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33 results
Medicine
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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 -
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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 -
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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 -
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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 -
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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 -
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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: 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 -
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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 -
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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: 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, 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: 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 -
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Referral: Ambroxol and bromhexine-containing medicines
ambroxol, bromhexine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/11/2015, EC decision date: 14/01/2016, Last updated: 05/02/2016 -
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Referral: Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum
bromocriptine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 20/08/2014, EC decision date: 30/10/2014, Last updated: 08/12/2014 -
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Referral: Diacerein-containing medicines for oral administration
diacerein, associated names: Zondar, Article 31 referrals
Status: European Commission final decision, EC decision date: 04/09/2014, Last updated: 19/09/2014