Clenil Modulite 100mcg – additional batches released

Clenil Modulite 100mcg – additional batches released

May 12, 2020

To help address the current increased demand of Clenil Modulite 100mcg (beclometasone), Chiesi are releasing additional batches into the UK supply chain following authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) for a batch-specific variation. The first seven batches are expected to be in circulation from 11th May 2020. Further batches will be released over the coming months to address the increase in demand.

The batch numbers authorised by MHRA for release are: 1112190, 1112214, 1112215, 1112217, 1112218, 1112219

Key points related to the batch variation

  • These inhalers contain the same active ingredient, beclometasone; no changes are needed to the prescription or the way patients manage their asthma.
  • Drug is delivered by the same inhaler device (pressurised metered dose inhaler, pMDI)
  • The main changes relate to the product appearance: on the new batches the actuator is beige and the cap is yellow, instead of brown and beige, respectively on the original version.

  • The beige actuator is not embossed
  • There is no dose indicator on the new batches
  • There are no differences to the safety profile (adverse effects) of the drug
  • When dispensing the product, healthcare professionals should carefully check the dosage written on the labelling on the package due to the similarities in colour with Clenil 50mcg inhaler.
  • As usual, patients should be recommended to keep track of when they started using the inhaler as there is no dose indicator; at the usual recommended dose the inhaler will last over a month.
  • The Clenil inhalers are compatible with a Volumatic Spacer Device.
  • Patients should be reminded of the importance of cleaning their inhaler once a week

Chiesi advise that – ‘We continue to work closely with all stakeholders involved to respond to this unprecedented increase in demand as best and as efficiently as possible. This includes working hard to manage supply, consistently releasing stock weekly at average demand levels to supply the wholesalers. We expect continued stock deliveries over the coming weeks and months, and we have good stock levels of all our products. We can also confirm that production of all our respiratory products continues uninterrupted at all of our manufacturing sites.

We repeat our appeal to all healthcare professionals involved in prescribing and dispensing our range of products to help us maintain supply by continuing to write monthly repeat prescriptions rather than prescriptions for multiple months’ supply of inhalers until such time as the short-term pressures begin to ease. This will help us immensely in being able to continue to supply all our products to all our patients during this time by bringing demand in line with supply.’

For further information please contact the Chiesi Customer Services team via email (CustomerServices.UK@chiesi.com)



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