Eiropas Savienība - horvātu - 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 - antineoplastična sredstva - 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. za daljnje informacije o stanju čovjeka epidermalnog faktora rasta receptora 2 (her2), molimo pogledajte odjeljak 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. dodatne informacije o statusu her2 potražite u odjeljku 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 - horvātu - EMA (European Medicines Agency)

hipra human health s.l. - sars-cov-2 virus recombinant spike (s) protein receptor binding domain (rbd) fusion heterodimer – b.1.351-b.1.1.7 strains - covid-19 virus infection - cjepiva - bimervax is indicated as a booster for active immunisation to prevent covid-19 in individuals 16 years of age and older who have previously received a mrna covid-19 vaccine.

Melnkalne - horvātu - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"berlin-chemie/menarini montenegro" d.o.o.- podgorica - febuksostat - film tableta - 80mg

Melnkalne - horvātu - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"berlin-chemie/menarini montenegro" d.o.o.- podgorica - febuksostat - film tableta - 120mg

Melnkalne - horvātu - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

druŠtvo za trgovinu na veliko farmaceutskim proizvodima "glosarij" d.o.o.-podgorica - apalutamid - film tableta - 60mg

Melnkalne - horvātu - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"berlin-chemie/menarini montenegro" d.o.o.- podgorica - febuksostat - film tableta - 80mg

Melnkalne - horvātu - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"berlin-chemie/menarini montenegro" d.o.o.- podgorica - febuksostat - film tableta - 120mg

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

bavarian nordic a/s - modificirana vakcina ankara - bavarska nordijska (mva-bn) virus - smallpox vaccine; monkeypox virus - drugih virusnih cjepiva, - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4. 4 i 5. korištenje ovog cjepiva mora se provoditi u skladu sa službenim preporukama.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

ceva santé animale - inaktiviran coxiella burnetii cjepivo, soj nine mile - immunologicals for bovidae, inactivated bacterial vaccines (including mycoplasma, toxoid and chlamydia) - goats; cattle - cattle: , for the active immunisation of cattle to lower the risk for non-infected animals vaccinated when non-pregnant to become shedder (5 times lower probability in comparison with animals receiving a placebo), and to reduce shedding of coxiella burnetii in these animals via milk and vaginal mucus. , onset of immunity: not established. , duration of immunity: 280 days after completion of the primary vaccination course. , goats: , for the active immunisation of goats to reduce abortion caused by coxiella burnetii and to reduce shedding of the organism via milk, vaginal mucus, faeces and placenta. , onset of immunity: not established. , duration of immunity: one year after completion of the primary vaccination course.

Eiropas Savienība - horvātu - EMA (European Medicines Agency)

zoetis belgium sa - synthetic peptide analogue of gnrf conjugated to diptheria toxoid - imunološke za suidae - male pigs (from 8 weeks of age); female pigs (from 14 weeks of age) - male pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of testicular function. for use as an alternative to physical castration for the reduction of boar taint caused by the key boar taint compound androstenone, in entire male pigs following the onset of puberty. drugi ključni čimbenik za svinjsku kosu, skatole, također može biti smanjen kao neizravni učinak. također su smanjene agresivne i seksualne (montirane) ponašanja. female pigs:induction of antibodies against gnrf to produce a temporary immunological suppression of ovarian function (suppression of oestrus) in order to reduce the incidence of unwanted pregnancies in gilts intended for slaughter, and to reduce the associated sexual behaviour (standing oestrus).