Ronapreve Eiropas Savienība - grieķu - EMA (European Medicines Agency)

ronapreve

roche registration gmbh  - casirivimab, imdevimab - covid-19 virus infection - Άνοσοι οροί και ανοσοσφαιρίνες, - ronapreve is indicated for:treatment of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe covid-19 (see section 4. prevention of covid-19 in adults and adolescents aged 12 years and older weighing at least 40 kg (see section 4. the use of ronapreve should take into account information on the activity of ronapreve against viral variants of concern. Βλ. Ενότητες 4. 4 και 5.

Tyruko Eiropas Savienība - grieķu - EMA (European Medicines Agency)

tyruko

sandoz gmbh - natalizumab - multiple sclerosis, relapsing-remitting; multiple sclerosis - Ανοσοκατασταλτικά - 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 και 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.

STAMARIL POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN PREFILLED SYRINGE Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

stamaril powder and solvent for suspension for injection in prefilled syringe

sanofi pasteur. (0000010487) 14 espace henry vallee, lyon, 69007 - yellow fever virus,live attenuated,17d-204 strain - powder and solvent for suspension for injection in prefilled syringe - yellow fever virus,live attenuated,17d-204 strain (8000004019) 1000iu

IMIPENEM + CILASTATINA VENUS PHARMA 500MG + 500MG ΚΟΝΙΣ ΓΙΑ ΕΝΕΣΙΜΟ ΕΓΧΥΜΑ Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

imipenem + cilastatina venus pharma 500mg + 500mg κονισ για ενεσιμο εγχυμα

venus pharma gmbh (0000008606) am bahnhof 1-3, werne, 59368 - imipenem monohydrate; cilastatin sodium - ΚΟΝΙΣ ΓΙΑ ΕΝΕΣΙΜΟ ΕΓΧΥΜΑ - 500mg + 500mg - imipenem monohydrate (8000002422) 530mg; cilastatin sodium (8000020157) 530,6mg - imipenem and enzyme inhibitor

ORAMORPH 10MG/5ML ORAL SOLUTION Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

oramorph 10mg/5ml oral solution

glenwood gmbh (0000011526) arabellastrasse 17, bogenhausen, munich, 81925 - morphine sulfate - oral solution - 10mg/5ml - morphine sulfate (0000064313) 10mg

BLEO-CELL 15MG/VIAL POWDER FOR SOLUTION FOR INJECTION Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

bleo-cell 15mg/vial powder for solution for injection

cell pharm gmbh - ΒΛΥΟΜΥΚΙΝΗ ΘΕΙΟΥ - powder for solution for injection - 15mg/vial - 0009041934 - bleomycin sulfate - 15 mg - bleomycin

PROBENECID BIOKANOL 500MG TABLETS Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

probenecid biokanol 500mg tablets

biokanol pharma gmbh (0000003726) kehler strasse 7, rastatt, 76437 - probenecid - tablets - 500mg - probenecid (0000057669) 500mg - probenecid

Hukyndra Eiropas Savienība - grieķu - EMA (European Medicines Agency)

hukyndra

stada arzneimittel ag - adalimumab - arthritis, psoriatic; arthritis, juvenile rheumatoid; arthritis, rheumatoid; colitis, ulcerative; crohn disease; hidradenitis suppurativa; psoriasis; spondylitis, ankylosing; uveitis - Ανοσοκατασταλτικά - rheumatoid arthritishukyndra in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Το adalimumab έχει αποδειχθεί ότι μειώνει το ρυθμό εξέλιξης της αρθρικής βλάβης, όπως αξιολογείται ακτινολογικά και ότι βελτιώνει τη λειτουργική ικανότητα όταν χορηγείται σε συνδυασμό με μεθοτρεξάτη. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritishukyndra in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. hukyndra can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. Το adalimumab δεν έχει μελετηθεί σε ασθενείς ηλικίας κάτω των 2 ετών. enthesitis-related arthritishukyndra is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5. axial spondyloarthritisankylosing spondylitis (as)hukyndra is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of ashukyndra is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritishukyndra is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. Το adalimumab έχει αποδειχθεί ότι μειώνει το ρυθμό εξέλιξης της περιφερικής αρθρικής βλάβης, όπως αξιολογείται ακτινολογικά σε ασθενείς με πολυαρθρική συμμετρική υποτύπων της νόσου (βλ. παράγραφο 5. 1) και βελτιώνει την φυσική λειτουργία. psoriasishukyndra is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasishukyndra is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)hukyndra is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 και 5. crohn’s diseasehukyndra is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseasehukyndra is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitishukyndra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitishukyndra is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitishukyndra is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitishukyndra is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Libmyris Eiropas Savienība - grieķu - EMA (European Medicines Agency)

libmyris

stada arzneimittel ag - adalimumab - arthritis, rheumatoid; arthritis, juvenile rheumatoid; spondylitis, ankylosing; arthritis, psoriatic; psoriasis; hidradenitis suppurativa; crohn disease; colitis, ulcerative; uveitis - Ανοσοκατασταλτικά - rheumatoid arthritislibmyris in combination with methotrexate, is indicated for:- the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs (dmards) including methotrexate has been inadequate. - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Το adalimumab έχει αποδειχθεί ότι μειώνει το ρυθμό εξέλιξης της αρθρικής βλάβης, όπως αξιολογείται ακτινολογικά και ότι βελτιώνει τη λειτουργική ικανότητα όταν χορηγείται σε συνδυασμό με μεθοτρεξάτη. juvenile idiopathic arthritispolyarticular juvenile idiopathic arthritislibmyris in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more dmard. libmyris can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5. Το adalimumab δεν έχει μελετηθεί σε ασθενείς ηλικίας κάτω των 2 ετών. enthesitis-related arthritislibmyris is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. axial spondyloarthritisankylosing spondylitis (as)libmyris is indicated for the treatment of adults with severe active as who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of aslibmyris is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of as but with objective signs of inflammation by elevated crp and/or mri, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (nsaids). psoriatic arthritislibmyris is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous dmard therapy has been inadequate. Το adalimumab έχει αποδειχθεί ότι μειώνει το ρυθμό εξέλιξης της περιφερικής αρθρικής βλάβης, όπως αξιολογείται ακτινολογικά σε ασθενείς με πολυαρθρική συμμετρική υποτύπων της νόσου και βελτιώνει την φυσική λειτουργία. psoriasislibmyris is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasislibmyris is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies. hidradenitis suppurativa (hs)libmyris is indicated for the treatment of active moderate to severe hs (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic hs therapy (see sections 5. 1 και 5. crohn’s diseaselibmyris is indicated for treatment of moderately to severely active crohn’s disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. paediatric crohn's diseaselibmyris is indicated for the treatment of moderately to severely active crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies. ulcerative colitislibmyris is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. paediatric ulcerative colitislibmyris is indicated for the treatment of moderately to severely active ulcerative colitis in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-mp) or azathioprine (aza), or who are intolerant to or have medical contraindications for such therapies. uveitislibmyris is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. paediatric uveitislibmyris is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

SALOFALK 500MG GASTRO RESISTANT TABLET Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

salofalk 500mg gastro resistant tablet

dr. falk pharma gmbh (0000008100) leinenweberstr. 5, freiburg, d-79108 - mesalazine - gastro resistant tablet - 500mg - mesalazine (0000089576) 500mg - mesalazine