Freedom of Information request on clinical and non-clinical documents for Orobalin 1mg Tablets (FOI 21/1119)
Published 27 April 2022
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12th October 2021
FOI 21/1119
Dear
Thank you for your email.
Orobalin 1 mg film-coated tablets (PL 48259/0045) was granted by a CoA on 04 January 2019.
The original product licence (PL 42924/0012) was granted on 26 October 2018.
If you have a query about the information provided, please reply to this email
If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.
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Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency