The clinical particulars - indications, contraindications etc of a medicinal product, including for regulatory purposes.

Describe the undesirable effects of the medicinal product.

The symptom, condition or undesirable effect.

Classification of the effect.

The frequency of occurrence of the effect.

The population group to which this applies.

The age of the specific population.

The gender of the specific population.

Race of the specific population.

The existing physiological conditions of the specific population to which this applies.

Indication for the Medicinal Product.

The disease, symptom or procedure that is the indication for treatment.

The status of the disease or symptom for which the indication applies.

Comorbidity (concurrent condition) or co-infection as part of the indication.

The intended effect, aim or strategy to be achieved by the indication.

Timing or duration information as part of the indication.

Information about the use of the medicinal product in relation to other therapies as part of the indication.

Information about the use of the medicinal product in relation to other therapies described as part of the indication.

The type of relationship between the medicinal product indication or contraindication and another therapy.

Reference to a specific medication (active substance, medicinal product or class of products) as part of an indication or contraindication.

The population group to which this applies.

Contraindication for the medicinal product.

The disease, symptom or procedure for the contraindication.

The status of the disease or symptom for the contraindication.

A comorbidity (concurrent condition) or coinfection.

Information about the use of the medicinal product in relation to other therapies as part of the indication.

Information about the use of the medicinal product in relation to other therapies described as part of the contraindication.

The population group to which this applies.

The interactions of the medicinal product with other medicinal products, or other forms of interactions.

The specific medication, food or laboratory test that interacts.

The type of the interaction.

The effect of the interaction.

The incidence of the interaction.

Actions for managing the interaction.