734 results
Keyword Ritmodan Retard Remove keyword
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Human medicine European public assessment report (EPAR): Elaprase
idursulfase, Mucopolysaccharidosis II
Date of authorisation: 08/01/2007,
, 
, Revision: 25, Authorised, Last updated: 15/12/2022
Manifestations Intellectual Disability Mental Retardation, X-Linked Congenital, Hereditary … Disorders, Nervous System Mental Retardation, X-Linked Mental Retardation, X-Linked Lysosomal Storage … -
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Referral: Doxazosin Retard "Arrow" 4 mg
Doxazosin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 28/06/2006, EC decision date: 11/10/2006, Last updated: 11/10/2006Doxazosin Retard "Arrow" 4 mg … decision Overview Doxazosin Retard "Arrow" 4 mg prolonged release … recognition of Doxazosin Retard “Arrow” 4 mg prolonged … -
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Human medicine European public assessment report (EPAR): Valtropin
somatropin, Turner Syndrome; Dwarfism, Pituitary
Date of authorisation: 24/04/2006,
, Revision: 5, Withdrawn, Last updated: 14/08/2012
analysis. Treatment of growth retardation in pre-pubertal children … -
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Direct healthcare professional communication (DHPC): Amfepramone-containing medicines will no longer be available on the EU market, as marketing authorisations will be revoked
Active substance: amfepramone, DHPC type: Referral - Article 31, Last updated: 08/02/202308/02/2023 Regenon Tenuate Retard Amfepramon-Hormosan Regenon Retard Related content Amfepramone-containing … -
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Referral: Saroten and associated names
amitriptyline, associated names: Saroten Retard, Redomex, Redomex Diffucaps, Saroten Tabs, Saroten retard Tabs, Saroten 2ml, Sarotex, Sarotex Retard, Sarotex Retard 25, Sarotex Retard 50, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/02/2017, EC decision date: 08/05/2017, Last updated: 06/06/2017namesamitriptyline Saroten Retard Redomex Redomex Diffucaps … Diffucaps Saroten Tabs Saroten retard Tabs Saroten 2ml Sarotex … Saroten 2ml Sarotex Sarotex Retard Sarotex … -
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Orphan designation: Acamprosate calcium for: Treatment of fragile X syndrome
Date of designation: 15/10/2014, Positive, Last updated: 03/11/2022moderate to severe mental retardation. Other symptoms include difficulty … protein called fragile X mental retardation protein (FMRP), which is … this leads to the mental retardation and other neurological symptoms … -
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Orphan designation: Tideglusib for: Treatment of fragile X syndrome
Date of designation: 19/03/2015, Withdrawn, Last updated: 21/02/2019moderate to severe mental retardation. Other symptoms include difficulty … protein called fragile X mental retardation protein (FMRP), which is … this leads to the mental retardation and other neurological symptoms … -
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Orphan designation: Mavoglurant
Date of designation: 10/10/2012, Positive, Last updated: 04/06/2018moderate to severe mental retardation. Other symptoms include social … this leads to the mental retardation and other neurological symptoms … moderate to severe mental retardation. Other symptoms include social … -
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Orphan designation: (3S)-(+)-(5-Chloro-2-methoxyphenyl)-1,3-dihydro-3-fluoro-6-(trifluoromethyl)-2H-indol-2-one for: Treatment of fragile X syndrome
Date of designation: 15/10/2014, Positive, Last updated: 12/11/2014moderate to severe mental retardation. Other symptoms include difficulty … protein called fragile X mental retardation protein (FMRP), which is … this leads to the mental retardation and other neurological symptoms … -
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Orphan designation: R-baclofen for: Treatment of fragile X syndrome
Date of designation: 15/04/2011, Positive, Last updated: 26/04/2011moderate to severe mental retardation. Other symptoms include social … protein called fragile X mental retardation protein (FMRP), which is … this leads to the mental retardation and other neurological symptoms … -
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Orphan designation: Recombinant human alpha-Mannosidase (velmanase alfa) for: Treatment of alpha-mannosidosis
Date of designation: 26/01/2005, Positive,deafness and profound mental retardation. The juvenile/adult form (type … less severe. Milder mental retardation occurs later, but hearing … deafness and profound mental retardation. The juvenile/adult form (type … -
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Referral: Nifedipine Pharmamatch 30 and 60 mg
nifedipine, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 27/01/2006, EC decision date: 03/04/2006, Last updated: 05/05/2006of Nifedipine Pharmamatch retard 30 and 60 mg tablets on the … for Nifedipine Pharmamatch retard 30 and 60 mg tablets, that … of Nifedipine Pharmamatch retard 30 and 60 mg tablets on … -
