Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

bayer ag - koncentrat za suspeneziju (sc) - etofumesat, 190 g/l (17,75 % w/w) fenmedifam, 200 g/l (18,49% w/w)

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

baxter d.o.o., letališka cesta 29a, ljubljana, slovenija - fibrinogen, ljudski aprotinin trombin, ljudski kalcijev klorid dihidrat - prašak i otapalo za tkivno ljepilo - 91 mg/ml + 3000 kiu/ml + 500 iu/ml + 40 µmol/ml - urbroj: komponenta 1: otopina proteina tkivnog ljepila (koncentrat proteina tkivnog ljepila (tisseel prašak, liofilizirani), rekonstituiran s otopinom aprotinina); fibrinogen, ljudski (protein koji sudjeluje u zgrušavanju) 91 mg/ml; aprotinin, sintetski 3000 kiu/ml; komponenta 2: otopina trombina trombin (prašak trombina, liofilizirani), rekonstituiran s otopinom kalcijevog klorida; trombin, ljudski 500 iu/ml; kalcijev klorid dihidrat 40 µmol/ml; 1, 2 ili 5 ml otopine proteina tkivnog ljepila i 1, 2 ili 5 ml otopine trombina miješanjem daju 2, 4 ili 10 ml otopine spremne za uporabu tisseel lyo sadrži ljudski koagulacijski faktor xiii (istovremeno izdvojen s ljudskim fibrinogenom) u rasponu od 0,6 – 5 iu/ml.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

dr. theiss naturwaren gmbh, michelinstrasse 10, homburg, njemačka - suhi ekstrakt bršljanovog lista (4-8 : 1), ekstrakcijsko otapalo: etanol 30 % (m/m) - sirup u vrećici - urbroj: jedna vrećica (5 ml) sadrži 33,0 mg ekstrakta (kao suhi ekstrakt) iz hedera helix l. folium (bršljanov list) (4 - 8 : 1). ekstrakcijsko otapalo: etanol 30 % (m/m).

Europska Unija - hrvatski - EMA (European Medicines Agency)

teva b.v. - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - antineoplastic agents, protein kinase inhibitors - imatinib-tewa indiciran za liječenje ofadult i pedijatrijska bolesnika s je prvi put dijagnosticiran Филадельфийской hromozoma (na bcr‑abl), koji je pozitivan (ph+) kronične mijeloične leukemije (kml), za koje je transplantacija koštane srži ne smatra se kao prva linija liječenja. za odrasle i pedijatrijska bolesnika s ph+ kml u fazi kroničnog neučinkovitosti interferon‑alfa terapija, ili u ubrzanu fazu ili бластного kriza. i pedijatrijski bolesne odrasle osobe s prvi put utvrđenom pozitivnom akutne limfoblastične leukemije Филадельфийская kromosom (ph+ all) u kombinaciji s kemoterapijom. za odrasle pacijenata s relaps ili vatrostalne ph+ all u monoterapiji. odraslih pacijenata s миелодиспластический/миелопролиферативными bolesti (mds/rafinerija), povezanim sa бляшк-выведенное ako uređaj primatelja faktor rasta (pdgfr) promjena u kromosomu preustroj. kod odraslih pacijenata sa sindromom napredno гиперэозинофильный (hes) i/ili kronične eozinofilni leukemije (osobe) sa fip1l1-pdgfra preokret. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib teva is indicated forthe treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacijenti koji imaju niske ili vrlo nizak rizik od recidiva, ne bi trebali primati adjuvantne terapije. the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - duloxetinum - želučanootporna kapsula, tvrda - 30 mg - urbroj: svaka kapsula sadrži 30 mg duloksetina (u obliku klorida)

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

actavis group ptc ehf, reykjavikurvegur 76-78, hafnarfjordur, island - duloxetinum - želučanootporna kapsula, tvrda - 60 mg - urbroj: svaka kapsula sadrži 60 mg duloksetina (u obliku klorida)

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti. .

Europska Unija - hrvatski - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - firocoxib - anti-inflammatory and anti-rheumatic products, non-steroids - psi - tabletsfor uklanjanje boli i upale povezane s osteoartritisa kod pasa. za olakšanje postoperativne boli i upale povezane s mekim tkivom, ortopedskim i dentalnim zahvatom kod pasa. oralni pastealleviation boli i upale povezane s osteoartritisom i smanjenje hromost kod konja.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - ciclosporinum - kapsula, meka - 10 mg - urbroj: svaka meka kapsula sadrži 10 mg ciklosporina

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

pliva hrvatska d.o.o., prilaz baruna filipovića 25, zagreb - ciclosporinum - kapsula, meka - 100 mg - urbroj: svaka meka kapsula sadrži 100 mg ciklosporina