Европейский союз - мальтийский - EMA (European Medicines Agency)

alnylam netherlands b.v. - givosiran - porphyrias, tal-fwied - varji ta'l-apparat alimentari u tal-metaboliżmu-prodotti - it-trattament ta akuta tal-fwied, porfirja (huma maħsuba) fl-adulti u adolexxenti minn 12-il sena u anzjani.

Европейский союз - мальтийский - EMA (European Medicines Agency)

novartis europharm limited - inclisiran - hypercholesterolemia; dyslipidemias - aġenti li jimmodifikaw il-lipidi - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin, oralone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Европейский союз - мальтийский - EMA (European Medicines Agency)

alnylam netherlands b.v. - vutrisiran sodium - amyloid neuropathies, familial - drogi oħra tas-sistema nervuża - treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Европейский союз - мальтийский - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tenecteplase - infart mijokardijaku - aġenti antitrombotiċi - metalyse huwa indikat għat-trattament thrombolytic ta-suspettata myocardial infarzjoni bl-elevazzjoni st persistenti jew riċenti xellug-gozz-fergħa blokk fi żmien sitt sigħat wara l-bidu tas-sintomi akuta-myocardial-infarzjoni.

Европейский союз - мальтийский - EMA (European Medicines Agency)

cis bio international  - besilesomab - osteomyelitis; radionuclide imaging - radjofarmaċewtiċi dijanjostiċi - dan il-prodott mediċinali tkun għal użu dijanjostiċi biss u l-indikazzjoni approvat huwa imaging scintigraphic, flimkien ma ' oħrajn modalitajiet immaġnar xieraq, għad-determinazzjoni tal-lokazzjoni ta ' infjammazzjoni/infezzjoni fl-għadam periferali fl-adulti b ' osteomyelitis suspettati. scintimun m'għandux jintuża għad-dijanjosi ta 'infezzjoni marda dijabetika.

Европейский союз - мальтийский - EMA (European Medicines Agency)

pacira ireland limited - bupivacaine - acute pain - amides, anesthetics, local - exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Европейский союз - мальтийский - EMA (European Medicines Agency)

novartis europharm limited - ribociclib succinate - neoplażmi tas-sider - aġenti antineoplastiċi - kisqali huwa indikat għall-kura ta 'nisa bl-ormon tat-riċettur (hr)‑pożittivi, tal-bniedem tar-riċettur tal-fattur tat-tkabbir epidermali 2 (her2) negattivi lokalment avvanzata jew metastatika tal-kanċer tas-sider f'kumbinazzjoni ma' inibitur aromatase jew fulvestrant bħala inizjali endokrinali bbażata fuq it-terapija, jew f'nisa li kienu rċevew qabel terapija endokrinali. fil‑ pre- jew perimenopausal-nisa, l-endokrinali it-terapija għandha tingħata flimkien ma 'ormon ta' lutejniżżazzjoni‑releasing hormone (lhrh) agonist.

Европейский союз - мальтийский - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. 1 of the smpc. aybintio, 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. aybintio, 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. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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. aybintio, in combination with 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Европейский союз - мальтийский - EMA (European Medicines Agency)

samsung bioepis nl b.v. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - aġenti antineoplastiċi - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. għal aktar informazzjoni dwar l-istatus tal-fattur tat-tkabbir tal-epidermide tal-bniedem 2 (her2), jekk jogħġbok irreferi għat-taqsima 5. onbevzi 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 onbevzi in combination with capecitabine. għal aktar informazzjoni dwar l-istatus ta 'her2, jekk jogħġbok irreferi għat-taqsima 5. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, in combination with 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. onbevzi, 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.

Европейский союз - мальтийский - EMA (European Medicines Agency)

gedeon richter plc. - follitropin alfa - anovulazzjoni - - ormoni tas-sess u modulaturi ta ' l-ġenitali-sistema, - in adult women:anovulation (including polycystic ovarian disease, pcod) in women who have been unresponsive to treatment with clomiphene citrate;stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (art) such as in vitro fertilisation (ivf), gamete intra-fallopian transfer (gift) and zygote intra-fallopian transfer (zift);follitropin alfa in association with a luteinising hormone (lh) preparation is recommended for the stimulation of follicular development in women with severe lh and fsh deficiency. fi provi kliniċi dawn il-pazjenti ġew definiti bil-livelli endoġeni tas-serum lh < 1. 2 iu / l. in adult men:follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hcg) therapy.