Umoja wa Ulaya - Kigiriki - EMA (European Medicines Agency)

amgen europe b.v. - carfilzomib - Πολλαπλό μυέλωμα - Αντινεοπλασματικοί παράγοντες - kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

Umoja wa Ulaya - Kigiriki - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - Πρόδρομη κυτταρική λεμφοβλαστική λευχαιμία-λέμφωμα - Αντινεοπλασματικοί παράγοντες - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Ugiriki - Kigiriki - Εθνικός Οργανισμός Φαρμάκων

amgen europe bv, breda, holland - pegfilgrastim - ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ - 6mg/0,6ml(10mg/ml) pf.pen - ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ

Kuprosi - Kigiriki - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

amgen europe b.v. (0000003326) minervum 7061, breda, nl-4817 zk - filgrastim - solution for injection - 0.3mg/ml vial - filgrastim (8000001271) 0,3mg - filgrastim

Kuprosi - Kigiriki - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

amgen europe b.v. (0000003326) minervum 7061, breda, nl-4817 zk - filgrastim - solution for injection in prefilled syringe - 30 mu (0,6 mg/ml) - filgrastim (8000001271) 0,3mg - filgrastim

Kuprosi - Kigiriki - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

amgen europe b.v. (0000003326) minervum 7061, breda, nl-4817 zk - filgrastim - solution for injection in prefilled syringe - 48 mu (0,96 mg/ml) - filgrastim (8000001271) 0,48mg - filgrastim

Umoja wa Ulaya - Kigiriki - EMA (European Medicines Agency)

amgen europe b.v. - adalimumab - arthritis, psoriatic; colitis, ulcerative; arthritis, juvenile rheumatoid; spondylitis, ankylosing; psoriasis; crohn disease; arthritis, rheumatoid - Ανοσοκατασταλτικά - rheumatoid arthritis  amgevita 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 including methotrexate has been inadequate. η θεραπεία της σοβαρής, ενεργού και εξελισσόμενης ρευματοειδούς αρθρίτιδας σε ενήλικες που δεν είχαν λάβει προηγουμένως θεραπεία με μεθοτρεξάτη. ,  amgevita can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. amgevita μειώνει το ρυθμό εξέλιξης της αρθρικής βλάβης, όπως μετρήθηκε με ακτίνες χ και βελτιώνει τη φυσική λειτουργικότητα, όταν χορηγείται σε συνδυασμό με μεθοτρεξάτη. juvenile idiopathic arthritis polyarticular juvenile idiopathic arthritis amgevita 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 disease-modifying anti-rheumatic drugs (dmards). amgevita μπορεί να χορηγηθεί ως μονοθεραπεία σε περίπτωση μη ανοχής στη μεθοτρεξάτη ή όταν η συνεχιζόμενη θεραπεία με μεθοτρεξάτη είναι ακατάλληλη (για την αποτελεσματικότητα ως μονοθεραπεία, βλέπε τμήμα 5. Το adalimumab δεν έχει μελετηθεί σε ασθενείς ηλικίας κάτω των 2 ετών. enthesitis-related arthritis amgevita 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 spondyloarthritis ankylosing spondylitis (as) amgevita is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. axial spondyloarthritis without radiographic evidence of as amgevita 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 non-steroidal anti-inflammatory drugs. psoriatic arthritis amgevita is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. amgevita 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. psoriasis amgevita is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy. paediatric plaque psoriasis amgevita 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) amgevita is indicated for the treatment of active moderate to severe hidradenitis suppurativa (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 disease amgevita 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 disease amgevita 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 colitis amgevita 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. uveitis amgevita 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 uveitis amgevita 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.

Umoja wa Ulaya - Kigiriki - EMA (European Medicines Agency)

amgen technology (ireland) uc - Εκουλιζουµάµπη - Αιμοσφαιρινουρία, παροξυσμική - Ανοσοκατασταλτικά - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). Η απόδειξη του κλινικού οφέλους έχει αποδειχθεί σε ασθενείς με αιμόλυση με κλινικό σύμπτωμα(s) ενδεικτική υψηλή δραστηριότητα της νόσου, ανεξάρτητα από μετάγγιση ιστορία (βλέπε τμήμα 5.

Ugiriki - Kigiriki - Εθνικός Οργανισμός Φαρμάκων

amgen europe bv, breda, holland - denosumab - ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ - 60mg/ml - ΒΙΟΤΕΧΝΟΛΟΓΙΚΑ

Ugiriki - Kigiriki - Εθνικός Οργανισμός Φαρμάκων

amgen europe bv, breda, holland - pegfilgrastim - ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ - 6mg/0,6ml(10mg/ml) pf.syr - ΦΑΡΜΑΚΕΥΤΙΚΟ ΠΡΟΪΟΝ