Worksheet 1

Content type: European public Output generated Sun, 02/10/2022 - 11:17

assessment at:
reports (EPARs)

Category Medicine name Therapeutic area International non- Active substance

proprietary name
(INN) / common
name

Human Fetcroja Gram-Negative Bacte

cefiderocol cefiderocol sulfate to
Human Senshio Postmenopause ospemifene ospemifene
Human Mulpleo (previously Thrombocytopenia lusutrombopag Lusutrombopag
Human Rizmoic Constipation naldemedine Naldemedine tosilat

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Domenico Scarlattilaan 6 * 1083 HS Amsterdam * The Netherlands

Tel.: +31 (0)88 781 6000
Send a question via our website: www.ema.europa.eu/en/contact

An agency of the European Union

Product number Patient safety Authorisation ATC code

status

EMEA/H/C/004829 no Authorised J01D

EMEA/H/C/002780 no Authorised G03XC05
EMEA/H/C/004720 no Authorised B02BX
EMEA/H/C/004256 no Authorised A06AH05

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The Netherlands

ropa.eu/en/contact

Additional Generic Biosimilar Conditional Exceptional

monitoring approval circumstances

yes no no no no
yes no no no no
yes no no no no
yes no no no no

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Accelerated Orphan medicine Marketing Date of refusal of Marketing

assessment authorisation date marketing authorisation
authorisation holder/company
name

no no 23/04/2020 Shionogi B.V.

no no 14/01/2015 Shionogi B.V.
no no 18/02/2019 Shionogi B.V.
no no 18/02/2019 Shionogi B.V.

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Human Vet Date of opinion Decision date Revision number

pharmacotherape pharmacotherape
utic group utic group

Antibacterials for systemic use, 17/08/2022 4

Sex hormones and modulators of the genital system, 24/02/2022 12
Antihemorrhagics, 13/12/2018 22/12/2021 7
Drugs for constipation, Peripheral opioid 13/12/2018 22/12/2021 6

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Condition / Species ATCvet code First published Revision date

indication

Fetcroja is indicated for the treatment of infections   due to aerobic Gram-negative

29/04/2020 organisms in adults with limited treatme
6/09/2022
Senshio is indicated for the treatment of moderate to seve 13/09/2017 5/07/2022
Mulpleo is indicated for the treatment of severe thrombocyto 14/03/2019 7/06/2022
Rizmoic is indicated for the treatment of opioid-induced cons 1/03/2019 10/01/2022

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URL

https://www.ema.europa.eu/en/medicines/human/EPAR/fetcroja
https://www.ema.europa.eu/en/medicines/human/EPAR/senshio
https://www.ema.europa.eu/en/medicines/human/EPAR/mulpleo
https://www.ema.europa.eu/en/medicines/human/EPAR/rizmoic

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