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

protein sciences corporation - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen (unii: 1se9z7d2qr) (influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen - unii:1se9z7d2qr), influenza a virus a/texas/50/2012 (h3n2) recombinant hemagglutinin antigen (unii: 1iqz1wce3y) (influenza a virus a/texas/50/2012 (h3n2) recombinant hemagglutinin antigen - unii:1iqz1wce3y), influenza b virus b/massachusetts/2/2012 recombinant hemagglutinin antigen (unii: ayr0wzx7jh) (influenza b virus b/massachus - flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes a and type b contained in the vaccine. flublok is approved for use in persons 18 years of age and older. in persons 18 through 49 years of age, this indication is based on a controlled clinical study demonstrating a decrease in influenza disease after vaccination with flublok. in persons 50 years of age and older, this indication is based on the immune response elicited by flublok; data demonstrating a decrease in influenza disease in persons 50 years and older after vaccination with flublok are not available. (see clinical studies [ 14]) flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see description [11] and postmarketing experience [6.2]). reproduction studies have been performed in rats at a dose approximately 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm to

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

protein sciences corporation - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen (unii: 1se9z7d2qr) (influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen - unii:1se9z7d2qr), influenza a virus a/switzerland/9715293/2013 (h3n2) recombinant hemagglutinin antigen (unii: d2053d6yqu) (influenza a virus a/switzerland/9715293/2013 (h3n2) recombinant hemagglutinin antigen - unii:d2053d6yqu), influenza b virus b/phuket/3073/2013 recombinant hemagglutinin antigen (unii: poq8dqo9s3) (influenza b - flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes a and type b contained in the vaccine. flublok is approved for use in persons 18 years of age and older. in persons 18 through 49 years of age, this indication is based on a controlled clinical study demonstrating a decrease in influenza disease after vaccination with flublok. in persons 50 years of age and older, this indication is based on the immune response elicited by flublok; data demonstrating a decrease in influenza disease in persons 50 years and older after vaccination with flublok are not available. (see clinical studies [ 14] ) flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see description [11] and postmarketing experience [6.2] ). reproduction studies have been performed in rats at a dose approximately 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm t

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

protein sciences corporation - influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen (unii: 1se9z7d2qr) (influenza a virus a/california/7/2009 (h1n1) recombinant hemagglutinin antigen - unii:1se9z7d2qr), influenza a virus a/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen (unii: 2i1eol437m) (influenza a virus a/hong kong/4801/2014 (h3n2) recombinant hemagglutinin antigen - unii:2i1eol437m), influenza b virus b/brisbane/60/2008 recombinant hemagglutinin antigen (unii: 058u2312cr) (influenza b virus b/b - flublok is a vaccine indicated for active immunization against disease caused by influenza virus subtypes a and type b contained in the vaccine. flublok is approved for use in persons 18 years of age and older. in persons 18 through 49 years of age, this indication is based on a controlled clinical study demonstrating a decrease in influenza disease after vaccination with flublok. in persons 50 years of age and older, this indication is based on the immune response elicited by flublok; data demonstrating a decrease in influenza disease in persons 50 years and older after vaccination with flublok are not available. (see clinical studies [ 14] ) flublok is contraindicated in individuals with known severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine (see description [11] and postmarketing experience [6.2] ). reproduction studies have been performed in rats at a dose approximately 300 times the human dose (on a mg/kg basis) and have revealed no evidence of impaired fertility or harm t

Canada - English - Health Canada

sigmacon lifesciences inc - citalopram (citalopram hydrobromide) - tablet - 20mg - citalopram (citalopram hydrobromide) 20mg - selective-serotonin reuptake inhibitors

Canada - English - Health Canada

sigmacon lifesciences inc - citalopram (citalopram hydrobromide) - tablet - 40mg - citalopram (citalopram hydrobromide) 40mg - selective-serotonin reuptake inhibitors

Singapore - English - HSA (Health Sciences Authority)

gilead sciences singapore pte. ltd. - sofosbuvir - tablet, film coated - sofosbuvir 400.0mg

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 12mg (drug layer 1 = 3.6 mg, drug layer 2 = 8.4 mg.) - modified release tablet - 12 mg - active: paliperidone 12mg (drug layer 1 = 3.6 mg, drug layer 2 = 8.4 mg.) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide red iron oxide yellow macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 3mg (drug layer 1 = 0.9 mg, drug layer 2 = 2.1 mg) - modified release tablet - 3 mg - active: paliperidone 3mg (drug layer 1 = 0.9 mg, drug layer 2 = 2.1 mg) excipient: butylated hydroxytoluene carnauba wax cellulose acetate glycerol hyetellose hypromellose iron oxide red iron oxide yellow lactose macrogol 3350 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or mood stabilisers (lithium and valproate).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 6mg (drug layer 1 = 1.8 mg, drug layer 2 = 4.2 mg.) - modified release tablet - 6 mg - active: paliperidone 6mg (drug layer 1 = 1.8 mg, drug layer 2 = 4.2 mg.) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide red iron oxide yellow macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega is indicated for the treatment of acute exacerbations of schizoaffective disorder as monotherapy and in combination with antidepressants and/ or mood stabilisers (lithium and valproate).

New Zealand - English - Medsafe (Medicines Safety Authority)

janssen-cilag (new zealand) ltd - paliperidone 9mg (drug layer 1: 2.7 mg, drug layer 2: 6.3 mg) - modified release tablet - 9 mg - active: paliperidone 9mg (drug layer 1: 2.7 mg, drug layer 2: 6.3 mg) excipient: butylated hydroxytoluene carnauba wax cellulose acetate hyetellose hypromellose iron oxide black iron oxide red macrogol 3350 macrogol 400 opacode black ns-78-17821 polyethylene oxide povidone sodium chloride stearic acid titanium dioxide - invega prolonged release tablet is indicated for the treatment of schizophrenia, including acute treatment and recurrence prevention.