20140 results
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Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec) for: Treatment of X-linked myotubular myopathy
Date of designation: 10/08/2015, Positive, Last updated: 18/09/2020now known as resamirigene bilparvovec. On 10 August 2015, orphan … Audentes Therapeutics UK Limited, United Kingdom, for adeno-associated … adeno-associated viral vector serotype 8 containing the human MTM1 gene for the … -
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Opinion/decision on a Paediatric investigation plan (PIP): Adeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene bilparvovec)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-002571-PIP01-19, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 14/08/2020, Last updated: 31/01/2023, Compliance check: XAdeno-associated viral vector serotype 8 containing the human MTM1 gene (resamirigene … human MTM1 gene (resamirigene bilparvovec) OtherP/0309/2020EMEA-002571-PIP01-19 … deferral for resamirigene bilparvovec (EMEA-002571-PIP01-19) PDF … -
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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, Revision: 7, Withdrawn, Last updated: 29/07/2021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 … as Pemetrexed Hospira UK Limited) Agency product number EMEA/H/C/004488 … medicine. A generic medicine contains the same active substance(s … -
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Orphan designation: Recombinant human bile-salt-stimulated lipase for: Treatment of cystic fibrosis
Date of designation: 26/01/2005, Withdrawn, Last updated: 10/08/2016Sweden, for recombinant human bile-salt-stimulated lipase for the treatment … patients affected by the condition? At the time of designation … patients affected by the condition is estimated and assessed … -
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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 … previously Docetaxel Hospira UK Limited ) Agency product number EMEA/H/C/003925 … medicine. A generic medicine contains the same active substance(s … -
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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 for the treatment … cells for the treatment of limbal stem cell deficiency. Expand … Collapse section What is limbal stem cell deficiency … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Ophthalmology
PIP number: EMEA-000347-PIP02-16-M03, Route(s) of administration: Ocular use, Pharmaceutical form(s): Eye drops, solution
Decision date: 03/12/2021, Last updated: 15/03/2023, Compliance check: XKey facts Bilaxten and associated names Bilastine OphthalmologyP/0526/2021EMEA-000347-PIP02-16-M03 … solution Treatment of allergic conjunctivitis Ocular use FAES FARMA, S.A … paediatric investigation plan for bilastine … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Dermatology; Oto-rhino-laryngology; Pneumology-allergology
PIP number: EMEA-000347-PIP05-20, Route(s) of administration: Oral use, Intramuscular use, Intravenous use, Pharmaceutical form(s): Oral solution, Orodispersible tablet, Solution for injection, Tablet
Decision date: 17/06/2020, Last updated: 04/03/2021, Compliance check: XInvented name Bilaxten and associated names Active … associated names Active substance Bilastine Therapeutic area Dermatology … Solution for injection Tablet Condition(s) / indication(s) Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: EMEA-000347-PIP01-08-M06, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet, Orodispersible tablet, Oral liquid
Decision date: 04/09/2015, Last updated: 15/06/2015, Compliance check: V, 13/11/2015Invented name Bilaxten and associated names Active … associated names Active substance Bilastine Therapeutic area Pneumology-allergology … Orodispersible tablet Oral liquid Condition(s) / indication(s) Treatment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Dermatology
PIP number: EMEA-000347-PIP03-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Orodispersible film
Decision date: 19/07/2018, Last updated: 22/11/2018, Compliance check: XKey facts Bilaxten and associated names Bilastine DermatologyP/0206/2018EMEA-000347-PIP03-18 … in all age groups for all conditions or indications Decision P/0206/2018 … product specific waiver for bilastine … -
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Herbal medicinal product: Tiliae tomentosae flos
Tilia tomentosa Moench, Silver lime flower, F: Assessment finalised, Last updated: 09/07/2012recommended uses of a medicine containing a herbal substance or a herbal … Tiliae tomentosae flosSilver lime flowerTilia tomentosa Moench … EMA/HMPC/510064/2011Adopted 09/07/2012 09/07/2012 Consultation Document details Draft assessment … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, pseudoephedrine
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: EMEA-003164-PIP01-21, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release tablet
