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99 results
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Summary of opinion: Nexviadyme
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 02/08/2021 -
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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: Pirfenidone AET
pirfenidone, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Filsuvez
birch bark extract, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Kinpeygo
budesonide, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Zokinvy
lonafarnib, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Upstaza
eladocagene exuparvovec, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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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: Xenpozyme
olipudase alfa, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Pepaxti (new)
melphalan flufenamide, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Vyvgart (new)
efgartigimod alfa, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Summary of opinion: Scemblix (new)
asciminib, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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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: Roctavian (new)
Valoctocogene roxaparvovec, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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Opinion/decision on a Paediatric investigation plan (PIP): Zynteglo, betibeglogene autotemcel
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001665-PIP01-14-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 08/06/2021, Last updated: 28/04/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Zejula, Niraparib (tosilate monohydrate)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-002268-PIP02-18-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age appropriate oral liquid formulation
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Gazyvaro, Obinutuzumab
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001207-PIP01-11-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 10/05/2021, Last updated: 17/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): NexoBrid, Concentrate of proteolytic enzymes in bromelain
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-000142-PIP02-09-M11, Route(s) of administration: Cutaneous use, Pharmaceutical form(s): Powder and gel for gel
Decision date: 10/05/2021, Last updated: 16/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Translarna, Ataluren
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000115-PIP01-07-M11, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 10/05/2021, Last updated: 16/02/2022, Compliance check: X -
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 14/04/2021, Last updated: 18/01/2022, Compliance check: X