(c) Description of accompanying reconstitution diluent(s); and For drug products supplied with reconstitution diluent(s) that are not commercially available in Canada or have not been reviewed and approved in connection with another drug submission with Health Canada, information on the diluent(s) should be provided in a separate Drug Product ("P") portion, as appropriate.
»). Il faut déclarer les constituants au moyen de leur nom propre ou commun et indiquer les normes de qualité qu’ils respectent (p. ex., U.S.P., Ph.Eur., maison) et, le cas échéant, leur qualité (p. ex., « Cellulose microcristalline NF (PH 102) »).