A pill used by many Romanians has been withdrawn from the market by the National Medicines Agency.
Popular drug withdrawn from market – Photo Shutterstock
Produced in Romania, the medicine Paduden Express Forte 400 mg soft capsules, manufactured by Terapia SA, has been withdrawn from the market, ProTV News reports.
On February 22, 2024, the European Medicines Agency (EMA) concluded an in-depth evaluation of Ibuprofen NVT 400 mg soft capsules, following a conflict of opinion between the member states of the European Union regarding their authorization.
Laboratorios Liconsa SA, a Spanish company, applied for recognition of the marketing authorization for Ibuprofen NVT 400 mg, which had been granted in Lithuania on June 8, 2022, in Spain. However, the member states failed to reach a consensus and the Medicines Regulatory Agency of Lithuania referred the case to the EMA for arbitration on 17 November 2023.
The Spanish authorities concluded that Ibuprofen NVT 400 mg is not bioequivalent to the reference medicine. Bioequivalence means that the active substances in both drugs are absorbed into the body at the same rate and in the same amount.
“The Agency (EMA) concluded that the benefits of Ibuprofen NVT 400 mg do not outweigh the risks and the marketing authorization granted in Lithuania cannot be recognized in Spain, where the company applied for a marketing authorisation. In addition, marketing authorizations in Lithuania and other Member States where the medicine is authorized (Estonia, France, Latvia, Poland and Romania) should be suspended“, transmitted the EMA.
Ibuprofen NVT is a type of pain reliever and anti-inflammatory that belongs to the class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs).
This is a generic medicine, which means that it has been developed to contain the same active substance and to have the same mode of action as a “reference medicine” already authorized in the EU, in this case Nurofen Rapid 400 mg soft capsules .
Seven drugs sold in Romania, including Posaconazole, Ibuprofen Nutra Essential, Loperamide, Tadalafil (20 mg and 5 mg) and Erlotinib (100 mg and 150 mg), could have their marketing authorization suspended. These medicines, produced in India, were found non-compliant by the experts of the European Medicines Agency. The European Commission requested the withdrawal of the authorizations in view of previous concerns about the quality and safety of medicines originating in India. Some pills made in India have even led to deaths in the past.
