To address current drug supply gaps, a limited contingent of ibuprofen fever juice in Ukrainian packaging has been launched in Germany. Also, painkillers are currently available in English and French labeling.
Pharmaceutical manufacturer Berlin-Chemie AG has placed about 90,000 packs of Eudorlin (ibuprofen) in suspension sizes of 20 mg/ml and 40 mg/ml in Ukrainian packaging on the German market. The German Federal Office for Drugs and Medical Devices (BfArM) granted an exemption limited until March 31, 2023. It serves “to ensure supply in the pediatric area of application, since ibuprofen-containing fever juices are currently only available in Germany to a limited extent.” This was reported by the Federal Association of German Pharmacists (ABDA).
Eudorlin (ibuprofen) 20 mg/ml suspension is approved for mild to moderate pain and fever in children weighing 5 to 29 kilograms or more. Eudorlin (ibuprofen) 40 mg/ml suspension is approved for mild to moderate pain and fever in children weighing 10 kilograms or more, adolescents, and adults.
Exception due to “critical care situation”
The fever juices have been produced by the company’s regular contract manufacturer and were originally intended for the Ukrainian market. This is said not to jeopardize the continued supply to people in Ukraine. The packaging and bottles are labeled in Ukrainian. According to the company, due to the special situation, no pharmaceutical central number is available and the products are also not listed in the article master of the ABDA. Each delivery is accompanied by an up-to-date information letter in German, which points out the current supply situation. The German instructions for use can be accessed through the letter, in part through QR codes.
Packaging in English and French labeling
Similarly, the pharmaceutical company Walter Ritter GmbH + Co. KG of Hamburg is allowed to put paracetawal 125 mg and 250 mg paracetamol fever suppositories on sale in Germany in English and French packaging for a limited period until March 31, 2023. Paracetawal is approved for mild to moderate pain and fever in children. The market exit of a market participant for paracetamol-containing juice at the beginning of 2022 resulted in a shortage of paracetamol-containing juice in the market, BfArM explains. “The shortage subsequently expanded to include paracetamol-containing suppositories as well as ibuprofen-containing dosage forms for children due to the significant increase in the number of cases of illness.” There is currently a critical supply situation for antipyretic preparations for use in children, he said. The exemption granted is necessary to ensure patient care, he said. The manufacturer must include an up-to-date package insert with each shipment, along with an information letter that indicates the current supply situation.