For help on how to get the results you want, see our search tips.
74 results
Medicine
Shortages Remove Shortages filter
Summaries of opinion Remove Summaries of opinion filter
Referrals Remove Referrals filter
Referral type
Article 31 referrals Remove Article 31 referrals filter
Article 5(11) referrals (prior to January 2010) Remove Article 5(11) referrals (prior to January 2010) filter
Article 107 procedures (prior to July 2012) Remove Article 107 procedures (prior to July 2012) filter
Referral safety status
Yes Remove Yes filter
-
List item
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 -
List item
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 -
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: 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: 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: 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: 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: 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: 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 -
List item
Referral: Dienogest/ethinylestradiol-containing medicinal products indicated in acne
dienogest / ethinylestradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/01/2017, EC decision date: 22/03/2017, Last updated: 24/03/2017 -
List item
Referral: Linoladiol N and Linoladiol HN
estradiol, Article 31 referrals
Status: European Commission final decision, opinion/position date: 25/04/2014, EC decision date: 19/08/2014, Last updated: 11/09/2014 -
List item
Referral: Monovalent and multivalent measles, mumps, rubella and / or varicella vaccines
Monovalent and multivalent measles, mumps, rubella and varicella vaccines (live), associated names: Amunovax, Priorix, Priorix Tetra, Provarivax, R.O.R. Vax, Rouvax, Trivivac, Varilrix, Varivax, Article 31 referrals
Status: European Commission final decision, opinion/position date: 13/12/2012, EC decision date: 27/06/2013, Last updated: 12/03/2014 -
List item
Referral: Baxter dialysis solutions
Baxter dialysis solutions, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/10/2011, EC decision date: 16/12/2011, Last updated: 20/11/2013 -
List item
Referral: Octagam
human normal immunoglobulin, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 04/10/2010, Last updated: 18/11/2013 -
List item
Referral: Antifibrinolytic medicines
aprotinin, aminocaproic acid, tranexamic acid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/06/2012, Last updated: 06/11/2013 -
List item
Referral: Calcitonin
calcitonin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/07/2012, EC decision date: 13/02/2013, Last updated: 19/07/2013 -
List item
Referral: Tolperisone
Tolperisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/10/2012, EC decision date: 21/01/2013, Last updated: 02/04/2013 -
List item
Referral: Orlistat
orlistat, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/02/2012, EC decision date: 24/04/2012, Last updated: 21/12/2012 -
List item
Referral: Trimetazidine
Trimetazidine, associated names: Vastarel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/06/2012, EC decision date: 03/09/2012, Last updated: 17/10/2012 -
List item
Referral: Buflomedil
buflomedil, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 17/11/2011, EC decision date: 13/02/2012, Last updated: 13/06/2012 -
List item
Referral: Meprobamate
meprobamate, associated names: Equanil and other trade names, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 19/01/2012, EC decision date: 30/03/2012, Last updated: 08/06/2012 -
List item
Referral: Somatropin
somatropin, associated names: Genotropin, Humatrope, Maxomat, Norditropin, Saizen, Zomacton, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 15/12/2011, EC decision date: 27/02/2012, Last updated: 23/04/2012 -
List item
Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/06/2011, EC decision date: 20/01/2012, Last updated: 19/04/2012