21 results
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Human medicine European public assessment report (EPAR): Semglee (updated)
insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018,
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, Revision: 8, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Hefiya
adalimumab, Spondylitis, Ankylosing; Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis
Date of authorisation: 26/07/2018,, Revision: 12, Authorised, Last updated: 18/04/2023
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Human medicine European public assessment report (EPAR): Kanjinti
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 16/05/2018,, Revision: 10, Authorised, Last updated: 24/03/2023
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Human medicine European public assessment report (EPAR): Trazimera
trastuzumab, Stomach Neoplasms; Breast Neoplasms
Date of authorisation: 26/07/2018,, , Revision: 11, Authorised, Last updated: 17/10/2022
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Human medicine European public assessment report (EPAR): Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 10/10/2009,
, Revision: 11, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Halimatoz
adalimumab, Hidradenitis Suppurativa; Psoriasis; Arthritis, Juvenile Rheumatoid; Uveitis; Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic
Date of authorisation: 26/07/2018,, , Revision: 8, Withdrawn, Last updated: 29/01/2021
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Human medicine European public assessment report (EPAR): Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 26/09/2008, Revision: 3, Withdrawn, Last updated: 21/03/2012 -
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Summary of opinion: RenuTend
tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells, opinion date: 16/02/2022, Positive, Last updated: 21/02/2022 -
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Referral: Engerix B
hepatitis B recombinant vaccine, adsorbed, Article 30 referrals
Status: European Commission final decision, opinion/position date: 13/04/2000, EC decision date: 28/08/2000, Last updated: 28/08/2000 -
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Biologics Working Party documents
Last updated: 30/03/2021 -
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News: Better monitoring of biological medicines
Last updated: 15/08/2016 -
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Biologicals: finished product
Last updated: 04/07/2016 -
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Biologicals: active substance
Last updated: 27/06/2016 -
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VICH GL34 Biologicals: testing for the detection of Mycoplasma contamination - Scientific guideline
Last updated: 13/03/2013 -
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News: European Medicines Agency publishes new document on regulatory procedural advice on similar biological medicines
Last updated: 11/04/2012 -
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Biologics Working Party
Last updated: 31/12/2009 -
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Press release: GlaxoSmithKline Biologicals withdraws its application for a scientific opinion for Globorix
Last updated: 16/10/2007 -
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Press release: European Medicines Agency finalises set of guidelines on similar biological medicines and publishes two more new concept papers
Last updated: 08/03/2006 -
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VICH GL25 Biologicals: testing of residual formaldehyde - Scientific guideline
Last updated: 30/04/2002 -
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VICH GL26 Biologicals: testing of residual moisture - Scientific guideline
Last updated: 30/04/2002 -
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Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics) - Scientific guideline
Last updated: 21/10/1999