19159 results
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Orphan designation: N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine for: Treatment in solid organ transplantation
Date of designation: 13/04/2022, Positive, Last updated: 19/07/2022N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3-phosphatidylethanolamine … mentioned in the minutes cannot be released at present following … 5 2.1.2. cannabidiol - EMA/OD/0000075999 … -
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Referral: Calcium Sandoz
Calcium lactate gluconate, Calcium carbonate, Article 30 referrals
Status: European Commission final decision, opinion/position date: 21/04/2005, EC decision date: 09/08/2005, Last updated: 09/08/2005Calcium Sandoz … Commission final decision Overview Calcium is an essential mineral … Medicinal products containing calcium lactate gluconate and calcium … -
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Orphan designation: Carboxypeptidase G2 (glucarpidase) for: Adjunctive treatment in patients at risk of methotrexate toxicity
Date of designation: 03/02/2003, Positive, Last updated: 20/01/2022Carboxypeptidase G2 glucarpidase … opinion on orphan designation Carboxypeptidase G2 for the adjunctive treatment … 30 Churchill Place ● Canary Wharf ● London E14 5EU … -
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Orphan designation: N-carboxymethyl-glycyl-L-threonyl-L-histidyl-L-3,3-diphenylalanyl-L-piperidincarboxy-3-yl-L-arginyl-L-S-methylthio-cystyl-L-arginyl-L-tryptophyl-aminohexanyl-N-carboxamidomethyl-glycine N-hexadecylamide for: Treatment of beta thalassaemia intermedia and major
Date of designation: 28/04/2016, Withdrawn, Last updated: 10/08/2017N-carboxymethyl-glycyl-L-threonyl-L-histidyl-L-3,3-diphenylalanyl-L-piperidincarboxy-3-yl-L-arginyl-L-S-methylthio-cystyl-L-arginyl-L-tryptophyl-aminohexanyl-N-carboxamidomethyl-glycine … opinion on orphan designation N-carboxymethyl-glycyl-L-threonyl-L-histidyl-L-3,3-diphenylalanyl-L-piperidincarboxy-3-yl-L-arginyl-L-S-methylthio-cystyl-L-arginyl-L-tryptophyl-aminohexanyl-N-carboxamidomethyl-glycine … -
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Orphan designation: N-carbamyl-L-glutamic acid for: Treatment of N-acetylglutamate synthetase (NAGS) deficiency
Date of designation: 18/10/2000, Expired, Last updated: 25/07/2014N-carbamyl-L-glutamic acid … opinion on orphan designation N-carbamyl-l-glutamic acid for the treatment of … 7 Westferry Circus ● Canary Wharf ● London E14 4HB … -
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Opinion/decision on a Paediatric investigation plan (PIP): glimepiride, Atorvastatin calcium
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Cardiovascular diseases
PIP number: EMEA-001232-PIP01-11, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 30/05/2012, Last updated: 25/06/2012, Compliance check: XEMEA-001232-PIP01-11 Cardiovascular diseases … Active substance glimepiride Atorvastatin calcium Therapeutic area Cardiovascular diseases Decision number … product specific waiver for glimepiride / atorvastatin calcium), (EMEA-001232-PIP01-11 … -
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Orphan designation: L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-alpha-aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex with keyhole limpet haemocyanin for: Treatment of glioma
Date of designation: 27/10/2011, Withdrawn, Last updated: 04/12/2020L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha glutamyl-L-lysyl-L-lysylglycyl-L-aspar … aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-complex … 7 Westferry Circus ● Canary Wharf ● London E14 4HB … -
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Opinion/decision on a Paediatric investigation plan (PIP): Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic acid (PSMA11-HBED-CC) (HBED Trasis)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002503-PIP01-18, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Kit for radiopharmaceutical preparation
Decision date: 12/06/2019, Last updated: 07/11/2019, Compliance check: XKey facts HBED Trasis Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic … membrane antigen in prostate cancer Intravenous use Trasis S.A … Glu-NH-CO-NH-Lys-(Ahx)-[N,N9-bis[2-hydroxy-5-(carboxyethyl) benzyl]ethylenediamine-N,N9-diacetic … -
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Opinion/decision on a Paediatric investigation plan (PIP): L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-α -aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001810-PIP01-15, Route(s) of administration: Intradermal use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 30/10/2015, Last updated: 22/12/2015, Compliance check: XL-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-α … injection Treatment of high-grade glioma Intradermal use Celldex Therapeutics … L-Cysteine, L-leucyl-L-α-glutamyl-L-α-glutamyl-L-lysyl-L-lysylglycyl-L-asparaginyl-L-tyrosyl-L-valyl-L-valyl-L-threonyl-L-Î … -
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Orphan designation: Glucopyranosyl lipid A stable emulsion and recombinant New York oesophageal squamous cell carcinoma-1 protein for: Treatment of soft tissue sarcoma
Date of designation: 21/03/2016, Withdrawn, Last updated: 15/10/2019Glucopyranosyl lipid A stable emulsion and … oesophageal squamous cell carcinoma-1 protein … Glucopyranosyl lipid A stable emulsion and … -
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Orphan designation: Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt for: Treatment of acromegaly
Date of designation: 06/12/2012, Positive, Last updated: 09/02/2016threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt … Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt … Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl- L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt … -
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Orphan designation: 20-pentaerythritol poly (oxy-1,2-ethanediyl)-carboxymethyl-glycinate-7-ethyl-10-hydroxycamptothecine 10-[1,4'-bipiperidine]-1'-carboxylate for: Treatment of ovarian cancer
