92 results
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Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG for: Treatment of multiple myeloma
Date of designation: 26/10/2018, Positive, Last updated: 10/01/2019the European Commission to Sellas Life Sciences Limited, Ireland … -
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Orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly for: Treatment of acute myeloid leukaemia
Date of designation: 28/04/2016, Positive, Last updated: 12/04/2019the European Commission to SELLAS Life Sciences Group UK, Limited … sponsorship was transferred to SELLAS Life Sciences Limited, Ireland … the European Commission to SELLAS Life Sciences Group UK, Limited … -
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Orphan designation: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly for: Treatment of malignant mesothelioma
Date of designation: 28/04/2016, Positive, Last updated: 12/04/2019the European Commission to SELLAS Life Sciences Group UK, Limited … sponsorship was transferred to SELLAS Life Sciences Limited, Ireland … the European Commission to SELLAS Life Sciences Group UK, Limited … -
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National expert: Roser Vives Vilagut, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 80.68 KB | PDF
- Curriculum Vitae - 29.05 KB | PDF
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National expert: Jesus Chesa Jimenez, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 21.93 KB | PDF
Metastase of Breast Cancer in Sella Turcica. NuklearMedizin … -
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National expert: Victor Mangas Sanjuan, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 34.19 KB | PDF
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Human medicine European public assessment report (EPAR): SonoVue
sulphur hexafluoride, Ultrasonography; Echocardiography
Date of authorisation: 26/03/2001, Revision: 19, Authorised, Last updated: 14/09/2021 -
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Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,
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, Authorised, Last updated: 17/11/2022
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,, , Revision: 1, Authorised, Last updated: 25/08/2022
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National expert: Emilio Perucca, Italian Medicines Agency (updated)
- Declaration of interests - 85.84 KB | PDF
- Curriculum Vitae - 116.29 KB | PDF
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Human medicine European public assessment report (EPAR): Pluvicto
lutetium (177Lu) vipivotide tetraxetan, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 09/12/2022,, Authorised, Last updated: 21/12/2022
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National expert: Francesco Rodeghiero, European Medicines Agency (updated)
- Declaration of interests - 82.47 KB | PDF
- Curriculum Vitae - 115.78 KB | PDF
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National expert: Maarten Naesens, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.87 KB | PDF
- Curriculum Vitae - 45.73 KB | PDF
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National expert: Loreto Carmona, European Medicines Agency (updated)
- Declaration of interests - 81.42 KB | PDF
- Curriculum Vitae - 108.52 KB | PDF
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Referral: Valproate and related substances
sodium valproate, valproate magnesium, valproate semisodium, valproic acid, valpromide, associated names: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/03/2018, EC decision date: 31/05/2018, Last updated: 07/06/2018 -
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Referral: Valproate and related substances
sodium valproate, valproic acid, valproate semisodium, valpromide, associated names: Absenor, Convival Chrono, Convulex, Convulsofin Tabletten, Delepsine, Depakine, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Leptilan, Micropakine L.P., Orfiril, Orlept, Petilin, Valberg, Valepil and Valhel, Article 31 referrals
Status: CMDh final position, opinion/position date: 19/11/2014, Last updated: 29/01/2015 -
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Referral: Valproate
valproic acid, valproate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/12/2009, EC decision date: 26/08/2010, Last updated: 29/04/2011 -
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Referral: Valproat Ratiopharm Chrono
valproic acid, valproate, Article 6(12) referrals (prior to January 2010)
Status: European Commission final decision, opinion/position date: 25/05/2010, EC decision date: 26/05/2010, Last updated: 23/07/2012Germany Acido valproico E sodio Valproato Ratiopharm 300 … Germany Acido valproico E sodio Valproato Ratiopharm 500 … -
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Referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions
methylprednisolone, Article 31 referrals
Status: CMDh final position, opinion/position date: 31/07/2017, Last updated: 04/09/2017 -
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Orphan designation: Sodium phenylbutyrate for: Treatment of pyruvate dehydrogenase complex deficiency
Date of designation: 11/11/2015, Positive, Last updated: 07/11/2022 -
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Referral: Polymyxin-containing medicines
colistimethate sodium, associated names: Colobreathe, Article 31 referrals
Status: European Commission final decision, opinion/position date: 23/10/2014, EC decision date: 16/12/2014, Last updated: 05/01/2015 -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021di potassio monoidrato e bicarbonato di potassio Trattamento … -
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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: 14/07/2015 -
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Orphan designation: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-β-D-galactopyranosyl]-4-O-(α-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide (rivipansel) for: Treatment of sickle cell disease
Date of designation: 05/08/2013, Positive, Last updated: 23/04/2020 -
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Orphan designation: Sodium thiosulfate for: Treatment of calciphylaxis
Date of designation: 23/02/2011, Withdrawn, Last updated: 03/02/2021kezelése Italian Tiosolfato di sodio Trattamento della calciphylaxis … kalcifilaksije Spanish Tiosulfato de sodio Tratamiento de calcifilaxia …