Freedom of Information request on Clozaril 25 mg Tablets (FOI 21/829)
Published 29 December 2021
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28th July 2021
FOI 21/829
Dear
Thank you for your email.
Please find below answers to the questions you have raised below.
The name and address of the original MAH of Clozaril 25 mg Tablets in the UK.
The original product licence for Clozaril 25mg Tablets was granted to Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 5SG (PL 00101/0228)
The dates when the MA underwent a change of ownership from the originator MAH to any other MAH, and finally to Mylan Products Ltd. Please include the name and address of the previous MAHs prior to the MA being transferred to Mylan Products.
There has been one Change of Authorisation Holder (CoA), effective date of grant is 04 November 2016, to change to the current MAH, Mylan Products Limited.
The date(s) when the MHRA approved any change in formulation of this product since approval of the original MA.
No variation has been granted by MHRA to change the formulation of the product.
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Yours sincerely
MHRA Customer Service Centre