Glossary

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A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

A

Active Substance(s)
The substance responsible for the pharmacological activity of a product expressed as its basic form, i.e. excluding salts, esters etc. The amount of the active substance contained in each dosage unit (by volume or weight according to the dosage) is usually the amount expressed in the strength qualifier.

In respect of the establishment of maximum residue limits (for veterinary medicines only) the active substance is usually defined precisely, i.e. including salts and esters, when the substance is included in Annex II (no MRL value required) of Regulation (EEC) No 2377/90.

Adjuvants
Special ingredients that have little or no pharmacological activity by themselves, but which may increase or modify the activity of other ingredients when given at the same time.

ATC Code(s)
Anatomical Therapeutic Chemical classification system. Within this system, each product is issued a unique code, the ATC Code, and grouped according to its therapeutic usage.

Authorisation Status
Current legal situation of the product (e.g. indicates whether the authorisation is active or suspended).

Authorised By
The country or body that authorised the product. The date the product was authorised is also displayed, if available.

B

bg
Abbreviation for the Bulgarian language.

C

Centralised Procedure
A Community registration procedure for the authorisation of medicinal products. This involves a single application and a single evaluation for each medicinal product, resulting in a single Marketing Authorisation valid for the whole of the European Union.

Classification
Indicates the annex of Regulation (EEC) No 2377/90 where the active substance is listed and its maximum residue limit (MRL) is established. This applies to veterinary products only.

cs
Abbreviation for the Czech language.

D

da
Abbreviation for the Danish language.

Data Provider
Name of the National Competent Authority or body (e.g. European Medicines Agency) responsible for the supply of product information to EudraPharm.

de
Abbreviation for the German language.

Domain
Indicates whether the product is for human or veterinary use.

E

EEA
Abbreviation for European Economic Area. The European Economic Area (EEA) was created following an agreement which entered into force on 1 January 1994. The EEA comprises Iceland, Liechtenstein and Norway, as well as all Member States of the European Union.

el
Abbreviation for the Greek language.

en
Abbreviation for the English language.

es
Abbreviation for the Spanish language.

et
Abbreviation for the Estonian language.

EU
Abbreviation for European Union. This is the Union of the following Member States: Belgium, Bulgaria, Czech Republic, Denmark, Germany, Estonia, Greece, Spain, France, Ireland, Italy, Cyprus, Latvia, Lithuania, Luxembourg, Hungary, Malta, Netherlands, Austria, Poland, Portugal, Romania, Slovenia, Slovakia, Finland, Sweden, United Kingdom.

EU Authorisation Number
Reference number assigned by the European Commission when it approves a medicinal product in line with centralised procedures.

European Medicines Agency
This is the Agency responsible for coordinating the existing scientific resources put at its disposal by the National Competent Authorities of the Member States for the evaluation and supervision of medicinal products.

Excipients
Ingredients with no medicinal properties that have been added to the active substance(s) to help in the manufacture of the product.

F

fi
Abbreviation for the Finnish language.

Formulation
Pharmaceutical form and strength.

fr
Abbreviation for the French language.

G

Generic
A product which has the same qualitative and quantitative composition in active substance(s) and the same pharmaceutical form as a reference product, and whose bioequivalence with the reference product has been demonstrated through appropriate bioavailability studies. The reference product is a product that has already been authorised and marketed for ten years or more in the EU.

H

hu
Abbreviation for the Hungarian language.

I

Ingredients
Different substances that are part of the product, including active substances, excipients and adjuvants.

Indication
The basis for using a medicinal product (diagnosis or treatment of a disease, or of its symptoms).

is
Abbreviation for the Icelandic language.

it
Abbreviation for the Italian language.

J

K

L

Labelling
Labelling refers to a medicine’s packaging carton and label.

Languages
The language abbreviations used in EudraPharm are as follows:
bg - Bulgarian
es - Spanish
cs - Czech
da - Danish
de - German
et - Estonian
el - Greek
en - English
fr - French
is - Icelandic
it - Italian
lv - Latvian
lt - Lithuanian
hu - Hungarian
mt - Maltese
nl - Dutch
no - Norwegian
pl - Polish
pt - Portuguese
ro - Romanian
sk - Slovak
sl - Slovenian
fi - Finnish
sv - Swedish

Latest Variation
The date that the latest change (variation) to the Marketing Authorisation became effective, along with a comment about the variation, if available.

lt
Abbreviation for the Lithuanian language.

lv
Abbreviation for the Latvian language.

M

Marker Residue
This is the active substance or any of its metabolites, or a combination of any of these, the concentration of which decreases in a known relationship to the concentration of the total residues in target tissues (muscle, fat, liver, kidney), eggs, milk or honey. The analytical methods for monitoring of residues are developed to detect the marker residue.

Marketing Authorisation (MA)
Approval to market a medicinal product in a given territory.

Marketing Authorisation Holder
Name of the legal entity (generally a company) that has been authorised to market a product in a given territory.

