Eiropas Savienība - grieķu - EMA (European Medicines Agency)

novartis europharm limited - secukinumab - arthritis, psoriatic; psoriasis; spondylitis, ankylosing - Ανοσοκατασταλτικά - plaque psoriasiscosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults and children from the age of 6 years old who are candidates for systemic therapy. hidradenitis suppurativa (hs)cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hs therapy. Ψωριασική arthritiscosentyx, μόνο του ή σε συνδυασμό με μεθοτρεξάτη (mtx), ενδείκνυται για τη θεραπεία της ενεργού ψωριασικής αρθρίτιδας σε ενήλικες ασθενείς όταν η ανταπόκριση σε προηγούμενη τροποποιητική της νόσου αντι ρευματικές φάρμακο (dmard) θεραπεία έχει αποδειχθεί ανεπαρκής. axial spondyloarthritis (axspa)Αγκυλοποιητική σπονδυλίτιδα (as, ακτινολογική axial spondyloarthritis)cosentyx ενδείκνυται για τη θεραπεία της ενεργού αγκυλοποιητικής σπονδυλίτιδας σε ενήλικες που δεν ανταποκρίνονται επαρκώς στη συμβατική θεραπεία. non-radiographic axial spondyloarthritis (nr-axspa)cosentyx is indicated for the treatment of active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated c-reactive protein (crp) and/or magnetic resonance imaging (mri) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (nsaids). juvenile idiopathic arthritis (jia)enthesitis-related arthritis (era)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. juvenile psoriatic arthritis (jpsa)cosentyx, alone or in combination with methotrexate (mtx), is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Eiropas Savienība - grieķu - EMA (European Medicines Agency)

novartis europharm limited  - gozetotide - Απεικόνιση ραδιονουκλεϊδίων - Διαγνωστικά ραδιοφαρμακευτικά προϊόντα - Αυτό το φαρμακευτικό προϊόν προορίζεται μόνο για διαγνωστική χρήση. locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (psma) positive lesions with positron emission tomography (pet) in adults with prostate cancer (pca) in the following clinical settings:primary staging of patients with high risk pca prior to primary curative therapy,suspected pca recurrence in patients with increasing levels of serum prostate specific antigen (psa) after primary curative therapy,identification of patients with psma positive progressive metastatic castration resistant prostate cancer (mcrpc) for whom psma targeted therapy is indicated (see section 4.

Eiropas Savienība - grieķu - EMA (European Medicines Agency)

amicus therapeutics europe limited - cipaglucosidase alfa - Τύπος ΙΙ της νόσου αποθήκευσης γλυκογόνου - Άλλα προϊόντα πεπτικής οδού και μεταβολισμού, - pombiliti (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with late-onset pompe disease (acid α-glucosidase [gaa] deficiency).

Eiropas Savienība - grieķu - EMA (European Medicines Agency)

novartis europharm limited - crizanlizumab - Αναιμία, sickle cell - other hematological agents - adakveo is indicated for the prevention of recurrent vaso occlusive crises (vocs) in sickle cell disease patients aged 16 years and older. it can be given as an add on therapy to hydroxyurea/hydroxycarbamide (hu/hc) or as monotherapy in patients for whom hu/hc is inappropriate or inadequate.

Eiropas Savienība - grieķu - EMA (European Medicines Agency)

biosimilar collaborations ireland limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - Αντινεοπλασματικοί παράγοντες - abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. Για περισσότερες πληροφορίες σχετικά με την κατάσταση του υποδοχέα 2 του ανθρώπινου επιδερμικού αυξητικού παράγοντα (her2), παρακαλούμε ανατρέξτε στην ενότητα 5. abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with abevmy in combination with capecitabine. Για περισσότερες πληροφορίες σχετικά με την κατάσταση her2, ανατρέξτε στην ενότητα 5. abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with epidermal growth factor receptor (egfr) activating mutations (see section 5. abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (international federation of gynecology and obstetrics [figo] stages iii b, iii c and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents. abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other vegf inhibitors or vegf receptor–targeted agents (see section 5. abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.

Eiropas Savienība - grieķu - EMA (European Medicines Agency)

novartis europharm limited  - lutetium (177lu) vipivotide tetraxetan - Νεοπλάσματα Του Προστάτη, Ο Ευνουχισμός Ανθεκτικό - Θεραπευτικά ραδιοφαρμακευτικά προϊόντα - pluvicto in combination with androgen deprivation therapy (adt) with or without androgen receptor (ar) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (psma)-positive metastatic castration-resistant prostate cancer (mcrpc) who have been treated with ar pathway inhibition and taxane based chemotherapy.

Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

mercury pharmaceuticals (ireland) limited (0000011125) 4045 kingswood road citywest business park, dublin, dublin 24 - warfarin sodium clathrate - tablets - 5mg - warfarin sodium clathrate (8000003239) 5mg - warfarin

Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

mercury pharmaceuticals (ireland) limited (0000011125) 4045 kingswood road citywest business park, dublin, dublin 24 - warfarin sodium clathrate - tablets - 3mg - warfarin sodium clathrate (8000003239) 3mg - warfarin

Kipra - grieķu - Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

mercury pharmaceuticals (ireland) limited (0000011125) 4045 kingswood road citywest business park, dublin, dublin 24 - warfarin sodium clathrate - tablets - 1mg - warfarin sodium clathrate (8000003239) 1mg base - warfarin

Eiropas Savienība - grieķu - EMA (European Medicines Agency)

amicus therapeutics europe limited - miglustat - Τύπος ΙΙ της νόσου αποθήκευσης γλυκογόνου - Άλλα προϊόντα πεπτικού συστήματος και μεταβολισμού - opfolda (miglustat) is an enzyme stabiliser of cipaglucosidase alfa long-term enzyme replacement therapy in adults with late-onset pompe disease (acid α- glucosidase [gaa] deficiency).