Europäische Union - Finnisch - EMA (European Medicines Agency)

orion corporation - tasipimidine sulfate - other hypnotics and sedatives - koirat - alleviation of situational anxiety and fear in dogs triggered by e. travel, noise, owner departure, veterinary visits.

Europäische Union - Finnisch - EMA (European Medicines Agency)

beigene ireland ltd - zanubrutinib - waldenstrom macroglobulinemia - antineoplastiset aineet - brukinsa as monotherapy is indicated for the treatment of adult patients with waldenström’s macroglobulinaemia (wm) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (mzl) who have received at least one prior anti-cd20-based therapy. brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (cll).

Europäische Union - Finnisch - EMA (European Medicines Agency)

sun pharmaceutical industries (europe) b.v. - ertapeneeminatrium - bakteeri-infektiot - ertapenem - treatmentertapenem sun is indicated in paediatric patients (3 months to 17 years of age) and in adults for the treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see sections 4. 4 ja 5. 1):- intra-abdominal infections- community acquired pneumonia- acute gynaecological infections- diabetic foot infections of the skin and soft tissue (see section 4. 4)preventionertapenem sun is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4. on otettava huomioon viralliset ohjeet antibioottien tarkoituksenmukaisesta käytöstä.

Europäische Union - Finnisch - EMA (European Medicines Agency)

oncopeptides ab - melphalan flufenamide hydrochloride - multiple myeloma - antineoplastiset aineet - pepaxti is indicated, in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-cd38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. for patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation (see section 4.

Europäische Union - Finnisch - EMA (European Medicines Agency)

samsung bioepis nl b.v. - ekulitsumabi - hemoglobinuria, paroxysmal - immunosuppressantit - epysqli is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

Europäische Union - Finnisch - EMA (European Medicines Agency)

amgen technology (ireland) uc - ekulitsumabi - hemoglobinuria, paroxysmal - immunosuppressantit - bekemv is indicated in adults and children for the treatment of paroxysmal nocturnal haemoglobinuria (pnh). todisteita kliininen hyöty on osoitettu potilailla, joilla on hemolyysi kanssa kliinisiä oireita(s) osoittaa korkea taudin aktiivisuus, riippumatta siitä, verensiirtoon historia (ks. kohta 5.

Europäische Union - Finnisch - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - cedazuridine, decitabine - leukemia, myeloidi - antineoplastiset aineet - inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (aml) who are ineligible for standard induction chemotherapy.

Europäische Union - Finnisch - EMA (European Medicines Agency)

daiichi sankyo europe gmbh - quizartinib dihydrochloride - leukemia, myeloidi - antineoplastic agents, protein kinase inhibitors - vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (aml) that is flt3-itd positive.

Europäische Union - Finnisch - EMA (European Medicines Agency)

eli lilly nederland b.v. - pirtobrutinib - lymfooma, mantle-cell - proteiinikinaasin estäjät - treatment of mantle cell lymphoma (mcl).

Finnland - Finnisch - Fimea (Suomen lääkevirasto)

stada arzneimittel ag - betahistine dihydrochloride - tabletti - 8 mg - betahistiini