Israel - English - Ministry of Health

tzamal bio-pharma ltd - quetiapine as fumarate - tablets prolonged release - quetiapine as fumarate 50 mg - quetiapine - quetiapine - seroquel xr is indicated for the treatment of schizophrenia .seroquel xr is effective in preventing relapse in stable schizophrenic patients who have been maintained on seroquel xr. seroquel xr is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder.treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.seroquel xr is indicated for the treatment of major depressive episodes in bipolar disorder. seroquel xr is indicated for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment as monotherapy or in combination with lithium or sodium valproate. seroquel xr is indicated for add-on treatment of major depressive episods in patients with major depressive disorder (mdd) who have had sub-optimal response to antidepressant monotherapy (see section 5.1 pharmacodynamic properties). prior to initiating treatment, clinicians should consider the safety profile of seroquel xr (see section 4.4 special warnings and precautions for use).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - quetiapine as fumarate - tablets prolonged release - quetiapine as fumarate 200 mg - quetiapine - quetiapine - seroquel xr is indicated for the treatment of schizophrenia .seroquel xr is effective in preventing relapse in stable schizophrenic patients who have been maintained on seroquel xr. seroquel xr is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder.treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.seroquel xr is indicated for the treatment of major depressive episodes in bipolar disorder. seroquel xr is indicated for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment as monotherapy or in combination with lithium or sodium valproate. seroquel xr is indicated for add-on treatment of major depressive episods in patients with major depressive disorder (mdd) who have had sub-optimal response to antidepressant monotherapy (see section 5.1 pharmacodynamic properties). prior to initiating treatment, clinicians should consider the safety profile of seroquel xr (see section 4.4 special warnings and precautions for use).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - quetiapine as fumarate - tablets prolonged release - quetiapine as fumarate 300 mg - quetiapine - quetiapine - seroquel xr is indicated for the treatment of schizophrenia .seroquel xr is effective in preventing relapse in stable schizophrenic patients who have been maintained on seroquel xr. seroquel xr is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder.treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.seroquel xr is indicated for the treatment of major depressive episodes in bipolar disorder. seroquel xr is indicated for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment as monotherapy or in combination with lithium or sodium valproate. seroquel xr is indicated for add-on treatment of major depressive episods in patients with major depressive disorder (mdd) who have had sub-optimal response to antidepressant monotherapy (see section 5.1 pharmacodynamic properties). prior to initiating treatment, clinicians should consider the safety profile of seroquel xr (see section 4.4 special warnings and precautions for use).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - quetiapine as fumarate - tablets prolonged release - quetiapine as fumarate 400 mg - quetiapine - quetiapine - seroquel xr is indicated for the treatment of schizophrenia .seroquel xr is effective in preventing relapse in stable schizophrenic patients who have been maintained on seroquel xr. seroquel xr is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder.treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.seroquel xr is indicated for the treatment of major depressive episodes in bipolar disorder. seroquel xr is indicated for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment as monotherapy or in combination with lithium or sodium valproate. seroquel xr is indicated for add-on treatment of major depressive episods in patients with major depressive disorder (mdd) who have had sub-optimal response to antidepressant monotherapy (see section 5.1 pharmacodynamic properties). prior to initiating treatment, clinicians should consider the safety profile of seroquel xr (see section 4.4 special warnings and precautions for use).

Israel - English - Ministry of Health

tzamal bio-pharma ltd - quetiapine as fumarate - tablets prolonged release - quetiapine as fumarate 150 mg - quetiapine - quetiapine - seroquel xr is indicated for the treatment of schizophrenia. seroquel xr is effective in preventing relapse in stable schizophrenic patients who have been maintained on seroquel xr. seroquel xr is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder.seroquel xr is indicated for the treatment of major depressive episodes in bipolar disorder. treatment of acute mania associated with bipolar i disorder as monotherapy or in combination with lithium or sodium valproate.seroquel xr is indicated for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment, as monotherapy or in combination with lithium or sodium valproate.seroquel xr is indicated for add-on treatment of major depressive episods in patients with major depressive disorder (mdd) who have had sub-optimal response to antidepressant monotherapy (see section 5.1 pharmacodynamic properties). prior to initiating treatment, clinicians should consider the safety profile of seroquel xr.

Israel - English - Ministry of Health

unipharm ltd, israel - aripiprazole - tablets - aripiprazole 5 mg - aripiprazole - aripiprazole - ariply is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.ariply is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (mdd). efficacy was established in two 6-week trials in adults with mdd who had an inadequate response to antidepressant therapy during the current episode.ariply is indicated for the treatment of irritability associated with autistic disorder. efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods).

Israel - English - Ministry of Health

unipharm ltd, israel - aripiprazole - tablets - aripiprazole 10 mg - aripiprazole - aripiprazole - ariply is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.ariply is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (mdd). efficacy was established in two 6-week trials in adults with mdd who had an inadequate response to antidepressant therapy during the current episode.ariply is indicated for the treatment of irritability associated with autistic disorder. efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods).

Israel - English - Ministry of Health

unipharm ltd, israel - aripiprazole - tablets - aripiprazole 15 mg - aripiprazole - aripiprazole - ariply is indicated for the treatment of schizophrenia, for the treatment of moderate to severe manic episodes in bipolar i disorder and for the prevention of a new manic episode in patient who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment.ariply is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (mdd). efficacy was established in two 6-week trials in adults with mdd who had an inadequate response to antidepressant therapy during the current episode.ariply is indicated for the treatment of irritability associated with autistic disorder. efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods).

European Union - English - EMA (European Medicines Agency)

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastic agents - glivec 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-pdgfra rearrangement. , the effect of glivec on the outcome of bone-marrow transplantation has not been determined. glivec is indicated for: , 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 treatment;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and / or metastatic dfsp who are not eligible for surgery. , in adult and paediatric patients, the effectiveness of glivec 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 gist and dfsp and on recurrence-free survival in adjuvant gist. the experience with glivec in patients with mds / mpd associated with pdgfr gene re-arrangements is very limited (see section 5.1). except in newly diagnosed chronic phase cml, there are no controlled trials demonstrating a clinical benefit or increased survival for these diseases.,

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - lamotrigine, quantity: 200 mg - tablet, uncoated - excipient ingredients: magnesium stearate; microcrystalline cellulose; sodium starch glycollate; maize starch; lactose monohydrate - antiepileptic drug for the treatment of partial and generalised seizures in adults and children over 12 years of age.,there is extensive experience with lamotrigine used initially as add-on therapy. the use of lamotrigine has also been found to be effective as monotherapy following withdrawal of concomitant antiepileptic drugs.,initial monotherapy treatment in newly diagnosed paediatric patients is not recommended (see section 5.1 pharmacodynamic properties, clinical trials).