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Itions with risk of death, or for other products, such as contraceptives and vaccines. Although this type of event should not necessarily be included in line listings, such findings should be discussed in the PPR (see section 2.8), when clinically relevant. In addition, data on exposure or adverse events during pregnancy or lactation should be discussed in the PPR. The PPR is also an important tool for the marketing authorization holders to carry out systematic analyses on a regular basis, with.

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