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Keyword immunoglobulin Remove keyword
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Human medicine European public assessment report (EPAR): HyQvia
Human normal immunoglobulin, Immunologic Deficiency Syndromes
Date of authorisation: 16/05/2013, Revision: 20, Authorised, Last updated: 17/07/2023Authorised human normal immunoglobulin Overview This is a summary … diseases), also known as immunoglobulins. HyQvia is used as ‘replacement … deliver the human normal immunoglobulin under the skin and improve … -
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Human medicine European public assessment report (EPAR): Zutectra
human hepatitis B immunoglobulin, Immunization, Passive; Hepatitis B; Liver Transplantation
Date of authorisation: 30/11/2009, Revision: 15, Authorised, Last updated: 31/08/2022Authorised human hepatitis B immunoglobulin Overview This is a summary … substance , human hepatitis-B immunoglobulin. What is Zutectra used for … Zutectra, human hepatitis B immunoglobulin, is a purified antibody extracted … -
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Human medicine European public assessment report (EPAR): ImmunoGam
human hepatitis B immunoglobulin, Immunization, Passive; Hepatitis B
Date of authorisation: 16/03/2010, Withdrawn, Last updated: 26/01/2011Withdrawn human hepatitis B immunoglobulin Overview The marketing authorisation … gt;ImmunoGamEMEA/H/C/001055human hepatitis B immunoglobulinhuman hepatitis B immunoglobulinImmunization, PassiveHepatitis BJ06BB04 … ImmunoGam Human Hepatitis B Immunoglobulin On 15 March 2010 the European … -
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Human medicine European public assessment report (EPAR): Privigen
human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome
Date of authorisation: 24/04/2008, Revision: 31, Authorised, Last updated: 15/06/2023Authorised human normal immunoglobulin (IVIg) Overview Privigen … enough antibodies (also called immunoglobulins, proteins in the blood that … active substance human normal immunoglobulin. How is Privigen used? Privigen … -
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Human medicine European public assessment report (EPAR): Kiovig
human normal immunoglobulin (IVIg), Purpura, Thrombocytopenic, Idiopathic; Bone Marrow Transplantation; Immunologic Deficiency Syndromes; Guillain-Barre Syndrome; Mucocutaneous Lymph Node Syndrome
Date of authorisation: 18/01/2006, Revision: 26, Authorised, Last updated: 27/06/2022Authorised human normal immunoglobulin Overview Kiovig is a medicine … enough antibodies (also called immunoglobulins, proteins in the blood that … active substance human normal immunoglobulin. How is Kiovig used? Kiovig … -
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Human medicine European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif)
Human normal immunoglobulin, Mucocutaneous Lymph Node Syndrome; Guillain-Barre Syndrome; Bone Marrow Transplantation; Purpura, Thrombocytopenic, Idiopathic; Immunologic Deficiency Syndromes
Date of authorisation: 23/07/2007, Revision: 18, Authorised, Last updated: 04/02/2022Authorised human normal immunoglobulin Overview This is a summary … active substance human normal immunoglobulin. What is Flebogamma DIF used … Flebogamma DIF, human normal immunoglobulin, is a highly purified protein … -
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Human medicine European public assessment report (EPAR): Hizentra
human normal immunoglobulin (SCIg), Immunologic Deficiency Syndromes
Date of authorisation: 14/04/2011, Revision: 21, Authorised, Last updated: 13/01/2022Authorised human normal immunoglobulin (SCIg) Overview Hizentra … diseases), also known as immunoglobulins. It is used to treat the following … active substance human normal immunoglobulin. How is Hizentra used? Hizentra … -
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Opinion/decision on a Paediatric investigation plan (PIP): HyQvia, Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-000872-PIP01-10-M03, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for infusion
Decision date: 27/08/2015, Last updated: 13/11/2015, Compliance check: V, 30/10/2015Active substance Human normal immunoglobulin Therapeutic area Immunology-Rheumatology-Transplantation … investigation plan for human normal immunoglobulin (HyQvia) (EMEA-000872-PIP01-10-M03 … investigation plan for human normal immunoglobulin (HyQvia) (EMEA-000872-PIP01-10-M03 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Flebogamma DIF (previously Flebogammadif), 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-003121-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 11/03/2022, Last updated: 20/04/2023, Compliance check: XFlebogammadif) Human normal immunoglobulin Immunology-Rheumatology-TransplantationP/0094/2022EMEA-003121-PIP01-21 … specific waiver for human normal immunoglobulin (Flebogamma 5% DIF) (EMEA-003121-PIP01-21 … specific waiver for human normal immunoglobulin (Flebogamma 5% DIF), (EMEA-003121-PIP01-21 … -
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Orphan designation: Human Staphylococcus aureus immunoglobulin, human Staphylococcus epidermidis polyclonal immunoglobulin for: Late onset sepsis in premature infants of less or equal than 32 weeks of gestational age
Date of designation: 14/12/2005, Withdrawn, Last updated: 29/07/2008Human Staphylococcus aureus immunoglobulin / human Staphylococcus epidermidis … Staphylococcus epidermidis polyclonal immunoglobulin … Staphylococcus aureus polyclonal immunoglobulin and human Staphylococcus … -
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Orphan designation: Fusion protein composed of the first 2 immunoglobulin-like domains of the human Roundabout guidance receptor 2 fused to a human IgG1 crystallised fragment for: Treatment of focal segmental glomerulosclerosis
Date of designation: 16/05/2022, Withdrawn, Last updated: 27/07/2023protein composed of the first 2 immunoglobulin-like domains of the human Roundabout … protein composed of the first 2 immunoglobulin-like domains of the human roundabout … protein composed of the first 2 immunoglobulin-like domains of the human Roundabout … -
