Denemarken - Deens - Lægemiddelstyrelsen (Danish Medicines Agency)

accord healthcare b.v. - tadalafil - filmovertrukne tabletter - 2,5 mg

Denemarken - Deens - Lægemiddelstyrelsen (Danish Medicines Agency)

accord healthcare b.v. - tadalafil - filmovertrukne tabletter - 5 mg

Denemarken - Deens - Lægemiddelstyrelsen (Danish Medicines Agency)

orion corporation - tadalafil - filmovertrukne tabletter - 10 mg

Denemarken - Deens - Lægemiddelstyrelsen (Danish Medicines Agency)

orion corporation - tadalafil - filmovertrukne tabletter - 5 mg

Europese Unie - Deens - EMA (European Medicines Agency)

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - immunosuppressiva - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Europese Unie - Deens - EMA (European Medicines Agency)

pierre fabre medicament - tabelecleucel - lymphoproliferative disorders - ebvallo is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory epstein-barr virus positive post-transplant lymphoproliferative disease (ebv+ ptld) who have received at least one prior therapy. for solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.

Europese Unie - Deens - EMA (European Medicines Agency)

accord healthcare s.l.u. - filgrastim - neutropeni - immunostimulants, - accofil er angivet for den reduktion i varigheden af neutropeni og forekomsten af febril neutropeni hos patienter behandlet med etablerede cytotoksisk kemoterapi for malignitet (med undtagelse af kronisk myeloid leukæmi og myelodysplastisk syndrom) og for reduktion i varigheden af neutropeni hos patienter, der gennemgår myeloablative terapi efterfulgt af bone marrow transplantation, der anses for at være en øget risiko for langvarig svær neutropeni. sikkerheden og effekten af ​​accofil er ens hos voksne og børn, der får cytotoksisk kemoterapi. accofil is indicated for the mobilisation of peripheral blood progenitor cells (pbpcs). hos patienter, børn eller voksne med alvorlige medfødte, cyklisk, eller idiopatisk neutropeni med en absolut neutrophil count (anc) ≤ 0. 5 x 109/l, og en historie af alvorlige eller tilbagevendende infektioner, langsigtet forvaltning af accofil er angivet til at øge neutrofile tæller, og for at mindske hyppigheden og varigheden af infektionen-relaterede begivenheder. accofil is indicated for the treatment of persistent neutropenia (anc less than or equal to 1. 0 x 109/l) hos patienter med fremskreden hiv-infektion for at reducere risikoen for bakterielle infektioner, når andre muligheder for at administrere neutropeni er upassende.

Europese Unie - Deens - EMA (European Medicines Agency)

instituto grifols s.a. - humant normalt immunglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immune sera og immunoglobuliner, - replacement therapy in adults, children and adolescents (0-18 years) in: , primary immunodeficiency syndromes with impaired antibody production;, hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed;, hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation;, hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (hsct);, congenital aids with recurrent bacterial infections. , immunomodulation in adults, children and adolescents (0-18 years) in: , primary immune thrombocytopenia (itp), in patients at high risk of bleeding or prior to surgery to correct the platelet count;, guillain barré syndrome;, kawasaki disease.

Europese Unie - Deens - EMA (European Medicines Agency)

molmed spa - allogen t celler genetisk modificeret med en retroviral vektor kodning for en afkortet form af menneskelige lav affinitet nerve vækstfaktor receptor (Δlngfr) og herpes simplex virus thymidine kinase (hsv-tk mut2) - hematopoietic stem cell transplantation; graft vs host disease - antineoplastiske midler - zalmoxis er indiceret som supplerende behandling ved haploidentisk hæmatopoietisk stamcelle-transplantation (hsct) hos voksne patienter med højrisiko hæmatologiske maligniteter.

Europese Unie - Deens - EMA (European Medicines Agency)

merck sharp & dohme b.v. - letermovir - cytomegalovirusinfektioner - antivirale midler til systemisk anvendelse - prevymis er indiceret til forebyggelse af cytomegalovirus (cmv) reaktivering og sygdom i voksen cmv-seropositive modtagere [r +] af en allogen hæmatopoietisk stamcelletransplantation (hsct). det bør overvejes at officielle vejledning om hensigtsmæssig brug af antivirale agenter.