Examples of using Same active substance in English and their translations into Croatian
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These drugs contain the same active substance.
The same active substance, as it turned out, can work in many different ways.
Analogs have in the composition the same active substance and possess similar properties.
The same active substance- amoxicillin- inhibits the synthesis of the bacterial membrane.
Zoledronic Acid Accord contains the same active substance as found in Aclasta zoledronic acid.
But another medication- the pill"Plendil"- has a slightly different composition, although with the same active substance.
They have similar indications for use, the same active substance and have the same effect on the body.
This means that it is similar to a‘reference medicine'(in this case Lantarel FS)containing the same active substance methotrexate.
Although Lantus contains the same active substance as Toujeo(insulin glargine 300 units/ml), these medicines are not interchangeable.
This means that it is similar to‘reference medicines' containing the same active substance, but given in a different way.
Zoledronic acid Mylan contains the same active substance as found in medicinal products indicated for treatment of osteoporosis and Paget's disease of the bone.
There is another authorised medicinal product with the same pharmaceutical form, same active substance on the Croatian market.
This means that Tadalafil Generics contains the same active substance and works in the same way as a‘reference medicine' already authorised in the European Union(EU) called Adcirca.
Nexium Control is similar to a‘reference medicine' already authorized in the European Union(EU)containing the same active substance, called Nexium.
If several companies are interested in supporting the same active substance, they should preferably cooperate and submit a single common application.
No additional studies were needed as Busulfan Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Busilvex.
This means that Epoetin Alfa Hexal is similar to and contains the same active substance as a biological medicine that is already authorised in the European Union(EU), which is known as the‘reference medicine.
No additional studies were needed as Topotecan Hospira is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
There is no other authorised medicine with the same active substance and HALMED will approve entry/import at request of medicines not authorised in the Republic of Croatia, but in the other EU Member States.
There are other medicinal products of the same pharmaceutical form and same active substance available on the Croatian market.
There is no other authorised medicinal product with the same active substance on the Croatian market and requests for import/entry will be handled according to the legal exemption scheme for medicinal products without the Croatian marketing authorisation.
Before starting Zutectra,the patient will need to receive medicines that contain the same active substance as in Zutectra, but given into a vein.
Zoledronic acid Teva Pharma contains the same active substance found in Zometa(zoledronic acid), used for oncology indications, and a patient being treated with Zometa should be not be treated with Zoledronic acid Teva Pharma.
It contains the active substance tobramycin,which is the same active substance as that of the reference medicine, Tobi.
In order to avoid duplicative testing, any persons intending to seek an authorisation for a plant protection product shall, before carrying out tests or studies, consult the information referred to in Article 57 to ascertain if andto whom an authorisation has already been granted for a plant protection product containing the same active substance, safener or synergist or for an adjuvant.
This means that it is similar to a‘reference medicine' containing the same active substance, but Zalviso is available in a different form.
No additional studies were needed as Zoledronic acid Teva Pharma is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Aclasta.
This means that it is similar to a‘reference medicine' containing the same active substance, but Procysbi is available in a formulation that allows for a delayed release of the active substance in the body.
No additional studies were needed as Zoledronic Acid Hospira is given by infusion and contains the same active substance as the reference medicines, Zometa and Aclasta.
Because Zoledronic Acid Accord is given by infusion and contains the same active substance as the reference medicine, its benefits and risks are taken as being the same as the reference medicines.