Den Europæiske Union - dansk - EMA (European Medicines Agency)

laboratoire hra pharma - ulipristal - præception, postcoital - køn hormoner og modulatorer af den genitale system, , nød-prævention - nødprævention indenfor 120 timer (fem dage) af ubeskyttet samleje eller svangerskabsforebyggende svigt.

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

medac, gesellschaft für klinische spezialpräparate mbh - dacarbazincitrat - pulver til injektions-/infusionsvæske, opløsning - 200 mg

Danmark - dansk - Lægemiddelstyrelsen (Danish Medicines Agency)

reddy holding gmbh - bortezomib - pulver til injektionsvæske, opløsning - 3,5 mg

Den Europæiske Union - dansk - 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.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

pfizer europe ma eeig - tofacitinib - arthritis, reumatoid - immunosuppressiva - rheumatoid arthritistofacitinib in combination with methotrexate (mtx) is indicated for the treatment of moderate to severe active rheumatoid arthritis (ra) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (dmards) (see section 5. tofacitinib can be given as monotherapy in case of intolerance to mtx or when treatment with mtx is inappropriate (see sections 4. 4 og 4. psoriatic arthritistofacitinib in combination with mtx is indicated for the treatment of active psoriatic arthritis (psa) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (dmard) therapy (see section 5. ulcerative colitistofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (uc) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5. tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [rf+] or negative [rf-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (psa) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (dmards). tofacitinib can be given in combination with methotrexate (mtx) or as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. ankylosing spondylitistofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (as) who have responded inadequately to conventional therapy.

Den Europæiske Union - dansk - EMA (European Medicines Agency)

a. menarini industrie farmaceutiche riunite s.r.l. - delafloxacin meglumine - ef-erhvervede infektioner - antibakterielle midler til systemisk brug, - quofenix is indicated for the treatment of the following infections in adults:acute bacterial skin and skin structure infections (absssi),community-acquired pneumonia (cap), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4. 4 og 5. det bør overvejes at officielle vejledning om hensigtsmæssig brug af antibakterielle midler..

Den Europæiske Union - dansk - EMA (European Medicines Agency)

estetra sprl - estetrol monohydrate, drospirenone - contraceptives, oral - køn hormoner og modulatorer af den genitale system, - oral prævention. the decision to prescribe lydisilka should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (vte), and how the risk of vte with lydisilka compares with other combined hormonal contraceptives (chcs) (see sections 4. 3 and 4.

Den Europæiske Union - dansk - 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 -.

Den Europæiske Union - dansk - 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.

Den Europæiske Union - dansk - 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.