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245 results
Medicine
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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group (updated)
valsartan, candesartan, irbesartan, losartan and 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: 02/03/2021 -
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Referral: Varilrix (updated)
live attenuated varicella virus (OKA strain), Article 30 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 25/02/2021, Last updated: 26/02/2021 -
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Referral: Amfepramone-containing medicinal products (updated)
amfepramone, associated names: regenon, Regenon Retard, Tenuate, Article 31 referrals
Status: Procedure started, Last updated: 25/02/2021 -
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Referral: Ranitidine-containing medicinal products (updated)
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: Ulipristal acetate 5mg medicinal products (updated)
Ulipristal acetate, associated names: Esmya, Ulipristal Acetate Gedeon Richter, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 11/01/2021, Last updated: 03/02/2021 -
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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: Under evaluation, Last updated: 03/11/2020 -
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Referral: Panexcell
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: Leuprorelin-containing depot medicinal products
leuprorelin, associated names: Daronda, Depo-Eligard, Eligard, Eligard Depot, Eligard Mensua, Eligard Semestral, Eligard Trimestral, Elityran 1 Month Depot (Dps), Elityran 3 Month Depot (Dps), Enanton Depot Dual, Enanton Depot Set, Enantone, Enantone L.P, Enantone Lp, Enantone Monats-Depot, Ginecrin Depot, Klebrocid 3-Monats-Depot, Klebrocid Depot Zweikammerspritze, Leptoprol, Lerin, Leugon, Leuprex 3, Leuprol, Leuprolin Ratiopharm, Leuprone 1-Monatsdepot, Leuprone 3-Monatsdepot, Leuprorelin 1-Month Depot Gp-Pharm, Leuprorelin Hexal, Leuprorelin Sandoz, Leuprorelina Gp-Pharm, Leupro-Sandoz 1-Monats-Depot, Leupro-Sandoz 3-Monats-Depot, Leuprorelina Trimestral Sandoz, Leuprostin, Leuproreline Sandoz, Lucrin, Lucrin Depot, Lucrin Pds Depot, Lucrin Pds Depot 1 Maand, Lucrin Pds Depot 3 Maanden, Lucrin Pds Depot 6 Maanden, Lupron Depo, Lutrate 1 Month Depot, Lutrate 3 Month Depot, Lutrate Depo, Lutrate Depot, Lutrate Depot Trimestral, Politrate, Politrate Politrate Depot, Procren Depot, Procren Depot Pds, Procrin Mensual, Procrin Semestral, Procrin Trimestral, Prostap 3 Dcs, Prostap 6 Dcs, Prostap Sr Dcs, Prostaplant, Sixantone, Trenantone, Trenantone-Gyn, Zeulide, Елигард, Лутрат Депо, Article 31 referrals
Status: CMDh final position, opinion/position date: 24/06/2020, Last updated: 31/07/2020 -
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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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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: Cyproterone-containing medicinal products
cyproterone, Article 31 referrals
Status: CMDh final position, opinion/position date: 25/03/2020, Last updated: 20/05/2020 -
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Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use
estradiol, associated names: Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff, Montadiol, Article 31 referrals
Status: CMDh final position, opinion/position date: 30/01/2020, Last updated: 08/04/2020 -
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Referral: Methotrexate containing medicinal products
methotrexate, associated names: Nordimet, Jylamvo, Ledertrexate, Maxtrex, Metex, Metoject, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/08/2019, EC decision date: 21/10/2019, Last updated: 31/10/2019 -
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Referral: Bacterial lysates-containing medicinal products indicated for respiratory conditions
Haemophilus influenzae / Klebsiella pneumoniae / Moraxella catarrhalis / Staphylococcus aureus / Streptococcus mitis / S. pneumoniae / S. pyogenes, H. influenzae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes, S. pneumoniae / S. agalactiae / Staphylococcus aureus / H. influenzae, H. influenzae / K. ozaenae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes / S. viridans, H. influenzae / membrane fraction of K. pneumoniae / ribosomal fractions of K. pneumoniae / S. pneumoniae / S. pyogenes, Escherichia coli / K. pneumoniae / S. aureus / S. epidermidis / S. salivarius / S. pneumoniae / S. pyogenes / H. influenzae / Corynebacterium pseudodiphtheriticum / M. catarrhalis, 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: Septanest and associated names
articaine (hydrochloride) / adrenaline (tartrate), Article 30 referrals
Status: European Commission final decision, opinion/position date: 28/06/2018, EC decision date: 28/03/2019, Last updated: 19/06/2019 -
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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: 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: Scandonest and associated names
mepivacaine, associated names: Biocaine, Scandicaine, Article 30 referrals
Status: European Commission final decision, opinion/position date: 31/05/2018, EC decision date: 02/08/2018, Last updated: 07/08/2018 -
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Referral: Retinoid-containing medicinal products
acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tretinoin, tazarotene, associated names: Targretin, Panretin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/03/2018, EC decision date: 21/06/2018, Last updated: 02/07/2018 -
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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: Flupirtine-containing medicinal products
flupirtine, Article 31 referrals
Status: CMDh final position, opinion/position date: 21/03/2018, Last updated: 04/05/2018 -
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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 -
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Referral: Hydroxyethyl starch solutions for infusion
hydroxyethyl starch, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2013, EC decision date: 19/12/2013, Last updated: 12/01/2018