Public Assessment Report of the Reclassification of Almerg 180mg film-coated tablets
This PAR covers the assessment of an application to reclassify Almerg 180mg film-coated tablets from Prescription Only Medicine (POM) to Pharmacy (P) medicine.
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Almerg 180mg film-coated tablets can be used for the relief of symptoms associated with chronic idiopathic urticaria (CIU) in adults and children aged 12 years and over. Urticaria, also known as hives, includes swellings (wheals) that appear as a raised, itchy rash on the skin which are usually pink or red, with an oval or round shape. It is classed as chronic when the rash persists or comes and goes for more than 6 weeks, often over many years.
Each tablet contains 180 milligrams of fexofenadine hydrochloride.
The licence holder, Cipla (EU) Limited, applied to change the legal status of this product from Prescription Only Medicine (POM) to a Pharmacy (P) medicine (see Background for definition). A licence holder or marketing authorisation holder is the company with legal authorisation to make the medicine available to patients.
The Medicines and Healthcare Products Regulatory Agency (MHRA) considers this product sufficiently safe to be sold as a pharmacy medicine. This report outlines the evidence that the MHRA reviewed and which led to the decision to approve the application.