Page History

...

A medicinal product concept has a set of precise active ingredient substance(s), those substance(s) that provides the therapeutic effect of the medicinal product and which are described using the fullest and most specific description of the substance as it is used in the product(s) that the concept represents (as they are presented by the manufacturer in the manufactured dose form, before any dilution or transformation). The precise active ingredient substance may include various modifiers, such as salts, esters and/or polymers (e.g. pegylation); not all substances, even when used as the precise active ingredient substance, have a modification (see axitnitib). This is the attribute role that is used in the definition of the MP (precisely) concept, and in the definition of the CD (precisely). 
Examples:

• azithromycin hemiethanolate monohydrate
• haloperidol decanoate
• esomeprazole magnesium dihydrate
• oxybutynin chlorideparoxetine hydrochloride isopropyl solvate
• dexamethasone sodium phosphate
• sorafenib tosylate
• axitinib

...