Ema Medicines

Medicines the EMA committees (CHMP for human medicines, CVMP for veterinary) have recommended for or against EU approval, still awaiting the European Commission decision. Returns brand name, active substance, applicant, opinion status and the date the opinion was adopted. Answers "which new medicines did the CHMP recommend for approval", "what is in the EMA pipeline awaiting a Commission decision", "recent negative CHMP opinions".

Direct Healthcare Professional Communications (DHPCs) — urgent EU-wide safety communications the European Medicines Agency and national authorities send to doctors and pharmacists about a medicine, e.g. a new contraindication, adverse-event signal, quality defect or shortage. Returns the medicine, active substance(s), DHPC type, regulatory outcome, dissemination date and the DHPC document URL. Answers "what safety communications has the EMA issued about X", "recent EU direct healthcare professional communications", "has there been a DHPC for semaglutide".

Full European Medicines Agency record for one medicine, looked up by brand name or EMA product number (EMEA/H/C/...). Returns every published field: status, authorised indication, active substance, ATC code, holder, orphan / conditional / accelerated / PRIME flags, and the full date history from evaluation start through authorisation, suspension or withdrawal. Answers "what is the EU authorised indication for X", "when was X approved in Europe", "who holds the EU marketing authorisation for X".

Search the European Medicines Agency register of centrally authorised medicines by brand name, active substance or INN, therapeutic area, indication text, ATC code, or marketing-authorisation holder. Returns matching medicines with status, indication, holder, authorisation dates and EPAR link. Answers "is drug X authorised in the EU", "which EU medicines contain semaglutide", "what has AstraZeneca had authorised by the EMA", "EU authorised orphan medicines for cystic fibrosis".

European Medicines Agency orphan medicinal product designations — active substances designated by the EU as treatments for rare diseases, which carry incentives like protocol assistance and market exclusivity. Returns the active substance, medicine name (once assigned), intended therapeutic use, EU designation number, designation status (Positive, Withdrawn, Expired, Negative) and dates. Catalyst-relevant for biotech: a positive designation often precedes a clinical or regulatory catalyst by months to years. Answers "what orphan designations has the EMA granted for rare disease X", "is drug X an EU-designated orphan medicine", "recent EU orphan designations".

European Medicines Agency Paediatric Investigation Plans (PIPs) — the agreed or waived plan for studying a medicine in children, required for most new EU marketing-authorisation applications. Returns the active substance, invented name (if assigned), therapeutic area, condition/indication under study, decision type (agreement, modification, waiver, compliance check) and decision date. Answers "what paediatric studies has the EMA required for X", "is there an EU paediatric investigation plan for drug X", "recent EMA paediatric decision for asthma".

European Medicines Agency post-authorisation procedures — variations, label changes and other post-marketing procedure activity for centrally authorised medicines, distinct from the initial approval. Returns the medicine, active substance, procedure status, opinion status and date, and (for withdrawn applications) the withdrawal date. Answers "what post-authorisation variations has drug X had", "has the EMA changed the label for X recently", "which EU medicines had a post-authorisation opinion this month".

European Medicines Agency Periodic Safety Update Report Single Assessments (PSUSA) — the EU-wide pharmacovigilance procedure where all products containing a given active substance are jointly reassessed for safety on a fixed schedule. Returns the active substance, related medicine names, procedure number, regulatory outcome (e.g. "Maintenance", "Variation", "Suspension") and dates. The closest structured EU signal to a pharmacovigilance safety review. Answers "when was the last PSUSA outcome for X", "has ibuprofen had a periodic safety update review", "recent EU pharmacovigilance outcomes".

New medicines authorised for the European Union market by the European Medicines Agency, in a date window. Returns brand name, active substance / INN, therapeutic area and indication, marketing-authorisation holder, authorisation date and EPAR link. Answers "which drugs did the EMA approve in July 2026", "recent EU drug approvals", "new EU marketing authorisations this year". Filtered on the marketing-authorisation date, which is the date an initial authorisation was granted.

Medicines whose European Medicines Agency register entry changed most recently — new authorisations, status changes to withdrawn or suspended, refreshed product information. Returns the medicine, what its status is now, and when the entry was last updated. Answers "what changed at the EMA this week", "which EU medicines were recently withdrawn or suspended".

European Medicines Agency referral procedures — EU-wide reviews of a medicine or class of medicines triggered by a safety concern, quality issue or scientific disagreement between member states (Article 31, Article 20, Article 107i and related procedures). Returns the referral name, INN, current status, whether it is a safety referral, procedure type, key milestone dates (procedure start, PRAC recommendation, CHMP/CVMP opinion, European Commission decision) and the referral URL. Answers "what EU safety referrals are open for X", "why was drug X reviewed by the EMA", "recent Article 31 referrals", "EU referral outcome for valproate".

European Medicines Agency register of reported and ongoing medicine shortages in the EU. Returns the medicine, INN/active substance, shortage status (ongoing/resolved/discontinued), pharmaceutical forms and strengths affected, whether alternatives are available, start-of-shortage date and expected resolution. The EU counterpart of the FDA drug shortages database. Answers "which EU medicines are currently in shortage", "is there a shortage of X in Europe", "when will the semaglutide shortage resolve in the EU".

Full European Medicines Agency (EMA) herbal-inventory record for one plant/herb, looked up by Latin name or English common name, plus the direct links to its EU herbal monograph PDF and assessment-report PDF scraped from the herb's EMA page. Returns botanical name(s), therapeutic areas, assessment status, outcome, and dates. Answers "what is the EMA monograph link for valerian root", "get the EU assessment report for ginkgo leaf", "EMA record for Hamamelis virginiana".

The European Medicines Agency (EMA) herbal-monograph assessment status for one herb by Latin name — the HMPC assessment status code and label (e.g. finalised, ongoing call for scientific data), the outcome of the European assessment (EU herbal monograph and/or EU list entry), and a note on well-established-use vs traditional-use classification. Answers "is the EMA valerian monograph well-established use or traditional use", "what is the assessment status of the EU chamomile monograph".

Search the European Medicines Agency (EMA) herbal medicines inventory — the plant/botanical substances the EMA Committee on Herbal Medicinal Products (HMPC) has assessed or is assessing for use in herbal medicinal products across the EU. Search by common herb name, Latin/botanical name, therapeutic area, or assessment status. Returns each herb's status (e.g. assessment finalised, ongoing) and whether an EU herbal monograph or list entry exists. Answers "which herbs has the EMA assessed for anxiety", "is there an EU herbal monograph for chamomile", "EMA herbal inventory status for ginkgo".