Prancis - Prancis - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

curium netherlands b.v. - indium [111 in] (chlorure d') 37 mbq à la date de calibration - solution - 37 mbq à la date de calibration - pour 1 ml > indium [111 in] (chlorure d' 37 mbq à la date de calibration solution tampon > pas de substance active. - produit radiopharmaceutique à usage diagnostique - classe pharmacothérapeutique : produit radiopharmaceutique à usage diagnostique.code atc: v09hb01ce médicament est à usage diagnostique uniquement.marquage in vitro des éléments figurés du sang administrés ensuite par voie intraveineuse pour différents examens scintigraphiques et pour des mesures d'échantillons sanguins.les indications principales des cellules sanguines marquées à l'indium (111in) sont :scintigraphie aux leucocytes marqués à l’indium (111in), en complément d’autres techniques d’imagerie : localisation des sites inflammatoires ou d’abcès, notamment, abdominaux ; confirmation d’infection osseuse sur prothèse ; localisation de foyers infectieux dans le cas de fièvre inexpliquée ; diagnostic et suivi des maladies inflammatoires intestinales.plaquettes marquées à l’indium (111in) (thrombocytes ) : détermination de la durée de vie des plaquettes et de leur biodistribution, en particulier dans la rate et le foie en cas de thrombocytopénie ; scintigraphie pour le diagnostic de thromboses artérielles ou veineuses, d’anévrismes, de rejets de greffes rénales ou pancréatiques par exemple.erythrocytes marqués à l'indium (111in) : diagnostic et localisation d'une hémorragie digestive occulte.l'utilisation de l’oxinate d’indium (111in) entraîne une exposition à une faible quantité de radioactivité. votre médecin et le spécialiste de médecine nucléaire ont estimé que le bénéfice clinique que vous retirerez de l'examen réalisé avec ce médicament dépasse le risque dû aux radiations.

Prancis - Prancis - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

pfizer holding france - cytarabine 100 - poudre - 100,00 mg - pour un flacon de 100 mg de poudre > cytarabine 100,00 mg solvant > pas de substance active. - agents antinéoplasiques – antimétabolites – analogues de la pyrimidine - classe pharmacothérapeutique : agents antinéoplasiques - antimétabolites - analogues de la pyrimidine. (l. antinéoplasique et immunomodulateur) - code atc : l01bc01.ce médicament empêche la croissance de certaines cellules. il est utilisé dans le traitement de certaines maladies du sang.

Uni Eropa - Prancis - EMA (European Medicines Agency)

sandoz gmbh - époétine alfa - anemia; kidney failure, chronic - préparations antianémiques - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. l'état cardiovasculaire, pré-existant de l'anémie au début de la chimiothérapie).

Uni Eropa - Prancis - EMA (European Medicines Agency)

janssen-cilag international n.v. - daratumumab - le myélome multiple - monoclonal antibodies and antibody drug conjugates, antineoplastic agents - multiple myelomadarzalex is indicated: in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. en association avec le bortézomib, la thalidomide et la dexaméthasone pour le traitement de patients adultes atteints de myélome multiple nouvellement diagnostiqué, qui sont admissibles à une greffe de cellules souches autologues. en combinaison avec le lénalidomide et de la dexaméthasone, ou le bortézomib et la dexaméthasone, pour le traitement de patients adultes atteints de myélome multiple qui ont reçu au moins un traitement antérieur. in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy (see section 5. en tant que monothérapie pour le traitement des patients adultes en rechute et réfractaire myélome multiple, dont le traitement antérieur inclus un inhibiteur du protéasome et un agent immunomodulateur et qui ont démontré la progression de la maladie sur la dernière thérapie. al amyloidosisdarzalex is indicated in combination with cyclophosphamide, bortezomib and dexamethasone for the treatment of adult patients with newly diagnosed systemic light chain (al) amyloidosis.

Uni Eropa - Prancis - EMA (European Medicines Agency)

hexal ag - époétine alfa - anemia; kidney failure, chronic; cancer - préparations antianémiques - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. , le traitement de l'anémie et réduction des exigences en matière de transfusion chez les patients adultes recevant une chimiothérapie pour des tumeurs solides malignes de lymphome ou de myélome multiple, et au risque de transfusion évalué par le patient de l'état général (e. l'état cardiovasculaire, pré-existant de l'anémie au début de la chimiothérapie).

