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Medicine
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Referral: Estradiol-containing (0.01% w/w) medicinal products for topical use (updated)
estradiol, ?> associated names: Linoladiol, Linoladiol N, Linoladiol Estradiol, Estradiol Wolff, Montadiol, Article 31 referrals
Status: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 16/01/2020 -
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Referral: Flurbiprofen Geiser (updated)
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: 19/12/2019 -
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Referral: Ranitidine-containing medicinal products
ranitidine, ?> Article 31 referrals
Status: Procedure started, opinion/position date: 19/09/2019, Last updated: 18/12/2019 -
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Referral: Methocarbamol / paracetamol-containing medicinal products
methocarbamol/paracetamol, ?> associated names: Robaxisal compuesto, Article 31 referrals
Status: Under evaluation, opinion/position date: 29/05/2019, Last updated: 17/12/2019 -
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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: 16/12/2019 -
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Referral: Cyproterone-containing medicinal products
cyproterone, ?> Article 31 referrals
Status: Under evaluation, Last updated: 12/11/2019 -
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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 -
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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: 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 -
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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 -
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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: 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 -
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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: 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 -
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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 -
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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 -
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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 -
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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 -
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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: Position provided by CMDh, opinion/position date: 21/03/2018, -
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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, -
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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, -
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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, -
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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,