Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aurobindo pharma b.v. baarnsche dijk 1 3741 ln baarn - calciumcarbonaat (e 170) 1250 mg/stuk samenstelling overeenkomend met ; calcium (ca2+) 500 mg/stuk ; natriumrisedronaat 2,5-water 40,1 mg/stuk samenstelling overeenkomend met ; natriumrisedronaat 0-water 35 mg/stuk ; samenstelling overeenkomend met risedroninezuur 32,4 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; glyceroltriacetaat (e 1518) ; hyprolose (e 463) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; indigokarmijn aluminiumlak (e 132) ; lactose 1-water ; macrogol 400 ; macrogol 8000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; siliciumdioxide (e 551) ; titaandioxide (e 171), - risedronic acid and calcium, sequential

Europese Unie - Nederlands - EMA (European Medicines Agency)

immedica pharma ab - glycerol-fenylbutyraat - ureumcyclusstoornissen, aangeboren - andere maagdarmkanaal en metabolisme producten, - ravicti is geïndiceerd voor gebruik als adjuvante therapie voor chronische behandeling van patiënten met ureum cyclus aandoeningen (ucds) inclusief tekortkomingen van carbamoyl fosfaat-synthase-i (cps), ornithine carbamoyltransferase (otc), argininosuccinaatsynthetase (ass), argininosuccinaatsynthetase lyase (asl), arginase ik (arg) en ornithine translocase deficiëntie hyperornithinaemia-hyperammonaemia homocitrullinuria syndroom (hhh) die niet worden beheerd door een eiwitarm en/of aminozuur suppletie alleen. ravicti moet worden gebruikt met een eiwitarm en, in sommige gevallen, voedingssupplementen (e. essentiële aminozuren, arginine, citrulline, eiwitvrije calorie-supplementen).

Europese Unie - Nederlands - 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 - antineoplastische middelen - 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. patiënten met egfr-of alk-positieve tumor mutaties moet ook ontvangen gerichte therapie voor het ontvangen van 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.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

heumann pharma gmbh & co. generica kg südwestpark 50 90449 nÜrnberg (duitsland) - pantoprazol natrium 1,5-water samenstelling overeenkomend met ; pantoprazol - maagsapresistente tablet - ammonia (e 527) ; bruine inkt ; calciumstearaat (e 470a) ; copolymeer van ethylacrylaat-methacrylzuur (1:1) ; crospovidon (e 1202) ; hyprolose (e 463) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; mannitol (d-) (e 421) ; natriumcarbonaat 0-water (e 500 (i)) ; natriumlaurilsulfaat (e 487) ; polysorbaat 80 (e 433) ; propyleenglycol (e 1520) ; schellak glaze, gedeeltelijk veresterd ; talk (e 553 b) ; titaandioxide (e 171) ; triethylcitraat (e 1505), - pantoprazole

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

heumann pharma gmbh & co. generica kg südwestpark 50 90449 nÜrnberg (duitsland) - pantoprazol natrium 1,5-water samenstelling overeenkomend met ; pantoprazol - maagsapresistente tablet - ammonia (e 527) ; bruine inkt ; calciumstearaat (e 470a) ; copolymeer van ethylacrylaat-methacrylzuur (1:1) ; crospovidon (e 1202) ; hyprolose (e 463) ; hypromellose (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; mannitol (d-) (e 421) ; natriumcarbonaat 0-water (e 500 (i)) ; propyleenglycol (e 1520) ; schellak (e 904) ; talk (e 553 b) ; titaandioxide (e 171) ; triethylcitraat (e 1505), - pantoprazole

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

accord healthcare b.v. winthontlaan 200 3526 kv utrecht - solifenacinesuccinaat 10 mg/stuk samenstelling overeenkomend met ; solifenacine 7,5 mg/stuk - filmomhulde tablet - hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel ; talk (e 553 b) ; titaandioxide (e 171), - solifenacin

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

accord healthcare b.v. winthontlaan 200 3526 kv utrecht - solifenacinesuccinaat 5 mg/stuk samenstelling overeenkomend met ; solifenacine 3,8 mg/stuk - filmomhulde tablet - hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; lactose 1-water ; macrogol 6000 ; magnesiumstearaat (e 470b) ; maÏszetmeel ; talk (e 553 b) ; titaandioxide (e 171), - solifenacin

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - spironolacton 25 mg - filmomhulde tablet - 25 mg - spironolacton 25 mg - spironolactone

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - spironolacton 100 mg - filmomhulde tablet - 100 mg - spironolacton 101.9 mg - spironolactone

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pfizer sa-nv - spironolacton 50 mg - filmomhulde tablet - 50 mg - spironolacton 50 mg - spironolactone