Iclusig Europese Unie - Nederlands - EMA (European Medicines Agency)

iclusig

incyte biosciences distribution b.v. - ponatinib - leukemia, myeloid; leukemia, lymphoid - antineoplastic agents, protein kinase inhibitors - iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (cml) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutationphiladelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the t315i mutation. zie hoofdstuk 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.

Pemazyre Europese Unie - Nederlands - EMA (European Medicines Agency)

pemazyre

incyte biosciences distribution b.v. - pemigatinib - cholangiocarcinoma - antineoplastische middelen - pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (fgfr2) fusion or rearrangement that have progressed  after at least one prior line of systemic therapy.

Minjuvi Europese Unie - Nederlands - EMA (European Medicines Agency)

minjuvi

incyte biosciences distribution b.v. - tafasitamab - lymphoma, large b-cell, diffuse - antineoplastische middelen - minjuvi is indicated in combination with lenalidomide followed by minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) who are not eligible for autologous stem cell transplant (asct).

Opzelura Europese Unie - Nederlands - EMA (European Medicines Agency)

opzelura

incyte biosciences distribution b.v. - ruxolitinib phosphate - vitiligo - andere dermatologische preparaten - opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Coliprotec F4 Europese Unie - Nederlands - EMA (European Medicines Agency)

coliprotec f4

prevtec microbia gmbh - levende niet-pathogene escherichia coli o8: k87 - immunologicals for suidae, live bacterial vaccines, pig - varkens - voor de actieve immunisatie van varkens tegen enterotoxigene f4-positieve escherichia coli om:het verminderen van de incidentie van matige tot ernstige post-weaning escherichia coli-diarree (pwd) in varkens;het verminderen van de kolonisatie van het ileum en fecale vergieten van enterotoxigene f4-positieve escherichia coli van geïnfecteerde varkens.

Coliprotec F4/F18 Europese Unie - Nederlands - EMA (European Medicines Agency)

coliprotec f4/f18

elanco gmbh - levende niet-pathogene escherichia coli o141: k94 (f18ac) en o8: k87 (f4ac) - immunologicals for suidae, live bacterial vaccines - varkens - voor actieve immunisatie van varkens vanaf 18 dagen tegen enterotoxigene f4-positieve en f18-positieve escherichia coli om de incidentie van matige tot ernstige post-spenen e te verminderen. coli diarree (pwd) bij geïnfecteerde varkens en om de fecale uitscheiding van enterotoxigene f4-positieve en f18-positieve e te verminderen. coli van geïnfecteerde varkens.

Improvac Europese Unie - Nederlands - EMA (European Medicines Agency)

improvac

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - immunologicals voor suidae - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. een andere belangrijke bijdrage aan berengeur, skatol, kan ook worden verminderd als een indirect effect. agressief en seksueel (montage) gedrag wordt ook verminderd. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).

Ubac Europese Unie - Nederlands - EMA (European Medicines Agency)

ubac

laboratorios hipra, s.a. - lipoteichoic zuur van biofilm hechting onderdeel van streptococcus uberis, stam 5616 - immunologicals voor bovidae - vee - voor de actieve immunisatie van gezonde koeien en vaarzen aan het verminderen van de incidentie van klinische intramammary infecties veroorzaakt door streptococcus uberis, te verminderen van het celgetal in de streptococcus uberis positieve kwartaal melkmonsters en om de melkproductie verliezen veroorzaakt door streptococcus uberis intramammary infecties.

Mhyosphere PCV ID Europese Unie - Nederlands - EMA (European Medicines Agency)

mhyosphere pcv id

laboratorios hipra, s.a. - mycoplasma hyopneumoniae, strain 7304 (nexhyon), expressing the capsid protein of porcine circovirus type 2a, inactivated - immunologicals for suidae, inactivated viral and inactivated bacterial vaccines - varkens - for the active immunisation of pigs:to reduce lung lesions associated with porcine enzootic pneumonia caused by mycoplasma hyopneumoniae. also, to reduce the incidence of these lesions (as observed in field studies). to reduce viraemia, virus load in lungs and lymphoid tissues and the duration of the viraemic period associated with diseases caused by porcine circovirus type 2 (pcv2). efficacy against pcv2 genotypes a, b and d has been demonstrated in field studies. to reduce culling rate and the loss of daily weight gain caused by mycoplasma hyopneumoniae and/or pcv2 related diseases (as observed at 6 months of age in field studies). mycoplasma hyopneumoniae: onset of immunity: 3 weeks after vaccinationduration of immunity: 23 weeks after vaccinationporcine circovirus type 2:onset of immunity: 2 weeks after vaccinationduration of immunity: 22 weeks after vaccinationin addition, a reduction in nasal and faecal shedding and the duration of nasal excretion of pcv2 was demonstrated in animals challenged at 4 weeks and at 22 weeks after vaccination.