IgE antibodies are able to bind to high-affinity Fc eta receptors (Fc eta-RI) present on the surface of mast cells and basophils.

Allergen-induced Fc eta-RI cross-linking triggers the release of vasoactive mediators, chemotactic factors and cytokines that cause clinical signs of immediate hypersensitivity.

ETA number,

B eta (ΓΆ) error means the probability that the test

the primary field COP shall be included unless a change to the ETA or transfer level(s) requires the use of primary field COORDATA.

B eta (β) error means the probability that the test ed sample is truly non-compliant, even though a compliant measurement has been obtained (false compliant decision).

Withdrawal of an ETA

Modification of an ETA

A new ETA is issued replacing the previous ETA.

EUROPEAN TECHNICAL APPROVAL ETA

Where appropriate, refer to standards, ETA Guidelines or annex(es) to the ETA.

Rules relating to the granting of an ETA

The content and format of the ETA must correspond to the relevant ETA guideline.

Granting of an ETA without an ETA guideline (according to the Directive, Article 9.2)

Rules relating to the application for an ETA

Granting of an ETA on the basis of ETA guideline (according to the Directive - Article 9.1)

Circulation of the ETA is in accordance with 3.1.2.

GENERAL FORMAT OF EUROPEAN TECHNICAL APPROVAL (ETA)

Name, address and logo of approval body issuing the ETA;

Guideline indicate title and number of ETA Guideline on the basis of which the ETA is granted, unless ETA is issued without an ETA Guideline in accordance with point 3.2 of the Common Procedural Rules, pursuant to Article 9 (2) of the CPD.

Where necessary and appropriate, refer to annex(es) to the ETA.

Thelin is a potent (Ki 0.35 nM) and highly selective ETA antagonist (approximately 6,500-fold more selective for ETA as compared to ETB).

The application for extension must be accompanied by the relevant technical documents required in the ETA guidelines for the extension of an ETA.

If the ETA covers several products, each of them should be dealt with separately.

For modification of an ETA the procedure of a new application applies accordingly.

If in the Technical Board consensus is achieved the ETA is issued by the approval body.

When the application for an ETA is for a product of a family for which the procedure laid down in 3.2.3 has already been established the ETA must be based on that established procedure.

with a slightly higher affinity for ETA receptors (Ki = 4.1–43 nM) than for ETB receptors B

Bosentan competes with the binding of ET-1 and other ET peptides to both ETA and ETB receptors, B

Should the Commission of the EC establish, under provisions of Article 5. 1 of the CPD and after the advice of the Standing Committee, a shortcoming in a given ETA due to a shortcoming of an ETA guideline, the approval bodies shall not issue any more ETAs on the basis of the above ETA guideline.

The format of the ETA must correspond to the 'general format' as agreed by the Commission of the EC.

These effects are mediated by endothelin binding to ETA and ETB receptors located in the endothelium B

Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor.

Before issuing the ETA, the approval body sends the ETA draft to the relevant EOTA bodies and to the General Secretariat with the justifications provided by the applicant asking for their comments within two months.

The content and format of the ETA must correspond to the 'general format' agreed by the Commission of the EC.

Give the full name of EOTA in English and on a new line in the official language(s) of the approval body issuing the ETA

and gives general information (in italics) on how the various sections and specific clauses of the ETA should be drawn up.

Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors.

• Ambrisentan blocks the ETA receptor subtype, localized predominantly on vascular smooth muscle cells and cardiac myocytes.

If the ETA covers several products, the required system of conformity attestation should be indicated separately for each of them.

He has to ensure that these places can be visited by the approval body or its representative during working hours, in view of the issuing of the ETA.

The most common metabolic products are at least 10 times less potent as ETA antagonists than sitaxentan sodium in a standard in vitro test of activity.

The approval body shall withdraw the ETA if the Commission of the EC has informed the Member States according to Article 5 paragraph 1 of the Directive.

The approval body which issues the ETA sends it to: - all other EOTA bodies, - the General Secretariat who will send a copy to the Commission of the EC.

When appropriate for practical reasons or if the ETA holder wishes, the manufacturing plant(s) may also be laid down in a non-published supplement to the ETA which is kept by the issuing approval body and is to be communicated only to the approved bodies involved in the conformity attestation procedure.

In accordance with Article 8 (4) of the Directive, the period of validity of an ETA can be extended for a further period of (in general) five years provided that the EC Commission has not notified the concerned approval bodies and/or EOTA that conditions on which the original ETA were issued have changed.

ET-1 actions are mediated through endothelin A receptors (ETA), present on smooth muscle cells, and endothelin B receptors (ETB), present on endothelial cells.

Methods for the determination of product characteristics (testing, calculation or other methods in so far as reference to ETA Guidelines or standards is not possible),

If such ETA guidelines do not exist, the approval body after consultation with the EOTA bodies, will inform the applicant which technical documents have to be presented.

The ETA is issued by the approval body when all the relevant EOTA bodies have given consent in writing taking account of the Directive, Annex II, paragraph 2, sentence 3.