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Orphan designation: Human immunoglobulin for: Treatment of polymyositis
Date of designation: 24/10/2003, Withdrawn, Last updated: 08/10/2013Human immunoglobulin … orphan designation Human immunoglobulin for the treatment of polymyositis … orphan designation Human immunoglobulin for the treatment of polymyositis … -
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Orphan designation: Human immunoglobulin for: Treatment of dermatomyositis
Date of designation: 20/10/2003, Withdrawn, Last updated: 08/10/2013Human immunoglobulin … orphan designation Human immunoglobulin for the treatment of dermatomyositis … orphan designation Human immunoglobulin for the treatment of dermatomyositis … -
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Orphan designation: Hepatitis C immunoglobulin for: Prevention of recurrent hepatitis C virus induced liver disease in liver transplant recipients
Date of designation: 08/07/2005, Positive, Last updated: 18/08/2008Hepatitis C immunoglobulin … hepatitis C immunoglobulin for the prevention of recurrent … DESIGNATION OF hepatitis C immunoglobulin for the prevention of recurrent … -
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Referral: Vivaglobin
human normal immunoglobulin, Article 36 referrals (prior to July 2012)
Status: European Commission final decision, opinion/position date: 16/02/2012, EC decision date: 07/05/2012, Last updated: 18/11/2013that contains human normal immunoglobulin extracted from blood as the … active substance. Human normal immunoglobulins are antibodies (types of … events are known to occur with immunoglobulins given by injection into a … -
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Referral: Octagam
human normal immunoglobulin, Article 107 procedures (prior to July 2012)
Status: European Commission final decision, opinion/position date: 23/09/2010, EC decision date: 04/10/2010, Last updated: 18/11/2013that contains human normal immunoglobulin extracted from blood as the … active substance. Human normal immunoglobulins are antibodies (types of … for Octagam (human normal immunoglobulin 5% and 10%) PDF icon application/pdf … -
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Referral: Octagam
human normal immunoglobulin, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/04/2011, EC decision date: 30/05/2011, Last updated: 26/04/2011that contains human normal immunoglobulin extracted from blood as the … as the active substance. Immunoglobulins are antibodies (types of … of Octagam (human normal immunoglobulin 5% and 10%) PDF icon application/pdf … -
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Referral: Uman Big
human hepatitis B immunoglobulin, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/12/2008, EC decision date: 06/03/2009, Last updated: 21/03/2009Uman Big Human Hepatitis B Immunoglobulins, 180 IU/ml, solution for injection … solution of human hepatitis B immunoglobulins. Immunoglobulins are blood proteins that … donor plasma. Hepatitis B immunoglobulins contain high levels of antibodies … -
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Orphan designation: Human platelet antigen-1a immunoglobulin for: Prevention of fetal and neonatal alloimmune thrombocytopenia
Date of designation: 27/10/2011, Positive, Last updated: 02/03/2020Human platelet antigen-1a immunoglobulin … Human platelet antigen-1a immunoglobulin for the prevention of fetal … human platelet antigen-1a immunoglobulin for the prevention of fetal … -
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Orphan designation: Human normal immunoglobulin for: Treatment in solid organ transplantation
Date of designation: 20/04/2017, Positive, Last updated: 15/05/2017Human normal immunoglobulin … designation Human normal immunoglobulin for treatment in organ transplantation … designation Human normal immunoglobulin for treatment in organ transplantation … -
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Orphan designation: Human anthrax immunoglobulin for: Post-exposure prophylaxis of inhalation anthrax disease
Date of designation: 09/11/2009, Withdrawn, Last updated: 11/08/2016Human anthrax immunoglobulin … designation of human anthrax immunoglobulin for the post-exposure prophylaxis … designation of human anthrax immunoglobulin for the post-exposure prophylaxis … -
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Orphan designation: Human anthrax immunoglobulin for: Treatment of inhalation anthrax disease
Date of designation: 18/11/2009, Withdrawn, Last updated: 11/08/2016Human anthrax immunoglobulin … designation of human anthrax immunoglobulin for the treatment of inhalation … designation of human anthrax immunoglobulin for the treatment of inhalation … -
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Orphan designation: human monoclonal hepatitis B immunoglobulins for: Prevention of hepatitis-B re-infection following liver transplantation
Date of designation: 23/02/2004, Withdrawn, Last updated: 18/11/2010human monoclonal hepatitis B immunoglobulins … human monoclonal hepatitis B immunoglobulins for the prevention of hepatitis … human monoclonal hepatitis B immunoglobulins for the prevention of hepatitis … -
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Orphan designation: Human Staphylococcus aureus immunoglobulin for: Treatment of Staphylococcus aureus bacteraemia
Date of designation: 03/11/2005, Positive, Last updated: 18/08/2008Human Staphylococcus aureus immunoglobulin … human Staphylococcus aureus immunoglobulin for the treatment of Staphylococcus … human Staphylococcus aureus immunoglobulin for the treatment of Staphylococcus … -
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Orphan designation: Human cytomegalovirus immunoglobulin for: Prevention of congenital cytomegalovirus infection following primary cytomegalovirus infection
Date of designation: 31/10/2006, Positive, Last updated: 15/05/2009Human cytomegalovirus immunoglobulin … human cytomegalovirus immunoglobulin for the prevention of congenital … of human cytomegalovirus immunoglobulin for the prevention of …