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194 results

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Medicine Paediatric investigation plans Remove Paediatric investigation plans filter Summaries of opinion Remove Summaries of opinion filter Withdrawn applications Remove Withdrawn applications filter

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List item

Summary of opinion: Spravato

esketamine, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020
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Summary of opinion: Keytruda

pembrolizumab, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021
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Summary of opinion: Sirturo

bedaquiline, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021
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Summary of opinion: Tysabri

natalizumab, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021
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Summary of opinion: Vaxchora

Cholera vaccine (recombinant, live, oral), opinion date: 28/01/2021, Positive, Last updated: 01/02/2021
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Summary of opinion: Evrysdi

risdiplam, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021
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Summary of opinion: Cabometyx

cabozantinib, opinion date: 25/02/2021, Positive, 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: Quofenix

delafloxacin, opinion date: 25/02/2021, Positive, 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: Sarclisa

isatuximab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021
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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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Withdrawn application: Keytruda

pembrolizumab, date of withdrawal: 10/12/2019, Post-authorisation, Last updated: 19/03/2020
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Withdrawn application: Zydelig

idelalisib, date of withdrawal: 30/01/2018, Post-authorisation, Last updated: 23/02/2018
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Withdrawn application: Keytruda

pembrolizumab, date of withdrawal: 11/10/2017, Post-authorisation, Last updated: 28/11/2017
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Withdrawn application: Translarna

ataluren, date of withdrawal: 06/03/2017, Post-authorisation, Last updated: 24/03/2017
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Withdrawn application: Rienso

ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015
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Withdrawn application: Tysabri

natalizumab, date of withdrawal: 14/05/2013, Post-authorisation, Last updated: 31/05/2013
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Withdrawn application: Revlimid

lenalidomide, date of withdrawal: 20/06/2012, Post-authorisation, Last updated: 06/07/2012
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Withdrawn application: Evoltra

clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008
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Withdrawn application: Glivec

imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006
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Withdrawn application: Axumin

fluciclovine (18F), date of withdrawal: 11/02/2020, Post-authorisation, Last updated: 28/02/2020
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Withdrawn application: Tecentriq

atezolizumab, date of withdrawal: 22/10/2018, Post-authorisation, Last updated: 16/11/2018
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Withdrawn application: Tecentriq

atezolizumab, date of withdrawal: 08/01/2021, Post-authorisation, Last updated: 01/02/2021
List item

Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (updated)

Decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002153-PIP01-17-M01, Route(s) of administration: Inhalation use, Pharmaceutical form(s): Inhalation powder, pre-dispensed
Decision date: 14/02/2020, Last updated: 19/02/2021, Compliance check: X

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194 results

Summary of opinion: Spravato

Summary of opinion: Keytruda

Summary of opinion: Sirturo

Summary of opinion: Tysabri

Summary of opinion: Vaxchora

Summary of opinion: Evrysdi

Summary of opinion: Cabometyx

Summary of opinion: Temybric Ellipta

Summary of opinion: Quofenix

Summary of opinion: Elebrato Ellipta

Summary of opinion: Sarclisa

Summary of opinion: Trelegy Ellipta

Withdrawn application: Keytruda

Withdrawn application: Zydelig

Withdrawn application: Keytruda

Withdrawn application: Translarna

Withdrawn application: Rienso

Withdrawn application: Tysabri

Withdrawn application: Revlimid

Withdrawn application: Evoltra

Withdrawn application: Glivec

Withdrawn application: Axumin

Withdrawn application: Tecentriq

Withdrawn application: Tecentriq

Opinion/decision on a Paediatric investigation plan (PIP): Trelegy Ellipta, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (updated)