Examples of MAH in a sentence
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
For clarity, Licensee (or one of its Affiliates or their Sublicensees) shall always be the MAH of the Original ADC Licensed Products in the Territory.
For this generic application, the MAH has submitted one bioequivalence study, which is discussed below.
The MAH was also requested to present a synopsis of a Phase IV safety study and a plan for minimizing misuse/off-label use.The results from the post-marketing non-interventional safety study (XY-005-IM) are presently evaluated in the ongoing MRP type II variation (SE/H/638/01/II/05).
The MAH demonstrated through a bioequivalence study that the pharmacokinetic profile of the product is similar to the pharmacokinetic profile of this reference product.