{ "meta": { "total_records": 19, "timestamp": "2026-06-02T06:15:34Z" }, "data": [ { "name_of_medicine": "Dengue Tetravalent Vaccine (Live, Attenuated) Takeda", "ema_opinion_number": "EMEA/H/W/005362", "ema_opinion_status": "Positive opinion", "active_substance": "Dengue virus, serotype 2, expressing Dengue virus, serotype 1, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 3, surface proteins, live, attenuated;Dengue virus, serotype 2, expressing Dengue virus, serotype 4, surface proteins, live, attenuated;Dengue virus, serotype 2, live, attenuated", "international_non_proprietary_name_inn_common_name": "dengue tetravalent vaccine (live, attenuated)", "therapeutic_area_mesh": "Dengue", "atc_code_human": "J07BX04", "latest_procedure_affecting_product_information": "PSUR/0000308360", "opinion_holder": "Takeda Pharmaceuticals International AG Ireland Branch", "pharmacotherapeutic_group_human": "Vaccines", "therapeutic_indication": "Dengue Tetravalent Vaccine (Live, Attenuated) Takeda is indicated for the prevention of dengue disease in individuals from 4 years of age. The use of Dengue Tetravalent Vaccine (Live, Attenuated) Takeda should be in accordance with official recommendations.", "date_of_opinion": "13/10/2022", "date_of_outcome": "26/03/2026", "first_published_date": "14/10/2022", "last_updated_date": "08/05/2026", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/dengue-tetravalent-vaccine-live-attenuated-takeda" }, { "name_of_medicine": "Acoziborole Winthrop", "ema_opinion_number": "EMEA/H/W/006686", "ema_opinion_status": "Positive opinion", "active_substance": "acoziborole", "international_non_proprietary_name_inn_common_name": "acoziborole", "therapeutic_area_mesh": "Trypanosomiasis, African", "atc_code_human": "P01CX", "latest_procedure_affecting_product_information": "", "opinion_holder": "Sanofi Winthrop Industrie", "pharmacotherapeutic_group_human": "Antiprotozoals", "therapeutic_indication": "Acoziborole Winthrop is indicated for the treatment of both first-stage (hemo-lymphatic) and second-stage (meningo-encephalitic), including severe second-stage with ≥ 100 White Blood Cell (WBC)/μL with or without trypanosomes in cerebrospinal fluid (CSF), human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense (g-HAT) in adolescents ≥ 12 years old with body weight ≥ 40 kg, and in adults. Acoziborole should be used in line with official recommendations (see section 4.4).", "date_of_opinion": "24/02/2026", "date_of_outcome": "", "first_published_date": "27/02/2026", "last_updated_date": "15/04/2026", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/acoziborole-winthrop" }, { "name_of_medicine": "Mosquirix", "ema_opinion_number": "H-W-2300", "ema_opinion_status": "Positive opinion", "active_substance": "RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)]", "international_non_proprietary_name_inn_common_name": "Plasmodium falciparum and hepatitis B vaccine (recombinant, adjuvanted)", "therapeutic_area_mesh": "Malaria", "atc_code_human": "J07XA01", "latest_procedure_affecting_product_information": "II/0086", "opinion_holder": "", "pharmacotherapeutic_group_human": "Malaria vaccines", "therapeutic_indication": "Active immunisation of children aged 6 weeks up to 17 months against malaria caused by Plasmodium falciparum and against hepatitis B. The use of Mosquirix should be based on official recommendations considering Plasmodium falciparum malaria epidemiology in different geographical areas.", "date_of_opinion": "23/07/2015", "date_of_outcome": "27/03/2025", "first_published_date": "01/10/2015", "last_updated_date": "18/03/2026", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/mosquirix" }, { "name_of_medicine": "Lenacapavir Gilead", "ema_opinion_number": "EMEA/H/W/006659", "ema_opinion_status": "Positive opinion", "active_substance": "lenacapavir sodium", "international_non_proprietary_name_inn_common_name": "lenacapavir", "therapeutic_area_mesh": "HIV