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Referral: Zinbryta
daclizumab, 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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Summary of opinion: Onbevzi
bevacizumab, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Summary of opinion: Xarelto
rivaroxaban, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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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: SGLT2 inhibitors
canagliflozin, dapagliflozin,empagliflozin, associated names: Edistride, Ebymect, Xigduo, Vokanamet, Synjardy, Jardiance, Invokana, Forxiga, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 18/05/2016 -
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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: 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: Kixelle
insulin aspart, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Yuflyma
adalimumab, 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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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: 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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Summary of opinion: Rinvoq
upadacitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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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: 19/03/2019 -
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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: Tysabri
natalizumab, associated names: Tysabri, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 25/04/2016, Last updated: 12/05/2016 -
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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: SGLT2 inhibitors (previously canagliflozin)
canagliflozin, empagliflozin, dapagliflozin, canagliflozin / metformin, empagliflozin / metformin, dapagliflozin / metformin, associated names: Xigduo, Ebymect, Edistride, Synjardy, Forxiga, Jardiance, Vokanamet, Invokana, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 04/05/2017, Last updated: 08/05/2017 -
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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: Zinbryta
daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, Last updated: 12/01/2018