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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 14/11/2017
SPC BESPONSA 1 mg powder for concentrate for solution for infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 14/11/2017 and displayed until Current
Reasons for adding or updating:
  • Change to legal category
Date of revision of text on the SPC:   29-Jun-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The issue relates to the  legal sub-classification of the prescription medicine selected. So there are two:  sub-category S1A (non-renewable substances) and S1B (renewable substances).

Besponsa is listed as an S1B but Besponsa falls under the S1A category. Can this be updated please?

Updated on 11/07/2017 and displayed until 14/11/2017
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

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Active Ingredients

 
   Inotuzumab ozogamicin