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421 results

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List item

Withdrawn application: Memantine FGK

memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013
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Withdrawn application: Revlimid

lenalidomide, date of withdrawal: 20/06/2012, Post-authorisation, Last updated: 06/07/2012
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Withdrawn application: Pioglitazone Teva Generics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Withdrawn application: Pioglitazone ratiopharm GmbH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Withdrawn application: Pioglitazone ratio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Withdrawn application: Pioglitazone ratiopharm

pioglitazone, date of withdrawal: 03/02/2012, Initial authorisation, Last updated: 30/04/2012
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Withdrawn application: Desloratadine Krka

desloratadine, date of withdrawal: 14/10/2011, Initial authorisation, Last updated: 17/11/2011
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Withdrawn application: Ibandronic Acid Hexal

ibandronic acid, date of withdrawal: 21/07/2011, Initial authorisation, Last updated: 22/08/2011
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Withdrawn application: Epostim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Withdrawn application: Topotecan SUN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Withdrawn application: Repaglinide Sun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Withdrawn application: Docetaxel Mylan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Withdrawn application: Evoltra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: Glivec

imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006
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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: Tookad

padeliporfin, date of withdrawal: 14/12/2021, Post-authorisation, Last updated: 28/01/2022
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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): Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage (updated)

Active substance: semaglutide, liraglutide, DHPC type: Medicine shortage, Last updated: 01/12/2023
List item

Referral: Ocaliva (updated)

obeticholic acid, associated names: Ocaliva, Article 20 procedures
Status: Procedure started, Last updated: 10/11/2023
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Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes

Active substance: Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), DHPC type: Quality defect, Last updated: 20/09/2023
List item

Referral: Adakveo

crizanlizumab, associated names: Adakveo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/05/2023, EC decision date: 03/08/2023, Last updated: 29/08/2023
List item

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: Quinolone- and fluoroquinolone-containing medicinal products

nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 08/06/2023

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421 results

Withdrawn application: Memantine FGK

Withdrawn application: Revlimid

Withdrawn application: Pioglitazone Teva Generics

Withdrawn application: Pioglitazone ratiopharm GmbH

Withdrawn application: Pioglitazone ratio

Withdrawn application: Pioglitazone ratiopharm

Withdrawn application: Desloratadine Krka

Withdrawn application: Ibandronic Acid Hexal

Withdrawn application: Epostim

Withdrawn application: Topotecan SUN

Withdrawn application: Repaglinide Sun

Withdrawn application: Docetaxel Mylan

Withdrawn application: Evoltra

Withdrawn application: Glivec

Withdrawn application: Ambrisentan Zentiva

Withdrawn application: Erlotinib Accord

Withdrawn application: Teriparatide Cinnagen

Withdrawn application: Tookad

Withdrawn application: Sugammadex Lorien

Direct healthcare professional communication (DHPC): Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage (updated)

Referral: Ocaliva (updated)

Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes

Referral: Adakveo

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: Quinolone- and fluoroquinolone-containing medicinal products