Evrópusambandið - íslenska - EMA (European Medicines Agency)

eurogenerics holdings b.v. - teriparatíð - beinþynning - kalsíumsterastasis - qutavina is indicated in adults. meðferð við beinþynningu hjá konum eftir tíðahvörf og karlar við aukna hættu á beinbrotum. in postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. meðferð beinbrot tengslum við viðvarandi almenn sykurstera meðferð í konur og menn á jókst hættan fyrir beinbrot.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

pacira ireland limited - bupivacaine - acute pain - amides, anesthetics, local - exparel liposomal is indicated:in adults as a brachial plexus block or femoral nerve block for treatment of post-operative pain. in adults and children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

janssen-cilag international nv - adenovirus type 26 encoding the sars-cov-2 spike glycoprotein (ad26.cov2-s) - covid-19 virus infection - bóluefni - jcovden is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 18 years of age and older. notkun þetta bóluefni ætti að vera í samræmi við opinbera tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

astrazeneca ab - chadox1-sars-cov-2 - covid-19 virus infection - bóluefni - vaxzevria is indicated for active immunisation to prevent covid 19 caused by sars cov 2, in individuals 18 years of age and older. notkun þetta bóluefni ætti að vera í samræmi við opinbera tillögur.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biocryst ireland limited - berotralstat dihydrochloride - ofsabjúgur, arfgengur - other hematological agents - orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (hae) in adult and adolescent patients aged 12 years and older.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

eli lilly nederland b.v. - selpercatinib - carcinoma, non-small-cell lung; thyroid neoplasms - Æxlishemjandi lyf - retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced ret-mutant medullary thyroid cancer (mtc)advanced ret fusion-positive non-small cell lung cancer (nsclc) not previously treated with a ret inhibitoradvanced ret fusion-positive thyroid cancer who require systematic therapy following prior treatment.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - heila-og mænusigg, köstum tilkynnt - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

leo pharma a/s - tralokinumab - dermatitis, atópísk - aðrar húðsjúkdómar - adtralza is indicated for the treatment of moderate to severe atopic dermatitis in adult and adolescent patients 12 years and older who are candidates for systemic therapy.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

secura bio limited - duvelisib - leukemia, lymphocytic, chronic, b-cell; lymphoma, follicular - Æxlishemjandi lyf - copiktra monotherapy is indicated for the treatment of adult patients with: relapsed or refractory chronic lymphocytic leukaemia (cll) after at least two prior therapies.  follicular lymphoma (fl) that is refractory to at least two prior  systemic therapies.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - insúlín aspart - sykursýki - lyf notuð við sykursýki - kirsty is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.