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

moderna us, inc. - cx-024414 (unii: epk39pl4r4) (cx-024414 - unii:epk39pl4r4) - there is no information on the co-administration of the moderna covid-19 vaccine with other vaccines. in order to mitigate the risks of using this unapproved product under eua and to optimize the potential benefit of the moderna covid-19 vaccine, the following items are required. use of unapproved moderna covid-19 vaccine for active immunization to prevent covid-19 under this eua is limited to the following (all requirements must be met): full eua prescribing information: contents* 11 use in specific populations 1 authorized use 11.1 pregnancy 2 dosage and administration 11.2 lactation 2.1 preparation for administration 11.3 pediatric use 2.2 administration 11.4 geriatric use 2.3 dose and schedule 11.5 use in immunocompromised individuals 3 dosage forms and strengths 13 description 4 contraindications 14 clinical pharmacology 5 warnings and precautions 14.1 mechanism of action 5.1 management of acute allergic reactions 18 clinical trial results and supporting data for eua 18.1 efficacy of two-dose primary se

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

moderna us, inc. - cx-024414 (unii: epk39pl4r4) (elasomeran - unii:epk39pl4r4) - there is no information on the co-administration of the moderna covid-19 vaccine with other vaccines. in order to mitigate the risks of using this unapproved product under eua and to optimize the potential benefit of the moderna covid-19 vaccine, the following items are required. use of unapproved moderna covid-19 vaccine for active immunization to prevent covid-19 under this eua is limited to the following (all requirements must be met): complete and submit reports to vaers online at https://vaers.hhs.gov/reportevent.html. for further assistance with reporting to vaers, call 1-800-822-7967. the reports should include the words “moderna covid-19 vaccine eua” in the description section of the report. *serious adverse events are defined as: full eua prescribing information: contents* 11 use in specific populations 1 authorized use 11.1 pregnancy 2 dosage and administration 11.2 lactation 2.1 preparation for administration 11.3 pediatric use 2.2 administration 11.4 geriatric use 13 description 2.3 dosing and sc

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

moderna us, inc. - elasomeran (unii: epk39pl4r4) (elasomeran - unii:epk39pl4r4) - there is no information on the co-administration of the moderna covid-19 vaccine with other vaccines. in order to mitigate the risks of using this unapproved product under eua and to optimize the potential benefit of the moderna covid-19 vaccine, the following items are required. use of unapproved moderna covid-19 vaccine for active immunization to prevent covid-19 under this eua is limited to the following (all requirements must be met): full eua prescribing information: contents* 11 use in specific populations 11.1 pregnancy 11.2 lactation 11.3 pediatric use 11.4 use in immunocompromised individuals 13 description 14 clinical pharmacology 14.1 mechanism of action 18 clinical trial results and supporting data for eua 18.1 efficacy of two-dose primary series in participants 18 years of age and older 18.2 effectiveness of two-dose primary series in participants 6 years through 11 years of age 18.3 immunogenicity in solid organ transplant recipients 19 how supplied/storage and handling 2

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

moderna us, inc. - cx-024414 (unii: epk39pl4r4) (elasomeran - unii:epk39pl4r4) - there is no information on the co-administration of the moderna covid-19 vaccine with other vaccines. in order to mitigate the risks of using this unapproved product under eua and to optimize the potential benefit of the moderna covid-19 vaccine, the following items are required. use of unapproved moderna covid-19 vaccine for active immunization to prevent covid-19 under this eua is limited to the following (all requirements must be met): *serious adverse events are defined as: full eua prescribing information: contents* 11 use in specific populations 11.3 pediatric use 11.4 use in immunocompromised individuals 13 description 14 clinical pharmacology 14.1 mechanism of action 18 clinical trial results and supporting data for eua 18.1 efficacy of two-dose primary series in participants 18 years of age and older 18.2 effectiveness of two-dose primary series in participants 6 months through 5 years of age 18.3 immunogenicity in solid organ transplant recipients 19 how supplied/storage and handling 20 patient cou

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

moderna us, inc. - elasomeran (unii: epk39pl4r4) (elasomeran - unii:epk39pl4r4), cx-034476 omicron (ba.4/ba.5) (unii: tyf7yw7enf) (cx-034476 omicron (ba.4/ba.5) - unii:tyf7yw7enf) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of moderna covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months of age and older. moderna covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) is hereafter referred to as moderna covid-19 vaccine, bivalent. moderna covid-19 vaccine, bivalent is not licensed for any use. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the united states under certain circumstances including, but not limited to, when t

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

moderna us, inc. - elasomeran (unii: epk39pl4r4) (elasomeran - unii:epk39pl4r4), cx-034476 omicron (ba.4/ba.5) (unii: tyf7yw7enf) (cx-034476 omicron (ba.4/ba.5) - unii:tyf7yw7enf) - there is no information on the co-administration of moderna covid-19 vaccine, bivalent with other vaccines. in order to mitigate the risks of using this unapproved product under eua and to optimize the potential benefit of moderna covid-19 vaccine, bivalent, the following items are required. use of unapproved moderna covid-19 vaccine, bivalent for active immunization to prevent covid-19 under this eua is limited to the following (all requirements must be met): full eua prescribing information: contents* 1 authorized use 2 dosage and administration 2.1 preparation for administration 2.2 administration 2.3 dose and schedule 3 dosage forms and strengths 4 contraindications 5 warnings and precautions 5.1 management of acute allergic reactions 5.2 myocarditis and pericarditis 5.3 syncope 5.4 altered immunocompetence 5.5 limitations of vaccine effectiveness 6 overall safety summary 6.1 clinical trials experience 6.2 post-authorization experience 8 requirements and instructions for reporting adverse events and vacc

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

moderna us, inc. - cx-038839 omicron (xbb.1.5) (unii: 4f9qrs7zv2) (cx-038839 omicron (xbb.1.5) - unii:4f9qrs7zv2) - the u.s. food and drug administration (fda) has issued an emergency use authorization (eua) for the emergency use of moderna covid-19 vaccine (2023-2024 formula) for active immunization to prevent coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2) in individuals 6 months through 11 years of age. justification for emergency use of vaccines during the covid-19 pandemic there is currently an outbreak of covid-19 caused by sars-cov-2. the secretary of the department of health and human services (hhs) has: an eua is an fda authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the united states under certain circumstances including, but not limited to, when the secretary of hhs declares that the use of eua authority is justified, based on a determination that there is a public health emergency, or a significant potential for a public health emergency, that affects or

Bangladesh - English - DGDA (Directorate General of Drug Administration)

modern pharmaceuticals ltd. - benzoic acid + salicylic acid - ointment - 60 mg + 30 mg/gm

Bangladesh - English - DGDA (Directorate General of Drug Administration)

modern pharmaceuticals ltd. - magnesium hydroxide - suspension - 400 mg/5 ml

Bangladesh - English - DGDA (Directorate General of Drug Administration)

modern pharmaceuticals ltd. - benzoic acid + salicylic acid - ointment - 60 mg + 30 mg/gm