German SMPC Drug Dictionary

incl. legal data and leaflets

ABDA-Database German SMPC Drug Dictionary in a nutshell

WHAT DOES SMPC STAND FOR?

The Summary of Product Characteristics (SPC or SmPC) is a specific document required within the European Commission before any medicinal product or biocidal product is authorised for marketing.

ABDA DATABASE GERMAN SMPC DRUG DICTIONARY

The ABDA Database German SmPC Drug Dictionary lists comprehensive information on original pharmaceutical products and generics available in Germany, Switzerland, Austria and other countries.

  • check out all the structured data on Marketing Authorisation Holders´ (MAH) contact details in Germany
  • check out the Marketing Authorisation Holders of more than 58.000 registered medicinal products in Germany
  • Including active ingredients and their pharmacological and toxicological information, Clinical Particulars such as Interactions, Adverse Reactions, and Contra-Indications
  • The Marketing Authorisation Holders Drug Dictionaries are updated twice a month
R

Suitable for:

Pharma Industry, Pharma Trade, Health Insurance, Regulatory

Source: ABDATA PHARMA-DATA-SERVICE

Eschborn, Germany

Related subscription

This database can be accessed after purchasing the subscription package ‘Drug Dictionaries’ or ‘Premium’

What customers say

For me as Contract Research Organisation (CRO) the Marketing Authorisation Holder Drug Dictionaries are a big help to find SmPCs of the different MAHs in the authorised markets.

Christine Klipping

President, DINOX

What is practical is that you can find ALL the articles that are sold in the pharmacy in one portal: Medicines on the market, medical products, aids etc. on the market, medicines withdrawn from the market, foreign medicines etc..

Veronika Kneer

Head Teacher, Vocational School for PTA

We use the ABDA-Database German SMPC Drug Dictionary Medicines and International Medicines to offer our customers, in particular pharmacies and hospitals, international procurement opportunities for locally unavailable medicines (in Germany, for example, individual imports in accordance with §73.3 AMG). Thank you very much for your fast and good service!

Dr. Marcel Rossmy

Head of Division Pharma Supply Chain, CRITARION AG

Background information

List of content provided in the ABDA database German SMPC Drug Dictionary

ABDA Database – Medicinal Products

Composition
active ingredients including amount, additives

Classifications

  • ABDATA-indications
  • ATC-Code (German and WHO)

Structure of dosage form
The dosage forms are allocated to certain structures. Therefore, medicinal products can be combined to integrative groups according to certain criteria. It is being differentiated between the aspect „what is within the package? “and structures of application „how is the drug to be applied?“

Storage and durability after opening 
structured data for storage and durability after opening or preparation of a medicinal product

Standard advice sentences

  • application advices and dosage
  • additives
  • pregnancy
  • lactation period

Monograph to finished dosage pharmaceutical products 
comprehensive texts inform on

  • indication
  • contraindication
  • application advices and dosage
  • side effects
  • characteristics
  • stability period and storage
Structure of the information within the SmPC

Information is presented according to a predefined structure. Certain information is suitable in different sections but cross-references are made to avoid repetitive Information.

smpc structure

Source: https://www.ema.europa.eu/en/documents/presentation/presentation-summary-product-characteristics_en.pdf

What is not included in the EMA SmPC?

Detailed information on the scientific development, which is available in

the public assessment report

  • Information in non-approved indication
    • Because the MAH has not claimed the indication
    • An indication has been claimed but data did not demonstrate a positive benefit risk of the medicine; withdrawal or refusal AR provide available data.
    • Exception in the paediatric group; the Paediatric Regulation aims to improve the information regarding this subgroup by providing all information on clinically relevant trials
  • Specific issue for which data is lacking
  • General advice on the treatment of particular medical conditions
Where to find more information?

Related posts

ABDA-Database

Marketing Authorisation Holder Drug Dictionaries (ABDA-Database)The ABDA-database is a facility device for pharmaceutical and medical experts for comprehensive information on original pharmaceutical products and generics available in Germany, Switzerland, Austria and...

Our Databases – Overview

Our Databases: OverviewSince 1989 [pharmazie.com] offers comprehensive information on medication for medical and pharmaceutical experts in at the time 35 databases. Some of these databases are free of a license and costs, others require a license. The tool...

We are here for you

Any left questions?