Kesatuan Eropah - Romania - 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 - agenți antineoplazici - 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. pentru informații suplimentare cu privire la starea receptorului factorului de creștere epidermal uman 2 (her2), vă rugăm să consultați secțiunea 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. pentru informații suplimentare cu privire la starea her2, vă rugăm să consultați secțiunea 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.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

mylan ire healthcare limited - 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 - treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - hemipentahidrat de pemetrexed disodic - carcinoma, non-small-cell lung; mesothelioma - agenți antineoplazici - malignant pleural mesothelioma ciambra in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma. non-small cell lung cancer ciambra in combination with cisplatin is indicated for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. ciambra este indicat în monoterapie pentru tratamentul de întreținere de la nivel local avansat sau metastatic cu celule non-mici cancer pulmonar altul decât predominant tipul histologic cu celule scuamoase la pacienții a căror boală nu a progresat imediat după chimioterapie pe bază de platină. ciambra este indicat ca monoterapie pentru cea de-a doua linie de tratament a pacienților cu local avansat sau metastatic cu celule non-mici cancer pulmonar altul decât predominant tipul histologic cu celule scuamoase.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

pfizer europe ma eeig  - palbociclib - sânii neoplasme - agenți antineoplazici - ibrance este indicat pentru tratamentul de hormon receptor (hr) pozitiv, human epidermal growth factor receptor 2 (her2) negativ avansat local sau metastatic, cancer de sân:în combinație cu un inhibitor de aromatază;în combinație cu fulvestrant la femeile care au primit anterior terapie endocrine. În pre - sau femeile în pre-menopauză, terapia hormonală ar trebui să fie combinate cu un hormon luteinizant hormonului de eliberare (lhrh) agonist.

Kesatuan Eropah - Romania - EMA (European Medicines Agency)

actavis group ptc ehf - topotecan - uterine cervical neoplasms; small cell lung carcinoma - agenți antineoplazici - topotecan monotherapy is indicated for the treatment of:- patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy- patients with relapsed small cell lung cancer (sclc) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5. topotecan în asociere cu cisplatină este indicat pentru pacienții cu carcinom de col uterin recurente după radioterapie și pentru pacienții cu stadiul ivb boala. patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.

Moldova - Romania - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

astellas pharma europe b.v. - tacrolimus - concentrat pentru soluţie perfuzabilă - 5 mg/ml

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pharmathen international s.a - grecia - atomoxetinum - caps. - 10mg - psihostimulante si nootrope simpatomimetice cu actiune centrala

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pharmathen international s.a - grecia - atomoxetinum - caps. - 18mg - psihostimulante si nootrope simpatomimetice cu actiune centrala

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pharmathen international s.a - grecia - atomoxetinum - caps. - 25mg - psihostimulante si nootrope simpatomimetice cu actiune centrala

Romania - Romania - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

pharmathen international s.a - grecia - atomoxetinum - caps. - 40mg - psihostimulante si nootrope simpatomimetice cu actiune centrala