Lennart WaldenlindDatum:20091116 Dnr:
Läkemedelssäkerhet
Beslut om uppföljning av godkänt läkemedel
Antipsychotics update of SmPC 4.4, 4.8 and PL section 2, 4
Issue 1) Implementation of warnings on risk of venous thromboembolism
Issue 2) Implementation of warnings on increased mortality in elderly people with dementia for all conventional (typical) antipsychotics following CHMP article 5(3) referral
Please note: A warning on increased risk of death when used in elderly people with dementia should already have been implemented in the SmPC for all atypical antipsychotics since 2005.
Issue 1)
Following consideration of the available data relating to the risk of venous thromboembolism associated with antipsychotics and discussion at the CHMP Pharmacovigilance Working Party (PhVWP) and the Co-ordination Group for Mutual Recognition and Decentralised Products – human (CMD(h)), all Marketing Authorisation (MA) holders for antipsychotic products throughout the European Union are being requested to submit type II variations for relevant products to implement the final agreed texts (see ). The wordings have been agreed by the PhVWP and have been subject of consultation with brand leaders and industry bodies and are to be implemented without amendment.
Issue 2)
Following an Article 5(3) referral procedure which considered the available published data relating to conventional (typical) antipsychotics and increased risk of death in elderly people with dementia, the European Committee on Medicinal Products for Human Use (CHMP) recommended that the product information for all conventional (typical) antipsychotics should be updated to include warnings about the risk. Core SmPC and PL wording was discussed at the January 2009 meeting of the CHMP Pharmacovigilance Working party (PhVWP) and finalised at the February meeting of the Co-ordination Group for Mutual Recognition and Decentralised Products – human (CMD(h)). All Marketing Authorisation (MA) holders for conventional (‘typical’, ‘first generation’) antipsychotics throughout the European Union are now being requested to submit type II variations for relevant products to implement the final agreed texts (see ). The wordings have been agreed by the PhVWP and CMD(h) and are to be implemented without amendment.
Applications
The applications do not require supporting information and will be accepted by Member States Competent Authorities without further assessment or amendment. As a result, MR and DC Type II variations will follow an expedited (30 day) process which can be finalised at day 15 as follows: The RMS takes responsibility on behalf of CMS to request the variation from the MA holder and initiate the procedure. By Day 0 the RMS notifies the CMSs and the MAH of the timetable. At Day 15 the RMS circulates the final SPC and PL (with and without track-changes) to the CMSs and the MAH and the procedure is closed. No PVAR/FVAR should be needed as the RMS should take responsibility for the assessment of the implementation of the final SmPC and PL text.
With regard to PL wording, a consultation with patient groups has been organised via the EMEA, and further user-testing by individual MA holders will not be expected on this occasion.
You will be required to start incorporating updated PLs into new production batches within a 3-6 month timeframe, and no later than August 1, 2010.
You will find this request and texts for implementation, both SmPC and PL, at our website:
For your convenience the texts are both in English and Swedish and in word-format.
Läkemedelsverket har beslutat att innehavaren/ombudet ska inkomma med uppdaterad
produktinformation enligt ovanstående i form av en ändringsansökan Typ II senast
20091214.
Om ändringarna även påverkar andra avsnitt i SPC och PL skall dessa också uppdateras.
Elektroniskt underlag kan fås på begäran från Läkemedelsverket via
. Uppdaterad SPC och PL emotses elektroniskt med synliga
ändringar (Wordfunktionen ”Spåra ändringar”). Använd den av Läkemedelsverket
senast godkända Wordversionen.
En kopia av följebrevet, uppdaterade elektroniska texter samt eventuella frågor skickas
till . Referera alltid till diarienumret (Dnr) vid all korrespondens i
detta ärende.
På Läkemedelsverkets vägnar
Marie Andersson
Koordinator
BeslutandeFöredragande
Gunilla SjölinForsbergLennart Waldenlind
Chef Enheten för läkemedelssäkerhetKlinisk utredare
Kopia till:
IB
IVB
Lennart WaldenlindDate:16 November, 2009Dnr
Department of Drug Safety
Translation of the Medical Products Agency's Decision regarding
Postauthorisation Control of a Medicinal Product
Antipsychotics update of SmPC 4.4, 4.8 and PL section 2, 4
(Please see the text in the original request)
With regard to the above, the MPA has decided that the MAH/Local representative
shall submit a type II variation application with updated Product Information no later
than 14 December, 2009.
If the changes affect other sections of the SPC and PL, those sections should be
updated as well. For your convenience electronic texts can be requested by email to
. Changes in the texts of SPC and PL shall be sent electronically
with ”tracked changes” (Microsoft Word). Please use the latest Word version
approved by the MPA.
When submitting the application, please email a copy of the cover letter, updated
SPC and PL and any questions to . Please refer to the diary
number (Dnr) in all correspondence regarding this matter.
On behalf of the Medical Products Agency,
Marie Andersson
Coordinator
Decision made byPresenter
Gunilla SjölinForsbergLennart Waldenlind
Head, Department of Drug SafetyClinical Assessor
Copy to:
IB
IVB