{"id":"abrysvo","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"PRURITUS","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"WRONG PRODUCT ADMINISTERED","source":"FDA FAERS","actionTaken":"Reported 6 times"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"CONDITION AGGRAVATED","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"FOETAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"INSOMNIA","source":"FDA FAERS","actionTaken":"Reported 5 times"},{"date":"","signal":"MATERNAL EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"Reported 5 times"}],"drugInteractions":[{"drug":"Warfarin","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"P-glycoprotein inducers","action":"Avoid","effect":"Decreased exposure to abrysvo"},{"drug":"P-glycoprotein inhibitors","action":"Monitor","effect":"Increased exposure to abrysvo"},{"drug":"Strong CYP3A4 inducers","action":"Avoid","effect":"Decreased exposure to abrysvo"},{"drug":"Strong CYP3A4 inhibitors","action":"Monitor","effect":"Increased exposure to abrysvo"},{"drug":"CYP3A4 substrates","action":"Monitor","effect":"Increased exposure to CYP3A4 substrates"}],"commonSideEffects":[{"effect":"Pain at the injection site","drugRate":"40.6%","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"31%","severity":"common","organSystem":""},{"effect":"Muscle pain","drugRate":"26.5%","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"20%","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"15.7%","severity":"common","organSystem":""},{"effect":"Joint pain","drugRate":"12.4%","severity":"common","organSystem":""},{"effect":"Headache (60+ years)","drugRate":"12.9%","severity":"common","organSystem":""},{"effect":"Muscle pain (18-59 years with chronic conditions)","drugRate":"24.4%","severity":"common","organSystem":""},{"effect":"Pain at the injection site (18-59 years with chronic conditions)","drugRate":"35.3%","severity":"common","organSystem":""},{"effect":"Nausea (18-59 years with chronic conditions)","drugRate":"11.8%","severity":"common","organSystem":""},{"effect":"Pain at the injection site (60+ years)","drugRate":"10.6%","severity":"common","organSystem":""},{"effect":"Muscle pain (60+ years)","drugRate":"10.2%","severity":"common","organSystem":""}],"contraindications":["ABRYSO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components","An increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with ABRYSVO","Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO"],"specialPopulations":{"Pregnancy":"The vaccine has been approved for administration to pregnant women at 32 to 36 weeks of gestation. Clinical trials were performed to assess the vaccine safety and efficacy for administration at the approved interval of 32 to 36 weeks of gestation, and the results stated that there is insufficient data to support or refute causation between the Abrysvo vaccine and preterm births. The Abrysvo vaccine is administered to the pregnant mother to protect the infant from RSV infection during the first six months of life. Maternal immunization confers passive immunity to the fetus by transfer of antibodies via breastfeeding.","Geriatric use":"The vaccine has been approved for administration in adults aged 60 years and older.","Paediatric use":"text","Renal impairment":"text","Hepatic impairment":"text"},"seriousAdverseEvents":[]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T21:57:52.280581+00:00"},"dailyMed":{"url":"","method":"api_direct","source":"DailyMed (NIH/NLM)","rawText":"","confidence":1,"sourceType":"dailymed","retrievedAt":"2026-04-19T21:57:39.898873+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T21:57:59.795581+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6068489/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T21:57:45.999259+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:01.339687+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T21:57:44.699390+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T21:57:45.632542+00:00"},"rxnormFormulations":{"url":"https://rxnav.nlm.nih.gov/REST/drugs.json?name=abrysvo","method":"api_direct","source":"RxNorm (NIH)","rawText":"","confidence":1,"sourceType":"rxnorm","retrievedAt":"2026-04-19T21:57:38.760850+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:01.339669+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:01.339665+00:00"},"commercial.annualRevenue":{"url":"","method":"deterministic","source":"SEC EDGAR 10-K","rawText":"$1033M FY2025","confidence":0.8,"sourceType":"sec_edgar","retrievedAt":"2026-04-19T21:57:52.280619+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:01.339614+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T21:58:01.339639+00:00"}},"dailyMed":[{"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=be18292e-b1a2-4815-a0ed-003efaa6bea3","setid":"be18292e-b1a2-4815-a0ed-003efaa6bea3","title":"ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) KIT ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]"}],"offLabel":[],"timeline":[{"date":"1960s","type":"neutral","_source":"Wikipedia","milestone":"Attempts to develop an RSV vaccine began","regulator":"none"},{"date":"2013","type":"neutral","_source":"Wikipedia","milestone":"Study detailed the crystal structure of the RSV fusion (F) protein","regulator":"none"},{"date":"2019","type":"neutral","_source":"Wikipedia","milestone":"Paper claimed research toward developing a vaccine had advanced greatly","regulator":"none"},{"date":"2023-02","type":"neutral","_source":"Wikipedia","milestone":"Results","regulator":"none"},{"date":"2024-06","type":"positive","_source":"Wikipedia","milestone":"Committee for Medicinal Products for Human Use adopted a positive opinion","regulator":"EMA"},{"date":"2024-08","type":"positive","_source":"Wikipedia","milestone":"Mresvia was approved for medical use in the European Union","regulator":"EMA"}],"_dailymed":{"setId":"be18292e-b1a2-4815-a0ed-003efaa6bea3","title":"ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) KIT ABRYSVO (RESPIRATORY SYNCYTIAL VIRUS VACCINE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]","labeler":""},"aiSummary":"Abrysvo, developed by Pfizer, holds a significant market position as the world's best-selling RSV vaccine, generating $1.033 billion in revenue. Its competitive advantage lies in its robust efficacy and safety profile, setting it apart from other RSV treatments like Ribavirin, Synagis, Arexvy, Virazole, and Nirsevimab. A key risk is the lack of clinical trial data to support further indications, which may limit its expansion into new markets. Despite this, the pipeline outlook remains promising, with potential for additional indications that could further solidify its market leadership.","brandName":"Abrysvo","ecosystem":[],"isGeneric":true,"mechanism":{"target":"RSV","novelty":"best-in-class","modality":"vaccine","drugClass":"vaccine","explanation":"ABRYSVO is a vaccine designed to protect against respiratory syncytial virus (RSV). RSV is a highly contagious virus that affects people of all ages, but it is most severe in young children and older adults. The virus causes inflammation in the lungs and airways, leading to symptoms such as coughing, wheezing, and difficulty breathing. ABRYSVO works by stimulating the body's immune system to produce antibodies that can recognize and fight RSV.","oneSentence":"ABRYSVO is a vaccine that protects against respiratory syncytial virus (RSV).","technicalDetail":"ABRYSVO is a recombinant vaccine that uses a weakened version of the RSV virus to stimulate an immune response. The vaccine is administered via injection and is designed to provide long-term protection against RSV. ABRYSVO has been shown to be safe and effective in clinical trials, with a strong immune response and minimal side effects."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"Respiratory syncytial virus vaccine","extract":"A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus. RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year.","wiki_history":"== History ==\n=== Development ===\nAttempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactivated vaccine developed by exposing the RSV virus to formalin (formalin-inactivated RSV (FI-RSV)). This early vaccine induced vaccine-associated enhanced respiratory disease (VAERD), in which children who had not previously been exposed to RSV and were subsequently vaccinated would develop severe RSV disease if exposed to the virus itself, including fever, wheezing, and bronchopneumonia. A 2019 paper similarly claimed that research toward developing a vaccine had advanced greatly over the prior 10 years, with more than 30 candidates in some stage of development. The same study predicted that a vaccine would be available within ten years.\n\t\nA 2013 study detailed the crystal structure of the RSV fusion (F) protein and how its stability could be improved. This provided the basis for finding the most effective F protein constructs, which are used in RSV vaccines.\n\nIn February 2023, results of a phase III study of around 25,000 participants age 60+ were published. One dose of the Arexvy vaccine provided 94% efficacy against severe RSV pneumonia and 72% efficacy against RSV acute respiratory infection. An advisory panel to the FDA recommended approval of the vaccine in February 2023.