Abstract:
:For each medicinal product quality, safety and efficacy have to be proven to obtain a marketing authorisation. The national competent health authorities and the European Medicines Agency (EMEA) with support of the Heads of Medicines Agencies (HMA) work together to grant marketing authorisations for medicinal products. Several regulatory procedures to apply for a marketing authorisation in the European Community (EC) and associated countries exist. After approval by a national procedure a medicinal product can be marketed in only one country. If a medicinal product should enter the markets of two or more European countries of choice the application has to undergo the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP). A marketing authorisation granted by the Centralised Procedure (CP) is valid in the whole EC. The CP is mandatory for certain medicinal products, for example all products derived from recombinant DNA technology including recombinant allergens. The guidance documents applicable to allergen products comprise general as well as product-specific guidelines such as the Note for Guidance on Allergen Products and the Monograph on Allergen Products of the European Pharmacopoeia. So-called 'named patient products' have a special status and are applied to patients without having a marketing authorisation. Recombinant allergens as medicinal products are insufficiently covered by the existing allergen product-specific guidelines, but product-specific guidelines are in the development stage.
journal_name
Int Arch Allergy Immunoljournal_title
International archives of allergy and immunologyauthors
Lorenz AR,Luttkopf D,Seitz R,Vieths Sdoi
10.1159/000146074subject
Has Abstractpub_date
2008-01-01 00:00:00pages
263-75issue
4eissn
1018-2438issn
1423-0097pii
000146074journal_volume
147pub_type
杂志文章,评审abstract::Amino acid sequencing of the major mite allergen Der fII purified from mite body extract revealed that it is a mixture of at least two variants. Substitutions were found only at positions in which amino acid variations were predicted from the nucleotide sequences of three cloned cDNAs. When cDNAs corresponding to the ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236804
更新日期:1994-09-01 00:00:00
abstract:BACKGROUND/AIMS:The antioxidant properties of vitamin C and E are considered to be important for their anti-inflammatory activity. Recently, antioxidant resveratrol was found to suppress neopterin production and tryptophan degradation in mitogen-treated human peripheral blood mononuclear cells. METHODS:In this study, ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000096438
更新日期:2007-01-01 00:00:00
abstract:BACKGROUND:In developed countries, increasing food allergy prevalence and concern regarding food allergies have been reported. Although the use of complementary and alternative medicine (CAM) for the treatment of allergic diseases has increased in some Western countries, the actual proportion and patterns of CAM use fo...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,多中心研究
doi:10.1159/000338936
更新日期:2012-01-01 00:00:00
abstract::We have systematically investigated the capacity of highly purified human peripheral CD8+ T cells to produce interleukin (IL)-4 and interferon (IFN)-gamma when triggered by different stimuli. CD8+ T cells were isolated from peripheral blood by positive selection to > 99% purity and stimulated with one of three differe...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000237030
更新日期:1995-05-01 00:00:00
abstract:BACKGROUND:Egg allergy is one of the most common food allergies in children. The standard therapy for egg allergy is strict avoidance. Yet, there is considerable clinical and scientific interest in primary or secondary prevention. A major drawback of oral tolerance (OT) induction protocols, however, is the possibility ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000363110
更新日期:2014-01-01 00:00:00
abstract::Antibodies to rat Thy-1, and also to murine Thy-1, could provoke reverse passive cutaneous anaphylaxis-like (RPCA-like) reactions. The threshold amount of purified anti-Thy-1 antibodies for RPCA-like reactions was 12.5 microg/ml. No RPCA-like reactions were obtained with IgG1 F(ab')2 anti-Thy-1. Cross-linking the muri...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000237662
更新日期:1997-10-01 00:00:00
abstract:BACKGROUND:The implementation of allergen immunotherapy (AIT) requires extensive knowledge of allergen distribution in the region to identify high-risk regions for AIT utilization. However, the geographical distribution patterns of the major Dermatophagoides allergens in China remain unclear despite the increasing prev...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000499409
更新日期:2019-01-01 00:00:00
abstract:INTRODUCTION:Cow's milk protein allergy (CMA) is the most common type of food allergy in childhood and exclusion diet is a challenge for patients. OBJECTIVE:The study aim was to investigate the frequency of tolerance to baked foods containing milk and evaluate immediate skin prick test (SPT) and specific IgEs for diff...
