Loncastuximab Tesirine as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Registration
Biological Drug
FluMist
Influenza vaccine (intranasal, live attenuated) (LAIV trivalent): Influenza Virus Type A H1N1, Influenza Virus Type A H3N2, Influenza Virus Type B (Victoria lineage) 107±0.5 FFU Influenza Virus Type B (Victoria lineage)
Influenza vaccine (intranasal, live attenuated) (LAIV trivalent): Influenza Virus Type A H1N1, Influenza Virus Type A H3N2, Influenza Virus Type B (Victoria lineage) 107±0.5 FFU Influenza Virus Type B (Victoria lineage)
الاستخدامات الطبية المعتمدة
FluMist is indicated for the prophylaxis of influenza in individuals from 2 to less than 18 years of age.
Lijen Met is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
• In patients inadequately controlled on their maximally tolerated dose of metformin alone.
• In combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products.
In patients already being treated with the combination of linagliptin and metformin as separate tablets.
Lijen Met is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
• In patients inadequately controlled on their maximally tolerated dose of metformin alone.
• In combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products.
In patients already being treated with the combination of linagliptin and metformin as separate tablets.
Sirolimus is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Sirolimus be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Sirolimus may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued
Sirolimus is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Sirolimus be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Sirolimus may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued
Airsupra is indicated for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbation in patients with asthma 18 years of age and older.
-Airsupra is also indicated for the prevention of exercise-induced bronchoconstriction in patients with asthma 18 years of age and older.