A popular drug suspended from circulation. GIF informs about the risk to patients

These are Konaten (Atomoxetinum) hard capsules. It is used to treat children (over 6 years of age), adolescents and adults with attention deficit hyperactivity disorder (ADHD). It complements psychological therapy and psychoeducation. The Chief Pharmaceutical Inspector issued a statement after receiving information from the drug manufacturer about incorrect results of tests carried out in some batches of the preparation.

Konaten (Atomoxetinum) – GIF decision

In his announcement, the Chief Pharmaceutical Inspector provided details about the suspended drug for ADHD patients:

Konaten (Atomoxetinum), hard capsules, 10 mg, pack of 28 capsules

• GTIN 05909991390938,

• batch number: 1304010, expiry date: 28/02/2026,

• batch number: 1311190, expiration date: October 31, 2026,

• batch number: 1311191, expiration date: October 31, 2026.

Konaten (Atomoxetinum), hard capsules, 18 mg, pack of 28 capsules

• GTIN 05909991390952,

• batch number: 1400775, expiration date: November 30, 2026,

• batch number: 1400776, expiration date: November 30, 2026.

Konaten (Atomoxetinum), hard capsules, 25 mg, pack of 28 capsules

• GTIN 05909991390976,

• batch number: 1211303, expiry date 30/06/2025.

Konaten (Atomoxetinum), hard capsules, 40 mg, pack of 28 capsules

• GTIN 05909991390990,

• series number: 1310715, expiration date: October 31, 2026.

The responsible entity is neuraxpharm Arzneimittel GmbH based in Germany. The decision of the Chief Pharmaceutical Inspector applies to the entire country. It was made immediately enforceable.

Why did GIF suspend the sale of ADHD medicine?

“The ground for suspending trade in the above-mentioned batch of a medicinal product there is (…) a justified suspicion that it does not meet the quality requirements established for it. However, the information provided by the representative of the MAH to the Chief Pharmaceutical Inspector indicates that there are justified doubts as to the quality of specific batches of the medicinal product indicated above,” we read in the justification of the decision of the Chief Pharmaceutical Inspector. Konaten does not meet the quality requirements in terms of parameters such as active substance content and mass uniformity.