Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

alvogen ehf. - acidum ibandronicum mónónatríum - filmuhúðuð tafla - 150 mg

Evrópusambandið - íslenska - 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 - Æxlishemjandi lyf - 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. sjá nánar í kafla 5 til að fá nánari upplýsingar varðandi húðþéttni vaxtarþáttar viðtaka 2 (her2). 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. nánari upplýsingar um her2 stöðu, sjá kafla 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.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

zoetis belgium sa - live recombinant e2 gene-deleted bovine viral diarrhoea virus containing classical swine fever virus e2 gene (cp7_e2alf) - live viral vaccines, immunologicals for suidae - svín - fyrir virkan ónæmingu svína frá 7 vikna aldri til að koma í veg fyrir dauðsföll og draga úr sýkingu og sjúkdómum af völdum svínapestarveiru (csfv). onset of immunity: 14 days after vaccinationduration of immunity: at least 6 months after vaccinationfor active immunisation of breeding females to reduce transplacental infection caused by csfv. onset of immunity: 21 days after vaccinationduration of immunity has not been demonstrated.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

ceva-phylaxia co. ltd. - live recombinant fowlpox virus expressing the membrane fusion protein and the encapsidation protein of avian infectious laryngotracheitis virus (rfp-lt) and avian encephalomyelitis virus, strain calnek 1143 (ae) - immunologicals for aves, live viral vaccines, domestic fowl - kjúklingur - for active immunisation of chickens of 8 to 13 weeks of age in order to reduce the skin lesions due to fowlpox, to reduce the clinical signs and tracheal lesions due to avian infectious laryngotracheitis and to prevent egg production losses due to avian encephalomyelitis.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

laboratorios hipra s.a - lifa ge- tk- tvöfalt gen-eytt nautgripavirus tegund 1, stofn ceddel: 106,3-107,3 ​​ccid50 - Ónæmisfræðilegar upplýsingar - nautgripir - fyrir virka bólusetningar af nautgripum frá þriggja mánaða aldur gegn nautgripum herpesvírusinn tegund 1 (bohv-1) til að draga úr klínískum merki um smitandi nautgripum barkabólgu (ibr) og sviði veira skilst. upphaf ónæmis: 21 dagar eftir að grunnbólusetningarkerfið er lokið. lengd ónæmis: 6 mánuðum eftir að grunnbólusetningarkerfið er lokið.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - live recombinant marek’s disease (md) virus, serotype 1, strain rn1250 - Ónæmissjúkdómar fyrir fugla - kjúklingur - for active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by marek’s disease (md) virus (including very virulent md virus).

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - live recombinant marek’s disease virus, serotype 1, strain rn1250; live recombinant turkey herpesvirus, expressing the vp2 protein of infectious bursal disease virus, strain vhvt013-69 - immunologicals for aves, domestic fowl, avian herpes virus (marek's disease) + avian infectious bursal disease virus (gumboro disease) + newcastle disease virus/paramyxovirus - kjúklingur - for active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by marek’s disease (md) virus (including very virulent md virus), and to prevent mortality, clinical signs and lesions caused by infectious bursal disease (ibd) virus.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

intervet international b.v. - live attenuated canine distemper virus strain onderstepoort: 105.1 – 106.5 tcid50, live recombinant canine parvovirus strain 630a: 105.1 – 106.7 tcid50 - Ónæmislyf fyrir canidae - dogs (small) - for the active immunisation of puppies from 4 weeks of age onwards to prevent clinical signs and mortality of canine distemper virus infection and canine parvovirus infection and to prevent viral excretion following canine distemper virus infection and following canine parvovirus infection.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

merck sharp dohme limited - áhrif, raltegravir kalíum - hiv sýkingar - antivirals for systemic use, antivirals for treatment of hiv infections, combinations - dutrebis er ætlað ásamt öðrum anti‑retróveira lyf til meðferð hiv veira (hiv‑1) sýkingu í fullorðnir, unglingar, og börn frá 6 ára og vega að minnsta kosti 30 kg án staðar eða fortíð vísbendingar um friðhelgi andstöðu við veirum á höfða (integrase Þræði flytja hemil) og nrti (núkleósíð vixlrita hemil) flokkum (sjá kafla 4. 2, 4. 4 og 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

boehringer ingelheim international gmbh - tipranavir - hiv sýkingar - veirueyðandi lyf til almennrar notkunar - aptivus, sam-gefið með litlum skömmtum rítónavír, er ætlað fyrir samsetning andretróveirumeðferð hiv-1 sýkingu í mjög forhitaðar fullorðnir og unglingar 12 ára eða eldra með veiru þola margar próteasahemlar. aptivus skal aðeins notaður sem hluti af virkur samsetning antiretroviral meðferð í sjúklinga með engin önnur lækninga valkosti. Þetta merki er byggt á niðurstöður tvær áfanga-iii rannsóknir, flutt í mjög forhitaðar fullorðinn sjúklingar (akreinina númer 12 áður en antiretroviral lyf) með veiru þola próteasahemlar og einn áfanga-ii rannsókn rannsaka lyfjahvörf, öryggi og verkun aptivus í mestu meðferð-upplifað unglingum sjúklinga á aldrinum 12 til 18 ára. Í ákveðið að hefja meðferð með aptivus, sam-gefið með lítinn skammt rítónavír, vandlega íhugun ætti að meðferð sögu sjúklingur og mynstur stökkbreytingar tengslum með mismunandi lyf. arfgerðar eða svipgerðar prófa (þegar boði) og meðferð sögu ætti að fylgja því að nota aptivus. meðferð er hafin ætti að taka með í reikninginn sturtu stökkbreytingar sem getur neikvæð áhrif á veirufræðilega að bregðast við aptivus, sam-gefið með litlum skömmtum rítónavír.