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B BLOOD AND BLOOD FORMING ORGANS
B03 ANTIANEMIC PREPARATIONS
B03A IRON PREPARATIONS

This group comprises all plain iron preparations and all combination products containing more than 30 mg Fe2+ (or corresponding amounts of Fe3+ salts) per defined daily dose (DDD) of the product, regardless of therapeutic use.
Combined preparations with 30 mg or less Fe2+ per DDD should be classified as vitamin preparations in group A11 or as tonics in group A13. All iron preparations with "iron deficiency" as the main indication are classified in B03A, regardless of the amount of iron salts.
Only plain preparations should be classified in the groups B03AA, B03AB and B03AC. Combinations with stabilizing agents (e.g. ascorbic acid) are allowed at each 5th level. Combinations with e.g. laxatives are classified at separate 5th levels by using the 50-series.
Other combinations, see B03AD and B03AE.


B03AA Iron bivalent, oral preparations

The DDDs are based on treatment of iron deficiency anemia. The DDDs are established according to amount of Fe2+ and are equal for all compounds regardless of iron salt (i.e. the DDD corresponds to 0.2 g Fe2+).

B03AB Iron trivalent, oral preparations

Ferric citrate mainly used for the treatment of hyperphosphatemia, is classified in V03AE08.

The DDDs are based on treatment of iron deficiency anemia. Separate DDDs are established for the different trivalent iron salts. The DDDs are expressed in grams of Fe3+.

B03AC Iron, parenteral preparations

The DDDs are based on treatment of iron deficiency anemia. The DDDs are established according to amount of Fe and are equal for all compounds (i.e. the DDD corresponds to 0.1 g Fe).

B03AD Iron in combination with folic acid

This group comprises iron in combination with folic acid. Preparations containing additional substances, see B03AE.

Historically:
The DDDs have been based on prophylaxis of iron deficiency anemia and folic acid deficiency during pregnancy (i.e. about half the iron dose for treatment of anemia).

B03AE Iron in other combinations

This group comprises preparations, which in addition to iron or iron and folic acid contain other substances.
The group is subdivided:
B03AE01 - iron, vitamin B12 and folic acid
Intrinsic factor and/or liver extract are also allowed in this group
B03AE02 - iron, multivitamins and folic acid
B03AE03 - iron and multivitamins
B03AE04 - iron, multivitamins and minerals
B03AE10 - various combinations
This group comprises some "borderline" combined iron preparations i.e. preparations with an iron content of approximately 30 mg Fe2+ per defined daily dose (DDD).

Historically:
For combinations of iron, vitamin B12 and folic acid (B03AE01), the DDDs have been based on prophylaxis of iron deficiency anemia and folic acid deficiency during pregnancy.
Various combinations, classified in B03AE10, contain very small amounts of iron. The DDDs for these combinations have been based on dose recommendations, and can be as low as corresponding to 30 mg Fe2+.
The DDDs for iron in other combinations have been based on treatment of iron deficiency anemia, and correspond to a DDD of 0.2 g Fe2+.

Last updated: 2024-01-26