Combination Regimen definition

Combination Regimen has the meaning set forth in Section 1.106.

Combination Regimen means the administration of two or more drugs or biological products together for the treatment, diagnosis or prophylaxis of any Indication, including a Licensed Product and at least one other distinct drug or biological product that is not a Licensed Product, where such Product and other drug or biological product are packaged and sold separately.

Combination Regimen means any product or treatment regimen that comprises, or is a combination of (a) a BLU-285 Product, BLU-554 Product, or BLU-667 Product, and (b) any other product containing an Active Ingredient other than BLU-285, BLU-554, or BLU-667, where (a) and (b) are labeled for use together either simultaneously or in a separate or sequential administration, whether or not sold for a single price. For clarity, any Amalgamated Product that satisfies the requirement set forth in both clauses (a) and (b) is a Combination Regimen.

Examples of Combination Regimen in a sentence

• Combination Regimen containing anthracycline drugs: doxorubicin (Adriamycin) and epirubicin (Pharmorubicin) (Scully et al., 2012).

• Arbitration is more formal but is more final with limited grounds of appeal.

• Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma.” Issued September 26, 2019.

• Illustrative Example of Managing Food and Nutrition Interactions of a First-Line ARV Combination Regimen* One of the three first-line HAART regimens recommended by WHO for resource limited settings is a combination of zidovudine, lamivudine, and abacavir (the second regimen in Table 2).

• Source: Vertex press release of 26/7/2011 headlined ‘ Interim Data from Phase 2 Study of Combination Regimen Including VX-222 and INCIVEK Suggest Potential to Treat Genotype 1 Hepatitis C in as few as 12 Weeks and No More Than 24 Weeks’.

More Definitions of Combination Regimen

Combination Regimen means the administration of two or more drugs, biological products, cell therapies or gene therapies contemporaneously to a patient for the treatment, diagnosis or prophylaxis of any indication in the Field, including a Product and at least one other distinct drug, biological product, cell therapy or gene therapy that is not a Product, where such Product and other drug, biological product, cell therapy or gene therapy are packaged and sold separately. For clarity, the administration of a drug, biological product, cell therapy or gene therapy as an induction therapy prior to the administration of a Product (or vice versa), shall not be treated as a Combination Regimen.

Combination Regimen means, with respect to a given Licensed Product, the intended use of such Licensed Product for an Indication together with one or more other pharmaceutical products as two or more entities of active ingredients in a combination therapy, including concomitant or sequential therapy for commercial sale for such Indication as set forth in the approved label for such Licensed Product.

Combination Regimen means a single therapeutic regimen of the concomitant or sequential administration of (but not, for clarity, a single pharmaceutical formulation containing) (a) the Product, on the one hand, and (b) one or more other products, on the other hand.

Combination Regimen means, individually or collectively, as context requires, (a) a therapeutic combination comprising MGA012 and a Margetuximab Product or (b) a combination comprising MGA012 and a HER2 Trident Product, in each case ((a) and (b)) in concurrent or sequential administration.

Combination Regimen means any product or treatment regimen that comprises, or is a combination of (a) a Licensed Product, and (b) any Other Component (whether or not the intellectual property rights for such Other Component are Controlled by a Party), where (a) and (b) are labeled for use together or Regulatory Approval is being sought for use together either simultaneously or in a separate or sequential administration, whether or not sold for a single price.

Combination Regimen means, with respect to a given Product, the intended use of such Product for an indication together with one or more other pharmaceutical products as two or more entities of active ingredients in a combination therapy, including concomitant or sequential therapy for commercial sale for such indication as set forth in the approved label for such Product.

Combination Regimen has the meaning set forth in Section 3.3(c).