Date of designation: 27/09/2011, Positive,10-[1,4'-bipiperidine]-1'-carboxylate … 10-[1,4'-bipiperidine]-1'-carboxylate for the treatment of ovarian cancer 7 Westferry Circus … 7 Westferry Circus ● Canary Wharf ● London E14 4HB … -
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Opinion/decision on a Paediatric investigation plan (PIP): Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine] manganese complexes
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-002293-PIP01-17, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 11/04/2018, Last updated: 25/07/2018, Compliance check: XKey facts Calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine … product specific waiver for calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2 … product specific waiver for calcium, N,N'-1,2-ethanediylbis[N-[[3-(hydroxy-2-methyl-5-[(phosphonooxy)methyl]-4-pyridinyl]methyl]glycine … -
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Opinion/decision on a Paediatric investigation plan (PIP): L-carnitine, glucose, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium lactate, sodium chloride
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Uro-nephrology
PIP number: EMEA-003049-PIP01-21, Route(s) of administration: Intraperitoneal use, Pharmaceutical form(s): Solution for peritoneal dialysis
Decision date: 07/03/2022, Last updated: 19/04/2023, Compliance check: XKey facts L-carnitine glucose calcium chloride dihydrate magnesium … Treatment of renal failure with carnitine deficiency Intraperitoneal … granting of a deferral for L-carnitine glucose calcium chloride dihydrate / magnesium … -
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Human medicine European public assessment report (EPAR): Daurismo
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,
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, Revision: 4, Authorised, Last updated: 07/07/2021
Myeloid Leukemia Neoplasms Cancer Leukemia, Myeloid, Acute … Daurismo is a cancer medicine for treating adults … myeloid leukaemia (AML), a cancer of white blood cells. It … -
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Referral: Intravenous iron-containing medicinal products
ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 13/09/2013, Last updated: 28/07/2021CHMP. More information can be found under 'Committee … medicines. More information can be found under 'Committee … medicines. More information can be found under 'Committee … -
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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: 19/11/2020to multi-arm polyethylene glycol carrier through a cleavable linker … to multi-arm polyethylene glycol carrier through a cleavable linker … -
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Orphan designation: Adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human beta-glucocerebrosidase variant for: Treatment of Gaucher disease
Date of designation: 20/08/2021, Positive, Last updated: 01/03/2022codon-optimised expression cassette encoding human beta glucocerebrosidase variant … mentioned in the minutes cannot be released at present following … codon-optimised expression cassette encoding human beta glucocerebrosidase variant … -
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 27, Authorised, Last updated: 05/04/2023
Cometriq Neoplasms Cancer Head and Neck Neoplasms Endocrine … Neck Neoplasms Endocrine Gland Neoplasms Endocrine System … Authorised cabozantinib Overview This is a summary … -
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Human medicine European public assessment report (EPAR): Invokana (updated)
canagliflozin, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2013, Revision: 22, Authorised, Last updated: 30/05/2023Diseases Metabolic Diseases Glucose Metabolism Disorders Diabetes … Authorised canagliflozin Overview Invokana is a diabetes … medicine. active substance canagliflozin. It is used together with … -
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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 … magnesium acetate tetrahydrate calcium chloride sodium glycerophosphate … -
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Human medicine European public assessment report (EPAR): Vokanamet (updated)
canagliflozin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 23/04/2014, Revision: 21, Authorised, Last updated: 30/05/2023Vokanamet Diabetes Mellitus Glucose Metabolism Disorders Metabolic … Authorised canagliflozinmetformin Overview This is a summary … EPAR. More information can be found under 'European … -
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Orphan designation: Vector based on an adeno-associated virus serotype 2 backbone, pseudo-serotyped with a type 8 capsid, which carries the coding sequence of the human TYMP gene under the control of the human thyroxine binding globulin promoter for: Treatment of mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)
Date of designation: 22/08/2014, Positive, Last updated: 02/10/2014pseudo-serotyped with a type 8 capsid, which carries the coding sequence of the … the human thyroxine binding globulin promoter … 30 Churchill Place ● Canary Wharf ● London E14 5EU … -
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Opinion/decision on a Paediatric investigation plan (PIP): Glivec, imatinib mesilate
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-000463-PIP02-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Film-coated tablet, Capsule, hard, Age-appropriate oral solid dosage form
Decision date: 08/04/2011, Last updated: 12/05/2011, Compliance check: XEMEA-000463-PIP02-10 Cardiovascular diseases … Invented name Glivec Active substance imatinib … mesilate Therapeutic area Cardiovascular diseases Decision number … -
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Human medicine European public assessment report (EPAR): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,
, Revision: 16, Authorised, Last updated: 05/04/2023
Cabometyx Kidney Neoplasms Urologic … Diseases Adenocarcinoma Carcinoma Neoplasms Glandular and Epithelial Neoplasms … Pregnancy Complications Cancer Neoplasms Liver Neoplasms Digestive …