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209 results

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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: Kyprolis

carfilzomib, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020
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Summary of opinion: Retsevmo

selpercatinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020
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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: Enhertu

trastuzumab deruxtecan, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020
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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: Dupixent

dupilumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
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Withdrawn application: Keytruda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Withdrawn application: Zydelig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Withdrawn application: Keytruda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Withdrawn application: Translarna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Withdrawn application: Rienso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: Omontys

date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013
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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: Memantine FGK

memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013
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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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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy

Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa

Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020

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209 results

Summary of opinion: Xarelto

Summary of opinion: Kyprolis

Summary of opinion: Retsevmo

Summary of opinion: Bavencio

Summary of opinion: Doptelet

Summary of opinion: Spravato

Summary of opinion: Enhertu

Summary of opinion: Keytruda

Summary of opinion: Rinvoq

Summary of opinion: Dupixent

Withdrawn application: Keytruda

Withdrawn application: Zydelig

Withdrawn application: Keytruda

Withdrawn application: Translarna

Withdrawn application: Rienso

Withdrawn application: Omontys

Withdrawn application: Tysabri

Withdrawn application: Memantine FGK

Withdrawn application: Revlimid

Withdrawn application: Evoltra

Withdrawn application: Glivec

Withdrawn application: Axumin

Withdrawn application: Tecentriq

Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy

Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa