PROGESTERONE RETARD PHARLON (hydroxyprogesterone caproate), progestin
GYNAECOLOGY - Focus
Opinions on drugs - Posted on Oct 02 2015
Reason for request
Renewal of Inclusion
Moderate actual benefit in threatened preterm labour due to uterine hypermotility.
Insufficient actual benefit in the gynaecological indications and in threatened miscarriage or prevention of recurrent miscarriage from a proven luteal phase defect.
- PROGESTERONE RETARD PHARLON has Marketing Authorisation in gynaecological indications when the parenteral route is essential and in certain obstetrical indications.
- No clinical data on the actual benefit of its use in gynaecology have been identified.
- The only clinical data demonstrating an actual benefit are in the prevention of recurrent preterm labour in single-foetus pregnancies.
Évaluation des médicaments