Unia Europejska - chorwacki - EMA (European Medicines Agency)

mylan pharmaceuticals limited - tadalafil - poremećaj erekcije - urologicals - liječenje erektilne disfunkcije kod odraslih muškaraca. da bi tadalafil bio učinkovit, potrebna je seksualna stimulacija. tadalafil mylan u se ne navodi za žene.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - niraparib (tosilate monohydrate) - fallopian tube neoplasms; peritoneal neoplasms; ovarian neoplasms - antineoplastična sredstva - zejula is indicated: , as monotherapy for the maintenance treatment of adult patients with advanced epithelial (figo stages iii and iv) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. , as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.

Chorwacja - chorwacki - HALMED (Agencija za lijekove i medicinske proizvode)

viatris limited, damastown industrial park, mulhuddart, dublin, irska - вилдаглиптин - tableta - urbroj: jedna tableta sadrži 50 mg vildagliptina

Unia Europejska - chorwacki - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. dodatne informacije o statusu her2 potražite u odjeljku 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - vrsta ii za skladištenje glikogena - ostali prehrambeni proizvodi i proizvodi metabolizma - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).

Unia Europejska - chorwacki - EMA (European Medicines Agency)

novartis europharm limited - вилдаглиптин, metformin hidroklorid - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - eucreas is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

novartis europharm limited - вилдаглиптин, metformin hidroklorid - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - icandra is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4. 4, 4. 5 i 5. 1 za dostupne podatke o različitim kombinacijama).

Unia Europejska - chorwacki - EMA (European Medicines Agency)

viatris limited - sildenafil citrat - hipertenzija, plućna - urologicals - adultstreatment odraslih pacijenata s plućne arterijske hipertenzije, koji su klasificirani kao funkcionalna klasa ii i iii, kako bi mogli poboljšati kapacitet vježbanja. učinkovitost je pokazala primarnu plućnu hipertenziju i plućnu hipertenziju povezanu s bolestima vezivnog tkiva. vrtić populationtreatment pedijatrijska bolesnika u dobi od 1 godine do 17 godina, od plućne arterijske hipertenzije. djelotvornosti u smislu poboljšanja kapaciteta vježbanja ili plućnom haemodynamics je prikazano u primarne plućne hipertenzije i plućnom hipertenzijom povezanom s prirođene srčane greške (vidjeti dio 5.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

novartis europharm limited  - вилдаглиптин, metformin hidroklorid - dijabetes mellitus, tip 2 - lijekovi koji se koriste u dijabetesu - zomarist is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:in patients who are inadequately controlled with metformin hydrochloride alone. in patients who are already being treated with the combination of vildagliptin and metformin hydrochloride, as separate tablets. in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate.

Unia Europejska - chorwacki - EMA (European Medicines Agency)

marinus pharmaceuticals emerald limited - ganaxolone - epileptic syndromes; spasms, infantile - drugi antiepileptici sredstva - ztalmy is indicated for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (cdkl5) deficiency disorder (cdd) in patients 2 to 17 years of age. ztalmy may be continued in patients 18 years of age and older.