Actavis welcomes the announcement that a pharmacy licence for azithromycin has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The successful application relates to the pharmacy licence for Clamelle Azithromycin 500mg Tablets.
Actavis UK Ltd applied to switch azithromycin tablets from prescription-only to pharmacy status. Clamelle will be the first oral antibiotic available from a pharmacist without a doctor’s prescription.
Clamelle is indicated for the treatment of individuals with confirmed asymptomatic Chlamydia trachomatis genital infection and for the treatment of their sexual partners. The dosage is two tablets taken together as a single dose.
Clamelle will be available for people 16 years and over if they have tested positive for the infection and have no symptoms, and for their sexual partners. Individuals will be able to obtain over the counter (OTC) Clamelle from participating pharmacies following confirmation of diagnosis and a thorough consultation with the pharmacist, and without a prescription from their GP or GUM clinic.
Sara Vincent, Country Manager, Actavis UK:
“We are delighted to have been granted a pharmacy licence for Clamelle. This successful application is in line with Actavis UK’s programme of POM to P switches*, which is running in parallel with the expansion of the OTC brand portfolio through organic growth and strategic acquisitions.”
Actavis UK Ltd is now developing pharmacy training materials and launch plans for Clamelle, as well as a Clamelle-branded chlamydia test kit.
*POM to P: Prescription Only Medicine to Pharmacy (OTC).