Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: clinical data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Approved drug with widespread therapeutic use for many years

Data source

Materials and methods

Study type:
human medical data
Endpoint addressed:
basic toxicokinetics
dermal absorption
acute toxicity: oral
acute toxicity: dermal
skin irritation / corrosion
eye irritation
repeated dose toxicity: oral
repeated dose toxicity: dermal
genetic toxicity
carcinogenicity
toxicity to reproduction / fertility
developmental toxicity / teratogenicity

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results:
Norethisterone is an exogenous sex hormone and active ingredient of approved drugs since several decades. Norethisterone belongs to the category “progestin/progesteron”. Norethisterone has progestogenic properties resembling those of the naturally occuring progesterone but is a more potent inhibitor of ovulation. Norethisterone and norethisterone enanthate/acetate are widely used for oral contraception and in hormon replacement therapy for many years. Therefore a wide base of clinical experience is available pointing out various types of effects.

Applicant's summary and conclusion