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15 results

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Summary of opinion: Pemazyre

pemigatinib, opinion date: 28/01/2021, Positive, Last updated: 26/02/2021
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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: Sirturo

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

selinexor, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021
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Summary of opinion: Jemperli

dostarlimab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021
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Withdrawn application: Translarna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Withdrawn application: Omontys

date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013
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Withdrawn application: Memantine FGK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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Referral: Lartruvo

olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)

Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020
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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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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization

Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020
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Referral: Zynteglo

betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: Procedure started, Last updated: 12/03/2021
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Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy (new)

Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders (new)

Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021

15 results

Summary of opinion: Pemazyre

Summary of opinion: Retsevmo

Summary of opinion: Sirturo

Summary of opinion: Nexpovio

Summary of opinion: Jemperli

Withdrawn application: Translarna

Withdrawn application: Omontys

Withdrawn application: Memantine FGK

Referral: Lartruvo

Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)

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

Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization

Referral: Zynteglo

Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy (new)

Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders (new)