Uni Eropa - Prancis - EMA (European Medicines Agency)

merck sharp & dohme b.v. - pembrolizumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; endometrial neoplasms - agents antinéoplasiques - melanomakeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with stage iib, iic, or with stage iii melanoma and lymph node involvement who have undergone complete resection. non small cell lung carcinoma (nsclc)keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 50% tumour proportion score (tps) with no egfr or alk positive tumour mutations. keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no egfr or alk positive mutations. keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. keytruda  as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express pd l1 with a ≥ 1% tps and who have received at least one prior chemotherapy regimen. les patients avec l'egfr ou alk positif de la tumeur mutations devrait également avoir reçu la thérapie ciblée avant de recevoir keytruda. classical hodgkin lymphoma (chl)keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical hodgkin lymphoma who have failed autologous stem cell transplant (asct) or following at least two prior therapies when asct is not a treatment option. urothelial carcinomakeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express pd l1 with a combined positive score (cps) ≥ 10. head and neck squamous cell carcinoma (hnscc)keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 fu) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a cps ≥ 1. keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express pd l1 with a ≥ 50% tps and progressing on or after platinum containing chemotherapy. renal cell carcinoma (rcc)keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. keytruda  as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. microsatellite instability high (msi-h) or mismatch repair deficient (dmmr) cancerscolorectal cancer (crc)keytruda as monotherapy is indicated for theadults with msi-h or dmmr colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (msi h) or mismatch repair deficient (dmmr) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy.  non-colorectal cancerskeytruda as monotherapy is indicated for the treatment of the following msi h or dmmr tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. oesophageal carcinomakeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or her-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express pd l1 with a cps ≥ 10. triple negative breast cancer (tnbc)keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express pd l1 with a cps ≥ 10 and who have not received prior chemotherapy for metastatic disease. endometrial carcinoma (ec)keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. cervical cancerkeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express pd l1 with a cps ≥ 1. gastric or gastro-oesophageal junction (gej) adenocarcinomakeytruda, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic her2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express pd-l1 with a cps ≥ 1.

Uni Eropa - Prancis - EMA (European Medicines Agency)

adienne s.r.l. s.u. - thiotepa - transplantation de cellules souches hématopoïétiques - agents antinéoplasiques - en combinaison avec d'autres chimiothérapie les médicaments:avec ou sans irradiation corporelle totale (tbi), comme traitement de conditionnement préalable à l'allogreffe ou autogreffe de souches hématopoïétiques transplantation de cellules (hpct) dans les maladies hématologiques chez les adultes et les patients pédiatriques;lors de la chimiothérapie à haute dose avec hpct support est approprié pour le traitement de tumeurs solides chez les adultes et les patients pédiatriques. il est proposé que le tepadina doit être prescrit par des médecins expérimentés dans le traitement de conditionnement préalable à la greffe de cellules souches hématopoïétiques.

Prancis - Prancis - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

dr. reddy's laboratories (uk) ltd - chlorhydrate de bendamustine - poudre - 25 mg - composition pour un flacon de 25 ml > chlorhydrate de bendamustine : 25 mg . sous forme de : chlorhydrate de bendamustine monohydraté - groupe agents antineoplasiques, agents alkylants -

Swiss - Prancis - Swissmedic (Swiss Agency for Therapeutic Products)

roche pharma (schweiz) ag - epoetinum beta - les seringues préremplies - epoetinum beta 500 u.i., ureum, natrii chloridum, polysorbatum 20, natrii dihydrogenophosphas dihydricus, dinatrii phosphas dodecahydricus, calcii chloridum dihydricum, glycinum, leucinum, isoleucinum, threoninum, acidum glutamicum, phenylalaninum 0.15 mg, aqua ad iniectabile q.s. ad solutionem pro 0.3 ml corresp. natrium 0.48 mg. - la stimulation de l'Érythropoïèse - biotechnologika

Swiss - Prancis - Swissmedic (Swiss Agency for Therapeutic Products)

roche pharma (schweiz) ag - epoetinum beta - les seringues préremplies - epoetinum beta 2000 u.i., ureum, natrii chloridum, polysorbatum 20, natrii dihydrogenophosphas dihydricus, dinatrii phosphas dodecahydricus, calcii chloridum dihydricum, glycinum, leucinum, isoleucinum, threoninum, acidum glutamicum, phenylalaninum 0.15 mg, aqua ad iniectabile q.s. ad solutionem pro 0.3 ml corresp. natrium 0.48 mg. - la stimulation de l'Érythropoïèse - biotechnologika