\n\nIn April 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended to grant a marketing authorization for Arexvy for the prevention of RS","wiki_development":"=== Development ===\nAttempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactivated vaccine developed by exposing the RSV virus to formalin (formalin-inactivated RSV (FI-RSV)). This early vaccine induced vaccine-associated enhanced respiratory disease (VAERD), in which children who had not previously been exposed to RSV and were subsequently vaccinated would develop severe RSV disease if exposed to the virus itself, including fever, wheezing, and bronchopneumonia. A 2019 paper similarly claimed that research toward developing a vaccine had advanced greatly over the prior 10 years, with more than 30 candidates in some stage of development. The same study predicted that a vaccine would be available within ten years.\n\t\nA 2013 study detailed the crystal structure of the RSV fusion (F) protein and how its stability could be improved. This provided the basis for finding the most effective F protein constructs, which are used in RSV vaccines.\n\nIn February 2023, results of a phase III study of around 25,000 participants age 60+ were published. One dose of the Arexvy vaccine provided 94% efficacy against severe RSV pneumonia and 72% efficacy against RSV acute respiratory infection. An advisory panel to the FDA recommended approval of the vaccine in February 2023.\n\nIn April 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended to grant a marketing authorization for Arexvy for the prevention of RSV lower respir","wiki_medical_uses":"== Medical uses ==\nRespiratory syncytial virus vaccine is indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in people 60 years of age and older. Abrysvo is approved for use in pregnant women at 24 through 36 weeks and older adults in the European Union. and between 28 through 36 weeks and older adults in the United Kingdom.","wiki_society_and_culture":"== Society and culture ==\n\n=== Legal status ===\n\nIn June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Mresvia, intended for the prevention of lower respiratory tract disease caused by respiratory syncytial virus. The applicant for this medicinal product is Moderna Biotech Spain S.L. Mresvia was approved for medical use in the European Union in August 2024."},"chemblData":{"prodrug":0,"chemblId":"CHEMBL6068489","maxPhase":"4.0","chirality":1,"parenteral":false,"availability":-1,"moleculeType":"Vaccine component","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":false},"commercial":{"revenueYear":2025,"annualCostUS":"Not available","annualRevenue":1033,"genericStatus":"Generic — off-patent","revenueSource":"SEC 8-K Pfizer (2026-02-03)","currentRevenue":"64 million","revenueCurrency":"USD","patientPopulation":"64 million","peakSalesEstimate":"160,000 deaths","revenueConfidence":"verified (SEC filing)","revenueExtractedAt":"2026-04-01T11:46:07.628022","revenueExtractedBy":"revenue-sec"},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=abrysvo","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=abrysvo","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://en.wikipedia.org/wiki/abrysvo","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":6,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":7,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T10:49:25.003610+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Ribavirin","company":"Unknown","advantage":"Competes with Abrysvo in RSV Vaccination and Immunization, RSV, and Hepatitis C treatment"},{"name":"Synagis (palivizumab)","company":"Unknown","advantage":"Competes with Abrysvo in RSV Vaccination and Immunization, RSV treatment"},{"name":"Arexvy","company":"Unknown","advantage":"Competes with Abrysvo in RSV treatment"},{"name":"Virazole","company":"Unknown","advantage":"Competes with Abrysvo in RSV treatment"},{"name":"Nirsevimab","company":"Unknown","advantage":"Competes with Abrysvo in RSV treatment"},{"name":"Rebetol","company":"Unknown","advantage":"Competes with Abrysvo in RSV treatment"},{"name":"RibaTab","company":"Unknown","advantage":"Competes with Abrysvo in RSV treatment"}],"genericName":"abrysvo","indications":{"approved":[{"name":"Prevention of rabies in individuals who have been bitten or otherwise exposed to rabies or have been at risk of rabies exposure and have been vaccinated with a cell culture vaccine or an inactivated rabies vaccine.","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_drugWebsite":{"url":"https://www.abrysvo.com","content":"Find a Vaccine\nRSV protection starts with Pfizer's ABRYSVO® (Respiratory Syncytial Virus Vaccine)\n\nRespiratory syncytial virus (RSV) is a highly contagious virus that can lead to serious health consequences.\n\nActor portrayal\n\nAdults 50 years and older\n\nPfizer’s ABRYSVO is a vaccine to prevent respiratory disease from RSV. It is recommended for adults aged 75+ years and 50 to 74 with certain chronic conditions.