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41 results
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Withdrawn application: Kyndrisa
date of withdrawal: 31/05/2016, Initial authorisation, Last updated: 06/09/2016 -
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Withdrawn application: Ambrisentan Zentiva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Withdrawn application: Erlotinib Accord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Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013 -
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Withdrawn application: Pioglitazone ratiopharm GmbH
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012 -
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Withdrawn application: Pioglitazone ratio
pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012 -
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Withdrawn application: Docetaxel Mylan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Withdrawn application: Pioglitazone Teva Generics
pioglitazone, date of withdrawal: 26/01/2012, Initial authorisation, Last updated: 03/07/2012 -
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Withdrawn application: Aripiprazole Mylan
aripiprazole, date of withdrawal: 07/05/2015, Initial authorisation, Last updated: 20/07/2015 -
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Withdrawn application: Duloxetine Sandoz
duloxetine, date of withdrawal: 08/04/2015, Initial authorisation, Last updated: 24/04/2015 -
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Withdrawn application: Topotecan SUN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Withdrawn application: Rotigotine Mylan
rotigotine, date of withdrawal: 22/12/2017, Initial authorisation, Last updated: 11/07/2018 -
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Withdrawn application: Ertapenem Hospira
ertapenem, date of withdrawal: 13/09/2016, Initial authorisation, Last updated: 06/12/2016 -
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Withdrawn application: Tigecycline Accord
tigecycline, date of withdrawal: 12/09/2017, Initial authorisation, Last updated: 10/10/2017 -
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Withdrawn application: Doxorubicin Hydrochloride Tillomed
doxorubicin, date of withdrawal: 02/03/2020, Initial authorisation, Last updated: 27/07/2020 -
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Withdrawn application: Docetaxel SUN
docetaxel, date of withdrawal: 06/06/2016, Initial authorisation, Last updated: 29/09/2016 -
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Withdrawn application: Dimherity
dimethyl fumarate, date of withdrawal: 22/02/2022, Initial authorisation, Last updated: 03/11/2022 -
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Withdrawn application: Raltegravir Viatris
raltegravir potassium, date of withdrawal: 22/02/2023, Initial authorisation, Last updated: 21/04/2023 -
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Withdrawn application: Pemetrexed ditromethamine Hospira
pemetrexed, date of withdrawal: 22/09/2016, Initial authorisation, Last updated: 21/12/2016 -
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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: 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: 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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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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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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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