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Withdrawn application: Ibuprofen/Diphenhydramine Hydrochloride Wyeth
date of withdrawal: 07/01/2010, Initial authorisation, Last updated: 20/04/2010Ibuprofen/Diphenhydramine Hydrochloride Wyeth: Withdrawn … authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth ibuprofen and diphenhydramine hydrochloride … marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for … -
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Human medicine European public assessment report (EPAR): Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)
formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate, Pulmonary Disease, Chronic Obstructive
Date of authorisation: 23/04/2018, Revision: 4, Authorised, Last updated: 30/06/2023previously CHF 5993 Chiesi Farmaceutici S.p.A.) Respiratory Tract … previously CHF 5993 Chiesi Farmaceutici S.p.A.) : EPAR - Medicine … previously CHF 5993 Chiesi Farmaceutici S.p.A.) beclometasone formoterol formoterol … -
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Orphan designation: Mixture of two adeno-associated viral vectors of serotye 8 containing the 5'-half sequence of human ABCA4 gene and the 3'-half sequence of human ABCA4 gene for: Treatment of Stargardt's disease
Date of designation: 04/07/2014, Positive, Last updated: 07/11/20225'-half sequence of human ABCA4 gene and the 3'-half sequence … 3'-half sequence of human ABCA4 gene … 5’-half sequence of human ABCA4 gene and the 3’-half sequence … -
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Orphan designation: Lentiviral vector containing the human ABCA4 gene for: Treatment of Stargardt's disease
Date of designation: 02/02/2010, Positive, Last updated: 13/03/2023vector containing the human ABCA4 gene … vector containing the human ABCA4 gene for the treatment of … vector containing the human ABCA4 gene for the treatment of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lentiviral vector containing the human ABCA4 gene
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Ophthalmology
PIP number: EMEA-002407-PIP01-18, Route(s) of administration: Intraocular use, Pharmaceutical form(s): Solution for injection
Decision date: 14/06/2019, Last updated: 07/11/2019, Compliance check: Xvector containing the human ABCA4 gene Therapeutic area Ophthalmology … vector containing the human ABCA4 gene … -
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Orphan designation: Adeno-associated viral vector serotype 5 containing the human ABCA4 gene for: Treatment of Stargardt's disease
Date of designation: 07/02/2009, Withdrawn, Last updated: 16/10/2014serotype 5 containing the human ABCA4 gene … serotype 5 containing the human ABCA4 gene for the treatment of … serotype 5 containing the human ABCA4 gene for the treatment of … -
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Orphan designation: Adeno-associated viral vector serotype 9 containing the human ABCD1 gene for: Treatment of adrenoleukodystrophy
Date of designation: 11/11/2022, Positive, Last updated: 25/01/2023serotype 9 containing the human ABCD1 gene … serotype 9 containing the human ABCD1 gene … -
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Orphan designation: Allogeneic skin-derived ABCB5-positive mesenchymal stem cells for: Treatment of epidermolysis bullosa
Date of designation: 29/05/2019, Positive, Last updated: 09/08/2019Allogeneic skin-derived ABCB5-positive mesenchymal stem cells … Allogeneic skin-derived ABCB5-positive mesenchymal stem cells … -
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Human medicine European public assessment report (EPAR): Pedea
Ibuprofen, Ductus Arteriosus, Patent
Date of authorisation: 28/07/2004, Revision: 15, Authorised, Last updated: 08/11/2022Authorised ibuprofen Overview This is a summary … medicine. active substance ibuprofen. What is Pedea used for? Pedea … active substance in Pedea, ibuprofen, has been used since the 1960s … -
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Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA (elivaldogene autotemcel) for: Treatment of adrenoleukodystrophy
Date of designation: 06/06/2012, Withdrawn, Last updated: 04/04/2022Lenti-D encoding the human ABCD1 cDNA (elivaldogene autotemcel … Lenti- D encoding the human ABCD1 cDNA for the treatment of … Lenti-D encoding the human ABCD1 cDNA for the treatment of … -
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Orphan designation: Combination of two adeno-associated viral vectors of serotype 8 containing the 5'- and the 3'- half coding sequences of human ABCA4 fused to inteins for: Treatment of Stargardt's disease
Date of designation: 17/10/2019, Positive, Last updated: 07/11/2022coding sequences of human ABCA4 fused to inteins … coding sequences of human ABCA4 fused to inteins … -
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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: 26/10/2020Ibuprofen Kabi 400 mg Infusionslösung … ibuprofen … -
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Referral: Ibuprofen- and dexibuprofen-containing medicines
ibuprofen, dexibuprofen, Article 31 referrals
Status: CMDh final position, opinion/position date: 20/05/2015, Last updated: 14/07/2015Ibuprofen- and dexibuprofen-containing … advice on use of high‑dose ibuprofen … advice on use of high-dose ibuprofen Review confirms small cardiovascular … -
