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TL;DRAn active substance dossier, in German Wirkstoffdossier, is a structured clinical and pharmacological reference organised around an active substance rather than around a single product. It compiles the properties, pharmacology, dosing, undesirable effects and approved uses of a substance across all the medicines that contain it.
The distinction from product-level information is the whole point. A medicine's SmPC (Fachinformation) describes one authorised product from one marketing authorisation holder. An active substance dossier steps up one level: it looks at the substance itself, independent of the medicines it appears in, and pulls together what is known about it regardless of brand, pack or manufacturer. As ABDATA describes the module, the focus is on the active substance, independent of the medicinal products in which it is contained.
That difference in altitude is exactly what makes the dossier practical. When a substance appears in dozens of products from different manufacturers, the pharmacology, the interactions and the dosing logic do not change from brand to brand. Holding that knowledge once, at the substance level, means a professional can answer a clinical question without opening the product information of every single medicine that contains the ingredient, and without losing detail that a single product text would never carry.
A dossier is not a single text but a set of topic documents, each answerable on its own. For ibuprofen the platform carries around forty dossiers across all salt forms, and each opens into consultation views built for a specific question, for example paediatric use or overdose. The recurring sub-documents are these.
| Sub-document | What it answers |
|---|---|
| Eigenschaften (properties, pharmacology) | Mechanism, pharmacodynamics and pharmacokinetic parameters such as plasma concentrations and elimination half-lives |
| Unerwünschte Wirkungen | Undesirable effects of the substance |
| Dosierung and Paediatrie | Dosing across age and weight groups, with a dedicated paediatric view |
| Reproduktion | Pregnancy and lactation |
| Überdosierung / Intoxikation | Overdose and poisoning management |
| Krankenhausapotheke | Hospital pharmacy specific information |
| Heilberufsberatung and Patientenberatung | Counselling content for professionals and for self-medication or prescription dispensing |
Around these sit the head fields: the sites of application, the application groups from premature infants to seniors and to nursing mothers, effects on the ability to react, and dependence risk. Two keyword classes are attached: general keywords for the pharmacological classes, for example NSAID, COX inhibitor and antipyretic, and secured indications, a granular list of around one hundred approved uses.
The depth is what makes the dossier useful at the point of a question. For anti-infectives it records the antimicrobial spectrum, which supports the choice of an appropriate agent. For substances that need monitoring it carries pharmacokinetic parameters such as therapeutic plasma concentrations and elimination half-lives, the figures behind therapeutic drug monitoring. The topic-specific consultation views mean a hospital pharmacist checking an overdose and a community pharmacist advising on self-medication reach different, purpose-built sections of the same underlying dossier.
They answer different questions, and it is worth being precise, because reaching for the wrong one wastes time.
Because the dossier is organised by substance, it lines up naturally with the substance-level classification. The ATC code groups the active substance by the organ system it acts on and its chemical class, and the dossier holds the clinical detail behind that classification. The dossier also lists every salt form of the substance, for ibuprofen the lysine, sodium, arginine and further salts, so that data attached to one salt form is not lost when a product uses another.
The dossiers are one of the connected ABDA databases, searchable on their own or through the parallel search across the platform.
One honest limitation: the active substance dossier is a clinical-pharmacological reference, not the legally binding product information. Where the exact authorised wording matters, for a specific indication, warning or dose, the SmPC of the individual product is the authoritative text, and the dossier supplies the substance-level context around it.
