18067 results
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic acid (Custodiol-N)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP03-20, Pharmaceutical form(s): Solution for organ preservation
Decision date: 10/05/2021, Last updated: 14/02/2022, Compliance check: Xtryptophan aspartic acid n-acetyl-histidine (monohydrate glycine alpha-ketoglutaric acid arginine … alpha-ketoglutaric acid arginine potassium chloride magnesium chloride … tryptophan / aspartic acid / n-acetyl-histidine (monohydrate glycine / alpha- ketoglutaric acid … -
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Opinion/decision on a Paediatric investigation plan (PIP): Deferoxamine (mesylate), histidine, tryptophan, aspartic acid, n-acetyl-histidine (monohydrate), glycine, alpha-ketoglutaric acid, arginine, potassium chloride, magnesium chloride (hexahydrate), calcium chloride (dihydrate), sodium chloride, alanine, 3,4-dimethoxy-N-methylbenzohydroxamic
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-002735-PIP01-19, Route(s) of administration: Intracoronary use, Pharmaceutical form(s): Concentrate and solvent for solution for infusion
Decision date: 09/06/2021, Last updated: 26/04/2022, Compliance check: Xtryptophan aspartic acid n-acetyl-histidine (monohydrate glycine alpha-ketoglutaric acid arginine … alpha-ketoglutaric acid arginine potassium chloride magnesium chloride … tryptophan / aspartic acid / n-acetyl-histidine (monohydrate glycine / alpha- ketoglutaric acid … -
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Orphan designation: Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for: Treatment of acute myeloid leukaemia
Date of designation: 21/12/2004, Withdrawn, Last updated: 19/11/2009Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … -
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Orphan designation: Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for: Treatment of chronic myeloid leukaemia
Date of designation: 21/12/2004, Withdrawn, Last updated: 19/11/2009Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … GmbH, Germany, for Val-Leu-Gln-Glu-Leu-Asn-Val- Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … -
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Orphan designation: Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase 3) for: Treatment of myelodysplastic syndromes
Date of designation: 21/12/2004, Withdrawn, Last updated: 06/01/2006Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … -
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Opinion/decision on a Paediatric investigation plan (PIP): alanine, arginine, aspartic acid, cysteine, cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine, sodium chloride, potassium acetate, magnesium acetate tetrahydrate, calcium chloride, sodium glycerophosphate, glucose, soya bean oil, olive oil
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Nutrition
PIP number: Alanine, arginine, aspartic acid, cysteine/cystine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine monohydrate, methionine, ornithine hydrochloride, phenylalanine, proline, serine, taurine, threonine, tryptophan, tyrosine, valine; sod..., Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 02/10/2009, Last updated: 07/12/2009, Compliance check: V, 16/10/2009aspartic acid, cysteine/cystine, glutamic acid glycine, histidine, isoleucine, leucine … aspartic acid cysteine cystine glutamic acid glycine histidine isoleucine leucine … tyrosine valine sodium chloride potassium acetate magnesium acetate … -
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Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Authorised potassium citratepotassium hydrogen … disease also causes levels of potassium in the blood to fall, which … medicine. active substances potassium citrate and … -
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Orphan designation: N-acetylsarcosyl-glycyl-L-valyl-D-alloisoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-prolyl-N-ethylamide for: Treatment of soft tissue sarcoma
Date of designation: 12/12/2003, Withdrawn, Last updated: 15/10/2009N-acetylsarcosyl-glycyl-L-valyl-D-alloisoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-prolyl-N-ethylamide Overview Please note that … Office, United Kingdom, for N-acetylsarcosyl-glycyl-L-valyl-D-allo-isoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-propyl-N-ethylamide (ABT-510) for the treatment … -
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Human medicine European public assessment report (EPAR): Starlix
nateglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2001, Revision: 15, Withdrawn, Last updated: 28/06/2022Diseases Metabolic Diseases Glucose Metabolism Disorders Diabetes … nateglinide … authorisation for Starlix (nateglinide) in the European Union (EU … -
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Orphan designation: C-type natriuretic peptide conjugated to multi-arm polyethylene glycol carrier through a cleavable linker for: Treatment of achondroplasia
Date of designation: 27/07/2020, Positive, Last updated: 19/11/2020designation on the basis of potential activity. An orphan designation … orphan designation: C-type natriuretic peptide conjugated to multi-arm … to multi-arm polyethylene glycol carrier through a cleavable … -
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Human medicine European public assessment report (EPAR): Dutrebis
lamivudine, raltegravir potassium, HIV Infections
Date of authorisation: 26/03/2015, Withdrawn, Last updated: 27/04/2017Product details Name Dutrebis Agency product number … substance lamivudine raltegravir potassium International non-proprietary … International non-proprietary name (INN) or common … -
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Opinion/decision on a Paediatric investigation plan (PIP): N-Acetyl-L-Cysteine (corresponds to L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to L-Alanine and L-Glutamine), L-Arginine, Glycine, Glycyl-L-Tyrosine (corresponds to Glycine and L-Tyrosine), L-Histidine, L-Isoleucine, L-Leucine, L-Lysine acetate (corresponds to L-Lysine), LMethionine, L-Phenylalanine, L-Proline, L-Serine, Taurine, L-Threonine, L-Tryptophan, L-Valine
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Nutrition
PIP number: EMEA-000042-PIP01-07, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 07/09/2009, Last updated: 22/10/2009, Compliance check: XKey facts N-Acetyl-L-Cysteine (corresponds to L-Cysteine … L-Cysteine), L-Alanine, L-Alanyl-L-Glutamine (corresponds to L-Alanine … corresponds to L-Alanine and L-Glutamine), L-Arginine … -
