Rumanija -
Rumen -
ANMDM (Agentia Nationala a Medicamentului si a Dispozitivelor Medicale)
isoniazid
yuria-pharm ltd. - ucraina - isoniazidum - sirop - 100mg/5ml - medicamente pentru tratamentul tuberculozei hidrazide
Maldova -
Rumen -
ANSA (Agenţia Naţională pentru Siguranţa Alimentelor)
bi soli, pulb.hidrosolubilă
ooo brovafarma, ucraina - sulfat - pulbere hidrosolubilă
Unjoni Ewropea -
Rumen -
EMA (European Medicines Agency)
vitrakvi
bayer ag - larotrectinib sulfat de - neoplasmele abdominale - agenți antineoplazici - vitrakvi ca monoterapie este indicat pentru tratamentul pacienților adulți, adolescenți și copii cu tumori solide, care afișează o neurotrofic receptorilor tirozin kinazei (ntrk) gena de fuziune,care au o boala care este local avansat, metastatic sau în cazul în care rezecția chirurgicală este de natură să conducă la grave morbiditate, andwho nu au satisfăcătoare opțiuni de tratament.
Unjoni Ewropea -
Rumen -
EMA (European Medicines Agency)
rozlytrek
roche registration gmbh - entrectinib - cancer; carcinoma, non-small-cell lung - agenți antineoplazici - 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.
Unjoni Ewropea -
Rumen -
EMA (European Medicines Agency)
thiotepa riemser
esteve pharmaceuticals gmbh - tiotepa - hematopoietic stem cell transplantation; neoplasms - agenți antineoplazici - 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.
Unjoni Ewropea -
Rumen -
EMA (European Medicines Agency)
plerixafor accord
accord healthcare s.l.u. - plerixafor - multiple myeloma; hematopoietic stem cell transplantation - imunostimulante, - 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.
Unjoni Ewropea -
Rumen -
EMA (European Medicines Agency)
pedmarqsi
fennec pharmaceuticals (eu) limited - sodium thiosulfate - ear diseases; ototoxicity - toate celelalte produse terapeutice - 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.