Euroopa Liit - taani - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochlorid - multipel sklerose, recidiverende-remitterende - immunosuppressiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older:patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1)orpatients med hurtigt udviklende alvorlige relapserende remitterende multipel sklerose, der er defineret ved 2 eller flere invaliderende tilbagefald i et år, og med 1 eller flere gadolinium øge læsioner på hjernen mr-scanning eller en betydelig stigning i t2 læsion belastning i forhold til en tidligere de seneste mr -.

Euroopa Liit - taani - EMA (European Medicines Agency)

mylan ireland limited - fingolimod hydrochlorid - multipel sklerose, recidiverende-remitterende - immunosuppressiva - indicated as single disease modifying therapy in highly active relapsing remitting multiple sclerosis for the following groups of adult and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4. 4 og 5. 1) or patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Euroopa Liit - taani - EMA (European Medicines Agency)

eli lilly nederland b.v. - baricitinib - arthritis, reumatoid - immunosuppressiva - rheumatoid arthritisbaricitinib is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (dmards). olumiant kan anvendes som monoterapi eller i kombination med methotrexat. atopic dermatitisolumiant is indicated for the treatment of moderate to severe atopic dermatitis in adult and paediatric patients 2 years of age and older who are candidates for systemic therapy. alopecia areatabaricitinib is indicated for the treatment of severe alopecia areata in adult patients (see section 5. juvenile idiopathic arthritisbaricitinib is indicated for the treatment of active juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response or intolerance to one or more prior conventional synthetic or biologic dmards:- polyarticular juvenile idiopathic arthritis (polyarticular rheumatoid factor positive [rf+] or negative [rf-], extended oligoarticular),- enthesitis related arthritis, and- juvenile psoriatic arthritis. baricitinib may be used as monotherapy or in combination with methotrexate.

Euroopa Liit - taani - EMA (European Medicines Agency)

the medicines company uk ltd - bivalirudin - akut koronarsyndrom - antitrombotiske midler - angiox er indiceret som antikoagulant til voksne patienter, der gennemgår perkutan koronar intervention (pci), herunder patienter med st-segment-forhøjelse myokardieinfarkt (stemi) under primær pci. angiox er også indiceret til behandling af voksne patienter med ustabil angina / non-st-segment-elevation myocardial infarction (ua / nstemi) planlagte til akutte eller tidlig intervention. angiox bør administreres med acetylsalicylsyre og clopidogrel.

Euroopa Liit - taani - EMA (European Medicines Agency)

sanofi winthrop industrie - teriflunomide - multipel sclerose - selektive immunosuppressiva - aubagio is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (ms) (please refer to section 5. 1 for important information on the population for which efficacy has been established).

Euroopa Liit - taani - EMA (European Medicines Agency)

pierre fabre medicament - busulfan - hematopoietisk stamcelletransplantation - antineoplastiske midler - busilvex efterfulgt af cyclophosphamid (bucy2) er indiceret som konditionerende behandling før konventionelle hæmatopoietiske stamceller celle transplantation (hpct) hos voksne patienter, når kombinationen er betragtes som den bedste tilgængelige mulighed. busilvex følgende fludarabine (fb) er angivet som condition behandling forud for hæmatopoietisk stamcelletransplantation (hpct) hos voksne patienter, der er kandidater til en reduceret intensitet conditioning (ric) opskrift. busilvex efterfulgt af cyclophosphamid (bucy4) eller melphalan (bumel) er angivet som condition behandling forud for konventionelle hæmatopoietisk stamcelletransplantation i pædiatriske patienter.

Euroopa Liit - taani - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - busulfan - hematopoietisk stamcelletransplantation - alkylsulfonater - busulfan fresenius kabi efterfulgt af cyclophosphamid (bucy2) er indiceret som konditionerende behandling før konventionelle hæmatopoietiske stamceller celle transplantation (hpct) hos voksne patienter, når kombinationen er betragtes som den bedste tilgængelige mulighed. busulfan fresenius kabi efterfulgt af cyclophosphamid (bucy4) eller melphalan (bumel) er angivet som condition behandling forud for konventionelle hæmatopoietisk stamcelletransplantation i pædiatriske patienter.

Euroopa Liit - taani - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - immunosuppressiva - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. psoriasis arthritiscosentyx, alene eller i kombination med methotrexat (mtx), er indiceret til behandling af aktiv psoriasis artrit hos voksne patienter, når svar på tidligere sygdomsmodificerende anti-reumatiske lægemidler (dmard) behandling har været mangelfuld. aksial spondyloarthritis (axspa)ankyloserende spondylitis (som, røntgen aksial spondyloarthritis)cosentyx er indiceret til behandling af aktiv ankyloserende spondylitis i voksne, der har reageret tilstrækkeligt til konventionel behandling. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Euroopa Liit - taani - EMA (European Medicines Agency)

chiesi farmaceutici s.p.a. - cangrelor - acute coronary syndrome; vascular surgical procedures - antitrombotiske midler - kengrexal, co administreres med acetylsalicylsyre (asa), er indiceret til reduktion af kardiovaskulær tromber hos voksne patienter med koronararteriesygdom gennemgår perkutan koronar intervention (pci), som ikke har modtaget en mundtlig p2y12 hæmmer før proceduren pci og i hvem oral terapi med p2y12 hæmmere er ikke muligt eller ønskeligt.

Euroopa Liit - taani - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - thalidomid - multipelt myelom - immunosuppressiva - thalidomide bms in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. thalidomide bms is prescribed and dispensed according to the thalidomide celgene pregnancy prevention programme (see section 4.