Europese Unie - Nederlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - dasatinib - precursor cell lymphoblastic leukemia-lymphoma; leukemia, myelogenous, chronic, bcr-abl positive - antineoplastische middelen - dasatinib accordpharma is indicated for the treatment of adult patients with: newly diagnosed philadelphia chromosome positive (ph+) chronic myelogenous leukaemia (cml) in the chronic phase.  chronic, accelerated or blast phase cml with resistance or intolerance to prior therapy including imatinib.  ph+ acute lymphoblastic leukaemia (all) and lymphoid blast cml with resistance or intolerance to prior therapy. dasatinib accordpharma is indicated for the treatment of paediatric patients with: newly diagnosed ph+ cml in chronic phase (ph+ cml-cp) or ph+ cml-cp resistant or intolerant to prior therapy including imatinib.  newly diagnosed ph+ all in combination with chemotherapy.

Europese Unie - Nederlands - EMA (European Medicines Agency)

mylan pharmaceuticals limited - aripiprazole - schizophrenia; bipolar disorder - psycholeptica - aripiprazole mylan pharma is geïndiceerd voor de behandeling van schizofrenie bij volwassenen en bij adolescenten van 15 jaar en ouder. aripiprazole mylan pharma is geïndiceerd voor de behandeling van matige tot ernstige manische episodes bij bipolaire i-stoornis en voor de preventie van een nieuwe manische episode bij volwassenen die ervaren voornamelijk manische episodes en wiens manische episodes gereageerd op aripiprazole behandeling. aripiprazole mylan pharma is geïndiceerd voor de behandeling van maximaal 12 weken van matige tot ernstige manische episodes bij bipolaire i-stoornis bij adolescenten in de leeftijd van 13 jaar en ouder.

Europese Unie - Nederlands - EMA (European Medicines Agency)

taw pharma (ireland) limited - clopidogrel hydrochloride - peripheral vascular diseases; stroke; myocardial infarction; acute coronary syndrome - antitrombotische middelen - , , , , secondary prevention of atherothrombotic events, , clopidogrel is indicated in: , - adult patients suffering from myocardial infarction (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. , - adult patients suffering from acute coronary syndrome:,    - non-st segment elevation acute coronary syndrome (unstable angina or non-q-wave myocardial infarction), including patients undergoing a stent placement following percutaneous coronary intervention, in combination with acetylsalicylic acid (asa). ,     - st segment elevation acute myocardial infarction, in combination with asa in medically treated patients eligible for thrombolytic therapy. , , in patients with moderate to high-risk transient ischaemic attack (tia) or minor ischaemic stroke (is), clopidogrel in combination with asa is indicated in:, - adult patients with moderate to high-risk tia (abcd2  score ≥4) or minor is (nihss  ≤3) within 24 hours of either the tia or is event.  , , prevention of atherothrombotic and thromboembolic events in atrial fibrillation, in adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with vitamin k antagonists (vka) and who have a low bleeding risk, clopidogrel is indicated in combination with asa for the prevention of atherothrombotic and thromboembolic events, including stroke. , , for further information please refer to section 5. , , ,.

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

healthypharm b.v. van de reijtstraat 31-e 4814 ne breda - loperamidehydrochloride 2 mg/stuk samenstelling overeenkomend met ; loperamide 1,85 mg/stuk - capsule, hard - chinolinegeel (e 104) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide zwart (e 172) ; indigokarmijn (e 132) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel ; talk (e 553 b) ; titaandioxide (e 171), - loperamide

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

pharmascience international limited julia house, themistokli dervi, 3 p.c. 1066 nicosia (cyprus) - lacosamide - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hyprolose (e 463) ; ijzeroxide geel (e 172) ; macrogol 3350 ; magnesiumstearaat (e 470b) ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - lacosamide

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

pharmascience international limited julia house, themistokli dervi, 3 p.c. 1066 nicosia (cyprus) - lacosamide - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hyprolose (e 463) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; macrogol 3350 ; magnesiumstearaat (e 470b) ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - lacosamide

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

pharmascience international limited julia house, themistokli dervi, 3 p.c. 1066 nicosia (cyprus) - lacosamide - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hyprolose (e 463) ; indigokarmijn aluminiumlak (e 132) ; macrogol 3350 ; magnesiumstearaat (e 470b) ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - lacosamide

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

pharmascience international limited julia house, themistokli dervi, 3 p.c. 1066 nicosia (cyprus) - lacosamide - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hydroxypropylcellulose, laag gesubstitueerd (e 463) ; hyprolose (e 463) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; indigokarmijn aluminiumlak (e 132) ; macrogol 3350 ; magnesiumstearaat (e 470b) ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - lacosamide

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

pharmascience international ltd lampousas 1 1095 nicosia (cyprus) - deferasirox - dispergeerbare tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat (e 487) ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) - deferasirox

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

pharmascience international ltd lampousas 1 1095 nicosia (cyprus) - deferasirox - dispergeerbare tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; lactose 1-water ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat (e 487) ; povidon k 30 (e 1201) ; siliciumdioxide (e 551) - deferasirox