109 results
Keyword Albumina LFB Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin (LFB-IgSC)
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-001290-PIP01-12, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 20/12/2012, Last updated: 11/02/2013, Compliance check: XHuman normal immunoglobulin (LFB-IgSC) Immunology-Rheumatology-TransplantationP/0305/2012EMEA-001290-PIP01-12 … Immunodeficiency (PID) Subcutaneous use LFB Biotechnologies France E-mail … Biotechnologies France E-mail: micardt@lfb.fr Tel. +33 169821749 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Recombinant human anti-Rhesus D monoclonal antibody (LFB-R593)
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000512-PIP01-08, Route(s) of administration: Intravenous use, Intramuscular use, Pharmaceutical form(s): Solution for injection
Decision date: 16/06/2009, Last updated: 11/08/2009, Compliance check: Xanti-Rhesus D monoclonal antibody (LFB-R593) Immunology-Rheumatology-TransplantationP/117/2009EMEA-000512-PIP01-08 … Intravenous use Intramuscular use LFB Biotechnologies E-mail: chwed … Biotechnologies E-mail: chwedura@lfb.fr Country: France Phone … -
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Opinion/decision on a Paediatric investigation plan (PIP): Coagulation Factor VIIa (Recombinant)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001203-PIP02-14-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 09/08/2017, Last updated: 16/09/2021, Compliance check: V, 04/09/2020disorders Intravenous use LFB SA France Tel. +33 169827344 … 169827344 E-mail: nogierm@lfb.fr PM: decision on the application … -
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Orphan designation: Complement factor H for: Atypical haemolytic uraemic syndrome
Date of designation: 27/01/2007, Withdrawn, Last updated: 17/10/2013Fractionnement et des Biotechnologies (LFB), France, for complement … Fractionnement et des Biotechnologies (LFB) S.A. in April 2008. For … Fractionnement et des Biotechnologies (LFB), France, for complement … -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000558-PIP02-10, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 06/04/2011, Last updated: 12/05/2011, Compliance check: Xneuropathy (MMN) Intravenous use LFB Biotechnologies micardt lfb.fr France Phone +33 169821749 … application submitted by LFB Biotechnologies on 9 November … decision is addressed to LFB Biotechnologies, 3, avenue … -
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Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen (human plasma-derived)
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000457-PIP02-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for infusion
Decision date: 11/06/2014, Last updated: 15/07/2014, Compliance check: V, 16/12/2016deficiency Intravenous use LFB Biotechnologies France E-mail … Biotechnologies France E-mail: brossela@lfb.fr Tel. +33 169821786 Fax … application submitted by LFB Biotechnologies on 3 February … -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000558-PIP01-09-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 04/04/2014, Last updated: 14/05/2014, Compliance check: V, 23/05/2014Immunodeficiency (PID) Intravenous use LFB Biotechnologies France E-mail … France E-mail: metenanizi@lfb.fr Tel. +33 1698 21029 Fax … application submitted by LFB Biotechnologies on 13 December … -
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Opinion/decision on a Paediatric investigation plan (PIP): Chimeric monoclonal anti-Shiga toxin antibodies cαStx1 and cαStx2
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001134-PIP01-11, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 20/12/2011, Last updated: 19/01/2012, Compliance check: Xcomplications Intravenous use LFB Biotechnologies France … Biotechnologies France roussariec@lfb.fr +33 169828842 +33 169827182 … application submitted by LFB Biotechnologies on 14 March … -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: Human normal immunoglobulin, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for infusion
Decision date: 29/07/2011, Last updated: 15/09/2011, Compliance check: V, 15/10/2012immunodeficiency (PID) Intravenous use LFB Biotechnologies micardt lfb.fr France Phone: +33 169828842 … application submitted by LFB Biotechnologies on 2 May … decision is addressed to LFB Biotechnologies, 3, avenue … -
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Orphan designation: Recombinant chimeric monoclonal antibody against CD20 (ublituximab) for: Treatment of chronic lymphocytic leukaemia
