27 results
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Orphan designation: Givinostat for: Treatment of Duchenne muscular dystrophy
Date of designation: 04/07/2012, Positive, Last updated: 24/07/2012Lavoratori, 54 20092 Cinisello Balsamo (MI) Italy Tel. +39 0264 … Lavoratori, 54 20092 Cinisello Balsamo (MI) Italy Telephone: +39 … -
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Orphan designation: Givinostat for: Treatment of systemic-onset juvenile idiopathic arthritis
Date of designation: 28/01/2010, Withdrawn, Last updated: 25/06/2013Lavoratori 54 20092 Cinisello Balsamo (MI) Italy Tel. + 39 0264 … -
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Orphan designation: Givinostat for: Treatment of polycythaemia vera
Date of designation: 03/02/2010, Positive, Last updated: 04/03/2010Lavoratori 54 20092 Cinisello Balsamo (MI) Italy Tel. + 39 0264 … Lavoratori 54 20092 Cinisello Balsamo (MI) Italy Telephone … -
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Orphan designation: Givinostat for: Treatment of Becker muscular dystrophy
Date of designation: 31/07/2018, Positive, Last updated: 11/10/2018Lavoratori 54 20092 Cinisello Balsamo (MI) Italy Tel. + 39 0264 … -
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Referral: Nimesulide
nimesulide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 18/12/2003, EC decision date: 26/04/2004, Last updated: 13/05/2004 -
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Referral: Combined hormonal contraceptives
desogestrel, gestodene, norgestimate, etonogestrel, drospirenone, dienogest, chlormadinone, nomegestrol, norelgestromin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 16/01/2014, Last updated: 31/01/2014 -
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Referral: Norfloxacin
norfloxacin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/07/2008, EC decision date: 19/11/2008, Last updated: 24/07/2008 -
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Referral: Renin-angiotensin-system (RAS)-acting agents
captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014 -
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Referral: Piroxicam
piroxicam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/06/2007, EC decision date: 07/09/2007, Last updated: 31/01/2008 -
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Referral: Serotonin-specific reuptake inhibitors and serotonin-noradrenaline reuptake inhibitors
atomoxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 19/08/2005, Last updated: 03/11/2005 -
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Referral: Ergot-derived dopamine agonists
bromocriptine, cabergoline, dihydroergocryptine, lisuride, pergolide, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2008, Last updated: 26/06/2008 -
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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: Zolpidem-containing medicines
zolpidem, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 23/06/2014, Last updated: 04/08/2014 -
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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 -
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Referral: Bisphosphonates
alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid, associated names: Actonel, Aredia, Bonefos, Didronel, Fosamax, Nerixia, Skelid, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 13/07/2011, Last updated: 28/10/2011 -
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Referral: Domperidone-containing medicines
domperidone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/04/2014, EC decision date: 01/09/2014, Last updated: 11/09/2014 -
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Referral: Loratadine and pseudoephedrine
loratadine, pseudoephedrine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/11/2003, EC decision date: 28/04/2004, Last updated: 14/07/2004Lavoratori, 54 I-20092 Cinisello Balsamo Milano Italy Frinase … -
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Referral: Thiocolchicoside-containing medicines
thiocolchicoside, associated names: Muscoril and Coltramyl, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/11/2013, EC decision date: 17/01/2014, Last updated: 06/03/2014 -
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Referral: Paroxetine
paroxetine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 09/12/2004, EC decision date: 29/03/2005, Last updated: 22/11/2005 -
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Referral: GVK Biosciences
esomeprazole magnesium, candesartan cilexetil, nebivolol, desloratadine, donepezil, repaglinide, candesartan, esomeprazole, alendronic acid, ropinirole, cefpodoxime, quetiapine, trimetazidine, bosentan, tramadol, paracetamol, escitalopram, trimetazidine hydrochloride, entacapone, valsartan, hydrochlorothiazide, donepezil hydrochloride, ropinirole hydrochloride, clopidogrel hydrochloride, escitalopram oxalate, metformin hydrochloride, trimetazidine dihydrochloride, rizatriptan benzoate, metformin, fluconazole, eletriptan, rizatriptan, ebastine, ibuprofen, desmopressin, aciclovir, levetiracetam, irbesartan, venlafaxine, ciprofloxacin, cefpodoxime proxetil, tacrolimus, fexofenadine hydrochloride, phenoxymethylpenicillin, amlodipine besilate, metoclopramide, clopidogrel, levodopa, carbidopa, entacapone, atorvastatin, telmisartan, clindamycin hydrochloride, metoclopramide hydrochloride, clonazepam, clobazam, dexamethasone, thiamine hydrochloride, tramadol hydrochloride, pioglitazone, dipyridamole, fexofenadine, amlodipine, pantoprazole, hydrocortisone, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/05/2015, EC decision date: 16/07/2015, Last updated: 04/08/2015 -
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Referral: Diclofenac-containing medicines
diclofenac, Article 31 referrals
Status: European Commission final decision, opinion/position date: 26/06/2013, EC decision date: 25/09/2013, Last updated: 27/11/2013 -
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Opinion/decision on a Paediatric investigation plan (PIP): Givinostat
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: P/9/2010, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 29/01/2010, Last updated: 25/02/2010, Compliance check: XLavoratori, 54, 20092 Cinisello Balsamo (MI), Italy. Done at … -
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Opinion/decision on a Paediatric investigation plan (PIP): Givinostat
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000551-PIP04-21-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 04/12/2022, Last updated: 30/03/2023, Compliance check: XLavoratori, 54, 20092 - Cinisello Balsamo (Milan), Italy … -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 12/09/2022 -
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Press release: GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies
CHMP, Last updated: 23/01/2015