Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

aspen pharma trading limited - lidocainum inn - smyrsli - 50 mg/g

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

aspen pharma trading limited - lidocainum hýdróklóríð - stungulyf, lausn - 10 mg/ml

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

aspen pharma trading limited - lidocainum hýdróklóríð - stungulyf, lausn - 20 mg/ml

Ísland - íslenska - LYFJASTOFNUN (Icelandic Medicines Agency)

aspen pharma trading limited - lidocainum hýdróklóríð - hlaup - 20 mg/ml

Evrópusambandið - íslenska - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - Æxlishemjandi lyf - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

emdoka bvba - halófúgínón laktat - halofuginone, Önnur frumudýraeyðandi lyfjum - kálfar, nýfætt - Í nýfætt kálfa:fyrirbyggja niðurgangur vegna greind cryptosporidium parvum sýkingu, í bæjum með sögu cryptosporidiosis. gjöf ætti að byrja á fyrstu 24 til 48 klst. lækkun niðurgangur vegna greind cryptosporidium sýkingu parvum. gjöf ætti að hefjast innan 24 klukkustunda eftir að niðurgangur hefst. Í báðum tilvikum hefur verið sýnt fram á minnkun á útskilnaði oocysts.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

cipla (eu) limited - olanzapin - schizophrenia; bipolar disorder - psycholeptics - adultsolanzapine er ætlað fyrir meðferð geðklofa. olanzapin er virkt í að viðhalda klínískum endurbætur á áframhaldandi meðferð í sjúklingum sem hafa sýnt upphaflega meðferð svar. olanzapin er ætlað fyrir meðferð í meðallagi til alvarlega oflæti þættinum. Í sjúklingar sem oflæti þáttur hefur brugðist að olanzapin meðferð, olanzapin er ætlað til að fyrirbyggja endurkomu í sjúklinga með geðhvarfasýki.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

moderna biotech spain, s.l. - single-stranded, 5’-capped messenger rna (mrna) produced using a cell-free in vitro transcription from the corresponding dna templates, encoding the viral spike (s) protein of sars-cov-2 - covid-19 virus infection - bóluefni - spikevax is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older. spikevax bivalent original/omicron ba. 1 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against covid-19. spikevax bivalent original/omicron ba. 4-5 is indicated for active immunisation to prevent covid-19 caused by sars-cov-2 in individuals 6 months of age and older.  spikevax xbb. 5 is indicated for active immunisation to prevent covid 19 caused by sars-cov-2 in individuals 6 months of age and older. the use of this vaccine should be in accordance with official recommendations.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

biofrontera bioscience gmbh - 5-amínólevúlínsýru hýdróklóríð - keratosis, actinic; carcinoma, basal cell - Æxlishemjandi lyf - meðferð geislunarhyrning vægt til meðallagi á andlit og höfði (olsen bekk 1 til 2; sjá kafla 5. 1) og á sviði cancerization í fullorðnir. meðferð yfirborðsleg og/eða hnúðóttur grunn klefi krabbamein óhæf til skurðaðgerð vegna hægt meðferð-tengjast dánar og/eða fátækur snyrtivörur niðurstöðu í fullorðnir.

Evrópusambandið - íslenska - EMA (European Medicines Agency)

abz-pharma gmbh - filgrastim - neutropenia; hematopoietic stem cell transplantation; cancer - nýlendunni til að örva þáttum - sökum er ætlað til að draga í lengd mæði í tengslum og tíðni hita og mæði í tengslum í sjúklinga með komið frumudrepandi lyfjameðferð fyrir illkynja (með undantekning langvarandi merg hvítblæði og myelodysplastic heilkennum) og til að draga í lengd mæði í tengslum í gangast undir myeloablative meðferð eftir bein-marrow ígræðslu talið að vera í meiri hættu langvarandi alvarlega mæði í tengslum. Öryggi og verkun filgrastims eru svipuð hjá fullorðnum og börnum sem fá frumudrepandi krabbameinslyfjameðferð. sökum er ætlað til hafi verið kallaður út af blóði stofnfrumum (pbpc). Í sjúklingar, börnum eða fullorðnum, með alvarlega meðfætt, hringlaga, eða sjálfvakin mæði í tengslum við alger ss telja (samtÖkin) 0. 5 x 109/l, og saga um alvarlega eða endurtekin sýkingar, langtíma gjöf sökum er ætlað að auka ss sem skiptir máli og til að draga úr tíðni og lengd sýkingu-atburðum tengdum. sökum er ætlað fyrir meðferð viðvarandi mæði í tengslum (samtÖkin minna eða jafnt til 1.. 0 x 109 / l) hjá sjúklingum með langt gengna hiv sýkingu, til þess að draga úr hættu á bakteríusýkingum þegar aðrir valkostir til að stjórna daufkyrningafæð eru óviðeigandi.