Slovenia - Sloven - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Slovenia - Sloven - JAZMP (Javna agencija RS za zdravila in medicinske pripomočke)

ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2); ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - suspenzija za injiciranje - ha seva b/phuket/3073/2013, divji tip, podoben sevu b/phuket/3073/2013 15 µg / 1 brizga  ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2)15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/darwin/9/2021, ivr-228, podoben sevu a/darwin/9/2021 (h3n2) 15 µg / 1 brizga  ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/202115 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva b/michigan/01/2021, divji tip, podoben sevu b/austria/1359417/2021 15 µg / 1 brizga  ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p15 µg / 1 brizga; ha seva a/victoria/2897/2022, ivr-238, podoben sevu a/victoria/4897/2022 (h1n1)p - cepivo proti gripi, z delci virusov ali s površinskimi antigeni, inaktivirano

Uni Eropa - Sloven - EMA (European Medicines Agency)

mabxience research sl - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastična sredstva - alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. alymsys 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 alymsys in combination with capecitabine. alymsys, 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. alymsys, 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. alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. alymsys, 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. alymsys, 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. alymsys, 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. alymsys, 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.

Uni Eropa - Sloven - EMA (European Medicines Agency)

stada arzneimittel ag - 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 - oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. za nadaljnje informacije o statusu receptorja človeškega epidermičnega rastnega faktorja 2 (her2) glejte poglavje 5. oyavas 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 oyavas in combination with capecitabine. za nadaljnje informacije o statusu her2 glejte poglavje 5. oyavas, 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. oyavas, 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. oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. oyavas, 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. oyavas, 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. oyavas, 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. oyavas, 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.

Uni Eropa - Sloven - EMA (European Medicines Agency)

mylan ire healthcare 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 - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Uni Eropa - Sloven - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - 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 - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. za nadaljnje informacije o statusu receptorja človeškega epidermičnega rastnega faktorja 2 (her2) glejte poglavje 5. vegzelma 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 vegzelma in combination with capecitabine. za nadaljnje informacije o statusu her2 glejte poglavje 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma 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. vegzelma, 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.

Uni Eropa - Sloven - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - colesevelam (as hydrochloride) - hiperholesterolemija - sredstva za spreminjanje lipidov - cholestagel co-upravlja s 3-hydroxy-3-methyl-glutaryl-coenzyme-a (hmg-coa)-reduktazo zaviralci (statin) je navedena kot dodatno zdravljenje k dieti zagotoviti dodatek znižanje nizko-gostoto-lipoproteinov-raven holesterola v krvi (ldl-c) v odraslih bolnikih s primarno hiperholesterolemijo, ki ni ustrezno nadzorovana z statin sam. cholestagel kot monotherapy je označen kot adjunctive terapija za prehrane za zmanjšanje zvišan skupni holesterol in ldl-c pri odraslih bolnikih s primarno hypercholesterolaemia, v katero statin je neprimerno, ali ni dobro prenaša. cholestagel se lahko uporablja tudi v kombinaciji z ezetimibe, z ali brez statin, pri odraslih bolnikih s primarno hypercholesterolaemia, vključno z bolniki z družinsko hypercholesterolaemia (glej poglavje 5.

Uni Eropa - Sloven - EMA (European Medicines Agency)

krka, d.d., novo mesto - repaglinid - diabetes mellitus, tip 2 - zdravila, ki se uporabljajo pri diabetesu - repaglinide je indicirano pri bolnikih z diabetesom tipa 2 (non-insulina – odvisni diabetes mellitus (niddm)), katere hyperglycaemia ni več mogoče nadzorovati zadovoljivo z prehrana, zmanjšanje telesne teže in telesno vadbo. repaglinid je indiciran tudi v kombinaciji z metforminom pri bolnikih s sladkorno boleznijo tipa 2, ki niso zadovoljivo nadzorovali samo pri metforminu. zdravljenje naj se začne kot dodatek k prehrani in vadbi za znižanje glukoze v krvi glede na obroke.

Uni Eropa - Sloven - EMA (European Medicines Agency)

novartis europharm limited - deferasiroks - beta-thalassemia; iron overload - vsi drugi terapevtski izdelki - exjade je indicirano za zdravljenje kronične prenasičenosti z železom zaradi pogostih transfuzijah krvi (≥ 7 ml/kg/mesec pakiranih rdečih krvničk) pri bolnikih z beta thalassaemia večjih starih šest let in starejši. exjade je tudi navedeno, za zdravljenje kronične železa preobremenitve zaradi transfuzije krvi, če deferoxamine zdravljenje je kontraindicirano ali neustrezni v naslednjih bolnik skupine:pri bolnikih z beta talasemija major preobremenitve z železom zaradi pogoste transfuzije krvi (≥ 7 ml/kg/mesec pakirani rdečih krvnih celic), starih od dve do pet let;pri bolnikih z beta talasemija major preobremenitve z železom zaradi redke transfuzije krvi (< 7 ml/kg/mesec pakirani rdečih krvnih celic), starih od dveh let in starejše;pri bolnikih z drugimi anaemias v starosti dveh let in starejši. exjade je tudi navedeno, za zdravljenje kronične železa preobremenitve, ki zahtevajo chelation therapy, ko deferoxamine zdravljenje je kontraindicirano ali neustrezni pri bolnikih z ne-transfuzijo odvisna talasemija sindromov, starih 10 let in več.

Uni Eropa - Sloven - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - eprinomektin, fipronil, prazikvantel, (s) -metopren - antiparasitic products, insecticides and repellents, avermectins, eprinomectin, combinations, - mačke - za mačke z ali brez nevarnosti mešanih napadov cestod, nematod in ektoparazitov. zdravilo je izključno navedeno ko so vse tri skupine, ki so usmerjeni na istem času. ectoparasitestreatment in preprečevanje infestations za bolhe (ctenocephalides felis). odprava bolhe v 24 urah. eno zdravljenje, preprečuje nadaljnje infestations za vsaj en mesec. preprečevanje okoljskih bolh onesnaženja s zavira razvoj bolh nezreli fazi (jajca, ličinke in pupae) za več kot en mesec. izdelek se lahko uporablja kot del strategije zdravljenja za nadzor alergijskega dermatitisa bolha (fad). zdravljenje in preprečevanje infestations s klopi (ixodes ricinus). odstranitev klopov v roku 48 ur. eno zdravljenje, preprečuje nadaljnje infestations za do 3 tednov. zdravljenje notoedric mange (notoedres cati). cestodestreatment od infestations z tapeworms (dipylidium caninum, taenia taeniaeformis, echinococcus multilocularis, joyeuxiella pasqualei (za odrasle), in joyeuxiella fuhrmanni (za odrasle)). nematodestreatment od infestations z prebavil nematodes (l3, l4 ličinke in odrasle od toxocara cati, odraslimi toxascaris leonina, l4 ličinke in odrasle od ancylostoma tubaeforme in ancylostoma ceylanicum, in odraslimi ancylostoma brazilienze). zdravljenje infestations z mačji lungworms (l3 ličinke, l4 ličinke in odrasle od aelurostrongylus abstrusus, l4 ličinke in odrasle od troglostrongylus brevior). zdravljenje infestations z vesical črvi (capillaria plica). preprečevanje heartworm bolezni (dirofilaria immitis ličinke) za en mesec.