Freedom of Information request on the Risk Management Plan for Sodium Bicarbonate 500 mg Capsules, Clonazepam 0.5mg & 2mg Tablets and Naprosyn 250mg and 500mg Tablets (FOI 21/1283)
Published 31 May 2022
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FOI 21/1283
10th December
Dear,
Thank you for your email, dated 26th November 2021, in which you requested:
‘the risk management plan of below listed products:
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PL 20046/0004- Sodium Bicarbonate 500 mg Capsules
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PL 20620/0045-0046 – Clonazepam 0.5mg & 2mg Tablets
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PL 43252/0004-0005 - Naprosyn 250mg and 500mg Tablets’
Thank you for contacting us regarding this matter. Regarding your request for the specified Risk Management Plans (RMPs), as the Marketing Authorisation applications for the generic products to which you refer (Sodium Bicarbonate, Naproxen and Clonazepam) were made prior to the 2012 amendment in pharmacovigilance legislation, requiring an RMP for all new applications, the MHRA does not hold an RMP for these products.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division