Übersetzung für "Klinische angaben" in Englisch

The MAHs will produce fully harmonised Risk Minimisation tools that contain all of the important information from the Clinical Particulars section of the Core SPC.

These monographs contain relevant information for herbal medicinal products, such as a definition, the constituents, clinical particulars, pharmacological properties and bibliographical references.

By a decision of 1996, in accordance with that opinion, the Commission instructed the Member States concerned to amend certain clinical particulars required under the marketing authorisations of those drugs.

Two complete dossiers are required together with two summaries and six additional copies of Part III (Toxicological and Pharmacological) and Part IV (Clinical).

A clinical autopsy is a macroscopic medical examination by a physician of (if possible) all three body cavities of a deceased person, supplemented by clinical information relating to the medical history, cause of death, and clinical questions (Box 1).

As Quality-of-Life measurement results are stored together with other medical data inside the electronic medical record, clinical and outcome or patient benefit related information may now be evaluated in combination without additionally incurring workload.

Another requirement that needs to be kept in mind is the differentiation between technical and clinical claims and the need to prove clinical claims with respective clinical data.

Basic pharmacokinetic information concerning a new active substance is generally useful in the clinical context.

This included information from preclinical and clinical studies, as well as information provided by the companies that make the medicines.

The Commission does not accept amendments 189 and 190, which lay down a requirement to refer to clinical information using natural frequencies in the relevant part of the summary of product characteristics and to include the research designs.

It should be recalled that the objective of Directive 87/21/EEC is to achieve a greater degree of harmonisation in the rules of the Member States concerning the acceptability of abridged applications (which do not contain full pharmacotoxicological and clinical data) for authorisation for products which are copies of established proprietary medicinal products.

Particulars concerning clinical iríais shall be sufficiently detailed to enable an objective judgement to be made.

The clinical particulars to be provided pursuant to point 8 of Article 4 (2) of Directive 65/65/EEC must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing lhe granting of a marketing authorization.

The clinical particulars to be provided pursuant to point 8 of Article 4 (2) of Directive 65/65/EEC must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorization.

The clinical particulars to be provided pursuant to point 8 of Article 4 (2) of Directive 65/65/EEC must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorization.

Overdosage All available - pharmacological and clinical - information concerning symptoms and therapeutic measures in accidental overdosage or deliberate self-poisoning should be provided.

The clinical particulars to be provided pursuant to point 8 of Article 4 (2) of Directive 65/65/EEC must enable a sufficiently well-founded and scientifically valid opinion to be formed as to whether the medicinal product satisfies the criteria governing the granting of a marketing authorization.

For instance, the clinical description of 75% stenosis of an artery refers to the area, not the diameter.

This uncertainty is related to the limitations of the hitherto unstructured collection of data, potential duplicate registrations, unclear clinical and pathological data, the lack of information on the number of implants inserted as denominator, and, more than likely, undiagnosed cases (26, 27).

In this regard, the sponsor shall submit all the information and documents necessary for the assessment especially the results of the analytical and pharmacological-toxicological tests as well as the trial protocol and the clinical data on the medicinal product including the investigator's brochure.

Out of 407 performed re-keratoplasties 371 corneal buttons (from 308 patients) were available for examination with sufficient clinical data.

The competent higher federal authority may examine authorisation-related data and documents also in connection with a marketing authorisation pursuant to Article 3 paragraph 1 or 2 of Regulation (EC) No. 726/2004 in enterprises and facilities which develop, manufacture, test or clinically investigate medicinal products.