Ventricular Tachyarrhythmia risk from Ibrutinib

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare Products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

Dear Medicines and Healthcare Products Regulatory Agency,

This is a FOIA request to the MHRA regarding:

Ibrutinib / Imbruvica SmPC (PLGB 00242/0688 ; PLGB 00242/0689; PLGB 00242/0690 PLGB 00242/0691)
FLAIR trial (EudraCT 2013-001944-76 & IRAS 126738)

My questions:

1) SmPC: when was the variation to the ibrutinib SmPC to include the risk of ventricular tachyarrhythmia submitted by Janssen-Cilag Limited?
If another body submitted the change, please provide their name and the date

2) SmPC: when was the revised SmPC for Ibrutinib/Imbruvica approved? And when was it made available to the public?
See https://www.medicines.org.uk/emc/product... the section under arrhythmia and cardiac failure

3) FLAIR trial: when was ventricular tachyarrhythmia added to the FLAIR trial documentation both the date when information was made available to:
a) Clinicians, and
b) Trial participants

4) MHRA: What information is available on Adverse Drug Reactions from Ibrutinib / Imbruvica?

Thank you,

Yours faithfully,

Andrew Layton

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
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London 
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________________________________________ From: Andrew Layton
<[FOI #881312 email]> Sent: Monday, July 25, 2022
8:33:43 AM To: MHRA Customer Services Subject: Freedom of Information
request - Ventricular Tachyarrhythmia risk from Ibrutinib Dear Medicines
and Healthcare Products Regulatory Agency, This is a FOIA request to the
MHRA regarding: Ibrutinib / Imbruvica SmPC (PLGB 00242/0688 ; PLGB
00242/0689; PLGB 00242/0690 PLGB 00242/0691) FLAIR trial (EudraCT
2013-001944-76 & IRAS 126738) My questions: 1) SmPC: when was the
variation to the ibrutinib SmPC to include the risk of ventricular
tachyarrhythmia submitted by Janssen-Cilag Limited? If another body
submitted the change, please provide their name and the date 2) SmPC: when
was the revised SmPC for Ibrutinib/Imbruvica approved? And when was it
made available to the public? See
https://eur01.safelinks.protection.outlo...
the section under arrhythmia and cardiac failure 3) FLAIR trial: when was
ventricular tachyarrhythmia added to the FLAIR trial documentation both
the date when information was made available to: a) Clinicians, and b)
Trial participants 4) MHRA: What information is available on Adverse Drug
Reactions from Ibrutinib / Imbruvica? Thank you, Yours faithfully, Andrew
Layton -------------------------------------------------------------------
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/843

Dear Mr Layton,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 25th July 2022.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections

Dear MHRA Customer Services,

I have not had a reply from the MHRA to request 22/843 which was expected last week. I emailed for an update on 23rd August, but have not recurved a reply.

I first raised the request by email on 19th July, but my initial requests to the MHRA went unanswered.

I then raised it via WhatDoTheyKnow, which was confirmed under request no . 22/843 on 25th July, with a reply expected by 23rd August.

Please provide an update on the request and a new expected reply date.

Yours sincerely,

Andrew Layton

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Thank you for your email.  This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible. 
 
Please note that we may not respond if your query: 
 
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only 
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
Stay connected 
 
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC. 
 
The UK has left the EU, and the transition period ends on 31 December
2020. Ourguidance and information can be accessed here.

________________________________________ From: Andrew Layton
<[FOI #881312 email]> Sent: Monday, August 29, 2022
8:51:27 AM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - Ventricular Tachyarrhythmia risk from Ibrutinib
Dear MHRA Customer Services, I have not had a reply from the MHRA to
request 22/843 which was expected last week. I emailed for an update on
23rd August, but have not recurved a reply. I first raised the request by
email on 19th July, but my initial requests to the MHRA went unanswered. I
then raised it via WhatDoTheyKnow, which was confirmed under request no .
22/843 on 25th July, with a reply expected by 23rd August. Please provide
an update on the request and a new expected reply date. Yours sincerely,
Andrew Layton -----Original Message----- Our Ref: FOI 22/843 Dear Mr
Layton, RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000 Thank you
for your enquiry which we received on 25th July 2022. I confirm that your
request is now being handled under the Freedom of Information Act and you
should receive a reply within 20 working days from our date of receipt. If
you need to contact us again about this request, please quote the
reference number above. Please be aware that we publish FOIs replies and
these are redacted and are located on our website at the following link
below.
https://eur01.safelinks.protection.outlo...
Kind Regards, MHRA Customer Experience Centre Communications and
engagement team Medicines and Healthcare products Regulatory Agency 10
South Colonnade, Canary Wharf, London E14 4PU Telephone 020 3080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #881312 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/843

Dear Andrew Layton

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 29 August 2022.

This is just to inform you that we will respond as soon as possible and apologise for the delay.

Kind Regards,

MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections