1391 results
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Second international symposium on biopharmaceutical statistics
Berlin, Germany, from 01/03/2011 to 03/03/2011, Last updated: 18/11/2010international symposium on biopharmaceutical statistics … International Society for Biopharmaceutical Statistics and the International … -
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ICH M9 on biopharmaceutics classification system based biowaivers
Last updated: 11/02/2020ICH M9 on biopharmaceutics classification system based … ICH M9 on biopharmaceutics classification system based … M9 Step 2b on biopharmaceutics classification system based …
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Press release: DOR BIOPHARMA UK Ltd withdraws marketing authorisation application for orBec (beclomethasone dipropionate)
Last updated: 23/05/2008DOR BIOPHARMA UK Ltd withdraws marketing … formally notified by DOR BIOPHARMA UK Ltd of its decision to … PRESS RELEASE DOR BIOPHARMA UK Ltd withdraws marketing … -
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Appendix IV of the guideline on the investigation on bioequivalence: presentation of biopharmaceutical and bioanalytical data in module 2.7.1
Last updated: 18/11/2011bioequivalence: presentation of biopharmaceutical and bioanalytical data in … applications, bioequivalence data, biopharmaceutics classification system (BCS … CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in …
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European Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth annual regulatory conference on optimising the development of advanced therapies to meet patient needs
CCT venues, 40 Bank Street, Canary Wharf, London E14 5NR, 16/12/2016, Last updated: 03/02/2017Medicines Agency (EMA) / European Biopharmaceutical Enterprises (EBE) fifth annual … conference organised by European Biopharmaceutical Enterprises (EBE), with the … Generic Agenda - EMA / European Biopharmaceutical Enterprises (EBE) fifth annual … -
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Micro, small and medium-sized-enterprise (SME) workshop: Focus on chemistry, manufacturing and controls (CMC) regulatory compliance for biopharmaceuticals and advanced therapies
European Medicines Agency, London, 16/04/2015, Last updated: 01/06/2015regulatory compliance for biopharmaceuticals and advanced therapies … regulatory compliance for biopharmaceuticals and advanced therapies' aims … regulatory compliance for biopharmaceuticals and advanced therapies PDF … -
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Human medicine European public assessment report (EPAR): Glybera
alipogene tiparvovec, Hyperlipoproteinemia Type I
Date of authorisation: 25/10/2012,
, 
, Revision: 8, Withdrawn, Last updated: 30/10/2017
Publication details >uniQure biopharma B.V. 8 25/10/2012 uniQure biopharma B.V. Meibergdreef 61 NL-1105 … authorisation holder, uniQure biopharma B.V., not to apply for a … authorisation. uniQure biopharma B.V. confirmed that it did … -
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Human medicine European public assessment report (EPAR): Exondys
eteplirsen, Muscular Dystrophy, Duchenne
Date of refusal: 06/12/2018,
, Refused, Last updated: 12/12/2018
applied for authorisation, AVI Biopharma International Ltd, requested … -
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Human medicine European public assessment report (EPAR): Doxolipad
doxorubicin hydrochloride, Breast Neoplasms; Ovarian Neoplasms
Date of refusal: 08/08/2019, Refused, Last updated: 26/08/2019for authorisation is TLC Biopharmaceuticals B.V. The company requested … -
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Summary of opinion: Tuznue (updated)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 24/06/2022on 19 May 2022. Prestige Biopharma Belgium, the company that … 19/05/2022 Company name Prestige Biopharma Belgium Status Negative Application … on 19 May 2022. Prestige Biopharma Belgium, the company that … -
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Summary of opinion: Hervelous (updated)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 24/06/2022on 19 May 2022. Prestige Biopharma Belgium, the company that … 19/05/2022 Company name Prestige Biopharma Belgium Status Negative Application … on 19 May 2022. Prestige Biopharma Belgium, the company that … -
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Human medicine European public assessment report (EPAR): Evarrest
human fibrinogen, human thrombin, Hemostasis
Date of authorisation: 25/09/2013,, Revision: 4, Withdrawn, Last updated: 03/04/2018
Publication details >Omrix Biopharmaceuticals N. V.4 25/09/2013 Leonardo … authorisation holder, Omrix Biopharmaceuticals N. V., which notified the … Sealant Matrix to Omrix Biopharmaceuticals NV. This recommendation will … -
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Human medicine European public assessment report (EPAR): Vibativ
telavancin, Pneumonia, Bacterial; Cross Infection
Date of authorisation: 02/09/2011,, Revision: 10, Withdrawn, Last updated: 16/05/2018
Publication details >Theravance Biopharma Ireland Umited10 02/09/2011 … authorisation holder, Theravance Biopharma Ireland Ltd, which notified … -
