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Article Name - Importance of Information on Excipients with a Known Action or Effect in the Package Leaflet and an Oversight of the Situation in Albania

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  • Keywords Excipients; Adverse reactions; Regulatory landscape; Package leaflet; Observational study; Patient safety ... 2025-08-08
  • Introduction Pharmaceutical dosage forms contain both pharmacologically active compounds and excipients added to aid the formulation and manufacture of the subsequent dosage form for administration to patients [1] ... 2025-08-08
  • Literature Review In Albania, by law, medicinal products from the following countries can be registered and sold in the market: Albania (domestic products). EU member states, USA, Canada, Turkey, Switzerland, I ... 2025-08-08
  • Discussion Due to the fact that some of the companies whose products were included in this observation, have an obligation in their countries to comply with the requirement for providing in the leaflets the appr ... 2025-08-08
  • Conclusion The excipients in drug formulations have been described as inert because they do not have an active role in the prevention or treatment of particular ailments. This has led to the misconception among ... 2025-08-08
  • Limitations The limitations encountered during the study were that the Competent Authorities of Serbia and Israel did not answer through email. In the documents published in their websites, nothing available in E ... 2025-08-08
  • References Rowe RC, Sheskey PJ, Owen SC. Handbook of Pharmaceutical Excipients, Fifth Edition, 2006. Soremekun R, Ogbuefi I, Aderemi-Williams R. Prevalence of ethanol and other potentially harmful excipient ... 2025-09-09