{"id":"purethal-birch-20-000-aum-ml","safety":{"commonSideEffects":[{"rate":"30–50","effect":"Local injection site reactions (erythema, swelling, pruritus)"},{"rate":"1–5","effect":"Systemic allergic reactions (mild to moderate)"},{"rate":"<0.1","effect":"Anaphylaxis"},{"rate":"10–20","effect":"Itching or swelling of mouth/throat"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is an allergen immunotherapy (AIT) product containing standardized birch pollen extract. It works by inducing immune tolerance through repeated subcutaneous administration of increasing doses of the allergen, shifting the immune response from Th2-mediated (allergic) to Th1/Treg-mediated (tolerant) pathways. Over time, this reduces IgE-mediated reactions and increases IgG-blocking antibodies, thereby decreasing symptoms upon natural allergen exposure.","oneSentence":"PURETHAL Birch is an allergen extract that desensitizes the immune system to birch pollen through gradual exposure, reducing allergic responses.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:36:48.676Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Birch pollen-induced allergic rhinitis and/or allergic asthma"}]},"trialDetails":[{"nctId":"NCT01918956","phase":"PHASE4","title":"PURETHAL Birch RUSH Study","status":"COMPLETED","sponsor":"HAL Allergy","startDate":"2013-09","conditions":"Allergic Rhinitis, Allergic Rhinoconjunctivitis","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"PURETHAL Birch, 20.000 AUM/ml","genericName":"PURETHAL Birch, 20.000 AUM/ml","companyName":"HAL Allergy","companyId":"hal-allergy","modality":"Biologic","firstApprovalDate":"","aiSummary":"PURETHAL Birch is an allergen extract that desensitizes the immune system to birch pollen through gradual exposure, reducing allergic responses. Used for Birch pollen-induced allergic rhinitis and/or allergic asthma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}