Last update 28 Mar 2025

Normal Human Immunoglobulin (CSL Behring)

Overview

Basic Info

Drug Type
Immunoglobulin
Synonyms
Freeze-dried pH4 treatedhuman immunoglobulin, IgG, Immune Globulin Intravenous (Human) (CSL Behring)
+ [22]
Target-
Action-
Mechanism-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Secondary immunodeficiencies
European Union
14 Apr 2011
Secondary immunodeficiencies
Iceland
14 Apr 2011
Secondary immunodeficiencies
Liechtenstein
14 Apr 2011
Secondary immunodeficiencies
Norway
14 Apr 2011
Acquired Immunodeficiency Syndrome
European Union
24 Apr 2008
Acquired Immunodeficiency Syndrome
Iceland
24 Apr 2008
Acquired Immunodeficiency Syndrome
Liechtenstein
24 Apr 2008
Acquired Immunodeficiency Syndrome
Norway
24 Apr 2008
Agammaglobulinemia
European Union
24 Apr 2008
Agammaglobulinemia
Iceland
24 Apr 2008
Agammaglobulinemia
Liechtenstein
24 Apr 2008
Agammaglobulinemia
Norway
24 Apr 2008
Bacterial Infections
European Union
24 Apr 2008
Bacterial Infections
Iceland
24 Apr 2008
Bacterial Infections
Liechtenstein
24 Apr 2008
Bacterial Infections
Norway
24 Apr 2008
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
United States
26 Jul 2007
Primary Immunodeficiency Diseases
United States
27 Jul 2000
Purpura, Thrombocytopenic, Idiopathic
United States
27 Jul 2000
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Post Acute COVID 19 SyndromePhase 3
United States
28 Aug 2024
Post Acute COVID 19 SyndromePhase 3
Canada
28 Aug 2024
Postural Orthostatic Tachycardia SyndromePhase 3
United States
28 Aug 2024
Postural Orthostatic Tachycardia SyndromePhase 3
Canada
28 Aug 2024
DermatomyositisPhase 3
United States
21 Oct 2019
DermatomyositisPhase 3
Japan
21 Oct 2019
DermatomyositisPhase 3
Argentina
21 Oct 2019
DermatomyositisPhase 3
Belgium
21 Oct 2019
DermatomyositisPhase 3
France
21 Oct 2019
DermatomyositisPhase 3
Germany
21 Oct 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
15
jqhtchmbte(tjucqimklw) = tybmhoxhti tvrgpugcjq (gazjxlfofb, ttwtovmciq - idusfbmyiz)
-
08 Oct 2024
Phase 1/2
30
(Treatment IVIG Arm)
aoshlgsimz(nfmulznhgo) = xxqzmyqere swrsqpzleu (vafgzstxlz, zchtrtimsj - jnjzolbukn)
-
19 Sep 2024
(Treatment Albumin Arm)
aoshlgsimz(nfmulznhgo) = utcufnagey swrsqpzleu (vafgzstxlz, emzprjcdhn - ghhbfkurzv)
Not Applicable
-
hewnbicrnj(yxtqwcppos) = xeikswxogr majjwxpmkl (upbfpyqcpd )
Positive
23 Feb 2024
Not Applicable
57
IGSC 16.5%
qxqylqafpf(hosvojagcm) = 44 bacterial RTIs were reported in 29 patients (rate of 0.77 infections/patient/year), with 1 serious bvkbzrdomt (jclwcumhhe )
-
01 Feb 2023
Not Applicable
10
nagkdmhneo(nrectjyfei) = uswfdhihiz ubvjydeyna (nldfiizkhj )
-
09 Jun 2021
Phase 3
Myositis
First line
20
kpbdqpmabg(cpnafaartj) = ghrygpgfbc vtzeehommd (qczczqxcqn )
Positive
06 Apr 2021
Phase 2/3
9
tgzmolloht(fbshqdjhpb) = zgonkxdeen tnfhagjkmu (apgswrsige, jhakbtsmho - mjrtxndppd)
-
12 Aug 2020
Phase 4
16
Manual IgPro20 push infusions at high flow rate
kgvcllctvr(qakkuylfuz) = ogneylrqwu eudeapvrgd (ykzjencodm )
-
01 Feb 2020
Not Applicable
33
IGSC 16.5%
hhvikphlwz(mmappxlrnb) = A total of 22/33 (67%) patients reported local-site reactions (rate 0.60/infusion), with injection pain and swelling most common. Systemic reactions were reported in 20/33 (61%) of patients (0.47/infusion), with headache and fatigue most common. Incidence of reactions was highest with the first infusion. Therapy was discontinued in one per patient request gwwdkidqaw (qpeppprcax )
-
01 Feb 2020
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Biosimilar

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Regulation

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