Übersetzung für "Product efficacy" in Deutsch

Each product undergoes clinical efficacy and risk tests for its perfect safety.

Such changes are catastrophic for a drug product because efficacy is lost.

The product has restorative efficacy and is recommended for treating degenerative skin conditions and wrinkle formation.

Product efficacy has been documented in more than 300 long-term cases4 and more than15 independent scientific publications.

Product efficacy has been documented in more than 300 long-term cases4 and more than 15 independent scientific publications.

As the aforementioned indications have been included in the product information of these veterinary medicinal products for many years, the Committee considered that information on the removal of the indication should be given, thus the following warning sentence should be added to the product information: ‘The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.

Having taken into account the ANSM's inspection report, the available data and all arguments presented in the MAHs' replies, the CHMP concluded in its plenary meeting on January 2015 that in the absence of demonstration of bioequivalence to an EU Reference Medicinal Product, the efficacy, safety and tolerability of the concerned medicinal product cannot be established.

The Marketing Authorisation Holder was requested to substantiate the bioavailability/ bioequivalence of the product, justifying the efficacy of the product.

It is not practical for an SPC for an equine wormer to only indicate use of the product against 5 specific parasites that do not include the important Strongylus genus in horses, but to imply that the product has efficacy against a wider population of parasites.

The potential risk of resistance development, which might impact product efficacy, and overall animal and human health, is limited through:

In relation to clinical efficacy, the published literature demonstrates that even minor differences in formulation can significantly affect the duration of product efficacy.

The MAH further outlined studies submitted on behalf of various generic products, which showed that each product had acceptable efficacy compared to the originator product on the EU market, despite differences in excipient content.

In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the efficacy and safety of these medicinal products can not be established, and hence the benefit-risk balance cannot be considered positive.

The potential risk of resistance development which might impact product efficacy, and overall animal and human health, is limited through:

In spite of the fact that patient safety and product efficacy was always ensured, the MAH decided to clinically reinvestigate the current goserelin 1-month product.

If there is a compatibility statement with other immunological products in the summary of product characteristics, the efficacy of the association shall be investigated.

Therefore, an additional requirement for applying for a marketing authorisation that includes the results of studies conducted in compliance with an agreed paediatric investigation plan should be an obligation for the applicant to indicate how he proposes to ensure the long-term follow-up of possible adverse reactions to the use of the medicinal product and efficacy in the paediatric population.

If the formulation is sensitive to light or air, and would degrade in a way that impacts product safety or product efficacy, appropriate packaging should be used.

Only changes that substantially affect product safety or efficacy will still require prior authorisation by the competent authorities or the Commission before being implemented.

A medicinal product is therapeutically equivalent with an other product if it contains the same active substance or therapeutic moiety and, clinically shows the same efficacy and safety as that product, whose efficacy and safety has been established.