Evropska unija - slovenščina - EMA (European Medicines Agency)

ucb pharma s.a.   - fenfluramine hydrochloride - epilepsies, myoclonic - antiepileptics, - treatment of seizures associated with dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older. fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - sitagliptin hydrochloride - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - for adult patients with type 2 diabetes mellitus, sitagliptin accord is indicated to improve glycaemic control:as monotherapy:- in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. as dual oral therapy in combination with:- metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. - a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance. - a peroxisome proliferator-activated receptor gamma (ppary) agonist (i. a thiazolidinedione) when use of a ppary agonist is appropriate and when diet and exercise plus the ppary agonist alone do not provide adequate glycaemic control. as triple oral therapy in combination with:- a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. - a ppary agonist and metformin when use of a ppary agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control. sitagliptin accord is also indicated as add-on to insulin (with or without metformin) when diet and exercise plus stable dose of insulin do not provide adequate glycaemic control.

Evropska unija - slovenščina - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Evropska unija - slovenščina - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple myeloma - antineoplastična sredstva - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

lenis d.o.o. - raztopina za injiciranje - labetalol

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

lenis d.o.o. - fenilefrinijev klorid - kapljice za oko, raztopina - fenilefrinijev klorid 100 mg / 1 ml - fenilefrin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

lenis d.o.o. - petidin - raztopina za injiciranje - petidin 50 mg / 1 ml - petidin

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - benzidamin, cetilpiridinijev klorid - pastila - benzidamin 2,68 mg / 1 pastila; cetilpiridinijev klorid 1 mg / 1 pastila - razne učinkovine

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

krka, d.d., novo mesto - benzidamin, cetilpiridinijev klorid - pastila - benzidamin 2,68 mg / 1 pastila; cetilpiridinijev klorid 1 mg / 1 pastila - razne učinkovine

Slovenija - slovenščina - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

biomedis m.b. d.o.o. - raztopina za injiciranje - [89sr]stroncijev klorid