Infections;HIV-1", "atc_code_human": "J05AX31", "latest_procedure_affecting_product_information": "VR/0000323127", "opinion_holder": "Gilead Sciences Ireland Unlimited Company", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "therapeutic_indication": "Solution for injection: Lenacapavir Gilead injection is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV‑1 acquisition risk, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1). Film-coated tablets: Lenacapavir Gilead tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents with increased HIV‑1 acquisition risk, weighing at least 35 kg for: oral loading oral bridging (see sections 4.2, 4.4 and 5.1).", "date_of_opinion": "24/07/2025", "date_of_outcome": "", "first_published_date": "25/07/2025", "last_updated_date": "20/02/2026", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/lenacapavir-gilead" }, { "name_of_medicine": "Aluvia", "ema_opinion_number": "H-W-764", "ema_opinion_status": "Positive opinion", "active_substance": "lopinavir;ritonavir", "international_non_proprietary_name_inn_common_name": "lopinavir;ritonavir", "therapeutic_area_mesh": "HIV Infections", "atc_code_human": "J05AR10", "latest_procedure_affecting_product_information": "VR/0000256267", "opinion_holder": "AbbVie Deutschland GmbH & Co. KG", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "therapeutic_indication": "Aluvia is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children above the age of 2 years. The choice of Aluvia to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients.", "date_of_opinion": "21/09/2006", "date_of_outcome": "09/04/2025", "first_published_date": "20/08/2020", "last_updated_date": "02/12/2025", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/aluvia" }, { "name_of_medicine": "Fexinidazole Winthrop", "ema_opinion_number": "H-W-2320", "ema_opinion_status": "Positive opinion", "active_substance": "fexinidazole", "international_non_proprietary_name_inn_common_name": "fexinidazole", "therapeutic_area_mesh": "Trypanosomiasis, African", "atc_code_human": "P01CA03", "latest_procedure_affecting_product_information": "VR/0000287639", "opinion_holder": "", "pharmacotherapeutic_group_human": "Antiparasitic products, insecticides and repellents;Antiprotozoals;Agents against leishmaniasis and trypanosomiasis;Nitroimidazole derivatives", "therapeutic_indication": "Fexinidazole Winthrop is indicated for the treatment of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) of human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense (g‑HAT) and Trypanosoma brucei rhodesiense (r-HAT) in adults and children ≥ 6 years old and weighing ≥ 20 kg. Fexinidazole should be used in line with official recommendations (see section 4.4).", "date_of_opinion": "15/11/2018", "date_of_outcome": "09/10/2025", "first_published_date": "02/07/2018", "last_updated_date": "17/10/2025", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/fexinidazole-winthrop" }, { "name_of_medicine": "Dapivirine Vaginal Ring 25 mg", "ema_opinion_number": "H-W-2168", "ema_opinion_status": "Positive opinion", "active_substance": "dapivirine", "international_non_proprietary_name_inn_common_name": "dapivirine", "therapeutic_area_mesh": "Anti-HIV Agents", "atc_code_human": "G01AX17", "latest_procedure_affecting_product_information": "II/0025/G", "opinion_holder": "", "pharmacotherapeutic_group_human": "Other antiinfectives and antiseptics", "therapeutic_indication": "Reducing the risk of HIV-1 infection via vaginal intercourse in HIV-uninfected women 16 years and older in combination with safter sex practices when oral PrEP is not/cannot be used or is not available.", "date_of_opinion": "23/07/2020", "date_of_outcome": "19/06/2025", "first_published_date": "04/01/2021", "last_updated_date": "21/08/2025", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/dapivirine-vaginal-ring-25-mg" }, { "name_of_medicine": "Pyramax", "ema_opinion_number": "H-W-2319", "ema_opinion_status": "Positive