Kontrollerede studier med ACE- hæmmere er ikke gennemført på mennesker, men i et begrænset antal tilfælde af brug i første trimester synes der ikke at have været nogen misdannelser, der kan forenes med human fosterforgiftning som beskrevet nedenfor.
After an assessment of the documentation provided by the MAH and an evaluation of the current EU- wide clinical practices relating to the use of COVERSYL, the following was considered to be the most suitable harmonised Section 4.3 Contraindications text: • Hypersensitivity to perindopril, to any of the excipients or to any other ACE inhibitor; • History of angioedema associated with previous ACE inhibitor therapy; • Hereditary or idiopathic angioedema; • Second and third trimesters of pregnancy (see 4.6 “ Pregnancy and lactation”).