CRED SMPC 2024

23/09/2024

SmPC guideline

4.1: Therapeutic indications

Defines the target disease and the population where a positive benefit-risk has been demonstrated, specifying age group(s) as appropriate

4.2: Posology and method of administration

Recommended dose(s) in general population and special populations.

Also informs on the method of administration.

4.3: Contra-indications

Situations where the medicinal product must not be given for safety reasons

4.4: Special warnings and precautions for use

• Risks requiring a precaution for use prior or during treatment

• Special patient groups that are at increased risk

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SmPC Guideline

4.5: Interaction with other medicinal products and other forms of interaction

Emphasis on the interactions which result in a recommendation

4.6 Fertility, pregnancy and lactation

Reasons for the recommendations should be provided

4.7 Effects on ability to drive and use machines

On the basis of pharmacodynamics/pharmacokinetic/reported adverse reactions and/or specific studies.

4.8: Undesirable effects

All adverse reactions at least possibly causally related.

Data to be presented in a standard structure in order to provide clear and readily accessible information

The Organisation for Professionals in Regulatory Affairs

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