Translation of "Nicht ausreichend belegt" in English

Uses other than seed treatments are currently not adequately supported by data.

The efficacy and safety in this population is not well established.

There is insufficient evidence describing the efficacy of acupuncture to induce labour.

There was insufficient evidence to support its use as an add-on to other anticancer medicines.

However the benefit of adding Trajenta to pioglitazone treatment was not considered to have been sufficiently established.

This cannot be substantiated, but is the most likely explanation.

As regards the claim that the actual amounts should be used, those were in many instances either not submitted by the exporting producers concerned or not adequately supported by evidence and could therefore not be taken into consideration.

Often the data simply do not exist or they exist but are inadequately substantiated or of unsatisfactory quality.

Since the safety of the medicinal product has not been adequately demonstrated in young animals, careful monitoring is advised during the treatment of young dogs aged less than 6 months.

The major concern of the CHMP was that the effectiveness of Valdoxan/Thymanax had not been sufficiently shown:

Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the grounds that the efficacy had not been sufficiently substantiated in the dossier.

The safety and efficacy of TYSABRI in combination with other immunosuppressive and antineoplastic therapies have not been fully established.

Insufficient training of responsible officials, insufficient sampling and testing procedures and insufficient evidence that the export certificates correlate to the concerned consignment have been observed.

At the time of the initial recommendation the CHMP noted that the effectiveness of Avastin in combination with radiotherapy and temozolomide had not been sufficiently demonstrated.

Therefore, the currently available cardiovascular outcome data for Qsiva was considered inconclusive and the long term cardiovascular safety of Qsiva has not been sufficiently established.

Part of this pick-up, however, must be assumed to be cyclical amid an accelerating recovery as there is not enough data at present to confirm that it is of a structural nature.

However, SCHER considered that a number of statements and/or assumptions in the report were not supported by sufficient evidence and that for some scenarios rather worst case conditions were used.

If some assertions are not underpinned in a solid manner, the Commission services may have to ask more documents to underpin these claims.

As to the argument that pure commercial factors were the reason for that price difference, i.e. the increased production in the PRC, it is noted that this argument was not sufficiently substantiated in particular with regard to any possible correlation between the alleged increase in production and the situation on the demand side.