Cabazitaxel Accord (cabazitaxel, EMA product number EMEA/H/C/005178)

Läkemedelsverket hade inte den begärda informationen.

Dear Swedish Medical Products Agency,

We note the following text in sections 2.4.1 (page 17) and 2.4.4 (page 19) of the Assessment Report in respect of Cabazitaxel Accord (https://www.ema.europa.eu/en/documents/a...) (EMA/267872/2020):

“Due to a patent that was granted to the MAH of Jevtana for its use in patients with moderate hepatic impairment, the relevant dose adjustment/reduction was removed from the SmPC and replaced with appropriate warnings and contraindication (see SmPC sections 4.2, 4.3 and 4.4).”

We request the following information held by the Swedish Medical Products Agency (Lakemedelsverket) relating to the scientific evaluation of the medicinal product Cabazitaxel Accord (EMA product number EMEA/H/C/005178):

All correspondence between Lakemedelsverket (and its representatives) and the EMA or the Committee for Medicinal Products for Human Use (CHMP) relating to the clinical aspects of Cabazitaxel Accord in the period between submission of the application for marketing authorisation (25 March 2019) and the issue of the CHMP’s positive opinion (30 April 2020) containing:
• any of the following search terms: “patent”, “moderate hepatic impairment”, “carve out” (or “carve-out”), “contraindication”;
• references to moderate hepatic impairment in sections 4.2, 4.3 and 4.4 of the SmPC; and
• references to the existence of a patent that was granted to the marketing authorisation holder of Jevtana as regards use in patients with moderate hepatic impairment.

We look forward to hearing from you but please let us know if you have any questions. Thank you in advance for considering or request.

Yours faithfully,

Hugo Kent-Egan
Bristows LLP

Läkemedelsverket

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Enheten för informationshantering och säkerhet

Box 26, 751 03 Uppsala
Besöksadress: Dag Hammarskjöldsväg 42
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[Läkemedelsverket e-postadress för begäran om allmän handling]
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Utlämnandeärenden, Läkemedelsverket

Dear Hugo,

Thank you for your email regarding request for information such as correspondence between the Swedish Medical Products Agency (MPA) and EMA or CHMP relating to the scientific evaluation of the medicinal product Cabazitaxel Accord in the Central procedure for Cabazitaxel Accord (EMEA/H/C/005178).

You requested correspondence containing

•any of the following search terms: “patent”, “moderate hepatic impairment”, “carve out” (or “carve-out”), “contraindication”;

•references to moderate hepatic impairment in sections 4.2, 4.3 and 4.4 of the SmPC; and

•references to the existence of a patent that was granted to the marketing authorisation holder of Jevtana as regards use in patients with moderate hepatic impairment.

In the procedure mentioned above, the MPAs role was member state. No correspondence matching your request were registered in our database between the time frame 25 March 2019 and 30 April 2020.

On behalf of the Swedish Medical Products Agency
Kind regards
Anna Bergström

Swedish Medical Products Agency
Department of 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
[Läkemedelsverket e-postadress för begäran om allmän handling]
www.lakemedelsverket.se

Privacy notice

-----Ursprungligt meddelande-----
Från: Hugo Kent-Egan <[Registrators #1966 e-postadress]>
Skickat: den 1 september 2022 11:04
Till: Registrator <[e-postadress]>
Ämne: Freedom of Information request - Cabazitaxel Accord (cabazitaxel, EMA product number EMEA/H/C/005178)

Dear Swedish Medical Products Agency,

We note the following text in sections 2.4.1 (page 17) and 2.4.4 (page 19) of the Assessment Report in respect of Cabazitaxel Accord (https://www.ema.europa.eu/en/documents/a...) (EMA/267872/2020):

“Due to a patent that was granted to the MAH of Jevtana for its use in patients with moderate hepatic impairment, the relevant dose adjustment/reduction was removed from the SmPC and replaced with appropriate warnings and contraindication (see SmPC sections 4.2, 4.3 and 4.4).”

We request the following information held by the Swedish Medical Products Agency (Lakemedelsverket) relating to the scientific evaluation of the medicinal product Cabazitaxel Accord (EMA product number EMEA/H/C/005178):

All correspondence between Lakemedelsverket (and its representatives) and the EMA or the Committee for Medicinal Products for Human Use (CHMP) relating to the clinical aspects of Cabazitaxel Accord in the period between submission of the application for marketing authorisation (25 March 2019) and the issue of the CHMP’s positive opinion (30 April 2020) containing:

•any of the following search terms: “patent”, “moderate hepatic impairment”, “carve out” (or “carve-out”), “contraindication”;

•references to moderate hepatic impairment in sections 4.2, 4.3 and 4.4 of the SmPC; and

•references to the existence of a patent that was granted to the marketing authorisation holder of Jevtana as regards use in patients with moderate hepatic impairment.

We look forward to hearing from you but please let us know if you have any questions. Thank you in advance for considering or request.

Yours faithfully,

Hugo Kent-Egan

Bristows LLP

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