European Union - English - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaccines - active immunisation against h5 subtype of influenza a virus

United States - English - NLM (National Library of Medicine)

medimmune, llc - influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen (unii: fv9fgc9yzw) (influenza a virus a/norway/31694/2022 (h1n1) live (attenuated) antigen - unii:fv9fgc9yzw), influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen (unii: l7z42hp5rz) (influenza a virus a/norway/16606/2021 (h3n2) live (attenuated) antigen - unii:l7z42hp5rz), influenza b virus b/austria/1359417/2021 live (attenuated) antigen (unii: jv6nd6vmy5) (influenza b virus b/austria/1359417/2021 live (attenuated) - influenza a virus a/slovenia/2903/2015 (h1n1) live (attenuated) antigen 10000000 [ffu] in 0.2 ml - flumist®  quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . flumist quadrivalent is approved for use in persons 2 through 49 years of age. do not administer flumist quadrivalent to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine [see description (11)] including egg protein, or after a previous dose of any influenza vaccine. do not administer flumist quadrivalent to children and adolescents through 17 years of age who are receiving aspirin therapy or aspirin-containing therapy because of the association of reye’s syndrome with aspirin and wild-type influenza infection [see drug interactions (7.1)] . risk summary flumist quadrivalent is not absorbed systemically following intranasal administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations disease-ass

United States - English - NLM (National Library of Medicine)

glaxosmithkline biologicals sa - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (formaldehyde inactivated) 15 ug in 0.5 ml - fluarix quadrivalent is indicated for active immunization for the prevention of disease caused by influenza a subtype viruses and type b viruses contained in the vaccine [see description (11)] . fluarix quadrivalent is approved for use in persons aged 6 months and older. do not administer fluarix quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous administration of any influenza vaccine [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. available data from a pregnancy registry do not suggest an increased risk of major birth defects and miscarriage in individuals who received fluarix quadrivalent within 28 days prior to conception or during pregnancy (see d

United States - English - NLM (National Library of Medicine)

id biomedical corporation of quebec - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (uv, formaldehyde inactivated) (unii: a5pts27urj) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (uv, formaldehyde inactivated) - unii:9ha5c4xl36), influenza a virus a/darwin/9/2021 ivr-228 (h3n2) antigen (uv, formaldehyde inactivated) (unii: p483j7gx6d) (influenza a virus a/darwin/9/2021 ivr-228 (h3n2) hemagglutinin antigen (uv, formaldehyde inactivated) - unii:grn94tp8yv), influenza b virus b/austria/1359417/2021 - influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (uv, formaldehyde inactivated) 15 ug in 0.5 ml - flulaval quadrivalent is indicated for active immunization for the prevention of disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. flulaval quadrivalent is approved for use in persons aged 6 months and older. do not administer flulaval quadrivalent to anyone with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine [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 insufficient data on flulaval quadrivalent in pregnant women to inform vaccine-associated risks. a developmental toxicity study was performed in female rats administered flulaval quadrivalent prior to mating and during gestation and lactation p

United States - English - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) antigen (propiolactone inactivated) (unii: 0qk4u2v88l) (influenza a virus a/brisbane/02/2018 ivr-190 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:re1mnp1ne6), influenza a virus a/kansas/14/2017 x-327 (h3n2) antigen (propiolactone inactivated) (unii: al8g7d406d) (influenza a virus a/kansas/14/2017 x-327 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:mu3in5k1yc), influenza b virus b/maryland/15/2016 antigen (propiolacto - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated ba

United States - English - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) antigen (propiolactone inactivated) (unii: ytl6a60f5i) (influenza a virus a/victoria/2454/2019 ivr-207 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:540gm6ll7u), influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) antigen (propiolactone inactivated) (unii: oat4h11zt6) (influenza a virus a/hong kong/2671/2019 ivr-208 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:pc99fhq5w6), influenza b virus b/victoria/705/2018 bv - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com. risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated ba

United States - English - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) antigen (propiolactone inactivated) (unii: 6f59dl4eet) (influenza a virus a/victoria/2570/2019 ivr-215 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:qwb7m7p3k9), influenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) antigen (propiolactone inactivated) (unii: y9cjf75rbv) (influenza a virus a/cambodia/e0826360/2020 ivr-224 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:lw2jc76p6m), influenza b virus b/victoria/705/2 - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11] ) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated

United States - English - NLM (National Library of Medicine)

seqirus pty ltd. - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (propiolactone inactivated) (unii: uph9lrj9hu) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (propiolactone inactivated) - unii:x5dyv3mm4n), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (propiolactone inactivated) (unii: n4uxa9h8ka) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (propiolactone inactivated) - unii:zn6bmn7fsq), influenza b virus b/austria/1359417/2021 bvr-26 anti - afluria® quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza a subtype viruses and type b viruses contained in the vaccine. afluria quadrivalent is approved for use in persons 6 months of age and older. afluria quadrivalent is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine (see description [11]) . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to afluria quadrivalent during pregnancy. women who are vaccinated with afluria quadrivalent during pregnancy are encouraged to enroll in the registry by calling 1-855-358-8966 or sending an email to seqirus at us.medicalinformation@seqirus.com . risk summary all pregnancies have a risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated b

United States - English - NLM (National Library of Medicine)

seqirus, inc. - influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) antigen (formaldehyde inactivated) (unii: au5c98u4bb) (influenza a virus a/victoria/4897/2022 ivr-238 (h1n1) hemagglutinin antigen (formaldehyde inactivated) - unii:c46xjt9fq9), influenza a virus a/darwin/6/2021 ivr-227 (h3n2) antigen (formaldehyde inactivated) (unii: f5qv7af326) (influenza a virus a/darwin/6/2021 ivr-227 (h3n2) hemagglutinin antigen (formaldehyde inactivated) - unii:n969qk7xd2), influenza b virus b/austria/1359417/2021 bvr-26 antigen - 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

Ireland - English - HPRA (Health Products Regulatory Authority)

intervet ireland limited - bovine respiratory syncytial virus inactivated, parainfluenza-3 virus strain sf4 inactivated, pasteurella haemolytica serotype a1 antigen - suspension for injection - unknown - inactivated bovine parainfluenza virus vaccine + inactivated bovine respiratory syncytial virus va - bovine - immunological - inactivated vaccine