Biznes Fakty
Atorvastatin Medical Valley – all batches of the drug suspended from sale
The Chief Pharmaceutical Inspectorate has halted the nationwide distribution of Atorvastatin Medical Valley, a medication designed for patients with high blood cholesterol and triglyceride levels. „This product fails to meet the necessary quality standards,” states the announcement from the Chief Pharmaceutical Inspectorate (GIF).
The Chief Pharmaceutical Inspectorate announced on Tuesday the suspension of the nationwide distribution of the medicinal product Atorvastatin Medical Valley (Atorvastatinum), 40 mg, film-coated tablets, in a package of 30 tablets, GTIN number 05909991501662; the marketing authorization holder is Medical Valley Invest AB, located in Höllviken, Sweden; marketing authorization number: 27496.
This decision pertains to all batches of the medication and is effective immediately.
Atorvastatin Medical Valley is classified as a statin, a category of substances that manage lipid metabolism within the body. It is intended for patients with elevated blood cholesterol and triglyceride levels.
Adverse test findings
The rationale for this decision was based on the unfavorable outcome of quality assessments performed by the National Institute of Medicines, which revealed discrepancies in the tablets’ appearance.
GIF clarified that the trade suspension of a medicinal product arises from a justifiable suspicion that it does not fulfill the designated standards.
„On June 27, 2025, the Chief Pharmaceutical Inspector received notification from the National Institute of Medicines regarding an out-of-specification result related to the appearance parameter, accompanied by photographic evidence. Subsequently, on June 30, 2025, the Chief Pharmaceutical Inspector received a report from a test conducted by the National Institute of Medicines on a sample of the medicinal product provided by the marketing authorization holder. It was indicated (…) that this product does not satisfy the quality criteria due to a negative test result for the appearance parameter,” reads part of the justification.
The trading suspension is precautionary in nature. The manufacturer retains the right to reassess the situation or to appeal to the administrative court, but the decision is enforceable immediately.
