Vitamins constitute a comprehensive group of therapeutic and prophylactic preparations. Before classifying any product it is important to be familiar with the main subdivision of the group.
It may be necessary to consider whether a product is a vitamin preparation with iron or an iron preparation with vitamins, a mineral preparation with vitamins or a vitamin preparation with minerals, or if the product should be regarded as a tonic etc. As an aid to such considerations, guidelines are given at each sublevel.
Vitamin B12 is classified in B03 - Antianemic preparations.
Vitamin K is classified in B02 - Antihemorrhagics.
Vitamins administered as i.v. solution additives, see B05XC.
Multivitamins: Products containing minimum vitamins A, B, C and D. One B-vitamin is sufficient.
B-complex: Products containing minimum thiamine, riboflavine, pyridoxine, nicotinamide. The products may contain other B-vitamins.
A11A MULTIVITAMINS, COMBINATIONS
|The DDDs are based on prophylaxis. For simplicity, the DDDs for oral formulations are given as fixed doses (1 tablet = 1 UD; 30 ml mixture = 6 UD).|
The group is subdivided:
A11AA01 - multivitamins and iron
A11AA02 - multivitamins and calcium
A11AA03 - multivitamins and other minerals, incl. combinations
A11AA04 - multivitamins and trace elements
In A11AA01, 02 and 03, combinations with trace elements are allowed.
In A11AA04 only trace elements are allowed in addition to multivitamins.
Combinations with other substances, e.g. caffeine, are classified in A11AB.
Cholin, biotin, inositol and para-amino benzoic acid are regarded as vitamins and are allowed in preparations classified in A11AA.
A11AA01 multivitamins and iron
Preparations containing multivitamins and sub-therapeutic doses of iron are classified in this group.
Sub-therapeutic doses of iron are defined as 5-30 mg of Fe2+ per defined daily dose, with corresponding limits for the various Fe3+ salts, if the main indication is not "iron deficiency". Preparations containing more than 30 mg Fe2+ (or corresponding doses of Fe3+) are classified as iron preparations (B03A) regardless of therapeutic use.
See also A11AA.
A11AA02 multivitamins and calcium
Preparations containing multivitamins and sub-therapeutic doses of calcium are classified in this group, e.g. a calcium content of up to 500 mg calcium carbonate per tablet have been allowed.
See also A11AA.
Calcium preparations, see A12A.
A11AA03 multivitamins and other minerals, incl. combinations
Preparations containing multivitamins and sub-therapeutic doses of one or more mineral are classified in this group. Definitions of sub-therapeutic doses of iron and calcium, see A11AA01 and A11AA02. See also A11AA.
Mineral supplements, see A12.
A11AA04 multivitamins and trace elements
Preparations containing multivitamins and trace elements are classified in this group. No other combinations should occur in this group.
This group comprises all combined preparations with multivitamins, which are not classified in A11AA.
Preparations containing caffeine, strychnine etc. are classified in this group.
Preparations containing cholin, biotin, inositol, para-amino benzoic acid etc. should be classified in A11AA.
Last updated: 2013-12-19