Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

medice pharma gmbh & co. kg (3049544) - methylphenidathydrochlorid - hartkapsel, retardiert - teil 1 - hartkapsel, retardiert; methylphenidathydrochlorid (06085) 5 milligramm

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

medice pharma gmbh & co. kg (3049544) - methylphenidathydrochlorid - hartkapsel, retardiert - teil 1 - hartkapsel, retardiert; methylphenidathydrochlorid (06085) 40 milligramm

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

medice pharma gmbh & co. kg (3049544) - methylphenidathydrochlorid - hartkapsel, retardiert - teil 1 - hartkapsel, retardiert; methylphenidathydrochlorid (06085) 30 milligramm

Deutschland - Deutsch - BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)

medice pharma gmbh & co. kg (3049544) - methylphenidathydrochlorid - hartkapsel, retardiert - teil 1 - hartkapsel, retardiert; methylphenidathydrochlorid (06085) 10 milligramm

Europäische Union - Deutsch - EMA (European Medicines Agency)

instituto grifols s.a. - human normal immunoglobulin - mucocutaneous lymph node syndrome; guillain-barre syndrome; bone marrow transplantation; purpura, thrombocytopenic, idiopathic; immunologic deficiency syndromes - immunseren und immunglobuline, - 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.

Europäische Union - Deutsch - EMA (European Medicines Agency)

amgen europe b.v. - blinatumomab - vorläuferzelle lymphoblastische leukämie-lymphom - antineoplastische mittel - blincyto is indicated as monotherapy for the treatment of adults with cd19 positive relapsed or refractory b precursor acute lymphoblastic leukaemia (all). patients with philadelphia chromosome positive b-precursor all should have failed treatment with at least 2 tyrosine kinase inhibitors (tkis) and have no alternative treatment options. blincyto is indicated as monotherapy for the treatment of adults with philadelphia chromosome negative cd19 positive b-precursor all in first or second complete remission with minimal residual disease (mrd) greater than or equal to 0. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with philadelphia chromosome negative cd19 positive b precursor all which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic haematopoietic stem cell transplantation. blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed philadelphia chromosome negative cd19 positive b-precursor all as part of the consolidation therapy (see section 4.

Europäische Union - Deutsch - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastische mittel - vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with: intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification. vidaza is indicated for the treatment of adult patients aged 65 years or older who are not eligible for hsct with aml with >30% marrow blasts according to the who classification.

Europäische Union - Deutsch - EMA (European Medicines Agency)

celgene europe bv - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastische mittel - azacitidine celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high-risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29 % marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30 % blasts and multi-lineage dysplasia, according to world health organisation (who) classification,aml with >30% marrow blasts according to the who classification.

Europäische Union - Deutsch - EMA (European Medicines Agency)

betapharm arzneimittel gmbh - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastische mittel - azacitidine betapharm ist indiziert für die behandlung von erwachsenen patienten, die nicht förderfähig sind für die hämatopoetische stammzelltransplantation (hszt) mit:intermediate-2 und high-risk myelodysplastischen syndromen (mds) nach dem international prognostic scoring system (ipss),chronische myelomonocytic leukämie (cmml) mit 10 % 29 % knochenmark blasten ohne myeloproliferative störung,akute myeloische leukämie (aml) mit 20-30% blasten und multi-lineage dysplasie, nach angaben der world health organisation (who) klassifikation der aml mit > 30 % knochenmark blasten nach der who-klassifikation.

Europäische Union - Deutsch - EMA (European Medicines Agency)

mylan ireland limited - azacitidin - myelodysplastic syndromes; leukemia, myelomonocytic, chronic; leukemia, myeloid, acute - antineoplastische mittel - azacitidine mylan is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (hsct) with:intermediate 2 and high risk myelodysplastic syndromes (mds) according to the international prognostic scoring system (ipss),chronic myelomonocytic leukaemia (cmml) with 10 29% marrow blasts without myeloproliferative disorder,acute myeloid leukaemia (aml) with 20 30% blasts and multi lineage dysplasia, according to world health organisation (who) classification,aml with > 30% marrow blasts according to the who classification.