Hukyndra Den europeiske union - gresk - 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.

BIMASTAT 150 + 25 MG/ML ORAL SUSPENSION Kypros - gresk - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

bimastat 150 + 25 mg/ml oral suspension

panchris feeds (veterinary) ltd (0000003032) industrial zone aradippou, 7100 larnaca, p o box 40261 - sulfadiazine; neomycin sulfate - oral suspension - 150 + 25 mg/ml - sulfadiazine (0000068359) 150mg; neomycin sulfate (0001405103) 25mg - sulfonamides, comb with other antibacterials excl trimethoprim

ASACOL 400MG GASTRO RESISTANT TABLET Kypros - gresk - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

asacol 400mg gastro resistant tablet

tillotts pharma gmbh (0000010051) warmbacher str. 80, rheinfelden, 79618 - mesalazine - gastro resistant tablet - 400mg - mesalazine (0000089576) 400mg - mesalazine

DILAPAN 150MG CAPSULE,HARD Kypros - gresk - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

dilapan 150mg capsule,hard

remedica ltd (0000003171) aharnon str., lemesos, 3056 - fluconazole - capsule,hard - 150mg - fluconazole (0086386734) 150mg - fluconazole

MEDOCYCLINE 250MG CAPSULE,HARD Kypros - gresk - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

medocycline 250mg capsule,hard

medochemie ltd (0000003169) 1-10 constantinoupoleos str, lemesos, 3011, 51409 (3505) - tetracycline hydrochloride - capsule,hard - 250mg - tetracycline hydrochloride (0000064755) 250mg - tetracycline

NAFLOXIN EY.DRO.SOL 0.3% Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

nafloxin ey.dro.sol 0.3%

ΚΟΠΕΡ Α.Ε. ΑΡΙΣΤΟΒΟΥΛΟΥ 64, 11853 Κ. ΠΕΤΡΑΛΩΝΑ 3462102 3462108 - ciprofloxacin hydrochloride monohydrate - ey.dro.sol (ΟΦΘΑΛΜΙΚΕΣ ΣΤΑΓΟΝΕΣ, ΔΙΑΛΥΜΑ) - 0.3% - ciprofloxacin hydrochloride monohydrate 3,5mg - ciprofloxacin

MEROVIA PD.I.S.INF 500MG/VIAL Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

merovia pd.i.s.inf 500mg/vial

remedina abee ΓΟΥΝΑΡΗ 25 & ΑΡΕΩΣ, 13451 ΚΑΜΑΤΕΡΟ ΑΤΤΙΚΗ 2685552 - meropenem trihydrate - pd.i.s.inf (ΚΟΝΙΣ ΓΙΑ ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ/ΔΙΑΛΥΜΑ ΠΡΟΣ ΕΓΧΥΣΗ) - 500mg/vial - meropenem trihydrate 570mg - meropenem

MEROVIA PD.I.S.INF 1000 MG/VIAL Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

merovia pd.i.s.inf 1000 mg/vial

remedina abee ΓΟΥΝΑΡΗ 25 & ΑΡΕΩΣ, 13451 ΚΑΜΑΤΕΡΟ ΑΤΤΙΚΗ 2685552 - meropenem trihydrate - pd.i.s.inf (ΚΟΝΙΣ ΓΙΑ ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ/ΔΙΑΛΥΜΑ ΠΡΟΣ ΕΓΧΥΣΗ) - 1000 mg/vial - meropenem trihydrate 1.140mg - meropenem

CARBENEM PD.I.S.INF 500MG/VIAL Hellas - gresk - Εθνικός Οργανισμός Φαρμάκων

carbenem pd.i.s.inf 500mg/vial

ΚΟΠΕΡ Α.Ε. ΑΡΙΣΤΟΒΟΥΛΟΥ 64, 11853 Κ. ΠΕΤΡΑΛΩΝΑ 3462102 3462108 - meropenem trihydrate - pd.i.s.inf (ΚΟΝΙΣ ΓΙΑ ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ/ΔΙΑΛΥΜΑ ΠΡΟΣ ΕΓΧΥΣΗ) - 500mg/vial - meropenem trihydrate 570mg - meropenem