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Orphan designation: Diaspirin cross-linked haemoglobin for: Treatment of hepatocellular carcinoma
Date of designation: 19/11/2014, Positive, Last updated: 30/09/2019September 2019, New B Innovation Biopharmaceutical (Ireland) Limited changed … name to New Beta Innovation Biopharmaceutical (Ireland) Limited. On 19 … transferred to New B Innovation Biopharmaceutical (Ireland) Limited, Ireland … -
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Orphan designation: Diaspirin cross-linked haemoglobin for: Treatment of oesophageal cancer
Date of designation: 21/03/2016, Positive, Last updated: 30/09/2019September 2019, New B Innovation Biopharmaceutical (Ireland) Limited changed … name to New Beta Innovation Biopharmaceutical (Ireland) Limited. On 21 … transferred to New B Innovation Biopharmaceutical (Ireland) Limited, Ireland … -
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Human medicine European public assessment report (EPAR): Zevalin
ibritumomab tiuxetan, Lymphoma, Follicular
Date of authorisation: 16/01/2004, Revision: 23, Authorised, Last updated: 29/06/2021Marketing-authorisation holder Ceft Biopharma s.r.o. Revision 23 Date of … -
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Orphan designation: Recombinant humanised monoclonal IgG2 lambda antibody against human sclerostin for: Treatment of osteogenesis imperfecta
Date of designation: 27/06/2016, Positive, Last updated: 16/08/2017European Commission to Mereo Biopharma Group Limited, United Kingdom … was transferred to Mereo Biopharma 3 Limited, United Kingdom … was transferred to Mereo Biopharma Ireland Ltd, in July 2018 … -
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Orphan designation: Seletalisib for: Treatment of activated phosphoinositide 3-kinase delta syndrome
Date of designation: 22/02/2018, Withdrawn, Last updated: 19/10/2021European Commission to UCB Biopharma SPRL, Belgium, for seletalisib … syndrome. In October 2021, UCB Biopharma SPRL changed name to UCB Biopharma. Please note that this product … European Commission to UCB Biopharma SPRL, Belgium, for seletalisib … -
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Orphan designation: Rozanolixizumab for: Treatment of immune thrombocytopenia
Date of designation: 11/01/2019, Positive, Last updated: 19/10/2021European Commission to UCB Biopharma S.P.R.L., Belgium, for rozanolixizumab … thrombocytopenia. In October 2021, UCB Biopharma SPRL changed name to UCB Biopharma. What is immune thrombocytopenia … -
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Opinion/decision on a Paediatric investigation plan (PIP): tilmanocept
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Diagnostic
PIP number: EMEA-001255-PIP01-11-M03, Route(s) of administration: Intradermal use, Subcutaneous use, Intratumoral use, Peritumoural use, Intralymphatic use, Interstitial use, Pharmaceutical form(s): Kit for radiopharmaceutical preparation
Decision date: 11/04/2018, Last updated: 10/11/2020, Compliance check: XInterstitial use Navidea Biopharmaceuticals Europe Ltd. Navidea Biopharmaceuticals Europe Ltd. Tel: +1 614-973-7560 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Rilzabrutinib
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002438-PIP02-19, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Film-coated tablet, Age-appropriate oral solid dosage form
Decision date: 12/08/2020, Last updated: 18/06/2021, Compliance check: Xuse Gastric use Principia Biopharma, Inc. Tel. +1 6504167700 … application submitted by Principia Biopharma, Inc. on 28 October 2019 under … is addressed to Principia Biopharma, Inc., 220 E Grand Avenue … -
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Opinion/decision on a Paediatric investigation plan (PIP): Lixivaptan
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001078-PIP01-10, Route(s) of administration: Oral use, Pharmaceutical form(s): Capsule, hard
Decision date: 26/10/2011, Last updated: 23/02/2018, Compliance check: Xhyponatraemia Oral use Cardiokine Biopharma, LLC USA struocchio@cardiokine.com … application submitted by Cardiokine Biopharma, LLC on 13 December 2010 under … is addressed to Cardiokine Biopharma, LLC, 30 South 15th Street … -
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Opinion/decision on a Paediatric investigation plan (PIP): Bruton’s tyrosine kinase inhibitor
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-002438-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Tablet
Decision date: 03/01/2019, Last updated: 24/04/2019, Compliance check: Xpemphigus Oral use Principia Biopharma, Inc. Tel. +1 6504167700 … -
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Human medicine European public assessment report (EPAR): Inductos
dibotermin alfa, Tibial Fractures; Fracture Fixation, Internal; Spinal Fusion
Date of authorisation: 09/09/2002, Revision: 23, Authorised, Last updated: 18/10/2021medicinal product is Medtronic BioPharma B.V. They may request a re-examination … -
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Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,, , 
, Revision: 1, Authorised, Last updated: 31/08/2021