CRED SMPC 2024

Benefit information

• Reinforces the value of taking a medicine

• Provides context for ‘negative’ risk information

•

prescription medicines

• preventative medicines: when the patient is asymptomatic • long-term treatments

• Short non-promotional statement at the beginning of the PIL

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Extra-statutory Information

“The PIL may include . . . other information compatible with the SPC which is useful for the patient , to the exclusion of any element of a promotional nature”

This allows extra-statutory information in the PIL:

•

explanation of the benefits

• access to support services e.g. patient groups

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