QRD statements for metered dose inhalers containing fluorinated greenhouse gases
QRD statements for metered dose inhalers containing fluorinated greenhouse gases
QRD statements for metered dose inhalers containing fluorinated greenhouse gases
2024 European Medicines Agency annual report on independence
Applying for marketing authorisation: orphan medicines
Human medicines European public assessment report (EPAR): Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva, efavirenz,emtricitabine,tenofovir disoproxil, Date of authorisation: 17/07/2017, Revision: 12, Status: Authorised
Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification
Opinion on medicine for use outside EU: Ivermectin/Albendazole, ivermectin,albendazole, Parasitic Diseases,Helminthiasis,Hookworm Infections,Ascaridida Infections,Trichuriasis,Strongyloidiasis, 30/01/2025 Positive opinion
Human medicines European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.), beclometasone,formoterol, Date of authorisation: 23/04/2018, Revision: 7, Status: Withdrawn
Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan, Regadenoson, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Surgical and medical procedures, PIP number: P/0029/2024
Agenda of the CAT meeting 19-21 March 2025
ICH M11 Technical Specification - Updated step 2b