opinion", "active_substance": "artesunate;pyronaridine", "international_non_proprietary_name_inn_common_name": "artesunate;pyronaridine", "therapeutic_area_mesh": "Malaria", "atc_code_human": "P01BF06", "latest_procedure_affecting_product_information": "II/0036", "opinion_holder": "", "pharmacotherapeutic_group_human": "Antimalarials", "therapeutic_indication": "For tablets and granules combined: Pyramax tablets are indicated in the treatment of acute, uncomplicated malaria infection caused by Plasmodium falciparum or by Plasmodium vivax in adults and children weighing 20 kg or more. Pyramax Granules for oral suspension are indicated in the treatment of acute, uncomplicated malaria infection caused by Plasmodium falciparum or by Plasmodium vivax in children and infants weighing 5 kg to under 20 kg. Consideration should be given to official guidance on the appropriate use of antimalarial agents.", "date_of_opinion": "16/02/2012", "date_of_outcome": "05/06/2025", "first_published_date": "02/07/2018", "last_updated_date": "06/08/2025", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/pyramax" }, { "name_of_medicine": "Ivermectin/Albendazole", "ema_opinion_number": "H-W-5186", "ema_opinion_status": "Positive opinion", "active_substance": "ivermectin;albendazole", "international_non_proprietary_name_inn_common_name": "ivermectin;albendazole", "therapeutic_area_mesh": "Parasitic Diseases;Helminthiasis;Hookworm Infections;Ascaridida Infections;Trichuriasis;Strongyloidiasis", "atc_code_human": "P02CF01", "latest_procedure_affecting_product_information": "", "opinion_holder": "Laboratorios Liconsa S.A.", "pharmacotherapeutic_group_human": "Anthelmintics", "therapeutic_indication": "Ivermectin/Albendazole orodispersible tablets are indicated in adults, adolescents and children ≥ 5 years of age for the treatment of: Soil-transmitted helminth infections, caused by one or more of the following parasites (see section 5.1): hookworm (Ancylostoma duodenale, Necator americanus), roundworm (Ascaris lumbricoides), whipworm (Trichuris trichiura) and Strongyloides stercoralis. Proven or suspected microfilaraemia in patients with lymphatic filariasis caused by Wuchereria bancrofti. Ivermectin/albendazole should be used in accordance with official guidance, which may include guidance provided by the World Health Organization and public health authorities.", "date_of_opinion": "30/01/2025", "date_of_outcome": "", "first_published_date": "31/01/2025", "last_updated_date": "18/03/2025", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/ivermectin-albendazole" }, { "name_of_medicine": "Arpraziquantel", "ema_opinion_number": "EMEA/H/W/004252", "ema_opinion_status": "Positive opinion", "active_substance": "arpraziquantel", "international_non_proprietary_name_inn_common_name": "arpraziquantel", "therapeutic_area_mesh": "", "atc_code_human": "P02BA03", "latest_procedure_affecting_product_information": "", "opinion_holder": "Merck Europe B.V.", "pharmacotherapeutic_group_human": "Anthelmintics", "therapeutic_indication": "Treatment of schistosomiasis caused by Schistosoma mansoni or Schistosoma haematobium in children aged 3 months to 6 years.", "date_of_opinion": "14/12/2023", "date_of_outcome": "", "first_published_date": "19/12/2023", "last_updated_date": "08/02/2024", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/arpraziquantel" }, { "name_of_medicine": "Insulatard", "ema_opinion_number": "H-W-005780", "ema_opinion_status": "Positive opinion", "active_substance": "Insulin human (RDNA)", "international_non_proprietary_name_inn_common_name": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "atc_code_human": "A10AC01", "latest_procedure_affecting_product_information": "", "opinion_holder": "Novo Nordisk A/S", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "therapeutic_indication": "Treatment of diabetes