Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

alexion europe sas, france 103-105 rue anatole france, 92300 levallois-perret - ravulizumab - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 300mg/30ml (10mg/ml) - ravulizumab 300mg - ravulizumab

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - Αιμοσφαιρινουρία, παροξυσμική - Επιλεκτικά ανοσοκατασταλτικά - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

elan pharma international ltd. - natalizumab - crohn Νόσος - Ανοσοδιεγερτικά, - Θεραπεία της μέτρια έως σοβαρή ενεργό νόσο του crohn για τη μείωση των σημείων και συμπτωμάτων, καθώς και την επαγωγή και διατήρηση της παρατεταμένης ανταπόκρισης και ύφεσης σε ασθενείς που δεν έχουν ανταποκριθεί σε πλήρη, επαρκή θεραπευτική αγωγή κε ένα κορτικοστεροειδές και ένα ανοσοκατασταλτικό, ή έχουν δυσανεξία ή αντένδειξη για τέτοιες θεραπείες.

Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

novartis europharm limited, ireland (0000013045) vista building, elm park, merrion road, dublin 4, - - ranibizumab - ΕΝΕΣΙΜΟ ΔΙΑΛΥΜΑ - 10mg/ml - 0347396821 ranibizumab 10.000000 mg - ranibizumab

Ελλάδα - Ελληνικά - Εθνικός Οργανισμός Φαρμάκων

eculizumab - c/s.sol.in (ΠΥΚΝΟ ΔΙΑΛΥΜΑ ΓΙΑ ΠΑΡΑΣΚΕΥΗ ΔΙΑΛΥΜΑΤΟΣ ΠΡΟΣ ΕΓΧΥΣΗ) - 300mg/30ml (10mg/ml) - eculizumab 300mg - eculizumab

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

biogen netherlands b.v. - natalizumab - Πολλαπλή σκλήρυνση - Επιλεκτικά ανοσοκατασταλτικά - tysabri is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis for the following patient groups: , patients with highly active disease activity 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 relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more gadolinium enhancing lesions on brain mri or a significant increase in t2 lesion load as compared to a previous recent mri.

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; myopia, degenerative - Οφθαλμολογικά - byooviz is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

midas pharma gmbh - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - Οφθαλμολογικά - ranivisio is indicated in adults for:• the treatment of neovascular (wet) age-related macular degeneration (amd)• the treatment of visual impairment due to diabetic macular oedema (dme)• the treatment of proliferative diabetic retinopathy (pdr)• the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)• the treatment of visual impairment due to choroidal neovascularisation (cnv).

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

stada arzneimittel ag - ranibizumab - wet macular degeneration; macular edema; diabetic retinopathy; diabetes complications - Οφθαλμολογικά - ximluci is indicated in adults for:the treatment of neovascular (wet) age-related macular degeneration (amd)the treatment of visual impairment due to diabetic macular oedema (dme)the treatment of proliferative diabetic retinopathy (pdr)the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch rvo or central rvo)the treatment of visual impairment due to choroidal neovascularisation (cnv).

Ευρωπαϊκή Ένωση - Ελληνικά - EMA (European Medicines Agency)

novartis europharm limited - ranibizumab - wet macular degeneration; macular edema; diabetes complications; myopia, degenerative; choroidal neovascularization - Οφθαλμολογικά - Το lucentis ενδείκνυται σε ενήλικες για:Τη θεραπεία της νεοαγγειακής (υγρής μορφής) ηλικιακής εκφύλισης της ωχράς κηλίδας (amd), Η θεραπεία της όρασης που οφείλεται σε χοριοειδική νεοαγγείωση (cnv)από Την επεξεργασία της όρασης λόγω διαβητικού οιδήματος της ωχράς κηλίδας (dme), Η θεραπεία της όρασης λόγω οιδήματος της ωχράς κηλίδας δευτερεύουσα σε απόφραξη φλέβας του αμφιβληστροειδούς (υποκατάστημα rvo ή κεντρική rvo).