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2541 results
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Opinion on medicine for use outside EU: Fexinidazole Winthrop
fexinidazole, Trypanosomiasis, African, ATC code: P01CA03 Opinion number: H-W-2320, Positive opinion Opinion date: 15/11/2018, Last updated: 22/12/2022 -
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Opinion on medicine for use outside EU: Aluvia
lopinavir, ritonavir, HIV Infections, ATC code: J05AR10 Opinion number: H-W-764, Positive opinion Opinion date: 21/09/2006, Last updated: 15/12/2022 -
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Opinion on medicine for use outside EU: Dengue Tetravalent Vaccine (Live, Attenuated) Takeda
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, Dengue, ATC code: J07BX04 Opinion number: EMEA/H/W/005362, Positive opinion Opinion date: 13/10/2022, Last updated: 14/12/2022 -
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Opinion on medicine for use outside EU: Dapivirine Vaginal Ring 25 mg
dapivirine, Anti-HIV Agents, ATC code: G01AX17 Opinion number: H-W-2168, Positive opinion Opinion date: 23/07/2020, Last updated: 15/09/2022 -
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Opinion on medicine for use outside EU: Mosquirix
RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)], Malaria, ATC code: J07 Opinion number: H-W-2300, Positive opinion Opinion date: 23/07/2015, Last updated: 01/08/2022 -
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Opinion on medicine for use outside EU: Insulatard
Insulin human (RDNA), Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005780, Positive opinion Opinion date: 22/04/2022, Last updated: 28/07/2022 -
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Opinion on medicine for use outside EU: Actrapid
insulin human, Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005779, Positive opinion Opinion date: 22/04/2022, Last updated: 22/07/2022 -
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Opinion on medicine for use outside EU: Pyramax
artesunate, pyronaridine, Malaria, ATC code: P01BF06 Opinion number: H-W-2319, Positive opinion Opinion date: 16/02/2012, Last updated: 16/06/2022 -
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Opinion on medicine for use outside EU: Umbipro
chlorhexidine digluconate, Soft Tissue Infections, ATC code: D08AC02 Opinion number: H-W-3799, Withdrawn opinion Opinion date: 28/04/2016, Last updated: 08/04/2022 -
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Opinion on medicine for use outside EU: Globorix
Diphtheria toxoid, Tetanus 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, Immunization; Hepatitis B; Diphtheria-Tetanus-Pertussis Vaccine; Bordetella pertussis; Haemophilus influenzae type b; Neisseria meningitidis, Serogroup A; Neisseria meningitidis, Serogroup C, ATC code: J07CA09 Opinion number: H/W/848, Withdrawn application , Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Tritanrix HB
Bordetella pertussis (inactivated), Diphtheria toxoid, hepatitis B surface antigen, tetanus toxoid, Hepatitis; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, ATC code: J07CA05 Opinion number: H-W-3838, Withdrawn opinion Opinion date: 19/12/2013, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Hemoprostol
misoprostol, Postpartum Hemorrhage, ATC code: G02AD06 Opinion number: H-W-2652, Withdrawn opinion Opinion date: 23/01/2014, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Hexaxim
Diphtheria toxoid, Tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, Inactivated poliovirus: type 1 (Mahoney strain), Inactivated poliovirus: type 2 (MEF-1 strain), Inactivated poliovirus: type 3 (Saukett strain), hepatitis B surface antigen, Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate), Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria, ATC code: J07CA09 Opinion number: H-W-2495, Withdrawn opinion Opinion date: 21/06/2012, Last updated: 06/07/2018 -
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Opinion on medicine for use outside EU: Lamivudine ViiV
lamivudine, HIV Infections, ATC code: J05AF05 Opinion number: H/W/673, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -
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Opinion on medicine for use outside EU: Lamivudine / Zidovudine ViiV (previously Lamivudine / Zidovudine GSK)
lamivudine, zidovudine, HIV Infections, ATC code: J05AR01 Opinion number: H/W/672, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -
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Opinion/decision on a Paediatric investigation plan (PIP): Verquvo, Vericiguat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001636-PIP01-14-M03, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Age-appropriate oral liquid dosage form
Decision date: 28/10/2022, Last updated: 30/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Xofluza, Baloxavir marboxil (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-002440-PIP01-18-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Granules for oral suspension
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Vitrakvi, Larotrectinib (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001971-PIP02-16-M04, Route(s) of administration: Gastric use, Oral use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tabelecleucel (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Oncology
PIP number: EMEA-002025-PIP04-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for injection
Decision date: 21/12/2020, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Cyclophosphamide (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002644-PIP01-19-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Powder for oral solution
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Soticlestat (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-002572-PIP02-19-M01, Route(s) of administration: Oral use, Gastric use, Intestinal use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral formulation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H1N1), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A (H3N2), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Yamagata lineage), Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B (Victoria lineage) [QIVc] (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002068-PIP01-16-M04, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Nuvaxovid, Severe acute respiratory syndrome coronavirus 2 recombinant spike protein nanoparticle vaccine/ matrix-M1 adjuvant (NVX-CoV2373) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Vaccines
PIP number: EMEA-002941-PIP01-20-M01, Route(s) of administration: Intramuscular use, Pharmaceutical form(s): Suspension for injection
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP03-20-M01, Pharmaceutical form(s): Solution for organ preservation
Decision date: 03/12/2021, Last updated: 29/03/2023, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology
PIP number: EMEA-001501-PIP08-20, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 28/03/2023, Compliance check: X