\n\nFor Adults\nHealthcare Professionals\n\nActor portrayal\n\nPregnant women to protect their baby\n\nPfizer's ABRYSVO is the only RSV vaccine given during pregnancy from 32 through 36 weeks that helps protect your baby against respiratory disease caused by RSV, from birth through 6 months.\n\nFor Pregnant Women\nHealthcare Professionals\n\nPrescribing Information\n\nImportant Safety Information & Uses\nImportant Safety Information\nABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components\nAn increased risk of Guillain-Barré syndrome (severe muscle weakness) was observed after vaccination with ABRYSVO\nFor pregnant individuals: To avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age\nFainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury due to fainting\nAdults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO\nVaccination with ABRYSVO may not protect all people\nIn adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain\nIn adults aged 18-59, the most common side effects (≥10%) were pain at the injection site, muscle pain, joint pain, and nausea\nIn pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea\nIn clinical trials where ABRYSVO was compare"},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[],"_emaApprovals":[{"date":"15/09/2023","name":"ABRYSVO","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"chemblId":"CHEMBL6068489","moleculeType":"Vaccine component","molecularWeight":""},"administration":{"formulation":"0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection [Abrysvo]"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"rxcui":"2642144","chemblId":"CHEMBL6068489","pubchemSID":"483929543"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":"VACCINE ANTIGEN","targetChemblId":"CHEMBL2364165","mechanismComment":null,"mechanismOfAction":"Fusion glycoprotein F0 vaccine antigen"}],"developmentCodes":[],"ownershipHistory":[{"notes":"Applied for marketing authorization for Mresvia","period":"2024-present","_source":"Wikipedia","companyName":"Moderna Biotech Spain S.L.","relationship":"Applicant"}],"publicationCount":91,"therapeuticAreas":["Infectious Disease"],"_revenueScrapedAt":"2026-04-01 10:46:07.654344+00","biosimilarFilings":[],"recentPublications":[{"pmid":"41741000","title":"Maternal perspectives on the RSV vaccine (Abrysvo): a thematic analysis of survey findings from the first season of implementation in England and Scotland.","authors":"O'Hagan S, Williams TC, Marlow R, Drysdale SB, Cunningham S","journal":"Arch Dis Child","pubDate":"2026 Feb 27"},{"pmid":"40901480","title":"Evaluating the efficacy, safety, and immunogenicity of FDA-approved RSV vaccines: a systematic review of Arexvy, Abrysvo, and mResvia.","authors":"Alandijany TA, Qashqari FS","journal":"Front Immunol","pubDate":"2025"},{"pmid":"39946699","title":"In brief: New warning for the RSV vaccines Arexvy and Abrysvo.","authors":"","journal":"Med Lett Drugs Ther","pubDate":"2025 Feb 17"},{"pmid":"39355078","title":"Use of the Abrysvo Vaccine in Pregnancy to Prevent Respiratory Syncytial Virus in Infants: A Review.","authors":"Patel D, Chawla J, Blavo C","journal":"Cureus","pubDate":"2024 Aug"},{"pmid":"39631022","title":"Respiratory Syncytial Virus (RSV) Vaccine (Abrysvo®).","authors":"","journal":"","pubDate":"1994"},{"pmid":"39631015","title":"Vacuna contra el Virus Sincitial Respiratorio (VSR) (Abrysvo®).","authors":"","journal":"","pubDate":"1994"},{"pmid":"38966073","title":"A new era in maternal-child health: Abrysvo's role in RSV prevention.","authors":"Shaukat A, Batool UEA, Nasser N","journal":"Health Sci Rep","pubDate":"2024 Jul"},{"pmid":"38905561","title":"RSVpreF (Abrysvo) and Nirsevimab-alip (Beyfortus) for the Prevention of Respiratory Syncytial Virus Infection.","authors":"Nodelman M, Scott AM","journal":"Am Fam Physician","pubDate":"2024 Jun"},{"pmid":"37755690","title":"Two vaccines (Arexvy and Abrysvo) for prevention of RSV disease.","authors":"","journal":"Med Lett Drugs Ther","pubDate":"2023 Oct 2"}],"rxnormFormulations":[{"tty":"SBD","name":"0.5 ML respiratory syncytial virus pre-fusion F protein, A, recombinant, stabilized 0.12 MG/ML / respiratory syncytial virus pre-fusion F protein, B, recombinant, stabilized 0.12 MG/ML Injection [Abrysvo]","rxcui":"2642148","synonym":"Abrysvo 60 MCG / 60 MCG per 0.5 ML Injection"}],"_drugWebsiteChecked":true,"participantFlowData":[],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[],"genericManufacturerList":[],"phase":"marketed","status":"active","companyName":"Pfizer","companyId":"pfizer","modality":"vaccine","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2023-09-15T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":"2023-09-15T00:00:00.000Z","mah":"","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":6,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T10:49:25.003610+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}