Übersetzung für "Innovator product" in Deutsch

Biosimilars are not exact copies of the innovator biological product.

The PK parameters have been compared to the innovator product however the results of the PK study had not been included.

The Applicant claimed essential similarity to the innovator product Targocid, despite acknowledging differences in the profile of glycopeptides.

The Applicant is, therefore, requested to fully justify whether or not additional clinical data is required in the form of a comparative safety and efficacy study with the innovator product in advance of the product being granted a Marketing Authorisation.

The harmonisation to ten years (plus, for medicines for human use, one year for new therapeutic indications) of the period of data protection afforded to innovator companies will prevent an applicant for a generic (copy) product from making an abridged applications in Austria64, Denmark, Greece, Finland, Ireland, Luxembourg, Portugal, and Spain on the expiry of six years from the date of first authorisation of the innovator product in the EU.

The harmonisation to ten years (plus, for medicines for human use, one year for new therapeutic indications) of the period of data protection afforded to innovator companies will prevent an applicant for a generic (copy) product from making abridged applications in Austria39, Denmark, Greece, Finland, Ireland, Luxembourg, Portugal, and Spain on the expiry of six years from the date of first authorisation of the innovator product in the EU.

The harmonisation to ten years (plus, for medicines for human use, one year for new therapeutic indications) of the period of data protection afforded to innovator companies will prevent an applicant for a generic (copy) product from making abridged applications in Austria88, Denmark, Greece, Finland, Ireland, Luxembourg, Portugal, and Spain on the expiry of six years from the date of first authorisation of the innovator product in the EU.

An abridged application is one where the applicant does not present the results of his/her own safety and efficacy testing but relies upon the data underlying the authorisation of the innovator product.

An abridged application is one where the applicant does not present the results of his own safety and efficacy testing but relies upon the data underlying the authorisation of the innovator product.

Pharmaceutical products essentially similar to an "Innovator" product are usually designated as "generics" or "branded generics".

A product is an "innovator" product if its marketing authorization has been obtained on the basis of a dossier with full documentation.

An enterprise can innovate either by introducing a technologically new or improved product on the market (product innovator) or by adopting a new or improved process (process innovator).

For Fermín, the absence of a scientific position regarding the possibility of automatically substituting between a biosimilar and the innovator product remains a key issue.

The innovator team's first product called PrepJet is an Excel add-in that simplifies and speeds up the most common data processing steps.

So Roche and other companies believe that all biopharmaceutical medicines need to be identifiable throughout the prescribing and dispensing processes, a practice that would not be possible under the current INN system if biosmilars were to use the same INN as the innovator product," stresses Fermín. He states that a unique and universally available identifier system could ensure that all approved biopharmaceutical medicines are individually identifiable.