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197 results
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Summary of opinion: Trelegy Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Elebrato Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Temybric Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Senshio
ospemifene, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
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Summary of opinion: Amversio
betaine anhydrous, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Yescarta
axicabtagene ciloleucel, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Retsevmo
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Ertapenem SUN
ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Sugammadex Fresenius Kabi
sugammadex, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Accord
sitagliptin, metformin hydrochloride, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Ganirelix Gedeon Richter
ganirelix, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Rinvoq
upadacitinib, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Nexpovio
selinexor, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Rinvoq (new)
upadacitinib, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Nuvaxovid (new)
COVID-19 Vaccine (recombinant, adjuvanted), opinion date: 23/06/2022, Positive, Last updated: 23/06/2022 -
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Summary of opinion: Crysvita (new)
burosumab, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Enhertu (new)
trastuzumab deruxtecan, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Roctavian (new)
Valoctocogene roxaparvovec, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Kinpeygo
budesonide, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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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 -
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Opinion/decision on a Paediatric investigation plan (PIP): Kevzara, sarilumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001045-PIP01-10-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 17/03/2021, Last updated: 06/05/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-002077-PIP01-16-M04, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 17/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto, Venetoclax
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Oncology
PIP number: EMEA-002018-PIP02-16-M04, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Tablet for oral suspension
Decision date: 09/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology; Uro-nephrology
PIP number: EMEA-001943-PIP01-16-M06, Route(s) of administration: Intravenous use, Subcutaneous use, Pharmaceutical form(s): Concentrate for solution for infusion, Solution for injection
Decision date: 17/06/2021, Last updated: 28/04/2022, Compliance check: X