AEMPS CIMA

This application includes all medicinal products authorized in Spain and its purpose is to provide information on each of them. Drugs whose marketing authorizations were revoked, remain for information 5. For those drugs whose authorization has been suspended temporarily remain in suspension. There may be a lag between the emergence of this new situation in CIMA and the date has been effective the new situation of the authorization.

Among many other data, and most important by collecting the terms of use of medicines authorized documents, the application provides access to the data sheet (or summary of product characteristics) and leaflets.

The data sheet is a document containing the description of the drug, its indications, dosage, contraindications and precautions, adverse reactions, pharmaceutical data and properties of the drug.

This document is the result of scientific and technical performs Spanish Agency for Medicines and Health Products for all the scientific information submitted by holders of applications for approval of drug evaluation. The sheet is part of the authorization granted to the Agency a drug.

The content of the technical specifications is updated during the marketing of the drug in order to include the new information becomes available, always with new evaluation and approval by the Agency.

The data sheet is exclusively directed to the health professional.

For patients and other users, the application provides access to the latest approved version of the prospectus, which is the document that is included in the box of medicine and whose purpose is to inform the patient.

The electronic publication of factsheets and leaflets responds to our desire to provide health professionals and other citizens, respectively, the official information about medications.

The Spanish Agency for Medicines and Health Products can not be held responsible for illegal, improper, or manipulation of the content and information of this computer application use. The access to this application, and the use made of the information and content thereof, shall be the sole responsibility of the person performing.

AVAILABLE INFORMATION

This application contains the information of medicinal products authorized in Spain in order to be a valuable tool to use correctly.

 For each drug the following information and documents are included:

 • Name of medication

• Name of the active substance

• Name of the holder of the marketing authorization

• National Code

• Registration

• Date of approval

• Name of the presentation

• Status of submission: Authorized / temporarily suspended / revoked

Details on the conditions of prescription and use

• Need recipe and type

• Driving Pictogram warning

• Datasheet (health professionals)

• Prospect (non-health citizens)