Danimarka - Danca - Lægemiddelstyrelsen (Danish Medicines Agency)

1a farma a/s - paroxetin - filmovertrukne tabletter - 40 mg

Danimarka - Danca - Lægemiddelstyrelsen (Danish Medicines Agency)

hexal a/s - paroxetinhydrochlorid anhydrat - filmovertrukne tabletter - 20 mg

Danimarka - Danca - Lægemiddelstyrelsen (Danish Medicines Agency)

hexal a/s - paroxetinhydrochlorid anhydrat - filmovertrukne tabletter - 40 mg

Danimarka - Danca - SEGES Landbrug & Fødevarer

dow agrosciences danmark a/s - propyzamid - suspensionskoncentrat - 500 g/l propyzamid

Danimarka - Danca - Lægemiddelstyrelsen (Danish Medicines Agency)

paranova danmark a/s - clarithromycin - depottabletter - 500 mg

Avrupa Birliği - Danca - EMA (European Medicines Agency)

krka, d.d., novo mesto - capecitabin - colonic neoplasms; breast neoplasms; colorectal neoplasms; stomach neoplasms - antineoplastiske midler - ecansya er indiceret til adjuverende behandling af patienter efter operation af fase iii (dukes 'stadium-c) tyktarmskræft. ecansya er indiceret til behandling af metastatisk kolorektal cancer. ecansya er angivet for first-line behandling af fremskreden gastrisk cancer i kombination med en platin-baseret regime. ecansya i kombination med docetaxel er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi. tidligere behandling skulle have inkluderet en antracyklin. ecansya er også indiceret som monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter svigt af taxaner og en antracyklin, der indeholder kemoterapi, eller for hvem yderligere antracyklin terapi er ikke oplyst.

Danimarka - Danca - Lægemiddelstyrelsen (Danish Medicines Agency)

sandoz a/s - isoniazid, rifampicin - filmovertrukne tabletter - 150+75 mg

Avrupa Birliği - Danca - EMA (European Medicines Agency)

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. undtagen i nyligt diagnosticeret kronisk cml-fase, der er ingen kontrollerede undersøgelser, der påviser en klinisk fordel eller øget overlevelse for disse sygdomme. .

Danimarka - Danca - Lægemiddelstyrelsen (Danish Medicines Agency)

orifarm a/s - bendroflumethiazid, kaliumchlorid - overtrukne tabletter - 2,5+573 mg

Danimarka - Danca - Lægemiddelstyrelsen (Danish Medicines Agency)

orifarm a/s - bendroflumethiazid, kaliumchlorid - overtrukne tabletter - 1,25+573 mg