Electronically communicated caution in use letters for batch-specific requests

HPRA may approve a batch-specific request (BSR) application from a Marketing Authorisation Holder (MAH) to ensure the continued availability of a medicine on the Irish market. Such applications may be appropriate when product in full compliance with its registered Marketing Authorisation (MA) dossier is temporarily unavailable. Please see Batch-specific Requests for further details.

It may be necessary for the MAH to communicate with healthcare professionals such as community pharmacists, in order to highlight the deviation from the registered MA. These communications are called Caution-in-use (CIU) letters. CIU letters are normally physically provided to healthcare professionals but in some cases, e.g. due to difficulties in providing physical letters related to COVID-19 restrictions, electronic communication may be accepted. To support the provision of electronic CIUs in exceptional circumstances, the HPRA is maintaining a list of the CIU letters that have been electronically disseminated to community pharmacists.

This does not replace the requirement for MAHs to disseminate CIUs, but acts as a support to the process. Responsibility for the dissemination of Caution in Use letter lies with the Marketing Authorisation Holder. Healthcare professionals with questions about a specific BSR can find details in the table below. If further information is required contact info@hpra.ie.

If a patient has any concerns about their medicine, the HPRA advises that they should discuss their treatment with their doctor or pharmacist



Please use search function below to find relevant product or active ingredient

 
Product name and MA number
Marketing Authorisation Holder
Active ingredient
Date of BSR
CIU letter/Additional information
         
Tracrium 10 mg/ml,  
Solution for Injection or Infusion,
ampoules

PA1691/029/001

Aspen Pharma Trading Limited

Atracurium Besilate  28/05/2020  eCIU Tracrium 10 mg/ml Solution for Injection or Infusion, ampoules
Bonasol Once Weekly 70 mg Oral Solution

PA1572/001/001
Xeolas Pharmaceuticals Limited Alendronic Acid   23/06/2020  eCIU Bonasol Once Weekly 70mg Oral Solution
Creon 10000 Gastro-resistant capsules 

PA2010/008/001
Mylan IRE Healthcare Limited    09/10/2020 eCIU Creon 10000 Gastro-resistant capsules

Menveo (EU/1/10/614/003) Meningococcal Group A, C, W135 and Y conjugate vaccine PIL
Menveo (EU/1/10/614/003) Meningococcal Group A, C, W135 and Y conjugate vaccine PIL
Menveo (EU/1/10/614/003) Meningococcal Group A, C, W135 and Y conjugate vaccine PIL