ABDA Database German SmPC Drug Dictionary

German Fachinformationen and package leaflets for finished medicines. Search structured SmPCs, active ingredients, clinical particulars and ATC codes for more than 58,000 authorised products, updated twice a month.

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Key Benefits
  • All German finished medicines, generics and further product types in one searchable portal
  • Structured SmPC content instead of scattered PDF leaflets
  • Marketing Authorisation Holder contact and registration data at hand
  • ATC codes in German and WHO notation for reliable classification
  • Updated twice a month by ABDATA Pharma-Daten-Service

What the ABDA Database German SmPC Drug Dictionary covers

The ABDA Database German SmPC Drug Dictionary lists structured information on original pharmaceutical products and generics available in Germany, Switzerland, Austria and further countries. It brings together the Summaries of Product Characteristics (SmPCs) of the different Marketing Authorisation Holders in one searchable resource.

  • Contact and registration details of Marketing Authorisation Holders (MAH) in Germany
  • Marketing Authorisation Holders for more than 58,000 registered medicinal products in Germany
  • Active ingredients with their pharmacological and toxicological information
  • Clinical particulars such as interactions, adverse reactions and contraindications

The Marketing Authorisation Holder Drug Dictionaries are updated twice a month.

What does SmPC stand for?

The Summary of Product Characteristics (SPC or SmPC) is a document required within the European Commission before a medicinal product is authorised for marketing. It describes how the product should be used and reflects the agreed position reached during the assessment process.

What the database contains

  • Composition: active ingredients including amount and additives
  • Classifications: ABDATA indications and ATC code (German and WHO)
  • Structure of dosage form, allowing medicinal products to be combined into integrative groups according to defined criteria
  • Storage and durability, including durability after opening or preparation
  • Standard advice sentences for application and dosage, additives, pregnancy and lactation
  • Monographs on finished medicinal products covering indication, contraindication, application and dosage, side effects, characteristics, stability and storage

Highlights of this database

Structured, searchable Fachinformationen

Every Summary of Product Characteristics follows a predefined structure, so indications, contraindications, dosage and side effects sit in consistent, machine-readable sections rather than free text.

  • Indications and contraindications
  • Dosage and application advice
  • Side effects and characteristics

Marketing Authorisation Holder data

Look up the Marketing Authorisation Holders behind more than 58,000 registered medicinal products in Germany, including their contact and registration details.

  • MAH contact details
  • Registration data per product
  • Authorised markets across DACH and beyond

Composition and classification

Each entry documents active ingredients, additives and derivatives, classified with ABDATA indications and ATC codes in both German and WHO notation.

  • Active ingredients, additives and amounts
  • ABDATA indications
  • ATC code (German and WHO)

Dosage forms, storage and monographs

Dosage forms are allocated to defined structures so products can be grouped by shared criteria. Detailed monographs add storage conditions and durability after opening or preparation.

  • Dosage form structure and integrative groups
  • Storage and durability after opening
  • Standard advice sentences for pregnancy, lactation and warnings

More background information

Summaries of Product Characteristics are the regulatory backbone of every finished medicine, yet the information is scattered across thousands of individual documents in different formats. A structured drug dictionary turns those documents into a single searchable source that professionals can query by product, active ingredient or Marketing Authorisation Holder.

Structure of a German SmPC (Fachinformation)
How the SmPC information is prepared

How SmPC information is structured

Information is presented according to a predefined structure. Certain details are relevant in more than one section, so cross-references are used instead of repeating the same text. This keeps each SmPC consistent and comparable across products and manufacturers.

What an EMA SmPC does not include

An SmPC deliberately leaves out some material. Detailed scientific development data lives in the public assessment report. Non-approved indications are omitted where the Marketing Authorisation Holder has not claimed them or where the data did not demonstrate a positive benefit-risk balance. Specific issues without supporting data and general advice on treating particular medical conditions are also excluded.

How the data is prepared

The dictionary is compiled by ABDATA Pharma-Daten-Service and refreshed twice a month. Composition, classification, dosage form structure, storage and durability, standard advice sentences and full monographs are maintained as structured fields, so the content stays queryable rather than locked inside PDF leaflets.

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