lääkeainetiivistelmä

Lääkeainetiivistelmä, often translated as "Summary of Medicinal Product Properties" or "Active Substance Summary," is a crucial document in the regulatory process for pharmaceuticals in Finland and other European Union member states. It provides a concise overview of the essential information pertaining to a specific medicinal product.

The primary purpose of a lääkeainetiivistelmä is to inform healthcare professionals, such as doctors and pharmacists, about the characteristics of a drug. This includes details about its composition, what it is used for (indications), how it should be administered (dosage and administration), and any contraindications or precautions. It also outlines potential side effects, the mechanism of action, pharmacokinetic properties, and any relevant information regarding its use in specific populations like pregnant women or the elderly.

This document is an integral part of the marketing authorization application for a medicinal product. Regulatory authorities, like the Finnish Medicines Agency (Fimea), review and approve the lääkeainetiivistelmä as part of the overall assessment of the drug's safety, efficacy, and quality. It serves as a standardized and reliable source of information, ensuring that healthcare providers have access to the most important data needed for safe and effective prescribing and dispensing of medicines. The content of the lääkeainetiivistelmä is legally binding and must accurately reflect the approved properties of the medicinal product.