The GCC Guidance for Presenting the SPC, PIL and Labeling ...

Appendix 3: Pregnancy statements1.- {Generic name} causes/is suspected to cause serious birth defects when administeredduring pregnancy.- {Trade name} is contraindicated (only in case of a strict contraindication see section 4.3)in pregnancy.and if necessary- Women of childbearing potential have to use effective contraception during (and up to xweeks after) treatment.2.- {Generic name} has harmful pharmacological effects on pregnancy and/or thefoetus/newborn child.- {Trade name} should not be used during pregnancy unless clearly necessary (thesecircumstances should be specified).3.- There are no adequate data from the use of {Generic name} in pregnant women.- Studies in animals have shown reproductive toxicity (see section 5.3). The potential riskfor humans is unknown.or- Animal studies are insufficient with respect to effects on pregnancy /and-or/embryonal/foetal development/ and-or/ parturition/ and-or/ postnatal development (seesection 5.3). The potential risk for humans is unknown.- {Trade name} should not be used during pregnancy unless clearly necessary (thesecircumstances should be specified where possible).Page 32 of 52