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2105 results
Medicine
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Summary of opinion: Rukobia
fostemsavir, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Plavix
clopidogrel, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Iscover
clopidogrel, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Heplisav B
hepatitis B surface antigen, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Doptelet
avatrombopag, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Spravato
esketamine, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lumoxiti
moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Kixelle
insulin aspart, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Yuflyma
adalimumab, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Inrebic
fedratinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lenalidomide Krka d.d.
lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Tukysa
tucatinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Keytruda
pembrolizumab, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Rinvoq
upadacitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Trimbow
beclometasone, formoterol, glycopyrronium bromide, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: COVID-19 Vaccine Moderna
COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 06/01/2021, Positive, Last updated: 06/01/2021 -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric anti-disialoganglioside (GD2) monoclonal antibody (ch14.18/CHO) (APN311) (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-001314-PIP01-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion, Concentrate for solution for infusion, Powder and solvent for solution for injection, Powder for solution for infusion
Decision date: 07/04/2014, Last updated: 12/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Doptelet, avatrombopag maleate (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001136-PIP01-11-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Powder for oral suspension
Decision date: 22/11/2019, Last updated: 12/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Allergen extracts of Dermatophagoides farinae and Dermatophagoides pteronyssinus (each 50%) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000860-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Dactylis glomarata (16%), Lolium perenne (16%), Phleum pratense (16%), Poa pratensis (16%), Anthoxhantum odoratum (16 %) and Secale cereale (20%) (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000857-PIP01-10-M01, Route(s) of administration: Sublingual use, Pharmaceutical form(s): Oromucosal solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Pollen from Betula pendula (updated)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000853-PIP01-10-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 27/11/2015, Last updated: 05/01/2021, Compliance check: X