Dear Swedish Medical Products Agency,

The procedural steps taken and scientific information after authorisation in respect of Bosulif (EMA product number EMEA/H/C/005178) records several amendments to the SmPC for Bosulif since it was first authorised in 2013 (https://www.ema.europa.eu/en/documents/p...).

We request documentation and correspondence held by the Swedish Medical Products Agency (Lakemedelsverket) and its representative at the Committee for Medicinal Products for Human Use (CHMP) in relation to amendments made to the SmPC between 18 February 2019 and 11 February 2021 which resulted in the addition of Table 9 to section 5.1 of the SmPC containing any of the following search terms: “Table 9”, “F317L”, “mutation”.

Yours faithfully,

Hugo Kent-Egan

Läkemedelsverket

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Registrator
Enheten för informationshantering och säkerhet

Box 26, 751 03 Uppsala
Besöksadress: Dag Hammarskjöldsväg 42
Telefon: 018 - 17 46 07, växel: 018 - 17 46 00
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[Läkemedelsverket e-postadress för begäran om allmän handling]
https://www.lakemedelsverket.se

Utlämnandeärenden, Läkemedelsverket

1 Bilaga

Dear Hugo Kent-Egan,

 

You have requested access to documents regarding specific changes in the
SmPC between February 2019 and February 2021. However, it seems that the
table you’re referring to was not added or changed within this timespan.
It was already there before February 2019, but within this timespan other
tables were added which made the table in question change number from
Table 6 to Table 9.

 

On behalf of the Swedish Medical Products Agency

 

Best regards

Sofie Persson

 

 

Swedish Medical Products Agency

Medical Products Administration

 

P.O. Box 26, SE-751 03 Uppsala, Sweden

Visiting address: Dag Hammarskjölds väg 42

Phone, switchboard: + 46 (0) 18 17 46 00

[1][Läkemedelsverket e-postadress för begäran om allmän handling]

[2]www.lakemedelsverket.se

 

[3]Privacy notice

 

 

 

-----Ursprungligt meddelande-----
Från: Hugo Kent-Egan <[Registrators #1967 e-postadress]>
Skickat: den 1 september 2022 11:06
Till: Registrator <[e-postadress]>
Ämne: Freedom of Information request - Bosulif (EMA product number
EMEA/H/C/005178)

 

Dear Swedish Medical Products Agency,

 

 

 

The procedural steps taken and scientific information after authorisation
in respect of Bosulif (EMA product number EMEA/H/C/005178) records several
amendments to the SmPC for Bosulif since it was first authorised in 2013
([4]https://www.ema.europa.eu/en/documents/p...).

 

 

 

We request documentation and correspondence held by the Swedish Medical
Products Agency (Lakemedelsverket) and its representative at the Committee
for Medicinal Products for Human Use (CHMP) in relation to amendments made
to the SmPC between 18 February 2019 and 11 February 2021 which resulted
in the addition of Table 9 to section 5.1 of the SmPC containing any of
the following search terms: “Table 9”, “F317L”, “mutation”.

 

 

 

Yours faithfully,

 

 

 

Hugo Kent-Egan

 

 

 

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