MRL
Abbreviation for maximum residue limit. This is the maximum concentration of residues that the European Union considers to be acceptable in a foodstuff produced from an animal in which a veterinary medicine has been used. Maximum residue limits are established for the target tissues in the relevant animal species and are expressed in μg/kg. This applies to veterinary products only.
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mt
Abbreviation for the Maltese language.

N

National Authorisation Number
Reference number assigned by a National Competent Authority when it approves a product.

National Competent Authorities
The authorities responsible for the authorisation and supervision of products in each of the Member States of the European Union (EU) and the European Economic Area (EEA).

nl
Abbreviation for the Dutch language.

no
Abbreviation for the Norwegian language.

O

Orphan Designation
Some products have a special 'orphan' status because they have been developed and authorised to diagnose, prevent or treat very serious conditions that are rare and affect no more than 5 in 10,000 persons in the European Union.

Other Provisions
Specific conditions related to the MRL established, or to the use of a substance in veterinary products. Including, but not restricted to, the expiry date in case of provisional MRLs, restrictions with regard to routes of administration of certain categories of animals, etc. This applies to veterinary products only.

P

Package Approval Date
Date on which the Marketing Authorisation for a presentation (package) was approved for the market.

Package Authorisation Status
Legal situation of the presentation.

Package Code
Designation that, within a given coding scheme, identifies the presentation.

Package Leaflet
A leaflet that accompanies the product and contains information for the user. The content of the Package Leaflet is consistent with the content of the Summary of Product Characteristics, but is written using language that is more easily understood by end users (patients, animal owners).

Package Legal Status
Classification of how the presentation can be supplied according to legislation (e.g. whether it is subject to medical prescription, subject to veterinary prescription, or not subject to any prescription).

Package Name
The package name contains additional relevant qualifiers that are not present in other descriptive fields of other core elements. This may be used if the presentation has a special descriptor, such as Refill, Pen etc.

Package Renewal Date
Date on which the marketing authorisation was renewed, in either a centralised or national procedure.

Package Variation Date
Date on which the last variation of the presentation became effective.

Packaging
The actual container for the product, for example, a blister pack or a vial.

Pharmaceutical Form
The form in which a pharmaceutical product is presented (e.g. tablet, capsule, solution for injection, cream).

pl
Abbreviation for the Polish language.

Presentation
The way the product is supplied (e.g. a box containing 28 x 100mg tablets, a pack containing 5 x 10ml vials, a 50g tube).

Procedure
Indicates whether the centralised procedure or a national procedure was used for obtaining the marketing authorisation. The procedure number may also be displayed, if available.

Product Legal Status
Classification of how the product can be supplied according to legislation (e.g. whether it is subject to medical prescription, subject to veterinary prescription, or not subject to any prescription).

Product Name
The name, generally the trade name, given to a product. This might be an invented name or a common or scientific name accompanied by a trademark of the name of the Marketing Authorisation Holder.

Product Renewal Date
Date on which the renewal of the Marketing Authorisation was granted.

Product Type
Classification of a product (e.g. Blood Product, Medicinal Product, Medical Device, Special Nutritional Product, Veterinary Medicinal Product).

pt
Abbreviation for the Portuguese language.

Q

R

Renewal
A National Competent Authority or the European Medicines Agency renews an existing Marketing Authorisation on the basis of a favourable risk-benefit balance after re-evaluation. The first renewal usually takes place after 5 years. The NCA or relevant European Medicines Agency scientific committee will also decide if further renewals are required.

ro
Abbreviation for the Romanian language.

Route of Administration
Path by which the product should be brought into contact with the subject’s body (e.g. oral, intravenous (into a vein), subcutaneous (under the skin) etc.).

S

sk
Abbreviation for the Slovak language.

sl
Abbreviation for the Slovenian language.

Strength
The content of an ingredient expressed quantitatively per dosage unit, per unit of volume or weight, according to the dosage form.

Summary of Product Characteristics
Document that describes the characteristics of a product as agreed during the assessment process. The Summary of Product Characteristics is the basis of information for healthcare professionals on how to use the product safely and effectively.

sv
Abbreviation for the Swedish language.

T

Target Population
Age range for which the product is intended.

Target Species
Animal species, or category of animals, for which the product is approved and/or for which MRLs have been established, as indicated in the annexes of Regulation (EEC) No 2377/90. This applies to veterinary products only.

Target Tissues
The edible tissue selected to monitor for the marker residue in the target animal, and for which an MRL is established. These are normally: muscle, fat (or skin and fat in natural proportions for pigs and poultry), liver, kidney, milk, eggs or honey, as appropriate. For fish, the target tissues are muscle and skin (in natural proportions). This applies to veterinary products only.

Therapeutic Area
The field in which the product is used (e.g. anti-viral agent, anti-hypertensive agent). The level shown is the third level of the ATC classification (pharmacological subgroup).

U

V

Variation
Modification to the terms of a marketing authorisation.

W

Withdrawal Period
The interval between the last administration of a product to an animal and the production of foodstuff from that animal, which is set to ensure that the foodstuff does not contain residue quantities in excess of the MRL. This applies to veterinary products only.

X

Y

Z

Please note that not all the information listed above may be displayed for all products. Only information supplied by the Data Providers is displayed.