Rumunia - rumuński - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

remedica ltd - cipru - pazopanibum - compr. film. - 400mg - inhibitori de protein-kinaza alti inhibitori de protein kinaza

Unia Europejska - rumuński - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; fallopian tube neoplasms; peritoneal neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - agenți antineoplazici - vegzelma in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. vegzelma in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. pentru informații suplimentare cu privire la starea receptorului factorului de creștere epidermal uman 2 (her2), vă rugăm să consultați secțiunea 5. vegzelma 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 vegzelma in combination with capecitabine. pentru informații suplimentare cu privire la starea her2, vă rugăm să consultați secțiunea 5. vegzelma, 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 (nsclc) other than predominantly squamous cell histology. vegzelma, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent nsclc with epidermal growth factor receptor (egfr) activating mutations (see section 5. vegzelma, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. vegzelma, 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. vegzelma, 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 vascular endothelial growth factor (vegf) inhibitors or vegf receptor–targeted agents. vegzelma 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. vegzelma, 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.

Unia Europejska - rumuński - EMA (European Medicines Agency)

alexion europe sas - eculizumab - hemoglobinurie, paroxismal - imunosupresoare - soliris este indicat la adulți și copii pentru tratamentul:hemoglobinurie paroxistică nocturnă (hpn). dovezi de beneficii clinice este demonstrată la pacienții cu hemoliză cu simptom clinic(s) indică un grad înalt de activitate a bolii, indiferent de transfuzie istorie (a se vedea secțiunea 5. atipic sindrom hemolitic-uremic (ahus). soliris este indicat la adulți pentru tratamentul:refractare generalizate miastenia gravis (gmg) la pacienții care sunt anti-receptorilor de acetilcolină (achr) anticorpi-pozitiv (a se vedea secțiunea 5. oftalmoneuromielită optica tulburare de spectru (nmosd) la pacienții care sunt anti-aquaporin-4 (aqp4) anticorpi pozitiv cu un curs recurente ale bolii.

Unia Europejska - rumuński - EMA (European Medicines Agency)

alexion europe sas - ravulizumab - hemoglobinurie, paroxismal - imunosupresoare selective - 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.

Rumunia - rumuński - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania s.l. - spania - lenalidomidum - caps. - 10mg - imunosupresoare alte imunosupresoare

Rumunia - rumuński - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania s.l. - spania - lenalidomidum - caps. - 15mg - imunosupresoare alte imunosupresoare

Rumunia - rumuński - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania s.l. - spania - lenalidomidum - caps. - 25mg - imunosupresoare alte imunosupresoare

Rumunia - rumuński - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

synthon hispania s.l. - spania - lenalidomidum - caps. - 5mg - imunosupresoare alte imunosupresoare

Rumunia - rumuński - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

apl swift services (malta) ltd. - malta - lenalidomidum - caps. - 10mg - imunosupresoare alte imunosupresoare

Rumunia - rumuński - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

apl swift services (malta) ltd. - malta - lenalidomidum - caps. - 15mg - imunosupresoare alte imunosupresoare