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45 results
Medicine
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Referral: Janus kinase inhibitors (JAKi) (updated)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 30/03/2023 -
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Referral: Amfepramone-containing medicinal products
amfepramone, associated names: Regenon, Tenuate Retard, Amfepramon-Hormosan, Regenon Retard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 10/11/2022, EC decision date: 13/01/2023, Last updated: 20/01/2023 -
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Referral: Synchron
Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 28/11/2022, Last updated: 16/12/2022 -
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Referral: Rubraca
rucaparib, associated names: Rubraca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2022, EC decision date: 21/09/2022, Last updated: 17/10/2022 -
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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: 08/07/2022 -
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Referral: Etifoxine-containing medicinal products
etifoxine, associated names: Stresam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/06/2021, EC decision date: 24/03/2022, Last updated: 21/04/2022 -
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Referral: Ifosfamide solutions
ifosfamide, associated names: Ifosfamide Eg, Ifo-Cell, Ifo-Cell N, Ifo-Cell N 2000, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2021, EC decision date: 21/06/2021, Last updated: 19/07/2021 -
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Referral: Ranitidine-containing medicinal products
ranitidine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/09/2020, EC decision date: 24/11/2020, Last updated: 17/02/2021 -
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Referral: Picato
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020 -
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Referral: Panexcell
atazanavir, atazanavir sulfate, Amoxicillin trihydrate, iron sucrose, amoxicillin, azithromycin dihydrate, carbocisteine, trimethoprim, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/02/2020, EC decision date: 24/09/2020, Last updated: 22/10/2020 -
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Referral: Yondelis
trabectedin, associated names: Yondelis, Article 20 procedures
Status: European Commission final decision, opinion/position date: 24/07/2020, EC decision date: 24/09/2020, Last updated: 09/10/2020 -
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Referral: Fosfomycin-containing medicinal products
fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, associated names: Afastural, Berny Adulti, Danifos Adulti, Fomicyt, Fosfocin, Fosfocina, Fosfocine, Fosfopharm, Fosfuro, Fosmol, Fostrofemge, Gynofostrome, Infectofos, Infeur Adulti, Interfos, Monural, Monuril, Monurol, Rapidnorm, Solufos, Symural, Uridoz, Urifos, Urinex, Urofast, Uromaste, Uroseptic, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/03/2020, EC decision date: 09/06/2020, Last updated: 06/07/2020 -
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Referral: Methocarbamol / paracetamol-containing medicinal products
methocarbamol, paracetamol, associated names: Robaxisal compuesto, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/03/2020, EC decision date: 09/06/2020, Last updated: 17/06/2020 -
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Referral: Xeljanz
tofacitinib, associated names: Xeljanz, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 31/01/2020, Last updated: 06/03/2020 -
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Referral: Lemtrada
alemtuzumab, associated names: Lemtrada, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 16/01/2020, Last updated: 04/02/2020 -
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2019, EC decision date: 09/09/2019, Last updated: 16/09/2019 -
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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: Basiron AC and associated names
benzoyl peroxide, Article 13 referrals
Status: European Commission final decision, opinion/position date: 28/03/2019, EC decision date: 04/07/2019, Last updated: 19/07/2019 -
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Referral: Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction
Omega-3 fatty acid ethyl esters, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 06/06/2019, Last updated: 13/06/2019 -
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Referral: Metamizole containing medicinal products
metamizole, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2018, EC decision date: 20/03/2019, Last updated: 28/03/2019 -
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Referral: Xofigo
radium Ra223 dichloride, associated names: Xofigo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 26/07/2018, EC decision date: 28/09/2018, Last updated: 11/10/2018 -
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Referral: Esmya
ulipristal acetate, associated names: Esmya, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/05/2018, EC decision date: 26/07/2018, Last updated: 08/08/2018 -
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Referral: Zinbryta
associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018 -
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Referral: Valproate and related substances
sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018 -
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Referral: Paracetamol modified-release
paracetamol, associated names: Alvedon, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2017, EC decision date: 19/02/2018, Last updated: 01/03/2018