Last update 27 May 2025

Human Normal Immunoglobulin (The Japan Blood Products Organization)

Overview

Basic Info

Drug Type
Immunoglobulin
Synonyms
IVIG, Nisseki Polyglobin-N, pH4-treated Acidic Human Normal Immunoglobulin
+ [9]
Target-
Action-
Mechanism-
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
Regulation-
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Graft Rejection
Japan
24 Sep 2024
Guillain-Barre Syndrome
Japan
08 Feb 2017
Pemphigoid, Bullous
Japan
27 Jul 2016
Otitis Media
Japan
02 Feb 2015
Pemphigus
Japan
05 Aug 2013
Myasthenia Gravis
Japan
26 Sep 2011
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Japan
07 Feb 2011
Dermatomyositis
Japan
27 Oct 2010
Polymyositis
Japan
27 Oct 2010
Mucocutaneous Lymph Node Syndrome
Japan
31 Jan 1996
Agammaglobulinemia
Japan
28 Jun 1991
Infectious Diseases
Japan
28 Jun 1991
Purpura, Thrombocytopenic, Idiopathic
Japan
28 Jun 1991
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Abortion, HabitualPhase 3
Japan
03 Jun 2014
Kidney Failure, ChronicPhase 3
Japan
01 Nov 2013
Autoimmune DiseasesPreclinical
United States
30 Oct 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
25
eycgkxyeow(wxzsdcwapz) = iaobfukvkp bwkchjkyif (ebyasaxrki, 1 - 000-10 to 500)
Positive
14 May 2024
eycgkxyeow(wxzsdcwapz) = kdocxqbwpi bwkchjkyif (ebyasaxrki, 1 - 000-10 to 500)
Not Applicable
651
yrqdupgvpp(xnbaxwqlrs) = fupdavrtxt hgmahmbpmv (oasfwcnbfl )
-
10 Dec 2023
Not Applicable
-
csmcofbyrh(wfwmiowfcv) = rjzicrxdyh qdirmjwxwy (foabybbuml )
-
01 Mar 2023
No IVIG
csmcofbyrh(wfwmiowfcv) = ukxxtpabjs qdirmjwxwy (foabybbuml )
Not Applicable
decreased IgA levels | concurrent treatment with an immunomodulating agent | prior reported drug-allergy ...
15
IVIG infusion
ibgxgohpth(cuyalkoibs) = xmxqorjhkp rjacarvoks (ptqdghcvtz )
Positive
01 Feb 2023
Not Applicable
Pain | Peripheral Nervous System Diseases
auto-/dysimmune antibodies
-
ofqsduafey(hrcdqlxfsb) = Four patients discontinued treatment before follow-up due to side effects hvqmbkmtng (ornuhughgc )
Positive
29 Sep 2022
Not Applicable
-
veetvihbwk(nezbqlmgmn) = eckcubyrst kciquecuta (pkkyjzqdxt, 1.19 - 2.10)
-
03 May 2022
rkdbwpjanc(pvqormqqav) = biobfqnzas ibglpwmbaa (kuspkuwumd )
Not Applicable
142
lsduqfwqho(olscidvszm) = allergic dermatitis qjunmcogma (cbtxbwfoiu )
-
03 May 2022
Not Applicable
53
(PCV13 vaccination)
kjdljmrpce(qifwihlmbm) = xhfdfncvgv elwisggdff (rxhhnnrbhg )
-
01 Feb 2022
(PPSV23 vaccination)
lrvvibcmvn(nwkljcukbi) = mxwvkygllq uhuavwgtgc (txjfrefxxp )
Not Applicable
anti-aquaporin 4 (AQP4) antibodies | anti-myelin oligodendrocyte glycoprotein (MOG) antibodies | anti-Human 3-hydroxy-3-methylglutaryl-Coenzyme A reductase (HMGCR) antibodies ...
-
IVIg preparations
nnbojqnkfu(mdchrfanil) = iynmavvgna brzwcwsyiw (prjhgktrjh, 41 - 816)
-
09 Apr 2019
Not Applicable
2
dcluwxcjuo(eoffvqwyqg) = Both OMA and MRI changes resolved significantly with 2 sessions of IVIG fmqckkrdtl (mzobdxnahf )
Positive
09 Apr 2019
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Clinical Trial

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Approval

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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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