AEMPS CIMA 1.0.1

This application includes all medicines authorized in Spain and its purpose is to provide information about each one of them. Medicines whose marketing authorizations have been revoked are kept for informational purposes for 5 years. In the case of medicines with temporarily suspended authorizations, they are maintained during the suspension. There may be a gap between the appearance of this new situation in CIMA and the date when the new authorization situation became effective.

Among many other data, and as the most important documents for capturing the authorized conditions of use of medicines, the application offers access to the technical data sheet (or summary of product characteristics) and the leaflets.

The technical data sheet is the document that includes the description of the medicine, its indications, dosage, precautions and contraindications, adverse reactions, pharmaceutical data, and properties of the medicine.

This document is the result of the scientific-technical evaluation carried out by the Spanish Agency of Medicines and Medical Devices on all scientific information submitted by holders of medicine authorization applications. The technical data sheet is part of the authorization granted by the Agency for a medicine.

The content of technical data sheets is updated during the commercialization period of the medicine to include new information becoming available, always with new evaluation and authorization by the Agency.

The technical data sheet is exclusively intended for healthcare professionals.

For patients and other users, the application provides access to the latest version of the authorized leaflet, which is the document included inside the medicine box and aims to inform the patient.

The electronic publication of technical data sheets and leaflets responds to our desire to provide healthcare professionals and other citizens with official information about medicines.

The Spanish Agency of Medicines and Medical Devices is not responsible for illegal, improper use, or manipulation of the content and information in this software application. Both access to this application and the use that may be made of its information and content will be the sole responsibility of the user.

AVAILABLE INFORMATION
This application contains information on medicines authorized in Spain with the aim of being a valuable tool for their correct use.
For each medicine, the following data and documents are included:
• Name of the medicine
• Name of active ingredient(s)
• Name of marketing authorization holder
• National code
• Registration number
• Authorization date
• Presentation name
• Presentation status: authorized/temporarily suspended/revoked
Data on prescription and use conditions:
• Prescription requirement and type
• Warning symbol for driving
• Technical data sheet (healthcare professionals)
• Leaflet (non-healthcare citizens)