Uniunea Europeană - daneză - EMA (European Medicines Agency)

viiv healthcare b.v. - fostemsavir trometamol - hiv infektioner - antivirale midler til systemisk anvendelse - rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant hiv-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Uniunea Europeană - daneză - 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 - antineoplastiske midler - 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.

Uniunea Europeană - daneză - 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 - antineoplastiske midler - 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. for yderligere information om human epidermal vækstfaktor receptor 2 (her2) status henvises til afsnit 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. for yderligere oplysninger om her2-status henvises til afsnit 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.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

hipra human health s.l. - sars-cov-2 virus recombinant spike (s) protein receptor binding domain (rbd) fusion heterodimer – b.1.351-b.1.1.7 strains - covid-19 virus infection - vacciner - bimervax is indicated as a booster for active immunisation to prevent covid-19 in individuals 16 years of age and older who have previously received a mrna covid-19 vaccine.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

bayer animal health gmbh  - pradofloxacin - antibakterielle midler til systemisk brug, fluoroquinoloner - dogs; cats - dogstreatment af:sår infektioner forårsaget af følsomme stammer af staphylococcus intermedius-gruppen (herunder s. pseudintermedius);overfladiske og dybe pyoderma forårsaget af følsomme stammer af staphylococcus intermedius-gruppen (herunder s. pseudintermedius);akut urin-tarmkanalen infektioner forårsaget af følsomme stammer af escherichia coli og staphylococcus intermedius-gruppen (herunder s. pseudintermedius);som adjuverende behandling til mekanisk eller kirurgisk parodontal behandling i behandling af alvorlige infektioner i gingiva og parodontale væv forårsaget af følsomme stammer af anaerobe organismer, for eksempel porphyromonas spp. og prevotella spp. catstreatment af akutte infektioner i de øvre luftveje, der er forårsaget af modtagelige stammer af pasteurella multocida, escherichia coli og staphylococcus intermedius-gruppen (herunder s. pseudintermedius).

Uniunea Europeană - daneză - EMA (European Medicines Agency)

accord healthcare s.l.u. - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastiske midler - azacitidine accord er indiceret til behandling af voksne patienter, der ikke er berettiget til hæmatopoietisk stamcelle transplantation (hsct) med:- intermediær-2 og højrisiko myelodysplastisk syndrom (mds) i henhold til international prognostic scoring system (ipss),- kronisk myelomonocytisk leukæmi (cmml) med 10-29 % marv blaster uden myeloproliferative lidelse,- akut myeloid leukæmi (aml) med 20-30 % blaster og multi-slægt dysplasi, ifølge world health organisation (who) klassifikation,- aml med >30% marv blaster i henhold til who-klassifikationen.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

accord healthcare s.l.u. - ibandronsyre - wounds and injuries; breast diseases; neoplastic processes; calcium metabolism disorders; water-electrolyte imbalance - narkotika til behandling af knoglesygdomme - ibandronic acid er angivet i voksne forprevention af skelet hændelser (patologiske frakturer, knogle komplikationer, som kræver strålebehandling eller operation) hos patienter med brystkræft og knoglemetastaser. behandling af tumor induceret hypercalcaemia med eller uden metastaser. behandling af osteoporose hos postmenopausale kvinder med øget risiko for fraktur (se afsnit 5. en reduktion af risikoen for vertebrale frakturer er blevet påvist, at effekten på lårbenshals brud er ikke blevet oprettet.

Uniunea Europeană - daneză - EMA (European Medicines Agency)

mylan ire healthcare limited - pretomanid - tuberkulose, multidrugt-resistent - antimyco-bakterielle midler - dovprela is indicated in combination with bedaquiline and linezolid, in adults, for the treatment of pulmonary extensively drug resistant (xdr), or treatment-intolerant or nonresponsive multidrug-resistant (mdr) tuberculosis (tb). det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Uniunea Europeană - daneză - EMA (European Medicines Agency)

bimeda animal health limited - meloxicam - oxicams - horses; pigs; cattle - cattlefor brug i akut respiratorisk infektion med passende antibiotisk behandling for at reducere kliniske symptomer hos kvæg. til brug i diarré i kombination med oral rehydreringsterapi for at reducere kliniske tegn i kalve på over en uge og unge, ikke-lakterende kvæg. til supplerende terapi til behandling af akut mastitis i kombination med antibiotikabehandling. pigsfor brug i infektiøse lidelser i bevægeapparatet til at reducere symptomer på halthed og inflammation. til supplerende terapi ved behandling af puerperal septikæmi og toksæmi (mastitis-metritis-agalactia syndrom) med passende antibiotikabehandling. horsesfor brug i lindring af betændelse og lindring af smerter i både akutte og kroniske muskuloskeletale lidelser. til lindring af smerte forbundet med hestekolik.

Danemarca - daneză - Lægemiddelstyrelsen (Danish Medicines Agency)

ge healthcare buchler gmbh . & co kg - iobenguan (131-i), natriumiodid (131-i) - injektionsvæske