1346 results
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: P/12/2009, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 27/01/2009, Last updated: 23/04/2009, Compliance check: XKey facts Ibuprofen paracetamol PainP/12/2009P/12/2009 … product specific waiver for ibuprofen, paracetamol, (EMEA-000313-PIP01-08 … product specific waiver for ibuprofen, paracetamol, (EMEA-000313-PIP01-08 … -
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Opinion/decision on a Paediatric investigation plan (PIP): paracetamol, Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-000564-PIP01-09, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, suspension
Decision date: 23/12/2009, Last updated: 25/01/2010, Compliance check: XKey facts paracetamol Ibuprofen PainP/259/2009EMEA-000564-PIP01-09 … waiver for paracetamol / ibuprofen (EMEA-000564-PIP01-09) in … waiver for paracetamol / ibuprofen (EMEA-000564-PIP01- 09) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, paracetamol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002002-PIP02-17, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 07/05/2018, Last updated: 27/11/2018, Compliance check: XKey facts Ibuprofen paracetamol PainP/0135/2018EMEA-002002-PIP02-17 … product-specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP02-17 … Ibuprofen paracetamol … -
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Orphan designation: Refusal of orphan designation for the treatment of patent ductus arteriosus in premature neonates of less than 34 week gestational age
Date of refusal of designation: 24/06/2005, Negative, Last updated: 11/10/2005Ibuprofen L-Lysinate (salt … negative smop ibuprofen treatment European … ORPHAN DESIGNATION OF ibuprofen L-lysinate for the treatment … -
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Orphan designation: Refusal of orphan designation for the prevention of patent ductus arteriosus in premature neonates of less than 34 week of gestational age
Date of refusal of designation: 07/07/2005, Negative, Last updated: 11/10/2005Ibuprofen L-Lysinate (salt … ORPHAN DESIGNATION OF ibuprofen L-lysinate for the prevention … on orphan designation of ibuprofen L-lysinate for the prevention … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, diphenhydramine hydrochloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Ibuprofen, diphenhydramine hydrochloride, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, soft
Decision date: 01/12/2008, Last updated: 29/01/2009, Compliance check: XIbuprofen, diphenhydramine hydrochloride … Key facts Ibuprofen diphenhydramine hydrochloride … hydrochloride PainP/118/2008Ibuprofen, diphenhydramine hydrochloride … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen (sodium dihydrate)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001599-PIP01-13, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection/infusion
Decision date: 30/09/2014, Last updated: 05/11/2014, Compliance check: XKey facts Ibuprofen (sodium dihydrate) OtherP/0255/2014EMEA-001599-PIP01-13 … granting of a waiver for ibuprofen (sodium dihydrate), (EMEA-001599-PIP01-13 … paediatric investigation plan: Ibuprofen (sodium dihydrate) for treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Acetylcysteine, Ibuprofen (sodium dihydrate)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oto-rhino-laryngology; Pneumology-allergology
PIP number: EMEA-002561-PIP02-20, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules for oral suspension
Decision date: 27/01/2021, Last updated: 29/09/2021, Compliance check: XKey facts Acetylcysteine Ibuprofen (sodium dihydrate) Oto-rhino-laryngologyPneumology-allergologyP/0054/2021EMEA-002561-PIP02-20 … waiver for acetylcysteine / ibuprofen (sodium dihydrate) (EMEA-002561-PIP02-20 … waiver for acetylcysteine / ibuprofen (sodium dihydrate) (EMEA-002561-PIP02-20 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Allogeneic skin-derived ATP-binding cassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem cells (allo-APZ2-EB)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Dermatology
PIP number: EMEA-002875-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Suspension for injection
Decision date: 09/07/2021, Last updated: 19/07/2022, Compliance check: Xcassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem … cassette, sub-family B, member 5 (ABCB5)-positive mesenchymal stem … sub-family B, member 5 (ABCB5)-positive mesenchymal stem … -
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Opinion/decision on a Paediatric investigation plan (PIP): autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ATP-binding cassette, sub-family D (ALD), member 1 (ABCD1) from cDNA
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-001244-PIP01-11-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 12/09/2018, Last updated: 16/09/2021, Compliance check: V, 04/09/2020sub-family D (ALD), member 1 (ABCD1) from cDNA NeurologyP/0290/2018EMEA-001244-PIP01-11-M02 … sub-family D (ALD), member 1 (ABCD1) from cDNA … -
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Press release: Wyeth Consumer Healthcare withdraws its marketing authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth
Last updated: 13/01/2010authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth … authorisation for the medicine Ibuprofen/Diphenhydramine Hydrochloride Wyeth 200 mg/25 … marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth was submitted … -
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Ibuprofen product-specific bioequivalence guidance
Last updated: 04/04/2022Ibuprofen product-specific bioequivalence … conditions. bioequivalence of ibuprofen. … Ibuprofen oral use immediate release …
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Press release: Updated advice on use of high-dose ibuprofen
CMDh, Last updated: 22/05/2015advice on use of high-dose ibuprofen … advice on the use of high-dose ibuprofen. This follows a review carried … patients taking high doses of ibuprofen (at or above 2,400 mg per … -
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Press release: PRAC recommends updating advice on use of high-dose ibuprofen
PRAC, Last updated: 13/04/2015advice on use of high-dose ibuprofen … advice on use of high-dose ibuprofen … advice on use of high‑dose ibuprofen 30 Churchill Place … -
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Press release: European Medicines Agency starts review of ibuprofen medicines
PRAC, Last updated: 13/06/2014Medicines Agency starts review of ibuprofen medicines … Medicines Agency starts review of ibuprofen medicines … Medicines Agency starts review of ibuprofen medicines Review to evaluate … -
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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: 04/08/2015benzoate metformin fluconazole eletriptan rizatriptan ebastine ibuprofen desmopressin aciclovir levetiracetam irbesartan venlafaxine ciprofloxacin cefpodoxime … -
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National expert: Michela Palmisano, Italian Medicines Agency (updated)
- Declaration of interests - 42.96 KB | PDF
- Curriculum Vitae - 32.6 KB | PDF
Cellulare e del Differenziamento (ABCD), Ravenna, September 2011 … September 2010 (1 poster) ▪ ABCD PhD National Meeting, Gubbio … June 2010 (1 poster) ▪ ABCD, Stem cells, Development and … -
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Human medicine European public assessment report (EPAR): Skysona
elivaldogene autotemcel, Adrenoleukodystrophy
Date of authorisation: 16/07/2021,
, Withdrawn, Last updated: 04/04/2022
18 years of age, with an ABCD1 genetic mutation, and for … change (mutation) in the ABCD1 gene. The mutation prevents … -
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Human medicine European public assessment report (EPAR): Dynastat
parecoxib sodium, Pain, Postoperative
Date of authorisation: 22/03/2002, Revision: 32, Authorised, Last updated: 17/08/2022other painkillers such as ibuprofen, ketorolac, morphine, tramadol … -
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Orphan designation: Recombinant human apolipoprotein A-I in a complex with phospholipids for: Treatment of ATP-binding cassette transporter A1 deficiency
Date of designation: 22/08/2014, Positive,cassette transporter A1 (ABCA1) is a protein that regulates … the body. In patients with ABCA1 deficiency, the ABCA1 protein is not produced in … mutation (defect) in their ABCA1 genes, and so cholesterol … -
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National expert: Iva Klarica Domjanovic, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 39.35 KB | PDF
- Curriculum Vitae - 39.23 KB | PDF
cytochrome P450 genes affect ibuprofen and diclofenac metabolism … 2018) Interaction between ABCG2 421C>A polymorphism and valproate … Of Cyp2d6, Cyp3a4/5, And Abcb1 Polymorphisms In Patients … -
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Orphan designation: 3-(3-(3,5-bis(trifluoromethyl)phenyl)-1h-pyrazol-1-yl)propanoic acid for: Treatment of Stargardt's disease
Date of designation: 24/04/2019, Withdrawn, Last updated: 13/04/2023abnormalities in a gene called ABCA4. The ABCA4 gene is responsible for the … production of a protein called ABCR that regulates the transport … with Stargardt’s disease, ABCR does not work properly. As … -
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Orphan designation: Ramiprilat for: Treatment of Stargardt's disease
Date of designation: 12/03/2013, Positive, Last updated: 17/01/2023abnormalities in a gene called ABCA4. The ABCA4 gene is responsible for the … production of a protein called ABCR that regulates the transport … with Stargardt's disease, ABCR does not work properly. This … -
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Orphan designation: 1-(3-{4-[3,4-difluoro-2-(trifluoromethyl)phenyl]piperidine-1-carbonyl}-1H,4H,5H,6H,7H-pyrazolo[3,4- c]pyridin-6-yl)ethan-1-one (Tinlarebant) for: Treatment of Stargardt's disease
Date of designation: 25/05/2018, Positive, Last updated: 01/12/2022abnormalities in a gene called ABCA4 . The ABCA4 gene is responsible for the … production of a protein called ABCR that regulates the transport … with Stargardt's disease, ABCR does not work properly. This … -
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Orphan designation: Etidronate disodium for: Treatment of pseudoxanthoma elasticum
Date of designation: 11/10/2022, Positive, Last updated: 24/01/2023designation for the treatment of ABCC6 deficiency …