For help on how to get the results you want, see our search tips.
46 results
Medicine
Shortages Remove Shortages filter
European public assessment reports (EPAR) Remove European public assessment reports (EPAR) filter
Referrals Remove Referrals filter
Categories
Human Remove Human filter
Referral authorisation model
Nationally authorised product(s) Remove Nationally authorised product(s) filter
-
List item
Referral: Cyproterone-containing medicinal products (updated)
cyproterone, ?> Article 31 referrals
Status: Under evaluation, Last updated: 12/11/2019 -
List item
Referral: Leuprorelin-containing depot medicinal products
leuprorelin, ?> associated names: Daronda, Depo-Eligard, Eligard, Eligard Depot, Eligard Mensua, Eligard Semestral, 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, Enantone-Gyn 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, Leupro-Sandoz 3-Monats-Depot, Leuprostin, 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: Under evaluation, Last updated: 31/10/2019 -
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: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 31/10/2019 -
List item
Referral: Fosfomycin-containing medicinal products
fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, ?> Article 31 referrals
Status: Under evaluation, opinion/position date: 13/12/2018, Last updated: 20/09/2019 -
List item
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 -
List item
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 -
List item
Referral: Fenspiride containing medicinal products
fenspiride, ?> Article 107i procedures
Status: Position provided by CMDh, opinion/position date: 29/05/2019, Last updated: 26/06/2019 -
List item
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 -
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: 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 -
List item
Referral: Paclitaxel Hetero and associated names
paclitaxel, ?> Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/10/2018, EC decision date: 11/01/2019, Last updated: 21/01/2019 -
List item
Referral: Hydroxyethyl starch (HES) containing medicinal products
hydroxyethyl starch (HES), ?> Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/10/2017, EC decision date: 17/07/2018, Last updated: 27/07/2018 -
List item
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 -
List item
Referral: Flupirtine-containing medicinal products
flupirtine, ?> Article 31 referrals
Status: Position provided by CMDh, opinion/position date: 21/03/2018, -
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, -
List item
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, -
List item
Referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions
methylprednisolone, ?> Article 31 referrals
Status: Position provided by CMDh, opinion/position date: 31/07/2017, -
List item
Referral: Fusafungine containing medicinal products for oromucosal and nasal use
fusafungine, ?> Article 31 referrals
Status: Position provided by CMDh, opinion/position date: 31/03/2016, -
List item
Referral: Ambroxol and bromhexine-containing medicines
ambroxol and bromhexine, ?> Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, -
List item
Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen and dexibuprofen, ?> Article 31 referrals
Status: Position provided by CMDh, opinion/position date: 20/05/2015, -
List item
Referral: Hydroxyzine
hydroxyzine, ?> associated names: Atarax, Article 31 referrals
Status: Position provided by CMDh, opinion/position date: 25/03/2015,