Финландия - фински - Fimea (Suomen lääkevirasto)

medical valley invest ab - ivermectin - tabletti - 3 mg - ivermektiini

Европейски съюз - фински - EMA (European Medicines Agency)

itm medical isotopes gmbh - lutetium (177lu) chloride - radionuklidien kuvantaminen - terapeuttiset radiofarmaseuttiset valmisteet - endolusiinibeta on radiofarmaseuttinen prekursori, eikä sitä ole tarkoitettu suoraan potilaille. sitä on tarkoitus käyttää vain sellaisten kantajamolekyylien radioaktiiviseen merkintään, jotka on erityisesti kehitetty ja sallittu radiolabeloitavaksi lutetium (177lu) -kloridilla.

Европейски съюз - фински - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxolaner - isoxazolines, systeemisesti käytettävät ulkoloislääkkeet - koirat - hoito kirpputartunnat koirilla (ctenocephalides felis ja c. canis) vähintään 5 viikkoa. tuotetta voidaan käyttää osana hoidostrategiaa kirppuallergisen dermatiitin (fad). hoito rasti tartuntoja koirilla (dermacentor reticulatus, ixodes ricinus, ixodes hexagonus, rhipicephalus sanguineus). yksi hoito tappaa punkit enintään yksi kuukausi. kirppujen ja puutiaisten täytyy kiinnittyä isäntä ja aloittaa imeminen, jotta ne altistuvat vaikuttavalle aineelle. hoito demodikoosi (demodex canis). syyhypunkkitartuntojen hoito (aiheuttaja sarcoptes scabiei var. canis).

Европейски съюз - фински - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - afoxolaner, milbemysiinioksiimia - endectocides, loisten ja hyönteisten häätöön tarkoitetut valmisteet, milbemysiinioksiimia, yhdistelmiä - koirat - hoitoon kirppu-ja puutiaistartuntojen koirilla silloin, kun samanaikainen sydänmatotartunnan ennaltaehkäisy (dirofilaria immitis-loisen toukat), angiostrongylosis (vähentää taso epäkypsien aikuisten (l5) ja aikuisten angiostrongylus vasorum), thelaziosis (aikuisten thelazia callipaeda) ja/tai hoitoon ruoansulatuskanavan sukkulamato tartuntoja on ilmoitettu. hoito kirpputartuntojen (ctenocephalides felis ja c. canis) koirilla, 5 viikkoa. hoito puutiaistartuntojen (dermacentor reticulatus, ixodes ricinus, ixodes hexagonus, rhipicephalus sanguineus) koirilla 4 viikkoa. kirppujen ja puutiaisten täytyy kiinnittyä isäntä ja aloittaa imeminen, jotta ne altistuvat vaikuttavalle aineelle. hoito tartuntoja aikuisten ruoansulatuskanavan sukkulamadot seuraavia lajeja: suolinkaisten (toxocara canis ja toxascaris leonina), hakamatojen (ancylostoma caninum, ancylostoma braziliense ja ancylostoma ceylanicum) ja piiskamato (trichuris vulpis). hoito demodikoosi (demodex canis). syyhypunkkitartuntojen hoito (aiheuttaja sarcoptes scabiei var. canis). ehkäisy sydänmatotartunnan (dirofilaria immitis-loisen toukat) kuukausittain hallinto. ehkäisy angiostrongylosis (pelkistämällä taso infektio epäkypsä aikuinen (l5) ja aikuisten vaiheissa angiostrongylus vasorum) kuukausittain hallinto. ehkäisy perustaminen thelaziosis (aikuisten thelazia callipaeda eyeworm infektio) kuukausittain hallinto.

Европейски съюз - фински - EMA (European Medicines Agency)

i.d.b. radiopharmacy b.v. - lutetium (177lu) chloride - radionuklidien kuvantaminen - terapeuttiset radiofarmaseuttiset valmisteet - lumark on radiofarmaseuttinen prekursori. sitä ei ole tarkoitettu suoraan potilaille. tätä lääkettä on käytettävä vain radiolabeloitavaksi kantajamolekyyleille, jotka on erityisesti kehitetty ja sallittu radiolabeloitavaksi tällä radionuklidilla.

Европейски съюз - фински - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - ipilimumabi - melanoma; carcinoma, renal cell; carcinoma, non-small-cell lung; mesothelioma, malignant; colorectal neoplasms - antineoplastiset aineet - melanomayervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.  yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. 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 (see sections 4. 4 ja 5. renal cell carcinoma (rcc)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5. non-small cell lung cancer (nsclc)yervoy in combination with nivolumab 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. malignant pleural mesothelioma (mpm)yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)yervoy in combination with nivolumab 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 (see section 5. oesophageal squamous cell carcinoma (oscc)yervoy in combination with nivolumab 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%.

Европейски съюз - фински - 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 - antineoplastiset aineet - 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.

Европейски съюз - фински - EMA (European Medicines Agency)

mallinckrodt deutschland gmbh - gadoversetamidi - magneettikuvaus - kontrastimediat - tämä lääkevalmiste on tarkoitettu vain diagnostiseen käyttöön. optimark on tarkoitettu käytettäväksi magneettikuvaus (mri) keskushermostoon (cns) ja maksan. se tarjoaa varjoainetta ja helpottaa visualisointia ja auttaa luonnehdinta fokaalimuutosten ja poikkeavien rakenteiden keskushermoston ja maksan potilailla, joilla tiedetään tai vahvasti epäillään patologian.

Европейски съюз - фински - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - sucroferric oxyhydroxide - hyperphosphatemia; renal dialysis - lääkkeitä hoitoon hyperkalemia ja hyperphosphatemia - velphoro on tarkoitettu fosforin seerumin aikuisten krooninen munuaisten saannissa (ckd) ohjausobjektiin hemodialyysiin (hd) tai vatsakalvodialyysia (pd). velphoro is indicated for the control of serum phosphorus levels in paediatric patients 2 years of age and older with ckd stages 4-5 (defined by a glomerular filtration rate.

Финландия - фински - Fimea (Suomen lääkevirasto)

norbrook laboratories (ireland) limited - ivermectin - oraalipasta - 18.7 mg/g - ivermektiini