journal_title:International archives of allergy and immunology
pub_type: 新闻
doi:10.1159/000511148
更新日期:2020-10-14 00:00:00
abstract:BACKGROUND:Cytosolic phospholipase A2 (cPLA2) plays a key role in the development of late-phase anaphylaxis. L-Glutamine (Gln), a nonessential amino acid, has anti-inflammatory activity via inhibiting cPLA2. METHODS:We used a penicillin-induced murine model of anaphylaxis, and late-phase anaphylaxis was quantified by ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000452103
更新日期:2016-01-01 00:00:00
abstract::Highly degenerate profilin-specific primers were used to amplify by polymerase chain reaction the profilin-coding sequence of wheat cDNA. Analyzing the sequencing data after subcloning revealed the existence of three isoforms. The high amino acid sequence identity with the birch pollen allergen Betv II suggests that w...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236824
更新日期:1994-10-01 00:00:00
abstract:BACKGROUND:Docosahexaenoic acid (DHA) found in fish oil is known to depress inflammation-related mediators. We investigated a novel delivery method of tridocosahexaenoyl-glycerol (DHA-TG). METHODS:BALB/c mice (6-8 weeks old) were primed intraperitoneally with ovalbumin (OVA) and Al(OH)(3) on days 0 and 7, and with aer...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000053645
更新日期:2000-12-01 00:00:00
abstract:BACKGROUND:DNA immunization and protein immunization with CpG motifs as adjuvants represent promising approaches in allergen-specific immunotherapy. OBJECTIVE:We investigated the effect of coinjection or prepriming with CpG-ODN on Th2-type responses induced by gene gun and protein immunization. METHODS:BALB/c mice we...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000053772
更新日期:2001-01-01 00:00:00
abstract:BACKGROUND:Specific immunotherapy for respiratory allergy, a seasonal disease, significantly reduces the inflammatory process, attenuating the clinical symptoms. The mechanism for the clinical beneficial effect of immunotherapy has not yet been clarified. Melatonin shows a circadian and seasonal variation and together ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000049498
更新日期:2001-09-01 00:00:00
abstract::CD95 (APO-1) is a member of the TNF/nerve growth factor receptor superfamily, which is expressed on the surface of different types of cells. Cross-linking of CD95 leads to the induction of apoptosis. This may be of importance in many physiological systems, but seems to play a special role for the maintenance of immuno...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000237293
更新日期:1996-07-01 00:00:00
abstract:BACKGROUND:Asthma, allergic conditions, and COPD overlap, but the effect of them and their combinations on disease severity, need for drugs, use of healthcare, and costs is poorly known. OBJECTIVE:To study how different allergic diseases co-occur in asthma and allergy patients and evaluate the use of medication well a...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000498861
更新日期:2019-01-01 00:00:00
abstract::Accumulation and activation of eosinophils in tissue are critical events in the allergic inflammatory response and adhesion molecules play important roles in this process. We previously demonstrated that human eosinophils expressed a nuclear receptor, peroxisome proliferator-activated receptor gamma (PPARgamma), and t...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000126054
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:Intravenous immunoglobulin (IVIG) is the mainstay therapy in human immune deficiency states characterized by qualitative and quantitative reductions in B cells. In addition, however, there is widespread use of IVIG in a number of other areas, including neuroimmunologic, infectious, dermatologic, hematologic,...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000093204
更新日期:2006-01-01 00:00:00
abstract:BACKGROUND:We analyzed the T cell activation potency and the IgE-binding properties (allergenicity) of nine isoforms of Bet v 1, the major allergen of birch pollen. METHODS:The capacity of recombinant Bet v 1 isoforms to bind serum IgE from allergic patients was evaluated by immunoblot experiments and skin prick tests...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000237524
更新日期:1997-05-01 00:00:00
abstract::T cells are central regulators and mediators of allergic sensitisation and disease. The house dust mite allergens are a biochemically diverse group of proteins which are present in extracts and the environment in a wide range of concentrations. Here the importance of ascertaining the contribution of the different alle...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000023824
