17697 results
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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Date of designation: 27/10/2011, Withdrawn, Last updated: 04/12/2020L-cysteine, L-leucyl-L-alpha-glutamyl-L-alpha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-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 … 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 the treatment … -
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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 … aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin OncologyP/0259/2015EMEA-001810-PIP01-15 … -
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Human medicine European public assessment report (EPAR): Pemetrexed Pfizer (previously known as Pemetrexed Hospira UK Limited)
pemetrexed ditromethamine, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 24/04/2017,
, Revision: 7, Withdrawn, Last updated: 29/07/2021
as Pemetrexed Hospira UK Limited) Carcinoma, Non-Small-Cell … Product details Name Pemetrexed Pfizer (previously … as Pemetrexed Hospira UK Limited) Agency product number EMEA/H/C/004488 … -
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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: 06/01/2006Glu-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 … Val-Leu-Gln-Glu-Leu-Asn-Val-Thr-Val (Pr1 nanopeptide, sequence 169-177, of proteinase … -
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Orphan designation: Cultured allogeneic corneal limbal stem cells for: Treatment of limbal stem cell deficiency
Date of designation: 15/10/2014, Positive, Last updated: 12/11/2014Cultured allogeneic corneal limbal stem cells Overview On 15 … European Commission to NHS National Services Scotland, trading … Scotland, trading as Scottish National Blood Transfusion Service … -
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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 … Product details Name Starlix Agency product number … EMEA/H/C/000335 Active substance nateglinide International non-proprietary … -
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Human medicine European public assessment report (EPAR): Taxespira (previously Docetaxel Hospira UK Limited )
docetaxel trihydrate, Stomach Neoplasms; Prostatic Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 28/08/2015,, Revision: 8, Withdrawn, Last updated: 15/10/2019
previously Docetaxel Hospira UK Limited ) Stomach Neoplasms Prostatic … Product details Name Taxespira (previously Docetaxel … previously Docetaxel Hospira UK Limited ) Agency product number EMEA/H/C/003925 … -
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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: 19/11/2020C-type natriuretic peptide conjugated to multi-arm … to multi-arm polyethylene glycol carrier through a cleavable … A/S, Denmark, for c-type natriuretic peptide conjugated to multi-arm … -
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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: 15/10/2009Abbott Laboratories Limited Abbott House Norden Road … for orphan designation of N-acetylsarcosyl-glycyl-L-valyl-D-allo-isoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-propyl-N-ethylamide for the treatment of soft … N-acetylsarcosyl-glycyl-L-valyl-D-allo-isoleucyl-L-threonyl-L-norvalyl-L-isoleucyl-L-arginyl-L-propyl-N-ethylamide for the treatment of soft … -
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Herbal medicinal product: Tiliae tomentosae flos
Tilia tomentosa Moench, Silver lime flower, F: Assessment finalised, Last updated: 09/07/2012Tiliae tomentosae flosSilver lime flowerTilia tomentosa Moench … tomentosa Moench, flos (silver lime) EMA/HMPC/160869/2010 22/03/2010 … tomentosa Moench Silver lime flower … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of mantle cell lymphoma
Date of designation: 23/02/2011, Positive, Last updated: 04/03/2011idiotype coupled to keyhole limpet hemocyanin Overview On 23 … idiotype coupled to keyhole limpet hemocyanin for the treatment … transferred to Biovest Europe Limited, United Kingdom, in September … -
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Opinion/decision on a Paediatric investigation plan (PIP): Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Oncology
PIP number: EMEA-001274-PIP01-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/08/2012, Last updated: 17/09/2012, Compliance check: Xidiotype coupled to keyhole limpet hemocyanin OncologyP/0180/2012EMEA-001274-PIP01-12 … idiotype coupled to keyhole limpet haemocyanin (EMEA-001274-PIP01-12 … idiotype coupled to keyhole limpet haemocyanin (EMEA-001274-PIP01-12) 7 … -
