Pregnancy Category - Germany

Germany

Category Description
Gr 1 Extensive human tests and animal studies have not shown the drug to be embryotoxic/teratogenic.
Gr 2 Extensive human tests of the drug have not shown the drug to be embryotoxic/teratogenic.
Gr 3 Extensive human tests of the drug have not shown the drug to be embryotoxic/teratogenic. However, the drug appears to be embryotoxic/teratogenic in animals.
Gr 4 No adequate and well-controlled studies of the drug's effects on humans are available. Animal studies have shown no embryotoxic/teratogenic effects.
Gr 5 No adequate and well-controlled studies of the drug's effects on humans are available.
Gr 6 No adequate and well-controlled studies of the drug's effects on humans are available. Animal studies have shown embryotoxic/teratogenic effects.
Gr 7 There is a risk that the drug is embryotoxic / teratogenic in humans, at least in the first trimester.
Gr 8 There is a risk that the drug is toxic to fetuses throughout the second and third trimesters.
Gr 9 There is a risk that the drug causes prenatal complications or abnormalities.
Gr 10 There is a risk that the drug causes hormone specific action on the human fetus.
Gr 11 There is a known risk that the drug is a mutagen/carcinogen.

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