Unione Europea - rumeno - EMA (European Medicines Agency)

intervet international bv - tildipirosin - antiinfectioase pentru uz sistemic - pigs; cattle - 40 mg/ml, soluție injectabilă pentru pigstreatment și metaphylaxis bolilor respiratorii la suine (srd) asociate cu actinobacillus pleuropneumoniae, pasteurella multocida, bordetella bronchiseptica și haemophilus parasuis sensibile la tildipirozină. prezența bolii în efectiv trebuie confirmată înainte de punerea în aplicare a metafilaxiei. 180 mg/ml, soluție injectabilă pentru cattlefor tratamentul și prevenirea bolilor respiratorii la bovine (brb) asociate cu mannheimia haemolytica, pasteurella multocida și histophilus somni sensibile la tildipirozină. prezența bolii în efectiv trebuie confirmată înainte de tratamentul preventiv.

Unione Europea - rumeno - 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).

Unione Europea - rumeno - EMA (European Medicines Agency)

accord healthcare s.l.u. - doxorubicin hydrochloride, liposomal - ovarian neoplasms; sarcoma, kaposi; multiple myeloma - doxorubicin - zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:• breast cancer that has spread to other parts of the body in patients at risk of heart problems. zolsketil pegylated liposomal is used on its own for this disease;• advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;• multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);• kaposi’s sarcoma in patients with aids who have a very damaged immune system. kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs. zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. this means that it is similar to a ‘reference medicine’ containing the same active substance called adriamycin. however, in zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for adriamycin.

Moldavia - rumeno - AMDM (Agenţia Medicamentului şi Dispozitivelor Medicale)

johnson & johnson srl - topiramatum - capsule - 25 mg

Unione Europea - rumeno - EMA (European Medicines Agency)

merck sharp & dohme b.v. - daptomicinei - gram-positive bacterial infections; bacteremia; soft tissue infections; endocarditis, bacterial - antibacteriene pentru uz sistemic, - cubicin este indicat pentru tratamentul următoarelor infecții. adulți, adolescenți și copii (de la 1 la 17 ani) pacienții cu complicate ale pielii și țesuturilor moi infecții (cssti). adulți pacienți cu endocardită infecțioasă dreaptă (rie), ca urmare a staphylococcus aureus. se recomandă ca decizia de a folosi daptomicină ar trebui să ia în considerare antibacterian susceptibilitatea organismului și ar trebui să fie bazat pe consultanță de specialitate. adulți, adolescenți și copii (de la 1 la 17 ani) pacienții cu bacteriemie cauzată de staphylococcus aureus (sab). la adulți, utilizarea în bacteriemie ar trebui să fie asociate cu rie sau cu cssti, în timp ce la pacienții copii și adolescenți, utilizarea în bacteriemie ar trebui să fie asociate cu cssti. daptomicina este activ împotriva bacteriilor gram pozitive numai. În infecții mixte unde gram negative și/sau de anumite tipuri de bacterii anaerobe sunt suspectate, cubicin trebuie să fie administrat concomitent cu medicamente antibacteriene adecvate agent(s). trebuie luate în considerare ghidurile oficiale referitoare la utilizarea adecvată a medicamentelor antibacteriene.

Unione Europea - rumeno - EMA (European Medicines Agency)

menarini international operations luxembourg s.a. - oritavancin (diphosphate) - soft tissue infections; skin diseases, bacterial - antibacteriene pentru uz sistemic, - tenkasi is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and paediatric patients aged 3 months and older (see sections 4. 2, 4. 4 și 5. trebuie luate în considerare ghidurile oficiale referitoare la utilizarea adecvată a medicamentelor antibacteriene.

Unione Europea - rumeno - 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).

Unione Europea - rumeno - 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.

Unione Europea - rumeno - 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.

Unione Europea - rumeno - 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.