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND:Little is known about the relation between allergic rhinitis severity and airborne pollen in combination with air pollutants. OBJECTIVE:To model the risk of suffering from severe seasonal allergic rhinitis (SAR) as a function of both pollen count and air pollution levels in a large nationwide sample of pati...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000332964
更新日期:2012-01-01 00:00:00
abstract::A high-dose, accelerated escalation schedule during subcutaneous allergen-specific immunotherapy (AIT) is safe and well-tolerated in adults. However, there are no data in children and adolescents. The aim of the present trial was to assess safety and tolerability of an accelerated dose escalation schedule of an AIT wi...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000512561
更新日期:2021-01-27 00:00:00
abstract:BACKGROUND:Protective acquired immunity against helminths and allergic sensitisation are both characterised by high IgE antibody levels. Levels of IgE antibodies are naturally tightly regulated by several mechanisms including binding of the CD23 receptor. Following observations that helminth infections and allergic sen...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000346545
更新日期:2013-01-01 00:00:00
abstract:BACKGROUND:Chronic granulomatous disease (CGD) is a rare genetic disorder characterized by failure of phagocytic leukocytes to destroy certain microbes. We present a study on CGD patients enrolled at a single medical center concerning the infectious and noninfectious complications and genetic properties of the disease....
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000507366
更新日期:2020-01-01 00:00:00
abstract::Profilins are ubiquitous proteins, present in all eukaryotic cells and identified as allergens in pollen, latex and plant foods. The highly conserved structure justifies the cross-reactive nature of IgE antibodies against plant profilins and their designation as pan-allergens. Primary sensitization to profilin seems t...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章,评审
doi:10.1159/000321178
更新日期:2011-01-01 00:00:00
abstract::Bronchial asthma is characterized by infiltration of the respiratory tracts by eosinophils. A wide variety of adhesion molecules expressed by eosinophils have been proposed to be involved in binding of eosinophils to the vascular endothelium and subsequent transmigration from the circulation to the airways, while litt...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000237722
更新日期:1997-10-01 00:00:00
abstract:BACKGROUND:Secretory phospholipases A(2) (sPLA(2)) are an emerging class of mediators of inflammation. These enzymes are released in vivo in patients with systemic inflammatory diseases and allergic disorders. sPLA(2)s may activate inflammatory cells by both enzymatic and nonenzymatic mechanisms. The aim of this study ...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000218117
更新日期:2009-01-01 00:00:00
abstract::Superoxide (O2-) and nitric oxide (NO) production by polymorphonuclear leukocyte (PMNs) and monocytes in patients with liver cirrhosis were evaluated. PMNs obtained from cirrhotic patients were less effective than those from controls in producing O2- after stimulation with opsonized zymosan, while they were more effec...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000236975
更新日期:1995-05-01 00:00:00
abstract::In this study, we postulated that repeated cycles of IgE passive sensitisation and antigen challenge may play a role in up-regulating eosinophil response in allergic conditions. Antigen-mediated stimulation of the pleural cavity of rats passively sensitised with a single injection of IgE anti-DNP resulted in mast cell...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000049530
更新日期:2001-12-01 00:00:00
abstract:BACKGROUND:The high-affinity IgE receptor, FcepsilonRI, is unresponsive on mast cells and basophils from people in several populations through an unknown mechanism. Similarly, FcepsilonRI-positive basophils from 'nonreleasers' are IgE-unresponsive and are deficient in the tyrosine kinase Syk. OBJECTIVE:To test the hyp...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000087355
更新日期:2005-09-01 00:00:00
abstract:BACKGROUND:It has been reported that protein tyrosine phosphorylation is essential for cytokine production in mouse Th1 cells but not in Th2 cells. However, little is known about the difference of signal transduction between human antigen-specific Th1 and Th2 cell clones. METHODS:Purified protein derivative-specific T...
journal_title:International archives of allergy and immunology
pub_type: 杂志文章
doi:10.1159/000024028
更新日期:1999-01-01 00:00:00