Uni Eropa - Belanda - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotische middelen - preventie van veneuze trombo-embolie (vte) bij volwassen patiënten die een electieve heup- of knievervangende operatie ondergaan. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 for haemodynamically unstable pe patients. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 voor haemodynamically instabiel pe-patiënten). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 en 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Uni Eropa - Belanda - EMA (European Medicines Agency)

amarin pharmaceuticals ireland limited - icosapent ethyl - dyslipidemie - lipidemodificerende middelen - indicated to reduce cardiovascular risk as an adjunct to statin therapy.

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires sterop sa-nv - epinefrine 0,5 mg/ml - oplossing voor injectie - 0,5 mg/1 ml - epinefrine 0.5 mg/ml - epinephrine

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

laboratoires sterop sa-nv - epinefrine 1 mg/ml - oplossing voor injectie - 1 mg/1 ml - epinefrine 1 mg/ml - epinephrine

Uni Eropa - Belanda - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotische middelen - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

gedeon richter plc - chloormadinonacetaat 2 mg; ethinylestradiol 0,03 mg - filmomhulde tablet - chlormadinone and ethinylestradiol

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - rivaroxaban 15 mg - filmomhulde tablet - rivaroxaban

Belgia - Belanda - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - rivaroxaban 20 mg - filmomhulde tablet - rivaroxaban

Uni Eropa - Belanda - EMA (European Medicines Agency)

accord healthcare s.l.u. - dabigatran etexilate mesilate - venous thromboembolism; arthroplasty, replacement - antitrombotische middelen - prevention of venous thromboembolic events.

Belanda - Belanda - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

mylan b.v. - capecitabine - filmomhulde tablet - cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; macrogol 400 ; magnesiumstearaat (e 470b) ; siliciumdioxide (e 551) ; talk (e 553 b) ; titaandioxide (e 171), - capecitabine