Roemenië - Roemeens - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

glaxosmithkline consumer healthcare gmbh & co. kg - germania - diclofenacum - gel - 11,6mg/g - medicamente topice pentru dureri articulare si musculare antiinflamatoare nesteroidiene de uz topic

Roemenië - Roemeens - ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)

glaxosmithkline consumer healthcare gmbh & co. kg - germania - diclofenacum - gel - 23,2mg/g - medicamente topice pentru dureri articulare si musculare antiinflamatoare nesteroidiene de uz topic

Europese Unie - Roemeens - EMA (European Medicines Agency)

janssen-cilag international nv - apalutamide - prostate neoplasme - terapia endocrină - erleada este indicat:la bărbați adulți pentru tratamentul non-metastatic rezistent la castrare cancerul de prostata (nmcrpc) care sunt la risc ridicat de a dezvolta boala metastatică. la bărbații adulți pentru tratamentul metastatic hormono-sensibile cancerul de prostata (mhspc) în combinație cu terapie de deprivare androgenică (adt).

Roemenië - Roemeens - Ecolab

ecolab deutschland gmbh -

Europese Unie - Roemeens - EMA (European Medicines Agency)

mylan ireland limited - acetat de abirateron - prostate neoplasme - endocrine therapy, other hormone antagonists and related agents - abiraterone mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mhspc) in adult men in combination with androgen deprivation therapy (adt). the treatment of metastatic castration resistant prostate cancer (mcrpc) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. the treatment of mcrpc in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Europese Unie - Roemeens - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. aybintio 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. 1 of the smpc. aybintio 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 anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with aybintio in combination with capecitabine. pentru informații suplimentare cu privire la starea her2, vă rugăm să consultați secțiunea 5. 1 of the smpc. aybintio, 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. aybintio, 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. 1 of the smpc). aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. aybintio, 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. 1 of the smpc). aybintio, 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. aybintio, in combination with 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. 1 of the smpc). aybintio, 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. 1 of the smpc).

Europese Unie - Roemeens - EMA (European Medicines Agency)

centus biotherapeutics europe limited - bevacizumab - colorectal neoplasms; breast neoplasms; ovarian neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell - agenți antineoplazici - bevacizumab în asociere cu chimioterapia pe bază de fluoropirimidină este indicat pentru tratamentul pacienților adulți cu carcinom metastatic al colonului sau rectului. bevacizumab în combinație cu paclitaxel este indicat pentru tratamentul de primă linie al pacienților adulți cu cancer de sân metastatic. pentru informații suplimentare cu privire la starea receptorului factorului de creștere epidermal uman 2 (her2), vă rugăm să consultați secțiunea 5. bevacizumab în combinație cu capecitabina este indicat pentru tratamentul de primă linie al pacienților adulți cu cancer de sân metastatic la care tratamentul cu alte chimioterapice opțiuni, inclusiv taxani sau antracicline nu este considerată adecvată. patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with equidacent in combination with capecitabine. pentru informații suplimentare cu privire la starea her2, vă rugăm să consultați secțiunea 5. bevacizumab, 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. bevacizumab, în combinație cu erlotinib, este indicat pentru tratamentul de primă linie al pacienților adulți cu avansat inoperabil, metastatic sau recurent non-scuamos non-cancer pulmonar cu celule mici cu receptorul factorului de creștere epidermal (egfr) activarea mutații. bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. bevacizumab, 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 iiib, iiic and iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5. bevacizumab, 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. bevacizumab în combinație cu paclitaxel și cisplatin sau, alternativ, paclitaxel și topotecanului la pacienții care nu pot primi platinum terapie, este indicat pentru tratamentul pacienților adulți cu persistent, recurent sau metastatic carcinom de col uterin.

Europese Unie - Roemeens - EMA (European Medicines Agency)

samsung bioepis nl b.v. - 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 - onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. onbevzi 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. onbevzi 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 onbevzi in combination with capecitabine. pentru informații suplimentare cu privire la starea her2, vă rugăm să consultați secțiunea 5. onbevzi, 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. onbevzi, 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. onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. onbevzi, 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. onbevzi, 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. onbevzi, in combination with 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. onbevzi, 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.

Europese Unie - Roemeens - 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.

Europese Unie - Roemeens - EMA (European Medicines Agency)

dr. friedrich eberth arzneimittel gmbh - tartrat de lasofoxifen - osteoporoza, postmenopauză - hormoni sexuali și modulatori ai sistemului genital, - fablyn este indicat pentru tratamentul osteoporozei la femeile aflate în postmenopauză cu risc crescut de fractură. sa demonstrat o reducere semnificativă a incidenței fracturilor vertebrale și non-vertebrale, dar nu a fracturilor de șold (vezi secțiunea 5. la determinarea alegerea fablyn sau alte terapii, inclusiv estrogeni, pentru o postmenopauză femeie, ar trebui luate în considerare simptomele de menopauză, efectele asupra uterin și de sân țesuturi, și cardiovascular riscurilor și beneficiilor (a se vedea secțiunea 5.