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146 results

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Withdrawn application: Epostim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Withdrawn application: Topotecan SUN

topotecan, date of withdrawal: 03/01/2011, Initial authorisation, Last updated: 23/02/2011
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Withdrawn application: Repaglinide Sun

repaglinide, date of withdrawal: 25/03/2010, Initial authorisation, Last updated: 15/05/2010
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Withdrawn application: Docetaxel Mylan

docetaxel, date of withdrawal: 08/03/2010, Initial authorisation, Last updated: 26/03/2010
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Withdrawn application: Evoltra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Withdrawn application: Ambrisentan Zentiva

ambrisentan, date of withdrawal: 29/04/2019, Initial authorisation, Last updated: 29/05/2019
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Withdrawn application: Erlotinib Accord

erlotinib, date of withdrawal: 28/05/2020, Initial authorisation, Last updated: 29/05/2020
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Withdrawn application: Teriparatide Cinnagen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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Withdrawn application: Iclusig

ponatinib, date of withdrawal: 11/08/2023, Post-authorisation, Last updated: 14/09/2023
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Withdrawn application: Sugammadex Lorien

date of withdrawal: 28/09/2023, Initial authorisation, Last updated: 13/10/2023
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Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)

Active substance: tocilizumab, Emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab, DHPC type: Quality defect, Last updated: 17/08/2023
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Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient

associated names: Vectra 3D, Melovem, Article 82
Status: European Commission final decision, opinion/position date: 08/12/2022, EC decision date: 28/03/2023, Last updated: 14/04/2023
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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: 08/07/2022
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products

capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020
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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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Referral: Factor VIII

associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017
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Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)

daclatasvir, dasabuvir, sofosbuvir, ledipasvir, simeprevir, ombitasvir, paritaprevir, ritonavir, associated names: Sovaldi, Olysio, Viekirax, Harvoni, Exviera, Daklinza, Article 20 procedures
Status: European Commission final decision, opinion/position date: 15/12/2016, EC decision date: 23/02/2017, Last updated: 09/03/2017
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Referral: Iclusig

ponatinib, associated names: Iclusig, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 15/01/2015, Last updated: 02/03/2015
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Referral: Renin-angiotensin-system (RAS)-acting agents

captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014
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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): 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): Myalepta (metreleptin): inconsistencies in the package leaflet

Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan

Active substance: Metreleptin, DHPC type: Medicine shortage, Last updated: 14/03/2023
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Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)

Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022

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146 results

Withdrawn application: Epostim

Withdrawn application: Topotecan SUN

Withdrawn application: Repaglinide Sun

Withdrawn application: Docetaxel Mylan

Withdrawn application: Evoltra

Withdrawn application: Ambrisentan Zentiva

Withdrawn application: Erlotinib Accord

Withdrawn application: Teriparatide Cinnagen

Withdrawn application: Iclusig

Withdrawn application: Sugammadex Lorien

Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)

Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient

Referral: Zynteglo

Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products

Referral: Lartruvo

Referral: Factor VIII

Referral: Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)

Referral: Iclusig

Referral: Renin-angiotensin-system (RAS)-acting agents

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): 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): Myalepta (metreleptin): inconsistencies in the package leaflet

Direct healthcare professional communication (DHPC): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan

Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)