3386 results
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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Date of designation: 26/01/2005, Withdrawn, Last updated: 10/08/2016Recombinant human bile-salt-stimulated lipase Overview … designation Recombinant human bile salt-stimulated lipase for … designation Recombinant human bile salt-stimulated lipase for … -
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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: 18/09/2020human MTM1 gene (resamirigene bilparvovec) Overview This medicine is … now known as resamirigene bilparvovec. On 10 August 2015, orphan … human MTM1 gene (resamirigene bilparvovec)Treatment of X-linked myotubular myopathy … -
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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: Xhuman MTM1 gene (resamirigene bilparvovec) OtherP/0309/2020EMEA-002571-PIP01-19 … deferral for resamirigene bilparvovec (EMEA-002571-PIP01-19) PDF … deferral for resamirigene bilparvovec (EMEA-002571-PIP01-19) in … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bilastine (updated)
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 … paediatric investigation plan for bilastine Bilaxten and associated names), (EMEA-000347-PIP02-16-M03 … paediatric investigation plan for bilastine Bilaxten and associated names), (EMEA-000347-PIP02-16-M03 … -
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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 … paediatric investigation plan for bilastine Bilaxten and associated names), (EMEA-000347-PIP01-08-M06 … -
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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 … product specific waiver for bilastine Bilaxten and associated names), (EMEA- 000347-PIP05-20 … -
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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 … product specific waiver for bilastine Bilaxten and associated names), (EMEA … Bilastine … -
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Orphan designation: Bovine bile extract for: Treatment of pancreatic cancer
Date of designation: 20/06/2005, Positive, Last updated: 18/03/2022Bovine bile extract Overview On 20 June … United Kingdom, for bovine bile extract for the treatment … pancreatic cancer. Bovine bile extract might be of potential … -
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Herbal medicinal product: Ginkgo folium
Ginkgo biloba L., Ginkgo leaf, Last updated: 15/02/2022leaf of the plant Ginkgo biloba L. This summary covers ginkgo … public Ginkgo leaf Ginkgo biloba L., folium This is a summary … leaf of the plant Ginkgo biloba L. This summary covers … -
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Herbal medicinal product: Myrtilli fructus siccus
Vaccinium myrtillus L., Dried Bilberry fruit, F: Assessment finalised, Last updated: 15/03/2022the medicinal uses of dried bilberry fruit. The Committee on Herbal … medicines containing dried bilberry fruit. This summary is not … medicines containing dried bilberry fruit. For practical information … -
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Herbal medicinal product: Myrtilli fructus recens
Vaccinium myrtillus L., Fresh Bilberry fruit, F: Assessment finalised, Last updated: 15/03/2022the medicinal uses of fresh bilberry fruit. The Committee on Herbal … medicines containing fresh bilberry fruit. This summary is not … medicines containing fresh bilberry fruit. For practical information … -
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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: 1, Authorised, Last updated: 08/12/2022Lutetium (177Lu) chloride Billev (previously Illuzyce) Diagnostic … Lutetium (177Lu) chloride Billev (previously Illuzyce … Lutetium (177Lu) chloride Billev1 (lutetium (177lu) chloride … -
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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 … Consulting S.A.R.L., France, for bilayer engineered collagen hydrogel-based … authorisation . Key facts Bilayer engineered collagen hydrogel-based … -
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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: 11/03/2015Bilayer engineered skin composed … Cellerix S.L., Spain, for bilayer engineered skin composed … medicine expected to work? The bilayer engineered skin composed … -
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,
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, Revision: 2, Authorised, Last updated: 05/10/2022
Diseases Liver Diseases Biliary Tract Diseases Bile Duct Diseases Cholestasis Cholestasis … of liver disease in which bile acids build up in the liver Bile acids are a component of bile, a fluid produced in the liver … -
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Human medicine European public assessment report (EPAR): Ocaliva
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,
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, Revision: 15, Authorised, Last updated: 04/01/2023
Diseases Cholestasis, Intrahepatic Biliary Tract Diseases Bile Duct Diseases Cholestasis Cholestasis … Processes Fibrosis Liver Cirrhosis, Biliary … disease known as primary biliary cholangitis. Primary biliary cholangitis is an autoimmune … -
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Human medicine European public assessment report (EPAR): Vedrop
tocofersolan, Cholestasis; Vitamin E Deficiency
Date of authorisation: 23/07/2009,, , Revision: 13, Authorised, Last updated: 22/08/2019
Digestive System Diseases Biliary Tract Diseases Bile Duct Diseases Nutritional … problems with the flow of bile from the liver to the gut Bile is a fluid produced in the … problems with the flow of bile from the liver to the gut Bile is a fluid produced in the … -
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Human medicine European public assessment report (EPAR): Livmarli
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,, , , Authorised, Last updated: 14/12/2022
Digestive System Diseases Biliary Tract Diseases Bile Duct Diseases Cholestasis Digestive … itching due to a build-up of bile) caused by Alagille syndrome … inherited disease in which bile (a fluid produced in the … -
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News: European Commission/European Medicines Agency - US Food and Drug Administration bilateral: update
Last updated: 22/04/2014Food and Drug Administration bilateral: update … number of key initiatives at a bilateral meeting which took place … organisations on a number of bilateral projects. Participants at … -
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Direct healthcare professional communication (DHPC): Ocaliva (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation
Active substance: Obeticholic acid, DHPC type: New contraindication, Last updated: 09/06/2022the treatment of primary biliary cholangitis (PBC) in patients … decompensation Liver Cirrhosis, Biliary … the treatment of primary biliary cholangitis (PBC) in patients … -
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National expert: Barbara Bilandzija, Agency For Medicinal Products And Medical Devices Of Croatia (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 16.41 KB | PDF
Barbara Bilandzija … Barbara Bilandzija … Vitae PERSONAL INFORMATION Barbara Bilandzija WORK EXPERIENCE January … -
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National expert: Biljana Temova, Agency For Medicinal Products And Medical Devices Of The Republic Of Slovenia (updated)
- Declaration of interests - 80.08 KB | PDF
- Curriculum Vitae - 16.44 KB | PDF
Biljana Temova … Biljana Temova … Vitae PERSONAL INFORMATION Biljana Temova WORK EXPERIENCE January … -
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Second EMA-EFPIA annual bilateral meeting
European Medicines Agency, London, UK, 10/07/2017, Last updated: 18/09/2017Second EMA-EFPIA annual bilateral meeting … context of the EMA annual bilateral meetings with Industry stakeholder … Second EMA-EFPIA annual bilateral meeting PDF icon application/pdf … -
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Bilateral interactions with non-EU regulators
Last updated: 28/09/2017Bilateral interactions with non-EU … less-developed regulatory systems. Bilateral interactions with non-EU …
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European Medicines Agency and COCIR bilateral meeting
Virtual meeting, 15:00-17:00 Amsterdam time (CET), 08/11/2021, Last updated: 09/11/2021Medicines Agency and COCIR bilateral meeting … summary The purpose of this bilateral meeting with COCIR is to exchange views … in the context of annual bilateral meetings with industry stakeholder …