Module 6

04/10/2024

Foundations of an SmPC

Source: EMA SmPC training presentation, 2013

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Scenarios when SmPCs may be useful…..

Royal Pharmaceutical Association Guidance…..

⚫ A patient has just bought a medication over the counter and wants to know if it is safe to use whilst breastfeeding. Section 4.6 ⚫ A patient wants to know if a particular prescribed medication has an excipient that she knows is derived from animals. Section 6.1

⚫ A patient wants to know how long a prescribed cream can be used for after opening it. Section 6.3

⚫ A nurse on the ward asks you how to administer an intravenous medicine. Section 4.2

⚫ A doctor calls and states a patient only needs half a tablet daily and wants to check if the tablet can be halved. Section 3

⚫ A nurse wants to know whether a specific tablet can be crushed for administration through a feeding tube. Section 4.2

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