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Orphan designation: Mogamulizumab for: Treatment of cutaneous T-cell lymphoma
Date of designation: 14/10/2016, Positive, Last updated: 28/01/2019been authorised in the EU as Poteligeo since 22 November 2018. Expand … immune system (the body's natural defences), which then kill … designation on the basis of potential activity. An orphan designation … -
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Orphan designation: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor for: Treatment of cystic fibrosis
Date of designation: 14/12/2018, Positive, Last updated: 25/01/2022United Kingdom, for ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide … in the lungs and from the glands in the gut and pancreas … Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, Potassium hydrogen carbonate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001357-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 07/12/2018, Last updated: 19/02/2019, Compliance check: V, 15/11/2019Active substance Potassium citrate monohydrated Potassium hydrogen carbonate Therapeutic … paediatric investigation plan Potassium citrate monohydrated Potassium hydrogen carbonate for treatment … Investigation Plan* (PIP) for Potassium citrate monohydrated Potassium hydrogen carbonate for treatment … -
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Human medicine European public assessment report (EPAR): Tookad
padeliporfin di-potassium, Prostatic Neoplasms
Date of authorisation: 10/11/2017,
, Revision: 6, Authorised, Last updated: 07/12/2022
Product details Name Tookad Agency product number … substance padeliporfin di-potassium International non-proprietary … International non-proprietary name (INN) or common … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, potassium hydrogen carbonate (ADV7103)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001535-PIP01-13-M01, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 17/07/2018, Last updated: 27/11/2018, Compliance check: XKey facts Potassium citrate monohydrated potassium hydrogen carbonate (ADV7103 … paediatric investigation plan for potassium citrate monohydrated potassium hydrogen carbonate (ADV7103 … paediatric investigation plan Potassium citrate monohydrated potassium hydrogen carbonate for Treatment … -
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, 
, Revision: 5, Authorised, Last updated: 28/04/2022
Poteligeo Cancer Neoplasms Lymphoma … Product details Name Poteligeo Agency product number EMEA/H/C/004232 … International non-proprietary name (INN) or common name mogamulizumab Therapeutic … -
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Human medicine European public assessment report (EPAR): Potactasol
topotecan, Uterine Cervical Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 06/01/2011,
, Revision: 10, Authorised, Last updated: 18/07/2022
Potactasol Carcinoma, Bronchogenic Bronchial … assessment report (EPAR) for Potactasol. It explains how the The committee … the conditions of use for Potactasol. What is Potactasol? Potactasol is a medicine that contains … -
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Opinion/decision on a Paediatric investigation plan (PIP): Medium-chain triglycerides, olive oil, Fish oil, Acetyl-cysteine, alanine, histidine, Isoleucin, leucine, Lysine acetate, methionine, phenylalanine, proline, tryptophan, tyrosine, valine, glucose, calcium chloride, potassium chloride, Sodium acetate, Zinc sulfate, Malic acid, arginine, glycine, serine, threonine, sodium glycerophosphate, soya bean oil, magnesium sulfate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Nutrition
PIP number: EMEA-002067-PIP02-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Emulsion for infusion
Decision date: 07/06/2017, Last updated: 24/07/2017, Compliance check: Xtryptophan tyrosine valine glucose calcium chloride potassium chloride Sodium acetate Zinc … sulfate Malic acid arginine glycine serine threonine sodium glycerophosphate soya bean oil magnesium sulfate … acetyl-cysteine / alanine / arginine / glycine / histidine / isoleucin … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium, Amlodipine besilate
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001390-PIP01-12, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet
Decision date: 30/04/2013, Last updated: 31/05/2013, Compliance check: XKey facts Losartan potassium Amlodipine besilate Cardiovascular … essential hypertension Oral use GlaxoSmithKline Trading Services Limited … amlodipine (besilate) / losartan (potassium) (EMEA-001390-PIP01-12) PDF … -
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Opinion/decision on a Paediatric investigation plan (PIP): Losartan potassium
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-000008-PIP01-07, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral liquid dosage form
Decision date: 29/02/2008, Last updated: 19/03/2008, Compliance check: V, 06/02/2009Key facts Losartan potassium Cardiovascular diseasesP/9/2008EMEA-000008-PIP01-07 … for Cozaar and associated names, losartan potassium EMEA-000008-PIP01-07 in accordance … for Cozaar and associated names, losartan potassium EMEA-000008-PIP01-07 in accordance … -
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Orphan designation: tegafur, gimeracil, oteracil potassium for: Treatment of gastric cancer
Date of designation: 20/12/2007, Withdrawn, Last updated: 28/03/2011tegafurgimeraciloteracil potassium Overview Please note that … tegafur, gimeracil, oteracil potassium for the treatment of gastric … tegafur, gimeracil, oteracil potassium might be of … -
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Herbal medicinal product: Tormentillae rhizoma
Potentilla erecta (L.) Raeusch., Tormentil, F: Assessment finalised, Last updated: 08/06/2020Latin name Tormentillae rhizoma English … Tormentillae rhizoma English common name Tormentil Botanical name Potentilla erecta (L.) Raeusch. Therapeutic … Tormentillae rhizoma Potentilla erecta (L.) Raeusch. Torment … -
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Summary of opinion: Bovilis Nasalgen-C
bovine coronavirus, strain CA25, live, opinion date: 15/02/2023, Positive, Last updated: 17/02/2023Bovilis Nasalgen-C: Pending EC decision … Bovilis Nasalgen-C … authorisation) Bovilis Nasalgen-C Common name: Bovine coronavirus vaccine …