Decision date: 13/05/2022, Last updated: 10/05/2023, Compliance check: XActive substance Bilastine pseudoephedrine Therapeutic … Prolonged-release tablet Condition(s) / indication(s) Treatment … of administration Oral use Contact for public enquiries FAES … -
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Herbal medicinal product: Ginkgo folium
Ginkgo biloba L., Ginkgo leaf, Last updated: 15/02/2022summary of the scientific conclusions reached by the The committee … Medicinal Products (HMPC). HMPC conclusions are taken into account by … licensing of herbal medicines containing ginkgo leaf. This summary … -
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Orphan designation: Bovine bile extract for: Treatment of pancreatic cancer
Date of designation: 20/06/2005, Positive, Last updated: 18/03/2022United Kingdom, for bovine bile extract for the treatment … transferred to Granzer Regulatory Consulting & Services GmbH, Germany … as insulin, that help to control blood sugar levels. About … -
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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 for the treatment … transferred to Biovest Europe Limited, United Kingdom, in September … patients affected by the condition? At the time of designation … -
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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 Therapeutic area … form(s) Solution for injection Condition(s) / indication(s) Treatment … administration Subcutaneous use Contact for public enquiries Biovest … -
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Herbal medicinal product: Myrtilli fructus siccus
Vaccinium myrtillus L., Dried Bilberry fruit, F: Assessment finalised, Last updated: 27/06/2023summary of the scientific conclusions reached by the The committee … the medicinal uses of dried bilberry fruit. The Committee on Herbal … Medicinal Products (HMPC). HMPC conclusions are taken into account by … -
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Herbal medicinal product: Myrtilli fructus recens
Vaccinium myrtillus L., Fresh Bilberry fruit, F: Assessment finalised, Last updated: 27/06/2023summary of the scientific conclusions reached by the The committee … the medicinal uses of fresh bilberry fruit. The Committee on Herbal … Medicinal Products (HMPC). HMPC conclusions are taken into account by … -
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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: 15/02/2023Scientific contributions should be sent in electronic … EMA/HMPC/337066/2011Draft: consultation closed 20/10/2011 20/10/2011 … Tilia x vulgaris Heyne, flos (lime flower) - First version EMA/HMPC/160868/2010 … -
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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 haemocyanin for the treatment … subsequently to Biovest Europe Limited, United Kingdom, in September … throughout the body), which are connected by a network of tiny lymphatic … -
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Human medicine European public assessment report (EPAR): Lutetium (177Lu) chloride Billev (previously Illuzyce)
lutetium (177Lu) chloride, Radionuclide Imaging
Date of authorisation: 15/09/2022, Revision: 2, Authorised, Last updated: 07/06/2023Lutetium (177Lu) chloride Billev (previously Illuzyce) Diagnostic … Lutetium ( 177 Lu) chloride Billev is a solution containing a radioactive form of lutetium … Lutetium ( 177 Lu) chloride Billev, it then carries the radioactivity … -
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Orphan designation: Bilayer engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts for: Treatment of partial deep dermal and full-thickness burns
Date of designation: 14/12/2015, Positive, Last updated: 03/08/2022Bilayer engineered collagen hydrogel-based … intended for use against a rare condition. The medicine must fulfil … European Commission to Voisin Consulting S.A.R.L., France, for … -
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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: 04/12/2020European Commission to Orphix Consulting GmbH, Germany, for 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 (also known as … -
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Orphan designation: Bilayer engineered skin composed of keratinocytes from the patient (autologous) and fibroblasts from a donor (allogeneic) embedded in a plasma matrix for: Treatment of epidermolysis bullosa
Date of designation: 22/05/2006, Positive, Last updated: 11/03/2015Cellerix S.L., Spain, for bilayer engineered skin composed … collagen essential for the connections of cells of the skin. There … bullosa. Some forms of the condition can be present at birth … -
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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: Xaspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin OncologyP/0259/2015EMEA-001810-PIP01-15 … in all age groups for all conditions or indications Decision P/0259/2015 … aspartyl-L-histidyl-S-[1-[(4-carboxycyclohexyl)methyl]-2,5-dioxo-3-pyrrolidinyl]-, complex with keyhole limpet haemocyanin (EMEA-001810-PIP01-15 …