Spring Intro 2023

03/03/2023

Probably the most difficult section for Toxicologists to agree on!! The following should be mentioned: Facts on human experience and conclusions from nonclinical toxicity study which are of relevance for the assessment of risks associated with exposure during pregnancy. Recommendations on the use of the medicinal product at different times during pregnancy in respect of gestation. Section 4.6 - Pregnancy and Lactation

47

Section 4.6 - Pregnancy and Lactation

Information on excretion of the active substance and/or its metabolite(s) in milk should be given. Recommendations on whether to stop or continue breast-feeding should be given. Information regarding fertility should also be given in Sections 4.3 (Contra Indications), 4.4 (Special Warnings), 4.8 (Undesirable Effects) or 5.3 (nonclinical Safety Data) as Appropriate.

48