SC II B. Monograph Titles for Formulated Preparations

1. The titles of monographs for formulated preparations combine the appropriate drug substance name and pharmaceutical form.

2. The drug substance name is a British Approved Name [BAN] which in general is also the recommended International Nonproprietary Name [rINN]. In cases where the drug substance name is a British Approved Name (Modified), the modifying term is omitted from the title for the formulated preparation except where there exist two or more formulations containing different forms (salts, hydrates etc.) of the drug substance. In such cases the modifying term is retained in the monograph title. Thus, for example, the title of the monograph for tablets containing Clonidine Hydrochloride is Clonidine Tablets since tablets containing clonidine are formulated only with the hydrochloride. The title of the monograph for tablets containing Isosorbide Dinitrate, on the other hand, is Isosorbide Dinitrate Tablets, since tablets formulated with the mononitrate are also available.

3. The terms for the pharmaceutical form are either (i) derived from the relevant General Monograph; or (ii) terms in established use in the UK.

4. When the pharmaceutical form is described as the term in established use in the UK, reference to the pharmaceutical form from the relevant General Monograph will be provided as a Subsidiary Title and incorporated into the Definition section of the monograph. For Codeine Linctus, for example, the title of the monograph and therefore the nonproprietary name of the preparation remains as Codeine Linctus, but the monograph contains the subsidiary title ‘Codeine Oral Solution’ and the Definition states that ‘Codeine Linctus is an oral solution containing …’.

5. Standard Terms, as published by the Council of Europe, are to be used for describing the pharmaceutical form in the Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labelling of medicinal products receiving a European Community authorisation. Member States may use different product names for national authorisations.