BfArM - Federal Institute for Drugs and Medical Devices

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Oral and rectal dosage forms of antiemetic agents containing dimenhydrinate and diphenhydramine for children up to the age of 3 years

Active substance: dimenhydrinate | diphenhydramine

The Federal Institute for Drugs and Medical Devices (BfArM) issues information on the conclusion of the graduated plan procedure ("Stufenplanverfahren") regarding the use of oral and rectal antiemetic agents containing dimenhydrinate/diphenhydramine in children under the age of three years.

To the risk assessment procedure (available in German only)

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