Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

biocodex - stiripentol - myoclonic epilepsy, juvenile - antiepileptika, - diacomit er indiceret til brug sammen med clobazam og natriumvalproat som tillægsbehandling af ildfaste generaliseret tonisk-kloniske anfald hos patienter med svær myoklon epilepsi i vorden (smei, dravets syndrom) hvis anfald ikke er tilstrækkeligt kontrolleret med clobazam og natriumvalproat.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

roche registration gmbh - vismodegib - carcinom, basalcelle - antineoplastiske midler - erivedge er indiceret til behandling af voksne patienter med:- symptomatisk metastatisk basal celle karcinom - lokalt avanceret basal celle karcinom upassende for kirurgi eller strålebehandling.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

instituto grifols s.a. - humant normalt immunglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immune sera og immunoglobuliner, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

ecuphar - meloxicam - anti inflammatorisk, og antireumatiske produkter - dogs; cats - oral suspension:hunde:lindring af betændelse og smerter i både akutte og kroniske muskuloskeletale lidelser. opløsning til injektion:hunde:lindring af betændelse og smerter i både akutte og kroniske muskuloskeletale lidelser. reduktion af postoperativ smerte og betændelse efter ortopædisk og blødvævkirurgi. katte:reduktion af postoperativ smerte efter ovariohysterectomy og mindre soft-tissue surgery.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

pierre fabre medicament - propranololhydrochlorid - hemangioma - betablokkende midler - hemangiol is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: , life- or function-threatening haemangioma,, ulcerated haemangioma with pain and/or lack of response to simple wound care measures,, haemangioma with a risk of permanent scars or disfigurement. , it is to be initiated in infants aged 5 weeks to 5 months.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

intervet international bv - indoxacarb - ectoparasiticides til udvortes brug, incl. insekticider, indoxacarb - dogs; cats - behandling og forebyggelse af loppeangreb. til hunde og katte: behandling og forebyggelse af loppeangreb. veterinærlægemidlet kan anvendes som led i en behandlingsstrategi for loppe-allergi dermatitis. udvikling af lopper i loppens umiddelbare omgivelser dræbes efter kontakt med activyl-behandlede kæledyr.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - højst tre af følgende renset, inaktiveret, mund-og klovesyge virus-stammer: o1 manisa ≥ 6 pd50*; o1 bfs ≥ 6 pd50*; o taiwan 3/97 ≥ 6 pd50*; a22 irak ≥ 6 pd50*; a24 cruzeiro ≥ 6 pd50*; en kalkun 14/98 ≥ 6 pd50*; asien 1 shamir ≥ 6 pd50*; sat2 saudi-arabien ≥ 6 pd50*; * pd50 – 50% beskyttende dosis i kvæg, som er beskrevet i ph. eur. monografi 0063. - immunologiske - pigs; cattle; sheep - aktiv immunisering af kvæg, får og svin fra 2 uger mod mund- og klovesyge for at reducere kliniske tegn.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

eco animal health europe limited - tylvalosin - antiinfectives til systemisk brug, antibakterielle midler til systemisk brug, makrolider - pheasants; chicken; turkeys; pigs - pigstreatment og methaphylaxis af svin enzootisk pneumoni, behandling af porcin proliferativ enteropathy (ileitis);behandling og methaphylaxis af svin, dysenteri. chickenstreatment og methaphylaxis for respiratorisk sygdom, der er forbundet med mycoplasma gallisepticum i kyllinger. pheasantstreatment for respiratorisk sygdom, der er forbundet med mycoplasma gallisepticum. turkeystreatment for respiratorisk sygdom, der er forbundet med tylvalosin følsomme stammer af ornithobacterium rhinotracheale i kalkuner.

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

intervet international b.v - fluralaner - ectoparasiticides til systemisk brug, isoxazolines - dogs; cats - hunde:- til behandling af kryds og loppe angreb;produktet kan bruges som en del af en behandlingsstrategi for kontrol af loppe allergi dermatitis (fad). - til behandling af demodicosis forårsaget af demodex canis;- til behandling af sarcoptic skab (sarcoptes scabiei var. canis) angreb. - for reduction of the risk of infection with babesia canis canis via transmission by dermacentor reticulatus. [chewable tablets only]cats:- for the treatment of tick and flea infestations;the product can be used as part of a treatment strategy for the control of flea allergy dermatitis (fad). - til behandling af angreb med øremider (otodectes cynotis).

Kesatuan Eropah - Denmark - EMA (European Medicines Agency)

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. se afsnit 4. 2 assessment of cardiovascular status prior to start of therapy and 4. 4 situations where an alternative treatment may be considered.