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<p><strong>2. INDICATION</strong></p> <p><strong>2.1 Diffuse Large B-Cell Lymphoma</strong><br> EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.</p> <p><strong>2.2 Follicular Lymphoma</strong></p> <p>EPKINLY is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.</p>
<p><strong>2. INDICATION</strong></p> <p><strong>2.1 Diffuse Large B-Cell Lymphoma</strong><br> EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.</p> <p><strong>2.2 Follicular Lymphoma</strong></p> <p>EPKINLY is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.</p>
**INDICATIONS** **ADULTS** **Rheumatoid Arthritis** Humira is indicated for reducing signs and symptoms and inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. Humira can be used alone or in combination with methotrexate or other DMARDs. Humira, in combination with MTX, can also be used in the treatment of patients with recently diagnosed moderate to severely active rheumatoid arthritis who have not received methotrexate. **Psoriatic Arthritis** Humira is indicated for reducing signs and symptoms of active arthritis in adult patients with moderate to severe psoriatic arthritis when the response to previous DMARD therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function. Humira can be used alone or in combination with DMARDs. **Ankylosing Spondylitis** Humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy. **Crohn’s Disease** Humira is indicated for the treatment of moderate to severe active Crohn’s disease in adults to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients who have had an inadequate response to conventional therapies, or who have lost response to or are intolerant of infliximab. For induction treatment, Humira should be given in combination with corticosteroids. Humira can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inadequate. **Ulcerative Colitis** Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. **Plaque Psoriasis** Humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate. **Hidradenitis Suppurativa** Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy. **Uveitis** Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. **PEDIATRICS** **Juvenile Idiopathic Arthritis** **_Polyarticular Juvenile Idiopathic Arthritis_** Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA), in patients 2 years of age and older, who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDS). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see **CLINICAL STUDIES** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Humira has not been studied in patients aged less than 2 years. **_Enthesitis-Related Arthritis_** Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy. **Pediatric Crohn’s Disease** Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients, 6 years of age and older, with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. **Pediatric Plaque Psoriasis** Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy. **Adolescent Hidradenitis Suppurativa** Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hidradenitis suppurativa (HS) therapy. **Pediatric Uveitis** Humira is indicated for the treatment of chronic non-infectious anterior uveitis in pediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. **Pediatric Ulcerative Colitis** Humira is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
**5\. INDICATION** 5.1 Fullness Associated with Submental Fat BELKYRA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults. 5.2 Limitation of use The safe and effective use of BELKYRA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
<p><strong>INDICATIONS</strong></p> <p><strong>Chronic Lymphocytic Leukemia</strong></p> <p>VENCLEXTA is indicated, in combination with rituximab or as monotherapy, for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.</p> <p>VENCLEXTA is indicated, in combination with obinutuzumab, for the treatment of patients with previously untreated CLL.</p> <p><strong>Acute Myeloid Leukemia</strong></p> <p>VENCLEXTA is indicated, in combination with a hypomethylating agent or in combination with low-dose cytarabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy [see <strong>CLINICAL STUDIES/USE IN SPECIFIC POPULATIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p><strong>INDICATIONS</strong></p> <p><strong>Chronic Lymphocytic Leukemia</strong></p> <p>VENCLEXTA is indicated, in combination with rituximab or as monotherapy, for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.</p> <p>VENCLEXTA is indicated, in combination with obinutuzumab, for the treatment of patients with previously untreated CLL.</p> <p><strong>Acute Myeloid Leukemia</strong></p> <p>VENCLEXTA is indicated, in combination with a hypomethylating agent or in combination with low-dose cytarabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy [see <strong>CLINICAL STUDIES/USE IN SPECIFIC POPULATIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
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