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Orphan designation: Ibuprofen for: Treatment of patent ductus arteriosus
Date of designation: 15/02/2001, Expired, Last updated: 06/03/2015Ibuprofen … opinion on orphan designation Ibuprofen for the treatment of patent … opinion on orphan designation Ibuprofen for the treatment of patent … -
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Orphan designation: Ibuprofen for: Patent ductus arteriosus in premature neonates of less than 34 weeks of gestational age
Date of designation: 06/03/2001, Withdrawn, Last updated: 15/05/2009Ibuprofen … orphan designation of ibuprofen for the prevention of … Orphan Europe, France, for ibuprofen for the prevention of patent … -
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Referral: Paracetamol/Ibuprofen 500 mg/150 mg film-coated tablets
paracetamol, ibuprofen, associated names: Paracomb, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 18/05/2017, EC decision date: 07/08/2017, Last updated: 18/08/2017substances paracetamol and ibuprofen. Both are well known medicines … Combinations of paracetamol and ibuprofen containing 500 mg paracetamol … mg paracetamol and 150 mg ibuprofen or similar doses are already … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002302-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 16/03/2018, Last updated: 19/06/2018, Compliance check: XKey facts Ibuprofen OtherP/0086/2018EMEA-002302-PIP01-17 … product- specific waiver for ibuprofen (EMEA-002302-PIP01-17) PDF … product specific waiver for ibuprofen (EMEA-002302-PIP01-17 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002017-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 20/12/2016, Last updated: 30/01/2017, Compliance check: XKey facts Ibuprofen OtherP/0366/2016EMEA-002017-PIP01-16 … product specific waiver for ibuprofen (EMEA-002017-PIP01-16) PDF … product specific waiver for ibuprofen (EMEA-002017-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002400-PIP01-18, Route(s) of administration: Topical use, Pharmaceutical form(s): Medicated plaster
Decision date: 07/12/2018, Last updated: 13/02/2019, Compliance check: XKey facts Ibuprofen PainP/0382/2018EMEA-002400-PIP01-18 … product specific waiver for ibuprofen (EMEA-002400-PIP01-18) PDF … Ibuprofen … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Famotidine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: Ibuprofen / Famotidine, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 09/10/2009, Last updated: 07/12/2009, Compliance check: XIbuprofen / Famotidine Pain … Ibuprofen / Famotidine … Microsoft Word - Decision ibuprofen famotidine EMEA-000616-PIP01-09 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, pseudoephedrine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Infectious diseases
PIP number: EMEA-002102-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral suspension
Decision date: 30/06/2017, Last updated: 24/07/2017, Compliance check: XKey facts Ibuprofen pseudoephedrine Infectious … product specific waiver for ibuprofen / pseudoephedrine (EMEA-002102-PIP01-16 … product specific waiver for ibuprofen / pseudoephedrine (EMEA-002102-PIP01-16 … -
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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-PIP01-16, Route(s) of administration: Oral use, Pharmaceutical form(s): Granules, Tablet
Decision date: 05/10/2016, Last updated: 23/11/2016, Compliance check: XActive substance Ibuprofen paracetamol Therapeutic area … product specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP01-16 … product specific waiver for ibuprofen / paracetamol (EMEA-002002-PIP01-16 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Tramadol
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001887-PIP01-15, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Solution for infusion, Granules for oral solution, Concentrate for solution for infusion
Decision date: 14/06/2016, Last updated: 26/08/2016, Compliance check: XKey facts Ibuprofen Tramadol PainP/0153/2016EMEA-001887-PIP01-15 … product specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15 … product specific waiver for ibuprofen / tramadol (EMEA-001887-PIP01-15 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Ibuprofen, Codeine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001713-PIP02-14, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 01/04/2015, Last updated: 06/07/2015, Compliance check: XKey facts Ibuprofen Codeine PainP/0078/2015EMEA-001713-PIP02-14 … product-specific waiver for ibuprofen/codeine (EMEA-001713-PIP02-14) PDF … product-specific waiver: Ibuprofen / codeine for treatment of … -
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Opinion/decision on a Paediatric investigation plan (PIP): Caffeine, Ibuprofen
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-001537-PIP01-13, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 22/01/2014, Last updated: 20/02/2014, Compliance check: XKey facts Caffeine Ibuprofen PainP/0024/2014EMEA-001537-PIP01-13 … product-specific waiver for caffeine / ibuprofen (EMEA-001537-PIP01-13) PDF … specific waiver for caffeine / ibuprofen (EMEA-001537-PIP01-13) in …
