A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

Inclusion Criteria:

• Participant is less than 9 years old for girls and less than 10 years old for boysat initiation of triptorelin treatment or at the time of signing the informedconsent.

• Participant must present evidence of CPP documented by:

• Onset of development of secondary sex characteristics (breast development in girlsor testicular enlargement in boys according to the Tanner method: Stage II) beforethe age of 8 years in girls and 9 years in boys.

• Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥6 IU/L) inboth sexes.

• Difference between bone age (BA) and CA >1 year.

• Girls with Tanner staging ≥2 for breast development and who have enlarged uterinelength and/or ovarian volume and at last 2 follicles with diameter >4 mm in theovary observed by pelvic type B ultrasound at the Screening visit; boys who havetesticular volume ≥4 mL observed by testicular orchidometer at the Screening visit.

• Girls who have already had menophania/menarche must have a negative highly sensitive (urine) pregnancy test as required by local regulations within 24 hours before thefirst dose of study intervention and should not be at risk of pregnancy throughoutthe study period.

Exclusion Criteria:

• Gonadotropin-independent (peripheral) precocious puberty: extrapituitary secretionof gonadotropins or gonadotropin-independent gonadal or adrenal sex steroidsecretion.

• Non-progressing isolated premature thelarche.

• Presence of an unstable intracranial tumour or an intracranial tumour requiringneurosurgery or cerebral irradiation. Participants with hamartomas not requiringsurgery are eligible.

• Prior or current therapy with a GnRHa (Gonadotropin-releasing Hormone Agonist) ,medroxyprogesterone acetate, growth hormone or insulin-like growth factor 1 (IGF 1).Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks priorto the Screening visit.