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183 results
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Summary of opinion: Recarbrio
imipenem, cilastatin, relebactam, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Blincyto
blinatumomab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Xarelto
rivaroxaban, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Symkevi
tezacaftor, ivacaftor, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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Summary of opinion: Dupixent
dupilumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Kyprolis
carfilzomib, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Tremfya
guselkumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Bavencio
avelumab, 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: Tecentriq
atezolizumab, 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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Withdrawn application: Keytruda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Withdrawn application: Zydelig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: Tecentriq
atezolizumab, date of withdrawal: 22/10/2018, Post-authorisation, Last updated: 16/11/2018 -
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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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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