Unió Europea - danès - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - adalimumab - hidradenitis suppurativa; arthritis, psoriatic; psoriasis; crohn disease; arthritis, juvenile rheumatoid; uveitis; arthritis, rheumatoid; colitis, ulcerative; spondylitis, ankylosing - immunosuppressiva - se venligst afsnit 4. 1 i resuméet af produktegenskaber i produktinformationsdokumentet.

Unió Europea - danès - EMA (European Medicines Agency)

ultragenyx germany gmbh - vestronidase alfa - mucopolysaccharidosis vii - enzymer - mepsevii er indiceret til behandling af ikke-neurologiske manifestationer af mucopolysaccharidosis vii (mps vii; sly syndrom).

Unió Europea - danès - EMA (European Medicines Agency)

era consulting gmbh - pegfilgrastim - neutropeni - immunostimulants, , koloni-stimulerende faktorer - reduktion i varigheden af neutropeni og forekomst af febril neutropeni hos voksne patienter behandlet med cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastisk syndromer).

Unió Europea - danès - EMA (European Medicines Agency)

baxalta innovations gmbh - vonicog alfa - von willebrand sygdomme - antihemorrhagics - veyvondi er indiceret hos voksne (18 år og ældre) med von willebrand sygdom (vwd), når desmopressin (ddavp) behandlingen alene er ineffektive eller ikke indiceret til behandling af blødning og kirurgisk blødning - forebyggelse af kirurgiske blødninger. veyvondi bør ikke anvendes i behandling af hæmofili a.

Unió Europea - danès - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - pegfilgrastim - neutropeni - immunostimulants, , koloni-stimulerende faktorer - reduktion i varigheden af neutropeni og forekomst af febril neutropeni hos voksne patienter behandlet med cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastisk syndromer).

Unió Europea - danès - EMA (European Medicines Agency)

baxalta innovations gmbh - rurioctocog alfa pegol - hemophilia a - antihemorrhagics - behandling og profylakse af blødning hos patienter 12 år og derover med hæmofili a (medfødt faktor viii-mangel).

Unió Europea - danès - EMA (European Medicines Agency)

dynavax gmbh - hepatitis b overflade antigen - hepatitis b - vacciner - heplisav b is indicated for the active immunisation against hepatitis b virus infection (hbv) caused by all known subtypes of hepatitis b virus in adults 18 years of age and older. the use of heplisav b should be in accordance with official recommendations. it can be expected that hepatitis d will also be prevented by immunisation with heplisav b as hepatitis d (caused by the delta agent) does not occur in the absence of hepatitis b infection.

Unió Europea - danès - EMA (European Medicines Agency)

sfl pharmaceuticals deutschland gmbh - nyxthracis - anthrax - immune sera og immunoglobuliner, - obiltoxaximab sfl is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to bacillus anthracis (see section 5. obiltoxaximab sfl is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.

Dinamarca - danès - Lægemiddelstyrelsen (Danish Medicines Agency)

glenmark arzneimittel gmbh - icatibantacetat - injektionsvæske, opløsning i fyldt injektionssprøjte - 30 mg

Unió Europea - danès - EMA (European Medicines Agency)

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressiva - tyruko is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (rrms) for the following patient groups: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (dmt) (for exceptions and information about washout periods see sections 4. 4 og 5. 1), or, patients with rapidly evolving severe rrms defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain magnetic resonance imaging (mri) or a significant increase in t2 lesion load as compared to a previous recent mri.