Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
The clinical pharmacology and the absorption, distribution, metabolism and excretion of norethisterone and its ester derivates are well characterized as described in the current label of approved drugs.
Type of information:
experimental study
Adequacy of study:
other information

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Norethisterone
EC Number:
200-681-6
EC Name:
Norethisterone
Cas Number:
68-22-4
Molecular formula:
C20H26O2
IUPAC Name:
17-ethynyl-17-hydroxyestr-4-en-3-one

Results and discussion

Applicant's summary and conclusion

Conclusions:
The clinical pharmacology and the absorption, distribution, metabolism and excretion of norethisterone and its ester derivates are well characterized as described in the current label of approved drugs.