For help on how to get the results you want, see our search tips.
232 results
Medicine
Shortages Remove Shortages filter
Withdrawn applications Remove Withdrawn applications filter
Referrals Remove Referrals filter
Referral type
Article 13 Remove Article 13 filter
Article 29(4) referrals Remove Article 29(4) referrals filter
Article 31 referrals Remove Article 31 referrals filter
Categories
Human Remove Human filter
-
List item
Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, 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: 19/03/2021 -
List item
Referral: Ifosfamide solutions
ifosfamide, associated names: Ifosfamide Eg, Ifo-Cell, Ifo-Cell N, Ifo-Cell N 2000, Article 31 referrals
Status: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 12/03/2021 -
List item
Referral: Amfepramone-containing medicinal products
amfepramone, associated names: regenon, Regenon Retard, Tenuate, Article 31 referrals
Status: Procedure started, Last updated: 25/02/2021 -
List item
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 -
List item
Referral: Ulipristal acetate 5mg medicinal products
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 -
List item
Referral: Ibuprofen Kabi 400 mg Infusionslösung and associated names
ibuprofen, associated names: Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie, Ibuprofen Fresenius Kabi 400 mg solution pour perfusion, Ibuprofen Kabi, Ibuprofen Kabi 400 mg oldatos infúzió, Ibuprofen Kabi 400 mg soluţie perfuzabilă, Ibuprofen Kabi 400 mg, Ibuprofen Kabi 400 mg raztopina za infundiranje, Ibuprofeno Kabi 400 mg solución para perfusion, Ibuprofen Kabi 400 mg Solution for Infusion, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/07/2020, EC decision date: 15/10/2020, Last updated: 26/10/2020 -
List item
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 -
List item
Referral: Budesonide SUN
budesonide, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 25/06/2020, EC decision date: 19/08/2020, Last updated: 16/09/2020 -
List item
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 -
List item
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 -
List item
Referral: Carbamazepin Tillomed
carbamazepin, associated names: Carbamazepin Tillomed, Carbamazepina Tillomed, Karbamazepin Tillomed, Karbamazepina Tillomed, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 25/06/2020, Last updated: 21/07/2020 -
List item
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 -
List item
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 -
List item
Referral: Cyproterone-containing medicinal products
cyproterone, Article 31 referrals
Status: CMDh final position, opinion/position date: 25/03/2020, Last updated: 20/05/2020 -
List item
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 -
List item
Referral: Flurbiprofen Geiser
flurbiprofen, associated names: Flurbiprofen Sejmet, Mentocaína Spray, Flurbiprofeno Geiser, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 17/10/2019, EC decision date: 16/12/2019, Last updated: 20/01/2020 -
List item
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 -
List item
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 -
List item
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 -
List item
Referral: Syner-Kinase and associated names
urokinase, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 28/02/2019, EC decision date: 16/05/2019, Last updated: 03/06/2019 -
List item
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 -
List item
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 -
List item
Referral: Diotop capsules
diclofenac, omeprazole, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 31/01/2019, Last updated: 15/02/2019 -
List item
Referral: Diclofenac Sodium Spray Gel 4%
diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019 -
List item
Referral: Perlinring and associated names
etonogestrel, ethinylestradiol, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 18/12/2018, Last updated: 21/01/2019