Euroopa Liit - eesti - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - antineoplastilised ained - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. patsiendid, kellel on egfr-või kristallimise positiivne kasvaja mutatsioonid peaks ka saanud suunatud ravi enne saanud keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Euroopa Liit - eesti - EMA (European Medicines Agency)

seqirus s.r.l.  - zoonotic influenza vaccine (h5n1) (surface antigen, inactivated, adjuvanted), influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: a/turkey/turkey/1/05 (h5n1)-like strain (nibrg-23) - influenza a virus, h5n1 subtype - vaktsiinid - active immunisation against h5 subtype of influenza a virus.

Eesti - eesti - Ravimiamet

merck sharp & dohme corp., a subsidiary of merck & co., inc. - pembrolizumab - infusioonilahuse kontsentraadi pulber - 50mg 1tk

Euroopa Liit - eesti - EMA (European Medicines Agency)

seqirus s.r.l.  - gripi viiruse pinna antigeeni (hemaglutiniini ja neuraminidaasi) tüvi: a/türgi/türgi/1/05 (h5n1)-nagu tüvi (nibrg-23) - influenza, human; immunization; disease outbreaks - vaktsiinid - aktiivne immuniseerimine gripiviiruse h5n1 alatüübi vastu. see näidustus põhineb immunogenicity andmeid tervisliku teemasid, alates vanusest 18 aastat aastast pärast manustamist kaks annust vaktsiini, mis sisaldab a/türgi/türgi/1/05 (h5n1)-nagu tüvi. aflunov tuleb kasutada vastavalt ametlikele soovitustele.

Euroopa Liit - eesti - EMA (European Medicines Agency)

boehringer ingelheim vetmedica gmbh - maksimaalne kolme järgmistest puhastatud inaktiveeritud suu-ja sõrataudi viiruse tüved: o1 manisa ≥ 6 pd50*; o1-bfs ≥ 6 pd50*; o taiwan 3/97 ≥ 6 pd50*; a22 iraagi ≥ 6 pd50*; a24 cruzeiro ≥ 6 pd50*; türgi 14/98 ≥ 6 pd50*; asia 1 shamir ≥ 6 pd50*; sat2 saudi araabia ≥ 6 pd50*; * pd50 – 50% kaitsvat doosi kohta veiste, nagu on kirjeldatud fr. eur. monograafia 0063. - immunoloogilised vahendid - pigs; cattle; sheep - veiste, lammaste ja sigade aktiivne immuniseerimine alates kahe nädala vanusest suu-ja sõrataudist kliiniliste tunnuste vähendamiseks.

Euroopa Liit - eesti - EMA (European Medicines Agency)

bavarian nordic a/s - modifitseeritud vaktsiin ankara - baieri põhja (mva-bn) viirus - smallpox vaccine; monkeypox virus - muud viirusevaktsiinide - active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults (see sections 4. 4 ja 5. kasutamist see vaktsiin peaks olema kooskõlas ametlike soovitustega.

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zoetis belgium sa - elav aroa geen kustutati escherichia coli, tüüp 078, tüvi ec34195 - immunoloogilised ravimid jaoks linnud, live bacterial vaccines - chicken; turkeys - aktiivse immuniseerimise kohta lihakanade ja tulevikus kihid / kasvatajad, et vähendada suremust ja kahjustused (perikardiit, perihepatitis, airsacculitis) seotud escherichia coli (serotüüp o78.

Euroopa Liit - eesti - EMA (European Medicines Agency)

ceva-phylaxia veterinary biologicals co. ltd - turkey herpes virus, strain rhvt/nd/ibd, expressing the fusion protein of newcastle disease virus and the vp2 protein of infectious bursal disease virus, live recombinant - immunoloogilised ained - embryonated chicken eggs; chicken - for the active immunisation of one-day-old chicks or 18-day-old chicken embryonated eggs to reduce mortality, clinical signs and lesions caused by newcastle disease virus (ndv) and to reduce virus shedding; to reduce mortality, clinical signs and bursa lesions caused by very virulent infectious bursal disease virus (ibdv); to reduce mortality, clinical signs and lesions caused by classical marek’s disease virus (mdv).

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siga technologies netherlands b.v. - tecovirimat - poxviridae infections; cowpox; monkeypox; vaccinia; smallpox - viirusevastased ravimid süsteemseks kasutamiseks - tecovirimat siga is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- smallpox- monkeypox- cowpoxtecovirimat siga is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4. 4 ja 5. tecovirimat siga should be used in accordance with official recommendations.

Euroopa Liit - eesti - EMA (European Medicines Agency)

eco animal health europe limited - tülvalosiin - antiinfectives süsteemseks kasutamiseks, antibacterials süsteemseks kasutamiseks, makroliidid - pheasants; chicken; turkeys; pigs - pigstreatment ja methaphylaxis sigade enzootilise pneumoonia;ravi sead proliferative enteropaatia (ileitis);ravi ja methaphylaxis sigade düsenteeria. chickenstreatment ja methaphylaxis hingamisteede haigus, mida seostatakse mycoplasma gallisepticum ' i kanadel. pheasantstreatment hingamisteede haigus, mida seostatakse mycoplasma gallisepticum ' i suhtes. turkeystreatment hingamisteede haigus, mida seostatakse tülvalosiin tundlike tüvede ornithobacterium rhinotracheale kalkunite.