Part 17Indications relating to pregnancy

Part 17—Indications relating to pregnancy

 

• Indications relating to pregnancy
• 1 Aid/assist healthy thyroid hormone production for pregnancy Scientific Indication can only be used for medicines that contain iodine as a mandatory component of one or more permitted active ingredients and the recommended daily dose of the medicine provides a minimum of 150 micrograms of iodine.

Label statement: If you have pre-existing thyroid conditions, seek advice from your medical practitioner before taking this medicine.

Product presentation must not imply or refer to any thyroid related diseases.

• 2 Aid/assist prepare uterus for childbirth Traditional Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.
• 3 Decrease/reduce/relieve morning sickness Scientific or Traditional Product presentation must not imply or refer to severe morning sickness such as hyperemesis gravidarum

Label statement: If symptoms persist or worsen talk to your medical practitioner.

• 4 Enhance/promote healthy foetal development Scientific Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.
• 5 Help to prevent neural tube defects such as spina bifida and/or anencephaly Scientific Indication can only be used for medicines that contain folic acid as an active ingredient and the recommended daily dose of the medicine provides a minimum of 400 micrograms of folic acid.

Product presentation referring to the prevention of neural tube defects must include at least one of the following label statements: when trying to conceive and during the first trimester of pregnancy, and/or when taken at least four weeks before conception and during the first trimester of pregnancy.

If directed to women, Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

• 6 Helps enhance/promote maternal health Scientific or Traditional Label statement: If you are concerned about the health of yourself or your baby, talk to your health practitioner.

If directed to women, Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

• 7 Helps enhance/promote preconception health Scientific or Traditional If directed to women, Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.

• 8 Helps maintains/support healthy foetal CNS/brain development Scientific Label statement: Advise your doctor of any medicine you take during pregnancy, particularly in your first trimester.