mellitus", "date_of_opinion": "22/04/2022", "date_of_outcome": "", "first_published_date": "22/04/2022", "last_updated_date": "28/07/2022", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/insulatard" }, { "name_of_medicine": "Actrapid", "ema_opinion_number": "H-W-005779", "ema_opinion_status": "Positive opinion", "active_substance": "insulin human", "international_non_proprietary_name_inn_common_name": "insulin human", "therapeutic_area_mesh": "Diabetes Mellitus", "atc_code_human": "A10AC01", "latest_procedure_affecting_product_information": "H-W-005779", "opinion_holder": "Novo Nordisk A/S", "pharmacotherapeutic_group_human": "Drugs used in diabetes", "therapeutic_indication": "Actrapid is indicated for treatment of diabetes mellitus.", "date_of_opinion": "22/04/2022", "date_of_outcome": "22/04/2022", "first_published_date": "22/04/2022", "last_updated_date": "22/07/2022", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/actrapid" }, { "name_of_medicine": "Umbipro", "ema_opinion_number": "H-W-3799", "ema_opinion_status": "Withdrawn opinion", "active_substance": "chlorhexidine digluconate", "international_non_proprietary_name_inn_common_name": "chlorhexidine", "therapeutic_area_mesh": "Soft Tissue Infections", "atc_code_human": "D08AC02", "latest_procedure_affecting_product_information": "H-W-3799-IAIN-0005", "opinion_holder": "", "pharmacotherapeutic_group_human": "Antiseptics and disinfectants;Biguanides and amidines", "therapeutic_indication": "Umbipro is indicated for prophylaxis of omphalitis (infection of the umbilical cord) in newborn infants.", "date_of_opinion": "28/04/2016", "date_of_outcome": "19/12/2019", "first_published_date": "12/07/2019", "last_updated_date": "08/04/2022", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/umbipro" }, { "name_of_medicine": "Hexaxim", "ema_opinion_number": "H-W-2495", "ema_opinion_status": "Withdrawn opinion", "active_substance": "Diphtheria toxoid;Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin;Inactivated Type 1 Poliovirus (Mahoney);Inactivated Type 2 Poliovirus (MEF-1);Inactivated Type 3 Poliovirus (Saukett);hepatitis B surface antigen;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);tetanus toxoid", "international_non_proprietary_name_inn_common_name": "diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)", "therapeutic_area_mesh": "Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria", "atc_code_human": "J07CA09", "latest_procedure_affecting_product_information": "H-W-2495-WS-1792-G", "opinion_holder": "Sanofi Pasteur", "pharmacotherapeutic_group_human": "Bacterial and viral vaccines, combined", "therapeutic_indication": "Hexaxim is indicated for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b.", "date_of_opinion": "21/06/2012", "date_of_outcome": "24/09/2020", "first_published_date": "06/07/2018", "last_updated_date": "", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/hexaxim" }, { "name_of_medicine": "Hemoprostol", "ema_opinion_number": "H-W-2652", "ema_opinion_status": "Withdrawn opinion", "active_substance": "misoprostol", "international_non_proprietary_name_inn_common_name": "misoprostol", "therapeutic_area_mesh": "Postpartum Hemorrhage", "atc_code_human": "G02AD06", "latest_procedure_affecting_product_information": "H-W-2652-IAIN-0003", "opinion_holder": "Linepharma International Limited", "pharmacotherapeutic_group_human": "Other gynecologicals", "therapeutic_indication": "Hemoprostol is indicated in women of childbearing age for treatment of Post Partum Haemorrhage due to uterine atony in situations where intravenous oxytocin is not available.", "date_of_opinion": "23/01/2014", "date_of_outcome": "26/03/2015", "first_published_date": "05/07/2018", "last_updated_date": "", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/hemoprostol" }, { "name_of_medicine": "Tritanrix HB", "ema_opinion_number": "H-W-3838", "ema_opinion_status": "Withdrawn opinion", "active_substance": "Bordetella pertussis (inactivated);Diphtheria toxoid;hepatitis B surface