20003 results
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Human medicine European public assessment report (EPAR): Alecensa (updated)
alectinib hydrochloride, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 16/02/2017,
, Revision: 12, Authorised, Last updated: 11/08/2022
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Human medicine European public assessment report (EPAR): Ranexa (previously Latixa) (updated)
ranolazine, Angina Pectoris
Date of authorisation: 08/07/2008, Revision: 22, Authorised, Last updated: 11/08/2022 -
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Direct animal healthcare professional communications (new)
Last updated: 11/08/2022 -
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News: EMA business hours over Assumption Day, 15 August (new)
Last updated: 11/08/2022 -
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Direct healthcare professional communication (DHPC): Hiprabovis IBR Marker Live (infectious bovine rhinotracheitis vaccine (live)) - Increase in the incidence of anaphylactic-type reactions in cattle (new)
Active substance: live gE- tk- double-gene-deleted bovine herpes virus type 1, strain CEDDEL: 106.3–107.3 CCID50, DHPC type: Adverse event, Last updated: 11/08/2022 -
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Orphan designation: allogeneic peripheral blood mononuclear cells incubated ex-vivo with 16, 16-dimethyl prostaglandin E2, dexamethasone for: Treatment in haematopoietic stem cell transplantation (updated)
Date of designation: 18/11/2016, Withdrawn, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Grasustek (updated)
pegfilgrastim, Neutropenia
Date of authorisation: 20/06/2019,, 
, Revision: 3, Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Vaxelis (updated)
Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein., Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B
Date of authorisation: 15/02/2016, Revision: 11, Authorised, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Metalyse (updated)
tenecteplase, Myocardial Infarction
Date of authorisation: 23/02/2001, Revision: 20, Authorised, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Gliolan (updated)
5-aminolevulinic acid hydrochloride, Glioma
Date of authorisation: 07/09/2007, Revision: 7, Authorised, Last updated: 10/08/2022 -
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Committee for Herbal Medicinal Products (HMPC): 18-20 July 2022 (updated)
from 18/07/2022 to 20/07/2022, Last updated: 10/08/2022 -
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HMPC: Agendas, minutes and meeting reports (updated)
Last updated: 10/08/2022 -
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Combination Herbal medicinal product: Species digestivae and stomachicae (updated)
Herbal tea combinations for use in gastrointestinal complaints, F: Assessment finalised, Last updated: 10/08/2022 -
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Herbal medicinal product: Paulliniae semen (updated)
Paullinia cupana Kunth (syn. Paullinia sorbilis Mart.), Guarana, F: Assessment finalised, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, Revision: 33, Authorised, Last updated: 10/08/2022
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Herbal medicinal product: Origani dictamni herba (updated)
Origanum dictamnus L., Dittany of Crete herb, F: Assessment finalised, Last updated: 10/08/2022 -
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Herbal medicinal product: Marrubii herba (updated)
Marrubium vulgare L., White horehound, F: Assessment finalised, Last updated: 10/08/2022 -
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Orphan designation: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor) for: Treatment of cystic fibrosis (updated)
Date of designation: 08/07/2008, Expired, Last updated: 10/08/2022 -
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Combination Herbal medicinal product: Hyperici herba and Cimicifugae rhizoma (updated)
Hypericum perforatum L., Cimicifuga racemosa (L.) Nutt., St. John's Wort, Black Cohosh, D: Draft under discussion, Last updated: 10/08/2022 -
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Herbal medicinal product: Liquiritiae radix (updated)
Glycyrrhiza glabra L.; Gycyrrhiza inflata Bat.; Glycyrrhiza uralensis Fisch., Liquorice Root, F: Assessment finalised, Last updated: 10/08/2022 -
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Herbal medicinal product: Centellae asiaticae herba (updated)
Centella asiatica (L.) Urb., Centella, F: Assessment finalised, Last updated: 10/08/2022 -
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Herbal medicinal product: Lichen islandicus (updated)
Cetraria islandica (L.) Acharius s.l., Iceland moss, F: Assessment finalised, Last updated: 10/08/2022 -
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Herbal medicinal product: Cnici benedicti herba (updated)
Cnicus benedictus L., St. Benedict's thistle (also blessed thistle, holy thistle or spotted thistle), D: Draft under discussion, Last updated: 10/08/2022 -
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Orphan designation: recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein, Eladocagene exuparvovec for: Treatment of aromatic L-amino acid decarboxylase deficiency (updated)
Date of designation: 18/11/2016, Positive, Last updated: 10/08/2022 -
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Human medicine European public assessment report (EPAR): Comirnaty (updated)
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2, COVID-19 virus infection
Date of authorisation: 21/12/2020,
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, Revision: 27, Authorised, Last updated: 10/08/2022