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

krka d.d. novo mesto d.d. - aripiprazol 20 mg - tablet - 20 mg - aripiprazol 20 mg - aripiprazole

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

krka d.d. novo mesto d.d. - oxycodonhydrochloride 10 mg - eq. oxycodon 9 mg; naloxonhydrochloridedihydraat 5,45 mg - eq. naloxonhydrochloride 5 mg - tablet met verlengde afgifte - 10 mg - 5 mg - oxycodonhydrochloride 10 mg; naloxonhydrochloridedihydraat 5.45 mg - oxycodone, combinations

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

krka d.d. novo mesto d.d. - oxycodonhydrochloride 20 mg - eq. oxycodon 18 mg; naloxonhydrochloridedihydraat 10,9 mg - eq. naloxonhydrochloride 10 mg - tablet met verlengde afgifte - 20 mg - 10 mg - oxycodonhydrochloride 20 mg; naloxonhydrochloridedihydraat 10.9 mg - oxycodone, combinations

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

krka d.d. novo mesto d.d. - oxycodonhydrochloride 40 mg - eq. oxycodon 36 mg; naloxonhydrochloridedihydraat 21,8 mg - eq. naloxonhydrochloride 20 mg - tablet met verlengde afgifte - 40 mg - 20 mg - oxycodonhydrochloride 40 mg; naloxonhydrochloridedihydraat 21.8 mg - oxycodone, combinations

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

krka d.d. novo mesto d.d. - solifenacinesuccinaat 5 mg - eq. solifenacine 3,8 mg - filmomhulde tablet - 5 mg - solifenacinesuccinaat 5 mg - solifenacin

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

krka d.d. novo mesto d.d. - solifenacinesuccinaat 10 mg - eq. solifenacine 7,5 mg - filmomhulde tablet - 10 mg - solifenacinesuccinaat 10 mg - solifenacin

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

krka d.d. novo mesto d.d. - metforminehydrochloride 1000 mg; sitagliptine 50 mg - filmomhulde tablet - 50 mg - 1000 mg - sitagliptine 50 mg; metforminehydrochloride 1000 mg - metformin and sitagliptin

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

krka d.d. novo mesto d.d. - sitagliptine 50 mg; metforminehydrochloride 850 mg - filmomhulde tablet - 50 mg - 850 mg - sitagliptine 50 mg; metforminehydrochloride 850 mg - metformin and sitagliptin

Europese Unie - Nederlands - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride monohydrate - multiple myeloma; lymphoma, follicular - immunosuppressiva - multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a). multiple myelomalenalidomide krka d. novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. lenalidomide krka d. novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. follicular lymphomalenalidomide krka d. novo mesto in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).

Europese Unie - Nederlands - EMA (European Medicines Agency)

krka, d.d., novo mesto  - lenalidomide hydrochloride hydrate - multiple myeloma; lymphoma, follicular; myelodysplastic syndromes - immunosuppressiva - multiple myelomalenalidomide krka d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. lenalidomide krka d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is geïndiceerd voor de behandeling van volwassen patiënten met eerder behandelde multipel myeloom die niet in aanmerking komen voor transplantatie. lenalidomide krka d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. myelodysplastic syndromeslenalidomide krka d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate. follicular lymphomalenalidomide krka d. in combination with rituximab (anti-cd20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (grade 1 – 3a).