Danska - danščina - Lægemiddelstyrelsen (Danish Medicines Agency)

orifarm a/s - buserelinacetat - injektionsvæske, opløsning - 1 mg/ml

Danska - danščina - Lægemiddelstyrelsen (Danish Medicines Agency)

paranova danmark a/s - buserelinacetat - injektionsvæske, opløsning - 1 mg/ml

Evropska unija - danščina - EMA (European Medicines Agency)

astrazeneca ab - fulvestrant - bryst neoplasmer - endokrine terapi, anti-østrogener - faslodex is indicated , as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:, , not previously treated with endocrine therapy, or, with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. , , , in combination with palbociclib for the treatment of hormone receptor (hr)-positive, human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. i præ - eller perimenopausal kvinder, kombinationen behandling med palbociclib bør kombineres med en luteiniserende hormon releasing hormon (lhrh) agonist.

Evropska unija - danščina - EMA (European Medicines Agency)

roche registration gmbh - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastiske midler - bryst cancermetastatic bryst cancerherceptin er indiceret til behandling af patienter med her2-positiv metastatisk brystkræft:som monoterapi til behandling af de patienter, der har modtaget mindst to kemoterapi regimer til deres metastatisk sygdom. før kemoterapi skal have omfattet mindst en antracyklin og en taxane medmindre patienter, der er uegnede til disse behandlinger. hormon-receptor-positive patienter skal også have undladt hormonbehandling, medmindre patienter, der er uegnede til disse behandlinger, og i kombination med paclitaxel til behandling af patienter, der ikke har fået kemoterapi for deres metastatisk sygdom, og for hvem en antracyklin er ikke egnet, og i kombination med docetaxel til behandling af de patienter, der ikke har fået kemoterapi for deres metastatisk sygdom, og i kombination med en aromatase inhibitor til behandling af postmenopausale patienter med hormon-receptor-positiv metastatisk brystkræft, der ikke tidligere er behandlet med trastuzumab. tidlig brystkræft cancerherceptin er indiceret til behandling af patienter med her2-positiv tidlig brystkræft efter operation, kemoterapi (neoadjuverende eller adjuvans) og strålebehandling (hvis relevant);efter adjuverende kemoterapi med doxorubicin og cyclophosphamid, i kombination med paclitaxel eller docetaxel, og i kombination med adjuverende kemoterapi, der består af docetaxel og carboplatin, og i kombination med neoadjuverende kemoterapi efterfulgt af adjuverende herceptin terapi, for lokalt avanceret (herunder inflammatoriske sygdomme eller tumor >2 cm i diameter. herceptin bør kun anvendes til patienter med metastatisk eller tidlig brystkræft, hvis tumorer har enten her2 overexpression eller her2-genet forstærkning, som bestemmes af en præcis og valideret analysen. metastatisk gastrisk cancerherceptin i kombination med capecitabin eller 5-fluorouracil og cisplatin er indiceret til behandling af patienter med her2-positiv metastatisk adenocarcinom i maven eller gastroøsofageal vejkryds, der ikke har modtaget forudgående anticancer behandling for deres metastatisk sygdom. herceptin bør kun anvendes til patienter med metastatisk gastrisk kræft, hvis tumorer har her2 overexpression som defineret af ihc2+ og en bekræftende sish eller fisk resultat, eller af en ihc3+ resultat. præcise og validerede analyse metoder, der bør anvendes.

Evropska unija - danščina - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - modificeret levende bovin viral diarrévirus type 1, ikke-cytopatisk stamme ke-9 og modificeret levende bovin viral diarrévirus type 2, ikke-cytopatisk stamme ny-93 - immunologicals for bovidae, live viral vacciner - til aktiv immunisering af kvæg fra 3 måneders alderen for at reducere hypertermi og til at minimere den reduktion af leukocyt tæller forårsaget af kvæg viral diarré virus (bvdv-1 og bvdv-2), og at reducere virus udgydelse og viraemia forårsaget af bvdv-2. til aktiv immunisering af kvæg mod bvdv-1 og bvdv-2 for at forhindre fødslen af ​​vedvarende inficerede kalve forårsaget af transplacental infektion.

Evropska unija - danščina - EMA (European Medicines Agency)

intervet international bv - leptospira interrogans serogruppe canicola serovar portland-vere (stamme ca-12-000), l. interrogans serogruppe serovar icterohaemorrhagiae copenhageni (stamme ic-02-001), l. interrogans serogruppe australis serovar bratislava (stamme, som-05-073), l. kirschneri serogruppe grippotyphosa serovar dadas (stamme gr-01-005) - immunologiske - hunde - til aktiv immunisering af hunde mod:leptospira interrogans serogruppe canicola serovar canicola at reducere infektion og urinudskillelse;l. interrogans serogruppe serovar icterohaemorrhagiae copenhageni at reducere infektion og urinudskillelse;l. interrogans serogruppe australis serovar bratislava for at reducere infektion;l. kirschneri serogruppe grippotyphosa serovar bananal / lianguang for at reducere infektion og urinudskillelse.

Evropska unija - danščina - EMA (European Medicines Agency)

mylan pharmaceuticals limited - lopinavir, ritonavir - hiv infektioner - antivirale midler til systemisk anvendelse - lopinavir/ritonavir angives i kombination med andre antiretrovirale lægemidler til behandling af human immundefekt virus (hiv-1) inficeret voksne, unge og børn over 2 år. valget af lopinavir/ritonavir til at behandle proteasehæmmer oplevet hiv-1-inficerede patienter bør være baseret på individuelle viral resistens test og historie behandling af patienter.

Evropska unija - danščina - EMA (European Medicines Agency)

sanofi winthrop industrie - dupilumab - dermatitis, atopic; prurigo; esophageal diseases; asthma; sinusitis - midler til dermatitis, undtagen kortikosteroider - atopic dermatitisadults and adolescentsdupixent is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy. children 6 months to 11 years of agedupixent is indicated for the treatment of severe atopic dermatitis in children 6 months to 11 years old who are candidates for systemic therapy. asthmaadults and adolescentsdupixent is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), see section 5. 1, who are inadequately controlled with high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. children 6 to 11 years of agedupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (feno), who are inadequately controlled with medium to high dose inhaled corticosteroids (ics) plus another medicinal product for maintenance treatment. chronic rhinosinusitis with nasal polyposis (crswnp)dupixent is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe crswnp for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. prurigo nodularis (pn)dupixent is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (pn) who are candidates for systemic therapy. eosinophilic esophagitis (eoe)dupixent is indicated for the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

Evropska unija - danščina - EMA (European Medicines Agency)

eli lilly nederland b.v. - abemaciclib - bryst neoplasmer - antineoplastiske midler - early breast cancerverzenios in combination with endocrine therapy is indicated for the adjuvant treatment of adult patients with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative, node positive early breast cancer at high risk of recurrence (see section 5. in pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (lhrh) agonist. advanced or metastatic breast cancerverzenios is indicated for the treatment of women with hormone receptor (hr) positive, human epidermal growth factor receptor 2 (her2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy. in pre- or perimenopausal women, the endocrine therapy should be combined with a lhrh agonist.

Evropska unija - danščina - EMA (European Medicines Agency)

novartis europharm limited  - indacaterol acetate, mometasone furoate - astma - medicin for obstruktiv sygdomme, - atectura breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.