Europese Unie - Nederlands - EMA (European Medicines Agency)

fresenius kabi deutschland gmbh - tocilizumab - arthritis, rheumatoid; cytokine release syndrome; arthritis, juvenile rheumatoid; covid-19 virus infection; giant cell arteritis - immunosuppressiva - tyenne, in combination with methotrexate (mtx), is indicated for- the treatment of severe, active and progressive rheumatoid arthritis (ra) in adults not previously treated with mtx. - the treatment of moderate to severe active ra in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (dmards) or tumour necrosis factor (tnf) antagonists. in these patients, tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tocilizumab has been shown to reduce the rate of progression of joint damage as measured by x-ray and to improve physical function when given in combination with methotrexate. tyenne is indicated for the treatment of coronavirus disease 2019 (covid-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. tyenne is indicated for the treatment of active systemic juvenile idiopathic arthritis (sjia) in patients 1 year of age and older, who have responded inadequately to previous therapy with nsaids and systemic corticosteroids. tyenne can be given as monotherapy (in case of intolerance to mtx or where treatment with mtx is inappropriate) or in combination with mtx. tyenne in combination with methotrexate (mtx) is indicated for the treatment of juvenile idiopathic polyarthritis (pjia; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with mtx. tyenne can be given as monotherapy in case of intolerance to mtx or where continued treatment with mtx is inappropriate. tyenne is indicated for the treatment of chimeric antigen receptor (car) t cell-induced severe or life-threatening cytokine release syndrome (crs) in adults and paediatric patients 2 years of age and older. tyenne is indicated for the treatment of giant cell arteritis (gca) in adult patients.

Europese Unie - Nederlands - EMA (European Medicines Agency)

biofrontera bioscience gmbh - 5-aminolevulinezuur hydrochloride - keratosis, actinic; carcinoma, basal cell - antineoplastische middelen - behandeling van actinische keratose van milde tot matige ernst op het gezicht en de hoofdhuid (olsen leerjaar 1 en 2; zie paragraaf 5. 1) en van field cancerization bij volwassenen. behandeling van oppervlakkige en/of nodulair basaalcelcarcinoom ongeschikt voor chirurgische behandeling als gevolg van de mogelijke behandeling gerelateerde morbiditeit en/of slecht cosmetisch resultaat bij volwassenen.

Europese Unie - Nederlands - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - venetoclax - leukemie, lymfocytisch, chronisch, b-cel - antineoplastische middelen - venclyxto in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (cll) (see section 5. venclyxto in combination with rituximab is indicated for the treatment of adult patients with cll who have received at least one prior therapy. venclyxto monotherapy is indicated for the treatment of cll:- in the presence of 17p deletion or tp53 mutation in adult patients who are unsuitable for or have failed a b cell receptor pathway inhibitor, or- in the absence of 17p deletion or tp53 mutation in adult patients who have failed both chemoimmunotherapy and a b-cell receptor pathway inhibitor. venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly  diagnosed acute myeloid leukaemia (aml) who are ineligible for intensive chemotherapy.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

saluvet gmbh - argentum metallicum (ho); lachesis mutus (ho); pyrogenium (ho) - oplossing voor injectie - argentum metallicum (ho) d30; lachesis mutus (ho) d8; pyrogenium (ho) d15, - geiten; paarden; runderen; schapen; varkens

Europese Unie - Nederlands - EMA (European Medicines Agency)

dr. friedrich eberth arzneimittel gmbh - lasofoxifene tartrate - osteoporose, postmenopauze - geslachtshormonen en modulatoren van het genitale systeem, - fablyn is geïndiceerd voor de behandeling van osteoporose bij postmenopauzale vrouwen met een verhoogd risico op fracturen. een significante vermindering van de incidentie van wervel- en niet-wervelbreuken maar niet van heupfracturen is aangetoond (zie rubriek 5).. bij het bepalen van de keuze van fablyn of andere therapieën, zoals oestrogenen, voor een postmenopauzale vrouw, aandacht moet worden gegeven om symptomen van de menopauze, effecten op baarmoeder-en borstkanker weefsels, en cardiovasculaire risico ' s en voordelen (zie sectie 5.

Europese Unie - Nederlands - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - telmisartan - geneesmiddelen die op het renine-angiotensine systeem, angiotensine ii-antagonisten, normaal - cats - vermindering van proteïnurie geassocieerd met chronische nierziekte (ckd).

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh - metoprololsuccinaat samenstelling overeenkomend met ; metoprololtartraat - tablet met verlengde afgifte - cellulose, microkristallijn (e 460) ; copolymeer van ethylacrylaat-methylmethacrylaat (2:1) ; hypromellose (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; saccharose ; siliciumdioxide (e 551) ; sugar spheres ; talk (e 553 b) ; titaandioxide (e 171), - metoprolol

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh - metoprololsuccinaat samenstelling overeenkomend met ; metoprololtartraat - tablet met verlengde afgifte - cellulose, microkristallijn (e 460) ; copolymeer van ethylacrylaat-methylmethacrylaat (2:1) ; hypromellose (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; saccharose ; siliciumdioxide (e 551) ; sugar spheres ; talk (e 553 b) ; titaandioxide (e 171), - metoprolol

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh - metoprololsuccinaat samenstelling overeenkomend met ; metoprololtartraat - tablet met verlengde afgifte - cellulose, microkristallijn (e 460) ; copolymeer van ethylacrylaat-methylmethacrylaat (2:1) ; hypromellose (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; saccharose ; siliciumdioxide (e 551) ; sugar spheres ; talk (e 553 b) ; titaandioxide (e 171), - metoprolol

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

ratiopharm gmbh - metoprololsuccinaat samenstelling overeenkomend met ; metoprololtartraat - tablet met verlengde afgifte - cellulose, microkristallijn (e 460) ; copolymeer van ethylacrylaat-methylmethacrylaat (2:1) ; hypromellose (e 464) ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel ; povidon (e 1201) ; saccharose ; siliciumdioxide (e 551) ; sugar spheres ; talk (e 553 b) ; titaandioxide (e 171), - metoprolol