Eiropas Savienība - latviešu - EMA (European Medicines Agency)

glaxosmithkline (ireland) limited - fluticasone furoate - rhinitis, allergic, seasonal; rhinitis, allergic, perennial - deguna preparāti, kortikosteroīdi - pieaugušie, pusaudži (12 gadi un vecāki) un bērni (6-11 gadi). avamys ir indicēts alerģiskā rinīta simptomu ārstēšanai.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan ireland limited - sugammadex sodium - neiromuskulārā blokāde - visi pārējie terapeitiskie produkti - reversal of neuromuscular blockade induced by   rocuronium or vecuronium in adults. for the paediatric population: sugammadex is only recommended for routine reversal of rocuronium induced blockade in children and adolescents aged 2 to 17 years.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

nova laboratories ireland limited - hydroxycarbamide - anēmija, sirpjveida šūna - antineoplastiski līdzekļi - profilakse skolas piens-occlusive komplikācijas sirpjveida šūnu slimība pacientiem, kas vecāki par 2 gadiem.

Eiropas Savienība - latviešu - 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 - antineoplastiski līdzekļi - 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. papildinformāciju par cilvēka epidermas augšanas faktora 2 receptora (her2) statusu, lūdzu, skatiet 5. sadaļā. 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. sīkāku informāciju par her2 statusu, lūdzu, skatiet 5. sadaļā. 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.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

bausch + lomb ireland limited - bromfenaka nātrija seskvihidrāts - pain, postoperative; ophthalmologic surgical procedures - oftalmoloģiskie līdzekļi - pēcoperācijas acu iekaisuma ārstēšana pēc kataraktas ekstrakcijas pieaugušajiem.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan ireland limited - dimethyl fumarate - multiplā skleroze, recidivējoši-pārskaitot - imūnsupresanti - dimethyl fumarate mylan is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

nova laboratories ireland limited - spironolactone - edema; heart failure; liver cirrhosis; ascites; nephrotic syndrome; hyperaldosteronism; essential hypertension - antihypertensives and diuretics in combination - in the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension. neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5. 1 un 5.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

crealta pharmaceuticals ireland limited - pegloticase - podagra - antigut preparāti - krystexxa ir norādīts, par attieksmi pret smagām novājinošām hroniska tophaceous podagra pieaugušiem pacientiem, kas var būt arī erozijas kopīgu iesaistīšanos un kas nav izdevies normalizēt seruma urīnskābes ar ksantīna oksidāzes inhibitori, pie maksimālā medicīniski attiecīgus devu vai par kuriem šīs zāles ir kontrindicēta.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hidrohlorīds - multiplā skleroze, recidivējoši-pārskaitot - imūnsupresanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 un 5. 1)orpatients strauji attīstās smagas recidivējoši pārskaitot multiplā skleroze definēts 2 vai vairāk atspējošana recidīvu vienu gadu, un ar 1 vai vairāk gadolīnija uzlabot bojājumi uz smadzeņu mri vai ievērojami palielināt t2 bojājumu slodzes salīdzinājumā ar iepriekšējā pēdējo mr.

Eiropas Savienība - latviešu - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hidrohlorīds - multiplā skleroze, recidivējoši-pārskaitot - imūnsupresanti - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 un 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.