CRED SMPC 2024

29 February 2024 EMA/295934/2018 v.6 # Human Medicines Division

Appendix II to the QRD templates for human medicinal products MedDRA terminology to be used in Section 4.8 “Undesirable effects” of SmPC

The Introductory Guide MedDRA provides the list of System Organ Classes to be used in section 4.8 of the SmPC, both in terms of terminology and order, and it is available in several EU languages (CZ, DE, EN, ES, ET, FR, HU, IT, LV, NL, PT and SV).

The table below shows the equivalent terminology in all EEA languages:

BG Bulgaria

IS Icelandic

CS Czech *

IT Italian *

DA Danish

LT Lithuanian

DE German *

LV Latvian

EL Greek

MT Maltese

EN English *

NL Dutch *

ES Spanish *

NO Norwegian

ET Estonian

PL Polish

PT Portuguese *

FI Finnish

FR French *

RO Romania

GA Irish

SK Slovak

HR Croatian

SL Slovenian

HU Hungarian *

SV Swedish

#v.6 Changes since last revision: Revision of terminology in EL (006, 008, 009, 011, 012, 015, 019-021, 025, 028, 030, 032, 033) and SV (008, 010, 013, 016-019, 022, 024-026, 028-029, 031-032)

#v.5 Changes since last revision: Revision of terminology in ES ( ‘ MedDRA- system organ class database ’ heading), HU (006), LV (006, 020, 021), MT (010, 033), SL (006) and SV (008, 010, 013, 016-019, 022, 024-026, 028-033)

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