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Referral: Amfepramone-containing medicinal products
amfepramone, associated names: Regenon, Tenuate Retard, Amfepramon-Hormosan, Regenon Retard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 10/11/2022, EC decision date: 13/01/2023, Last updated: 20/01/2023Amfepramon Hormosan 60 mg Retardkapseln, Regenon, Tenuate Retard 75 mg retardtablette and Regenon 25 mg capsule moi … Amfepramon-Hormosan 60 mg Retardkapseln, Regenon, Tenuate Retard 75 mg retardtablette and Regenon 25 mg capsule … -
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Orphan designation: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone for: Treatment of Rett syndrome
Date of designation: 19/02/2014, Positive, Last updated: 18/10/2018syndrome have severe mental retardation, which first appears between … syndrome have severe mental retardation, which first appears between … -
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Orphan designation: Desipramine chlorhydrate for: Treatment of Rett syndrome
Date of designation: 12/06/2009, Withdrawn, Last updated: 16/08/2017syndrome have severe mental retardation, which first appears between … syndrome have severe mental retardation, which first appears between … -
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Orphan designation: Betaine anhydrous for: Treatment of homocystinuria
Date of designation: 09/07/2001, Withdrawn, Last updated: 17/07/2017imbalance can lead to mental retardation, severe bone problems, osteoporosis … imbalance can lead to mental retardation, severe bone problems, osteoporosis … -
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Orphan designation: Parathyroid hormone (1-34) transglutaminase fusion protein fibrin matrix complex for: Treatment of solitary bone cysts
Date of designation: 11/04/2006, Positive, Last updated: 24/04/2009fracture and bone growth retardation. What is the estimated number … fracture and bone growth retardation. What is the estimated … -
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Orphan designation: Recombinant human insulin receptor monoclonal antibody-fused-α-L-iduronidase for: Treatment of mucopolysaccharidosis type I
Date of designation: 15/10/2014, Withdrawn, Last updated: 18/02/2022eyes, hearing loss and mental retardation. Without treatment, these … eyes, hearing loss and mental retardation. Without treatment, these … -
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Press release: Modified-release paracetamol-containing products to be suspended from EU market
CMDh, Last updated: 15/12/2017Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg … Panodil 665 mg, Paratabs Retard and Pinex Retard. Modified-release medicines … available under the names Diliban Retard or Doreta SR in Bulgaria … -
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Orphan designation: everolimus for: Treatment of tuberous sclerosis
Date of designation: 04/08/2010, Positive, Last updated: 29/05/2018may develop severe mental retardation, uncontrollable seizures and … may develop severe mental retardation, uncontrollable seizures and … -
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Opinion/decision on a Paediatric investigation plan (PIP): bucelipase alfa
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000822-PIP01-09-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Powder for oral solution
Decision date: 29/04/2013, Last updated: 31/05/2013, Compliance check: Xindication(s) Prevention of growth retardation due to lack of bile-salt-stimulated … Condition(s): Prevention of growth retardation due to lack of bile salt-stimulated … Condition: prevention of growth retardation due to lack of bile salt- stimulated … -
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News: EMA recommends withdrawal of marketing authorisation for amfepramone medicines
PRAC, Last updated: 10/06/2022Amfepramon Hormosan 60 mg Retardkapseln, Regenon, Tenuate Retard 75 mg retardtablette and Regenon 25 mg capsule … -
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News: EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
PRAC, Last updated: 28/10/2022Amfepramon‑Hormosan 60 mg Retardkapseln, Regenon, Tenuate Retard 75 mg retardtablette and Regenon 25 mg capsule … -
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News: EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
Last updated: 11/11/2022Amfepramon‑Hormosan 60 mg Retardkapseln, Regenon, Tenuate Retard 75 mg retardtablette and Regenon 25 mg capsule … -
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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: 01/03/2018Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg … Panodil 665 mg, Paratabs Retard and Pinex Retard. Modified-release medicines … available under the names Diliban Retard or Doreta SR in Bulgaria …