Europese Unie - Nederlands - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; spondylitis, ankylosing; crohn disease; colitis, ulcerative; hidradenitis suppurativa; psoriasis; arthritis, rheumatoid - immunosuppressiva - zie sectie 4. 1 van de samenvatting van de productkenmerken in het productinformatiedocument.

Europese Unie - Nederlands - EMA (European Medicines Agency)

ceva santé animale - influenza a virus/human strain: a/jena/vi5258/2009 (h1n1)pdm09, inactivated - immunologicals, geïnactiveerde virale vaccins voor varkens, varkensinfluenza-virus - varkens - actieve immunisatie van varkens vanaf de leeftijd van 8 weken vanaf pandemisch h1n1-varkensinfluenza-virus om virale longbelasting en virale uitscheiding te verminderen. the vaccine can be used during pregnancy up to three weeks before expected farrowing and during lactation lactation.

Europese Unie - Nederlands - 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 - antineoplastische middelen - 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. zie rubriek 5 voor meer informatie over de status van humane epidermale groeifactorreceptor 2 (her2). 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. raadpleeg sectie 5 voor meer informatie over her2-status. 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).

Europese Unie - Nederlands - 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 - antineoplastische middelen - 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.

Europese Unie - Nederlands - 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 - antineoplastische middelen - 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. zie rubriek 5 voor meer informatie over de status van humane epidermale groeifactorreceptor 2 (her2). 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. raadpleeg sectie 5 voor meer informatie over her2-status. 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

laboratorios hipra, s.a. - clostridioides difficile toxoid a, clostridioides difficile toxoid b, clostridium perfringens, type a, alpha toxoid - immunologicals for suidae, inactivated bacterial vaccines for pigs, clostridium - varkens - for the passive immunisation of neonatal piglets by means of the active immunisation of breeding sows and gilts:- to prevent mortality and reduce clinical signs and macroscopic lesions caused by clostridioides difficile toxins a and b. - to reduce clinical signs and macroscopic lesions caused by clostridium perfringens type a, alpha toxin.

Europese Unie - Nederlands - 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 - antineoplastische middelen - 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.

Europese Unie - Nederlands - 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 - antineoplastische middelen - 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. zie rubriek 5 voor meer informatie over de status van humane epidermale groeifactorreceptor 2 (her2). 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. raadpleeg sectie 5 voor meer informatie over her2-status. 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.

Europese Unie - Nederlands - EMA (European Medicines Agency)

eco animal health europe limited - tylvalosine - antimicrobiele middelen voor systemisch gebruik antibacteriële middelen voor systemisch gebruik, macroliden - pheasants; chicken; turkeys; pigs - pigstreatment en methaphylaxis van varkens enzootic longontsteking;behandeling van varkens proliferatieve enteropathie (ileitis);behandeling en methaphylaxis van varkens dysenterie. chickenstreatment en methaphylaxis van respiratoire aandoeningen geassocieerd met mycoplasma gallisepticum in kippen. pheasantstreatment van respiratoire aandoeningen geassocieerd met mycoplasma gallisepticum. turkeystreatment van respiratoire aandoeningen geassocieerd met tylvalosin gevoelige stammen van ornithobacterium rhinotracheale bij kalkoenen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxolaner, milbemycin oxime - endectocides, antiparasitaire middelen, insecticiden en insectenwerende middelen, milbemycin oxime, combinaties - honden - voor de behandeling van vlooien en teken parasitaire aandoeningen bij honden als de gelijktijdige preventie van hartworm ziekte (dirofilaria immitis larven), angiostrongylosis (vermindering in het niveau van de onvolwassen volwassenen (l5) en de volwassenen van angiostrongylus vasorum), thelaziosis (volwassen thelazia callipaeda) en/of de behandeling van gastro-intestinale parasitaire nematode is aangegeven. de behandeling van een vlo-plagen (ctenocephalides felis en c. canis) bij honden voor 5 weken. behandeling van vink parasitaire aandoeningen (dermacentor reticulatus, ixodes ricinus, de ixodes hexagonus, rhipicephalus sanguineus) bij honden voor 4 weken. vlooien en teken moeten zich hechten aan de gastheer en beginnen met voeden om te worden blootgesteld aan de werkzame stof. behandeling van infecties met volwassen intestinale nematoden van de volgende species: rondwormen (toxocara canis en toxascaris leonina), hookworms (ancylostoma caninum, ancylostoma braziliense en ancylostoma ceylanicum) en whipworm (trichuris vulpis). behandeling van demodicosis (veroorzaakt door demodex canis). behandeling van sarcoptic schurft (veroorzaakt door sarcoptes scabiei var. canis). preventie van hartworm ziekte (dirofilaria immitis larven) met de maandelijkse administratie. preventie van angiostrongylosis (door vermindering van de mate van besmetting met onvolgroeide volwassenen (l5) en volwassen stadia van angiostrongylus vasorum) met de maandelijkse administratie. preventie van de oprichting van thelaziosis (volwassen thelazia callipaeda eyeworm infectie) met de maandelijkse administratie.