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

sanochemia diagnostics deutschland gmbh (3343203) - gadopentetat-dimeglumin - injektionslösung - teil 1 - injektionslösung; gadopentetat-dimeglumin (23078) 469 milligramm

Europäische Union - Deutsch - EMA (European Medicines Agency)

roche registration gmbh  - entrectinib - cancer; carcinoma, non-small-cell lung - antineoplastische mittel - rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (ntrk) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior ntrk inhibitorwho have no satisfactory treatment options. rozlytrek as monotherapy is indicated for the treatment of adult patients with ros1 positive, advanced non small cell lung cancer (nsclc) not previously treated with ros1 inhibitors.

Europäische Union - Deutsch - EMA (European Medicines Agency)

esteve pharmaceuticals gmbh - thiotepa - hematopoietic stem cell transplantation; neoplasms - antineoplastische mittel - thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients. thiotepa riemser is indicated, in combination with other chemotherapy medicinal products:with or without total body irradiation (tbi), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (hpct) in haematological diseases in adult and paediatric patients;when high dose chemotherapy with hpct support is appropriate for the treatment of solid tumours in adult and paediatric patients.

Europäische Union - Deutsch - EMA (European Medicines Agency)

accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - immunostimulants, - adult patientsplerixafor accord is indicated in combination with granulocyte-colony stimulating factor (g-csf) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4. paediatric patients (1 to less than 18 years)plerixafor accord is indicated in combination with g-csf to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with g-csf (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.

Europäische Union - Deutsch - EMA (European Medicines Agency)

fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - alle anderen therapeutischen produkte - pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

roche pharma (schweiz) ag - entrectinibum - hartkapseln - entrectinibum 100 mg, lactosum 65 mg, cellulosum microcristallinum, acidum tartaricum, hypromellosum, crospovidonum, magnesii stearas, silica colloidalis anhydrica, kapselhülle: hypromellosum, e 171, e 172 (flavum), drucktinte: lacca, propylenglycolum, ammoniae solutio concentrata, e 132, pro capsula. - solide tumoren, nicht-kleinzelliges bronchialkarzinom (nsclc) - synthetika

Schweiz - Deutsch - Swissmedic (Swiss Agency for Therapeutic Products)

roche pharma (schweiz) ag - entrectinibum - hartkapseln - entrectinibum 200 mg, lactosum 130 mg, cellulosum microcristallinum, acidum tartaricum, hypromellosum, crospovidonum, magnesii stearas, silica colloidalis anhydrica, kapselhülle: hypromellosum, e 171, e 110 0.5543 mg, drucktinte: lacca, propylenglycolum, ammoniae solutio concentrata, e 132, pro capsula. - solide tumoren, nicht-kleinzelliges bronchialkarzinom (nsclc) - synthetika

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

medac gesellschaft für klinische spezialpräparate m.b.h. (3083854) - 5-amino-4-oxopentansäure-hydrochlorid - pulver zur herstellung einer lösung zum einnehmen - 5-amino-4-oxopentansäure-hydrochlorid (29223) 1,5 gramm

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

medac gesellschaft für klinische spezialpräparate mbh - melphalanhydrochlorid -

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

medac gesellschaft für klinische spezialpräparate m.b.h. (3083854) - melphalanhydrochlorid - pulver und lösungsmittel zur herstellung einer injektions- bzw. infusionslösung - teil 1 - pulver zur herstellung einer injektions-/infusionslösung; melphalanhydrochlorid (37252) 55,975 milligramm