antigen;tetanus toxoid", "international_non_proprietary_name_inn_common_name": "diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)", "therapeutic_area_mesh": "Hepatitis;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria", "atc_code_human": "J07CA05", "latest_procedure_affecting_product_information": "H-C-W-3838", "opinion_holder": "", "pharmacotherapeutic_group_human": "Vaccines", "therapeutic_indication": "Active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards.", "date_of_opinion": "19/12/2013", "date_of_outcome": "19/12/2013", "first_published_date": "05/07/2018", "last_updated_date": "", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/tritanrix-hb" }, { "name_of_medicine": "Globorix", "ema_opinion_number": "H/W/848", "ema_opinion_status": "Withdrawn application", "active_substance": "Diphtheria toxoid;Bordetella pertussis (inactivated);Haemophilus influenzae type b polysaccharide;Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid;Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid;hepatitis B surface antigen;tetanus toxoid", "international_non_proprietary_name_inn_common_name": "diphtheria (D), tetanus (T), pertussis (whole cell) (Pw), hepatitis B (rDNA) (HBV), Haemophilus type b (HIB) and Neisseria meningitidis group A and C (MenAC) conjugate vaccine (adsorbed)", "therapeutic_area_mesh": "Immunization;Hepatitis B;Diphtheria-Tetanus-Pertussis Vaccine;Bordetella pertussis;Haemophilus influenzae type b;Neisseria meningitidis, Serogroup A;Neisseria meningitidis, Serogroup C", "atc_code_human": "J07CA09", "latest_procedure_affecting_product_information": "", "opinion_holder": "", "pharmacotherapeutic_group_human": "Bacterial and viral vaccines, combined", "therapeutic_indication": "Primary immunisation of infants (during the first year of life) and for booster immunisation (during the second year of life) against diphtheria, tetanus, pertussis, hepatitis B, invasive disease caused by Haemophilus influenzae type b and Neisseria meningitidis serogroups A and C.", "date_of_opinion": "", "date_of_outcome": "", "first_published_date": "05/07/2018", "last_updated_date": "", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/globorix" }, { "name_of_medicine": "Lamivudine ViiV", "ema_opinion_number": "H/W/673", "ema_opinion_status": "Withdrawn opinion", "active_substance": "lamivudine", "international_non_proprietary_name_inn_common_name": "lamivudine", "therapeutic_area_mesh": "HIV Infections", "atc_code_human": "J05AF05", "latest_procedure_affecting_product_information": "H-W-673-WS-755", "opinion_holder": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "therapeutic_indication": "Lamivudine is indicated as part of antiretroviral combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children.", "date_of_opinion": "17/11/2005", "date_of_outcome": "17/09/2015", "first_published_date": "05/07/2018", "last_updated_date": "", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/lamivudine-viiv" }, { "name_of_medicine": "Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK)", "ema_opinion_number": "H/W/672", "ema_opinion_status": "Withdrawn opinion", "active_substance": "lamivudine;zidovudine", "international_non_proprietary_name_inn_common_name": "lamivudine;zidovudine", "therapeutic_area_mesh": "HIV Infections", "atc_code_human": "J05AR01", "latest_procedure_affecting_product_information": "H-W-672-WS-0755", "opinion_holder": "", "pharmacotherapeutic_group_human": "Antivirals for systemic use", "therapeutic_indication": "Lamivudine/zidovudine is indicated as part of antiretroviral combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children.", "date_of_opinion": "17/11/2005", "date_of_outcome": "17/09/2015", "first_published_date": "05/07/2018", "last_updated_date": "", "opinion_on_medicines_for_use_outside_eu_url": "https://www.ema.europa.eu/en/opinion-medicine-use-outside-EU/human/lamivudine-zidovudine-viiv-previously-lamivudine-zidovudine-gsk" } ] }