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Orphan designation: Autologous tumour-derived immunoglobulin idiotype coupled to keyhole limpet hemocyanin for: Treatment of follicular lymphoma
Date of designation: 28/08/2006, Positive, Last updated: 14/06/2012idiotype coupled to keyhole limpet hemocyanin Overview On 28 … idiotype coupled to keyhole limpet haemocyanin for the treatment … subsequently to Biovest Europe Limited, United Kingdom, in September … -
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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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Herbal medicinal product: Tiliae flos
Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne, Lime flower, F: Assessment finalised, Last updated: 15/02/2023Tilia x vulgaris Heyne, flos (lime flower) - First version EMA/HMPC/160868/2010 … Scop., Tilia x vulgaris Heyne Lime flower … -
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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 … -
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Orphan designation: Poly(oxy-1,2-ethanediyl), alpha-hydro-omega-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-alpha-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain (pegcetacoplan) for: Treatment of C3 glomerulopathy
Date of designation: 21/08/2019, Positive, Last updated: 03/02/2021alpha-hydro-omega-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L glutaminyl-L-alpha-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide … -
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Orphan designation: Poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L-glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide cyclic (2.fwdarw.12)-(disulfide); where two identical synthetic peptide domains are covalently linked at the ends of the polyethylene glycol chain for: Treatment of paroxysmal nocturnal haemoglobinuria
Date of designation: 22/05/2017, Positive, Last updated: 16/12/2021poly(oxy-1,2-ethanediyl),.alpha.-hydro-.omega.-hydroxy-,15,15'-diester with N-acetyl-L-isoleucyl-L-cysteinyl-L-valyl-1-methyl-L-tryptophyl-L glutaminyl-L-.alpha.-aspartyl-L-tryptophylglycyl-L-alanyl-L-histidyl-L-arginyl-L-cysteinyl-L-threonyl-2-[2-(2-aminoethoxy)ethoxy]acetyl-N6-carboxy-L-lysinamide … -
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Human medicine European public assessment report (EPAR): Natalizumab Elan Pharma
natalizumab, Crohn Disease
Date of refusal: 11/01/2008, Refused, Last updated: 25/01/2008Natalizumab Elan Pharma Crohn Disease … Refused natalizumab Overview On 19 July 2007 … for the medicinal product Natalizumab Elan Pharma concentrate for … -
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Human medicine European public assessment report (EPAR): Suboxone
buprenorphine, naloxone, Opioid-Related Disorders
Date of authorisation: 26/09/2006, Revision: 21, Authorised, Last updated: 17/01/2023Disorders Substance-Related Disorders Narcotic-Related Disorders Mental Disorders Opioid-Related … Product details Name Suboxone Agency product number … Active substance buprenorphine naloxone International non-proprietary … -
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Human medicine European public assessment report (EPAR): Trazec
nateglinide, Diabetes Mellitus, Type 2
Date of authorisation: 03/04/2001, Revision: 5, Withdrawn, Last updated: 24/08/2009Product details Name Trazec Agency product number … EMEA/H/C/000383 Active substance nateglinide International non-proprietary … International non-proprietary name (INN) or common … -
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Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,
, Revision: 24, Authorised, Last updated: 03/03/2023
Authorised naltrexonebupropion Overview This is a summary … medicine. active substances naltrexone and bupropion, which are … tablets containing 7.2 mg naltrexone and 78 mg bupropion and can … -
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Opinion/decision on a Paediatric investigation plan (PIP): Tysabri, natalizumab
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Neurology
PIP number: EMEA-001095-PIP02-12, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 19/10/2012, Last updated: 27/11/2012, Compliance check: V, 16/12/2016Invented name Tysabri Active substance natalizumab Therapeutic area Neurology … public enquiries Biogen Idec Limited Hema.borde@biogenidec.com … granting of a waiver for natalizumab (Tysabri) (EMEA-001095-PIP02-12 …