Примери за използване на Reference medicines на Английски и техните преводи на Български
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The reference medicines for Ibandronic Acid Teva are Bondronat and Bonviva.
Biosimilar medicines have been used safely in the EU since 2006 as an alternative to reference medicines.
The reference medicines for Ibandronic acid Accord are Bondronat and Bonviva.
This means that it is similar to one or more‘reference medicines' already authorised in the European Union(EU).
The reference medicines for these insulins were to be Humulin S, Humulin I and Humulin M3.
Biosimilar medicines have been used safely in the EU since 2006 as an alternative to reference medicines.
This means that Zalasta is similar to‘ reference medicines' already authorised in the European Union(EU) called Zyprexa and Zyprexa Velotab.
Because Ibandronic acid Accord is a generic, its benefits andrisks are taken as being the same as the reference medicines'.
While the reference medicines Effentora(buccal tablets) and Actiq(lozenges) are taken by mouth, PecFent is given as a spray into the nose.
No additional studies were needed as Zoledronic Acid Hospira is given by infusion andcontains the same active substance as the reference medicines.
This means that Olanzapine Teva is similar to‘ reference medicines' already authorised in the European Union(EU) called Zyprexa and Zyprexa Velotab.
Because Olanzapine Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicines.
Because PecFent is a hybrid medicine, the applicant presented data on the reference medicines in addition to results from its own studies.
Because Ibandronic Acid Teva is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines.
Because Olazax Disperzi is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as the reference medicines.
The criteria for deciding whether a post-marketing safety study is needed are the same for all medicines, including biosimilars and their reference medicines.
Because Zalasta is a generic medicine and is bioequivalent to the reference medicines, its benefit and risk are taken as being the same as those of the reference medicines.
Because Olazax Disperzi is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab.
In the context of biosimilars and reference medicines, it is important for healthcare professionals to be aware of the terminology to refer to interchangeability and substitution practices in the EU.
The company presented data from studies designed to show that the Marvel insulins were comparable with the reference medicines in experimental models and in humans.
Because Olanzapine Glenmark Europe is a generic medicine and is bioequivalent to the reference medicine, its benefit andrisk are taken as being the same as the reference medicines.
Because Zoledronic Acid Hospira is given by infusion andcontains the same active substance as the reference medicines, its benefits and risks are taken as being the same as the reference medicines'.
In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety andeffectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicines, Bondronat and Bonviva, and do not need to be repeated for Ibandronic acid Accord.
Over the last 10 years, the EU monitoring system for safety concerns has not identified any relevant difference in the nature, severity orfrequency of adverse effects between biosimilar medicines and their reference medicines.
Because Zalasta is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicines(i.e. that the medicines produce the same levels of the active substance in the body).
Because Olanzapine Glenmark Europe is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab.
No additional studies were needed as Ibandronic acid Accord is a generic medicine that is given by infusion or injection andcontains the same active substance as the reference medicines, Bondronat and Bonviva.