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Opinion on medicine for use outside EU: Pyramax (updated)
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: Fexinidazole Winthrop (updated)
fexinidazole, Trypanosomiasis, African, ATC code: P01CA03 Opinion number: H-W-2320, Positive opinion Opinion date: 15/11/2018, Last updated: 14/06/2022 -
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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chlorhexidine digluconate, Soft Tissue Infections, ATC code: D08AC02 Opinion number: H-W-3799, Withdrawn opinion Opinion date: 28/04/2016, Last updated: 08/04/2022 -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: 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: 06/01/2022 -
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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b; Neisseria meningitidis, Serogroup A; Neisseria meningitidis, Serogroup C, ATC code: J07CA09 Opinion number: H/W/848, Withdrawn application , Last updated: 05/07/2018 -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: 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lamivudine, zidovudine, HIV Infections, ATC code: J05AR01 Opinion number: H/W/672, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -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 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lamivudine, HIV Infections, ATC code: J05AF05 Opinion number: H/W/673, Withdrawn opinion Opinion date: 17/11/2005, Last updated: 05/07/2018 -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: 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: Mosquirix
RTS,S [Portion of P. falciparum circumsporozoite protein fused with hepatitis B surface antigen (RTS), and combined with hepatitis B surface antigen (S)], , ATC code: J07 Opinion number: H-W-2300, Positive opinion Opinion date: 23/07/2015, Last updated: 01/10/2015 -
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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: Aluvia
lopinavir, ritonavir, HIV Infections, ATC code: J05AR10 Opinion number: H-W-764, Positive opinion Opinion date: 21/09/2006, Last updated: 20/08/2020 -
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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: Insulatard
Insulin human (RDNA), Diabetes Mellitus, ATC code: A10AC01 Opinion number: H-W-005780, Positive opinion Opinion date: 22/04/2022, Last updated: 22/04/2022 -
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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: 22/04/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Isavuconazonium sulfate (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001301-PIP01-12, Route(s) of administration: Intravenous use, Oral use, Pharmaceutical form(s): Powder for solution for infusion, Capsule, hard
Decision date: 14/06/2013, Last updated: 29/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tislelizumab (updated)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002480-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 17/04/2019, Last updated: 27/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human beta-glucuronidase (rhGUS, UX003) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001540-PIP01-13-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 28/07/2016, Last updated: 16/06/2022, Compliance check: V, 11/12/2019 -
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Opinion/decision on a Paediatric investigation plan (PIP): Humanized anti-CD19, Fc engineered, monoclonal antibody (XmAb5871) (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002414-PIP01-18, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 16/08/2019, Last updated: 16/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Tabalumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000802-PIP02-11-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 27/10/2014, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Expanded human autologous mesenchymal adult stem cells extracted from adipose tissue (CX-401) (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000635-PIP01-09, Route(s) of administration: Intralesional use, Pharmaceutical form(s): Suspension for injection
Decision date: 19/02/2010, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Insulin peglispro (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001097-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/07/2014, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human heparan-N-sulfatase (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001634-PIP01-14, Route(s) of administration: Intrathecal use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 30/01/2015, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Methyl aminolevulinate hydrochloride (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Dermatology
PIP number: EMEA-000698-PIP02-10-M01, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Cream
Decision date: 06/05/2014, Last updated: 14/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): arimoclomol citrate (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001748-PIP03-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 28/01/2021, Last updated: 10/06/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Dupixent, dupilumab (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-001501-PIP04-19-M01, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 08/09/2021, Last updated: 10/06/2022, Compliance check: X