san), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (formaldehyde inactivated) (unii: p8orn3uom6) (influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:thg3pu0kok), influenza b virus b/victoria/705/2018 bvr-11 - fluad quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. fluad quadrivalent is approved for use in persons 65 years of age and older. this indication is approved under accelerated approval based on the immune response elicited by fluad quadrivalent [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. do not administer fluad quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see description (11)] , or to a previous influenza vaccine. risk summary fluad quadrivalent is not approved for use in persons < 65 years of age. there are insufficient human data to establish whether there is a vaccine-associated risk with use of fluad quadrivalent in pregnancy. there were no development

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

a-s medication solutions - recombinant varicella zoster virus glycoprotein e antigen (unii: cob9ff6i46) (recombinant varicella zoster virus glycoprotein e antigen - unii:cob9ff6i46) - shingrix is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older. limitations of use : do not administer shingrix to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of shingrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. there are no available human data to establish whether there is vaccine-associated risk with shingrix in pregnant women. a reproductive and developmental toxicity study was performed in female rats administered shingrix or the as01b adjuvant alone prior to mating, during gestation, and during lactation. the total dose was 0.2 ml on each occasion (a single human dose of shingrix is 0.5 ml). this study revealed no adverse e

ज़िम्बाब्वे - अंग्रेज़ी - Medicines Control Authority

gist brocades - rabies virus (inactivated adjuvanted) - injectable; injection - 80%

ज़िम्बाब्वे - अंग्रेज़ी - Medicines Control Authority

smithkline animal health (pty) limited - rabies virus (inactivated adjuvanted) - injectable; injection - 0.93ml/ml

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

a-s medication solutions - recombinant varicella zoster virus glycoprotein e antigen (unii: cob9ff6i46) (recombinant varicella zoster virus glycoprotein e antigen - unii:cob9ff6i46) - shingrix is a vaccine indicated for prevention of herpes zoster (hz) (shingles):     •    in adults aged 50 years and older.     •    in adults aged 18 years and older who are or will be at increased risk of hz due to immunodeficiency or immunosuppression caused by known disease or therapy. limitations of use : do not administer shingrix to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of shingrix [see description (11)] . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the data are insufficient to establish if there is vaccine-associated risk with shingrix in pregnant women. a developmental toxicity study was performed in female rats administered shingrix or the as01b adjuvant alone prior to mating, during gestation, and during lactation. the total dose was 0.2 ml on each occasion (a single human dose of shingrix is 0.5 ml). this study revealed no adverse effects on fetal or pre-weaning development due to shingrix (see data) . data animal data: in a developmental toxicity study, female rats were administered shingrix or the as01b adjuvant alone by intramuscular injection 28 and 14 days prior to mating, on gestation days 3, 8, 11, and 15, and on lactation day 7. the total dose was 0.2 ml on each occasion (a single human dose of shingrix is 0.5 ml). no adverse effects on pre-weaning development up to post-natal day 25 were observed. there were no vaccine-related fetal malformations or variations. risk summary it is not known whether shingrix is excreted in human milk. data are not available to assess the effects of shingrix on the breastfed infant or on milk production/excretion. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for shingrix and any potential adverse effects on the breastfed child from shingrix or from the underlying maternal condition. for preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. safety and effectiveness in individuals younger than 18 years have not been established. shingrix is not indicated for prevention of primary varicella infection (chickenpox). adults aged 60 years and older of the total number of subjects who received at least 1 dose of shingrix in studies 1 and 2 (n = 14,645), 2,243 (15%) were aged 60 to 69 years, 6,837 (47%) were aged 70 to 79 years, and 1,921 (13%) were aged 80 years and older. there were no clinically meaningful differences in efficacy across the age groups. [see clinical studies (14.1, 14.2, 14.3).] the frequencies of solicited local and general adverse reactions in subjects aged 70 years and older were lower than in younger adults (aged 50 through 69 years). [see adverse reactions (6.1).] immunocompromised adults aged 65 years and older of the total number of subjects who received at least 1 dose of shingrix in the auhsct study (n = 922), 172 (18.7%) were aged 65 years and older [see clinical studies (14.5)] . there were no clinically meaningful differences in efficacy between these subjects and younger adults (aged 18 through 64 years). of the total number of subjects who received at least 1 dose of shingrix across the 6 studies in immunocompromised subjects (n = 1,587), 337 (21.2%) were aged 65 years and older. the frequencies of solicited local and general adverse reactions in subjects aged 65 years and older were generally similar to or lower than those reported by younger adults (aged 18 through 64 years).

यूरोपीय संघ - अंग्रेज़ी - EMA (European Medicines Agency)

dynavax gmbh - hepatitis b surface antigen - hepatitis b - vaccines - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations.it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

seqirus, inc. - influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (formaldehyde inactivated) (unii: wd5e5vym2e) (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:erb9sj9vmq), influenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) antigen (formaldehyde inactivated) (unii: yy2tbu8yqs) ( iinfluenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:33qej7v9bf), influenza b virus b/victoria/705/201 - fluad quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and types b contained in the vaccine. fluad quadrivalent is approved for use in persons 65 years of age and older. this indication is approved under accelerated approval based on the immune response elicited by fluad quadrivalent [see clinical studies (14.1)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. do not administer fluad quadrivalent to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see description (11)] , or to a previous influenza vaccine. risk summary fluad quadrivalent is not approved for use in persons < 65 years of age. there are insufficient human data to establish whether there is a vaccine-associated risk with use of fluad quadrivalent in pregnancy. there were no development

संयुक्त अरब अमीरात - अंग्रेज़ी - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

nvx-cov2373 -

संयुक्त अरब अमीरात - अंग्रेज़ी - MOHAP (Ministry of Health & Prevention) - وزارة الصحة ووقاية المجتمع.الإمارات

pure health medical supplies austria - 10 multi-dose vials (10 doses of 0.5 ml) - injection - 33 au/ 0.5 ml - n/a

सऊदी अरब - अंग्रेज़ी - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

glaxo saudi arabia ltd., saudi arabia - varicella zoster virus glycoprotein e adjuvanted with as01b - powder for suspension for injection - 50 µg