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434 results

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Summary of opinion: Elzonris

tagraxofusp, opinion date: 23/07/2020, Positive, Last updated: 13/11/2020
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Summary of opinion: Tecartus

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: Kyprolis

carfilzomib, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020
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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: Lenalidomide Krka d.d. Novo mesto

lenalidomide, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020
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Summary of opinion: Lenalidomide KrKa

lenalidomide, 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: Sunitinib Accord

sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020
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Summary of opinion: Lumoxiti

moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020
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Summary of opinion: Inrebic

fedratinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020
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Summary of opinion: Lenalidomide Krka d.d.

lenalidomide, 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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Summary of opinion: Dupixent

dupilumab, opinion date: 15/10/2020, Positive, Last updated: 16/10/2020
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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): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity

Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020
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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): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter

Active substance: Letermovir, Last updated: 11/09/2020
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion

Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020
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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): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)

Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet

Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020

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434 results

Summary of opinion: Elzonris

Summary of opinion: Tecartus

Summary of opinion: Xarelto

Summary of opinion: Kyprolis

Summary of opinion: Bavencio

Summary of opinion: Lenalidomide Krka d.d. Novo mesto

Summary of opinion: Lenalidomide KrKa

Summary of opinion: Doptelet

Summary of opinion: Spravato

Summary of opinion: Sunitinib Accord

Summary of opinion: Lumoxiti

Summary of opinion: Inrebic

Summary of opinion: Lenalidomide Krka d.d.

Summary of opinion: Tecentriq

Summary of opinion: Keytruda

Summary of opinion: Rinvoq

Summary of opinion: Dupixent

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

Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity

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): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter

Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion

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

Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)

Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet