German SmPCs / Rote Liste

The Rote Liste is a drug directory for Germany. It contains short information on human medicinal products marketed in Germany (including EU authorisations) and certain medical devices, compiled for professional, usage and product information.

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Key Benefits
  • Legally grounded short texts based on the prescribing information for the German market
  • Short texts based on the Summaries of Product Characteristics for human medicinal products, including EU approvals
  • Listed by the European Medicines Agency among the national registers of authorised medicines for Germany
  • Refreshed twice a year
  • Searchable together with 25+ pharmaceutical databases in one query on pharmazie.com

German SmPCs / Rote Liste in a nutshell

The German SmPCs / Rote Liste dataset provides legally grounded drug information for the German market. It compiles short texts based on the Summaries of Product Characteristics (SmPCs), the professional prescribing information known in Germany as Fachinformation, together with indication data for human finished medicinal products marketed in Germany. Coverage includes products with EU approvals as well as selected medical devices.

The dataset is aimed strictly at medical and pharmaceutical professionals: physicians, pharmacists, hospital staff, nursing teams and pharmaceutical-technical assistants who need concise, structured information on the medicines available in Germany.

What the dataset contains

  • Statutory data on German medicinal products
  • Short texts based on the Summaries of Product Characteristics (SmPCs / Fachinformationen)
  • Short informational texts per product
  • Indication data

How products are included

Inclusion is registration based. A pharmaceutical company must actively register its products to have them listed. Products that are not registered do not appear, so the dataset reflects the information that manufacturers have submitted for publication.

Access on pharmazie.com

On pharmazie.com the German SmPCs / Rote Liste dataset is searchable alongside more than 25 pharmaceutical databases in a single query. Access is included with the Drug Dictionaries and Premium subscription packages.

Highlights of this database

Short texts based on the Summaries of Product Characteristics

Access the professional prescribing information (Fachinformation) that underpins clinical and regulatory decisions in Germany.

  • Indications, dosage and administration
  • Contraindications and interactions
  • Adverse reactions and warnings

Legally grounded German drug data

The dataset focuses on statutory information for medicinal products marketed in Germany.

  • Human finished medicinal products
  • Products with EU approvals
  • Selected medical devices

Structured indication data

Indication information supports search, filtering and therapeutic look-up across the German product range.

  • Rote Liste indication groups
  • Short informational texts per product
  • Consistent structure for professional use

Part of one unified search

On pharmazie.com the dataset sits next to more than 25 pharmaceutical databases, so professionals move from one source to the next without switching tools.

  • Single query across databases
  • Included in Drug Dictionaries and Premium packages
  • Refreshed twice a year

More background information

Drug information in Germany is spread across several authoritative sources, each with its own scope, update cycle and licensing terms. Professionals who need a complete picture of a medicinal product often have to reconcile prescribing information, statutory data and identifiers from more than one place. The German SmPCs / Rote Liste dataset addresses one part of that picture: the professional prescribing information for products marketed in Germany.

Why prescribing information matters

The Summary of Product Characteristics is the reference document for a medicine's approved use. It sets out indications, dosage, contraindications, interactions and adverse reactions. For physicians, pharmacists and hospital teams it is the basis for safe prescribing and dispensing, and for regulatory and market-access teams it is a primary source when assessing a product.

Registration-based coverage

Because inclusion depends on the manufacturer registering its products, the dataset reflects what companies have chosen to publish. Understanding this helps professionals interpret gaps: an absent product is not necessarily unavailable, it may simply not be registered for listing.

A recognised national source

The European Medicines Agency lists the source among the national registers of authorised medicines for Germany, which makes it a well established reference point for German drug information.

How it fits on pharmazie.com

On pharmazie.com the dataset is one of more than 25 databases available through a single search, so prescribing information can be combined with other pharmaceutical data in one workflow. Access is included with the Drug Dictionaries and Premium packages, and the data is refreshed twice a year.

Questions about this database

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