Date of designation: 26/11/2009, Positive, Last updated: 08/06/2020the European Commission to LFB-Biotechnologies, France, for recombinant chimeric … the European Commission to LFB-Biotechnologies, France, for recombinant chimeric … Sponsor’s contact details: LFB-Biotechnologies 59, rue de Trévise 59000 … -
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Orphan designation: Chimeric monoclonal antibody to shiga toxin 1 and 2 for: Treatment of shiga-toxin-producing bacterial infection
Date of designation: 26/08/2005, Positive, Last updated: 12/04/2019sponsorship was transferred to LFB-Biotechnologies, France, in March 2012. The … sponsorship was transferred to LFB-Biotechnologies, France, in March 2012. What … Sponsor’s contact details: LFB-Biotechnologies 3, Avenue des Tropiques … -
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National expert: Soline Berend, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.29 KB | PDF
- Curriculum Vitae - 16.59 KB | PDF
Manager of QC support unit LFB (France) Sponsor of viral … viral clerance studies for LFB products (2007-2013). Quality … 2007-2013). Quality control for LFB products under development … -
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Opinion/decision on a Paediatric investigation plan (PIP): Antithrombin alfa
Decision type: RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001154-PIP02-15, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 02/12/2016, Last updated: 30/01/2017, Compliance check: XFrance E-mail: metenanizi@lfb.fr Tel.: +33 169821029 Fax … -
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Plasma master file certificates (updated)
Last updated: 04/07/2022(ref. EMA/H/PMF/000014/08) LFB (ref. EMA/H/PMF/000015/09 …
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 80.08 KB | PDF
- Curriculum Vitae - 22.93 KB | PDF
alluminio in soluzioni di albumina umana: un monitoraggio italiano" … precallicreina in soluzioni di albumina umana" (Abs) La trasfusione … -
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National expert: Flora Peyvandi, European Medicines Agency (updated)
- Declaration of interests - 85.75 KB | PDF
- Curriculum Vitae - 147.78 KB | PDF
Purpura 01/2011-12/2014 LFB WILLFACT/WILLFACTIN VON WILLEBRAND … DISEASE 02/2006-12/2017 LFB-KEDRION-GRIFOLS PLASMA DERIVED FACTOR VIII … -
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Orphan designation: Iodine (123I) Serum Amyloid P for: Diagnosis of the extent of histologically proven amyloidosis
Date of designation: 14/02/2003, Withdrawn, Last updated: 10/08/2016Fractionnement et des Biotechnologies (LFB) S.A … et des Biotechnologies (LFB) S.A. 3 avenue des Tropiques … -
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COVID-19 treatments: research and development (updated)
Last updated: 04/07/2022Bio Products Laboratory, LFB, Octapharma, CSL Behring and …
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National expert: Maria Luisa Casini, Italian Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 26.27 KB | PDF
della stabilizzazione dell'albumina sierica da parte di sostanze … -
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National expert: Massimiliano Filosto, European Medicines Agency (updated)
- Declaration of interests - 82.69 KB | PDF
- Curriculum Vitae - 25.18 KB | PDF
Myositis 01/2017-12/2018 LFB biotechnologies I10E CIDP … -
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Human medicine European public assessment report (EPAR): Advate (updated)
octocog alfa, Hemophilia A
Date of authorisation: 02/03/2004, Revision: 31, Authorised, Last updated: 05/07/2022 -
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Human medicine European public assessment report (EPAR): ReFacto AF
moroctocog alfa, Hemophilia A
Date of authorisation: 13/04/1999, Revision: 39, Authorised, Last updated: 30/05/2022 -
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Human medicine European public assessment report (EPAR): Renvela
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 09/06/2009, Revision: 23, Authorised, Last updated: 02/12/2021 -
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Human medicine European public assessment report (EPAR): Voncento
Human coagulation factor VIII, human von willebrand factor, Hemophilia A; von Willebrand Diseases
Date of authorisation: 12/08/2013, Revision: 15, Authorised, Last updated: 13/05/2022 -
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,
, 
, Revision: 9, Authorised, Last updated: 07/04/2022