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32 results
Medicine
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Summary of opinion: Sondelbay
teriparatide, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
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Summary of opinion: Carvykti
ciltacabtagene autoleucel, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
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Summary of opinion: Polivy
polatuzumab vedotin, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
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Summary of opinion: Lunsumio
mosunetuzumab, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Retsevmo
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Kinpeygo (new)
budesonide, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Nexpovio (new)
selinexor, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Tuznue (new)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 20/05/2022 -
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Summary of opinion: Hervelous (new)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 20/05/2022 -
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Withdrawn application: Translarna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Withdrawn application: Omontys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Withdrawn application: Memantine FGK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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Withdrawn application: Epostim
epoetin alfa, date of withdrawal: 15/03/2011, Initial authorisation, Last updated: 19/04/2011 -
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Withdrawn application: Teriparatide Cinnagen
teriparatide, date of withdrawal: 09/09/2021, Initial authorisation, Last updated: 17/09/2021 -
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Referral: Rubraca (updated)
rucaparib, associated names: Rubraca, Article 20 procedures
Status: Procedure started, Last updated: 06/05/2022 -
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 11/10/2021 -
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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) 140 mg powder for concentrate for solution for injection: Important information on plastic vial flip-off cap colour
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
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Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022 (new)
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 29/04/2022 -
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Direct healthcare professional communication (DHPC): Infliximab (Remicade, Flixabi, Inflectra, Remsima and Zessly): Use of live vaccines in infants exposed in utero or during breastfeeding
Active substance: infliximab, DHPC type: New contraindication, Last updated: 07/03/2022 -
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Direct healthcare professional communication (DHPC): COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk of myocarditis and pericarditis
Active substance: Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), DHPC type: Safety signal, Last updated: 19/07/2021 -
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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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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021