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© European Medicines Agency, 2023. Reproduction is authorised provided the source is acknowledged.

21 March 2023

EMA/704692/2012

rev.2 1

Human Medicines Division

A cceptability of IU as abbreviation for International Units in the strength of human medicinal products

COUNTRY ABBREVIATION COMMENTS

AT I.E Not accepted. The abbreviation I.E. must be used. BE UI or IE or IU The following abbreviations are accepted:

UI (French)

IE (Dutch and German)

IU

BG IU Accepted CY IU Accepted

CZ IU Accepted

DE I.E. Not accepted. The abbreviation I.E. must be used. DK IU or IE IU is accepted for multilingual packs; however the abbreviation

IE must be used on Danish packs.

EE RÜ Not accepted. The abbreviation RÜ must be used. EL IU Accepted ES UI (or IU*) *IU would only be acceptable in exceptional cases following an appropriate justification (e.g. orphan medicinal products, certain multilingual packages). In the cases when it is accepted, it would be required to include an explanation in the PIL that “IU" means “UI" (unidades internacionales), since patients may have seen that acronym before and should know it is the same. Additionally, if feasible, when stating the active substance on

the outer package “IU" should be included in brackets following the translation for international units in Spanish, i.e. XX

unidades internacionales (IU).

FI IU Accepted

FR UI (or IU*) *IU would only be acceptable in exceptional cases following an appropriate justification (e.g. orphan medicinal products, certain multilingual packages). In the cases when it is accepted, it would be required to include an explanation in the PIL that “IU" means “UI" (unités internationales), since patients may have seen that acronym before and should know it is the same. Additionally, if feasible, when stating the active substance on the outer package “IU" should be included in brackets following the translation for international units in French, i.e. XX unités internationales (IU). 1 Rev. 2 Changes since publication: IS details updated. Acceptability of IU as abbreviation for International Units in the strength of human medicinal products

EMA/704692/2012 Page 2/2

COUNTRY ABBREVIAT

ION

COMMENTS

HR IU Accepted

HU NE Not accepted. At national level Hungary consequently translates egység).

IE IU Accepted

IS a.e. or IU a.e. must be used on Icelandic packs. IU is accepted for multilingual packs provided it is explained in the package leaflet (e.g. by adding IU in brackets after a.e.). IT UI Not accepted. The abbreviation UI must be used. LT TV Not accepted. The abbreviation TV (tarptautinis vienetas) must be used. LV SV Not accepted. The abbreviation SV (Ņŝ) must be used . In case of

Baltic multilingual packs there are

several examples where "IU" for three countries has national translation (respectively for LV, LT and EE).

MT IU Accepted

NL I.E. Not accepted. The abbreviation I.E. must be used. NO IU or IE IU is accepted for multilingual packs; however the abbreviation

IE must be used on Norwegian packs.

PL IU or j.m. IU is acceptable but not recommended. The abbreviation j.m. is highly recommended. PT UI IU should not be used in Portuguese. It could be confusing, since it is usually translated to UI (Unidades internacionais). There is not any medicinal product in the PT database with the abbreviation IU. RO UI Not accepted. The abbreviation UI (Unitati international) must be used. SE IU or IE IU is accepted for multilingual packs; however the abbreviation

IE must be used on Swedish packs.

SI i.e. Not accepted. The abbreviation i.e. must be used.

SK IU Accepted

UK (Northern Ireland) IU IU is acceptable but a consistent approach is needed (i.e. some medicines are IU and some are just U, and this causes confusion and dosing errors).quotesdbs_dbs7.pdfusesText_13

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