WHOPAR Guidance for Applicants
(2004; 140 pages)
Table of Contents
View the documentGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
View the documentAppendix 1 - Characteristics of WHOPAR Parts
View the documentAppendix 2 - Documentation to submit together with the initial submission
Close this folderAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
View the documentANNEX I - Summary of product characteristics - Word Templates
View the documentANNEX III - Labelling and package leaflet - Word Templates
View the documentANNEX I - Summary of product characteristics - annotated
View the documentANNEX III - Labelling and package leaflet
View the documentAPPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC
View the documentAPPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC
View the documentAPPENDIX III - Standards for required storage standards
View the documentAPPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling
View the documentConvention to be followed for EMEA-QRD templates
View the documentCompilation of QRD decisions on the use of terms
View the documentCompilation of QRD decisions on stylistic matters in product information
View the documentTables of non-standard abbreviations
View the documentAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

Tables of non-standard abbreviations

European Medicines Agency

Version 5 (Lot/Exp removed and published as Appendix IV to the PI templates)

07/2004

USE IN SUMMARY OF PRODUCT CHARACTERISTICS

FULL TERM

EN

DA

DE

EL

ES

FI

FR

IT

NL

PT

SV

NO

IS

angiotensin converting enzyme

ACE

ΜΕΑ

ECA

IEC

IECA

deoxyribonucleic acid

DNA

DNS or DNA

ADN

ADN

monoamine oxidase inhibitors

MAOI

MAO-Hemmer

αναστολείς ΜΑΟ

IMAO

MAO-estäjä

IMAO

IMAO

MAO-remmers

IMAO

MAO - hämmare

MAO - hemmere

MAO - hemill

volume of distribution

Vd

activated partial thromboplastin time

aPTT

X

X

X

TCA

*

*

half-life

area under the curve

AUC

ASC

maximum serum concentration

Cmax

minimum serum concentration

Cmin

time to maximum concentration

tmax

acquired immunodeficiency syndrome

AIDS

SIDA

SIDA

SIDA

ALNÆMI

cytomegalovirus

CMV

*

X

human immunodeficiency virus

HIV

VIH

VIH

VIH

tumour necrosis factor alpha

TNFá

X

X

FNTá

FNTá

electrocardiogram

ECG

EKG

ΗΚΓ

EKG

EKG

EKG

hjartalínurit (ECG)

magnetic resonance imaging

MRI

MRT

X

X

IRM

RMI

X

segulómun (MRI)

percutaneous transluminal coronary angioplasty

PTCA

X

ACPT

X

kransæðaví kkun

international unit

IU

I.E.

UI

UI

UI

IE

UI

IE

IE

a.e.

polyvinylchloride

PVC

high density polyethylene

HDPE

X

PEHD

X

low density polyethylene

LDPE

X

PEBD

X

New Member States:

FULL TERM

EN

CZ

EE

HU

LV

LT

PL

SK

SL

angiotensin converting enzyme

ACE

AKE

AKE

AKF

deoxyribonucleic acid

DNA

DNA

DNS

DNS

DNR

DNA

monoamine oxidase inhibitors

MAOI

IMAO

MAO-gátlók

MAO-inhibitori

MAO inhibitori ai

IMAO

IMAO

zaviralci MAO

volume of distribution

Vd

x

Vd

activated partial thromboplastin time

aPTT

aPTI

DATL

APTT

X

half-life

t½, t0,5

area under the curve

AUC

AUC

maximum serum concentration

Cmax

Cmax

minimum serum concentration

Cmin

Cmin

time to maximum concentration

tmax

tmax

acquired immunodeficiency syndrome

AIDS

AIDS

cytomegalovirus

CMV

CMV

human immunodeficiency virus

HIV

ˇIV

tumour necrosis factor alpha

TNFá

TNFį

electrocardiogram

ECG

EKG

EKG

EKG

EKG

EKG

EKG

EKG

EKG

magnetic resonance imaging

MRI

BMR

NMR

NMR

X

percutaneous transluminal coronary angioplasty

PTCA

PTKA

PTKA

X

international unit

IU

IU or m.j.

RÜ (IU can be used)

NE

SV

TV

j.m.

i.e.

polyvinylchloride

PVC

PVH

PVC

PCW

high density polyethylene

HDPE

ABPE

DTPE

low density polyethylene

LDPE

ZBPE

MTPE

same abbreviation as in English
X no abbreviation available in this language, use full term.

SMALL IMMEDIATE PACKAGING LABELLING ONLY

FULL TERM

EN

DA

DE

EL

ES

FI

FR

IT

NL

PT

SV

NO

IS

Intravenous

IV

i.v.

i.v.

e.v.

IV/I.V./i.v./i v

iv/IV

i.v.

Subcutaneous

SC

s.c.

s.c.

√ •

X

s.c.

SC/S.C./s.c/sc

sc/SC

s.c

Intramuscular

IM

i.m.

i.m.

i.m.

IM/I.M./i.m./im

im/IM

i.m.

New Member States:

FULL TERM

EN

CS

ET

HU

LV

LT

PL

SK

SL

Intravenous

IV

i.v.

i.v.

iv.

i.v.

i.v.

iv.

i.v.

i.v.

Subcutaneous

SC

s.c.

s.c.

sc.

s.c.

s.c.

sc.

s.c.

s.c.

Intramuscular

IM

i.m.

i.m.

im.

i.m.

i.m.

im.

i.m.

i.m.

same abbreviation as in English
X no abbreviation available in this language, use full term
• although not commonly used.

 

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