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Referral: Symbioflor 2
escherichia coli bacteria (cells and autolysate), associated names: Symbioflor E. Coli, Symbioflor® 2, Symbioflor Escherichia, Article 31 referrals
Status: European Commission final decision, EC decision date: 22/06/2017, Last updated: 07/09/2017bacteria, has been described as a probiotic, which means that it encourages … medicine has been described as probiotic, which means that it encourages … bacteria, has been described as a probiotic, which means that it encourages … -
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Bifidobacterium bifidum are so-called probiotics: bacteria that do not cause … from colonising the gut. Probiotics are currently used to prevent … Bifidobacterium bifidum are so-called probiotics: bacteria that do not cause … -
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Press release: EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome
CHMP, Last updated: 23/06/2017bacteria, has been described as a probiotic, which means that it encourages … bacteria, has been described as a probiotic, which means that it encourages … medicine has been described as probiotic, which means that it encourages … -
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Reducing the use of antimicrobial agents in animal husbandry
Last updated: 17/07/2018measures, such as vaccines, probiotics, prebiotics, bacteriophages …
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Orphan designation: Escherichia coli, strain Nissle 1917, expressing high affinity phenylalanine transporter, phenylalanine ammonia lyase and L-amino acid deaminase for: Treatment of hyperphenylalaninaemia
Date of designation: 21/06/2022, Positive, Last updated: 15/09/2022an engineered (modified) probiotic bacterium that was designed … -
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Human medicine European public assessment report (EPAR): Entyvio (updated)
vedolizumab, Colitis, Ulcerative; Crohn Disease
Date of authorisation: 22/05/2014, Revision: 25, Authorised, Last updated: 09/11/2023 -
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Human medicine European public assessment report (EPAR): Constella
linaclotide, Irritable Bowel Syndrome
Date of authorisation: 26/11/2012, Revision: 25, Authorised, Last updated: 24/05/2023 -
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Human medicine European public assessment report (EPAR): Zinplava
Bezlotoxumab, Enterocolitis, Pseudomembranous
Date of authorisation: 18/01/2017, Revision: 10, Authorised, Last updated: 18/07/2023 -
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Human medicine European public assessment report (EPAR): Prevenar 13 (updated)
Pneumococcal polysaccharide serotype 1, Pneumococcal polysaccharide serotype 3, Pneumococcal polysaccharide serotype 4, Pneumococcal polysaccharide serotype 5, Pneumococcal polysaccharide serotype 6A, Pneumococcal polysaccharide serotype 6B, Pneumococcal polysaccharide serotype 7F, Pneumococcal polysaccharide serotype 9V, Pneumococcal polysaccharide serotype 14, Pneumococcal polysaccharide serotype 18C, Pneumococcal polysaccharide serotype 19A, Pneumococcal polysaccharide serotype 19F, Pneumococcal polysaccharide serotype 23F, Pneumococcal Infections; Immunization
Date of authorisation: 09/12/2009, Revision: 45, Authorised, Last updated: 27/11/2023 -
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EU Innovation Network (EU-IN)
Last updated: 19/10/2023 -
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Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
Virtual meeting, 11/12/2020, Last updated: 11/12/2020 -
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Evaluation of medicinal products for the treatment of irritable bowel syndrome - Scientific guideline
Last updated: 25/09/2014 -
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News: Guideline on medicines for the treatment of irritable bowel syndrome released for a six-month public consultation
CHMP, Last updated: 19/07/2013 -
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Assessment of the effect of antimicrobial substances on dairy starter cultures - Scientific guideline
Last updated: 01/02/2016production of yoghurt and probiotic milk products. Lb. helveticus …
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Needs for paediatric medicines
Last updated: 11/05/2016 -
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Clinical investigation of medicinal products for the treatment of chronic constipation - Scientific guideline
Last updated: 14/09/2015 -
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EMA Human Scientific Committees' Working Parties with Patients' and Consumers' Organisations (PCWP) and Healthcare Professionals' Organisations (HCPWP) joint meeting: info session on antimicrobial resistance
European Medicines Agency, London, UK, 19/09/2017, Last updated: 09/10/2017 -
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Committee for Medicinal Products for Human Use (CHMP): 20-23 February 2017
European Medicines Agency, London, UK, from 20/02/2017 to 23/02/2017, Last updated: 06/01/2014 -
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Guidance documents related to data submission for authorised medicines
Last updated: 19/07/2022 -
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CHMP: meeting archive 2016-2018
Last updated: 26/02/2020