Janssen-Cilag International

34 products tracked · names used in filings: Janssen-Cilag International, Janssen Cilag International NV, Janssen-Cilag International NV

Upcoming milestones

No upcoming milestones listed.

Recent milestones

Fri 18 Sep 2026🇪🇺 EU approval (EC decision)

Icotyde (icotrokinra hydrochloride) approved in the EU

Marketing authorisation to Janssen-Cilag International; Additional monitoring · source

Thu 23 Jul 2026🇪🇺 CHMP positive opinion

Icotyde (icotrokinra hydrochloride): CHMP positive opinion

Janssen-Cilag International; Additional monitoring · source

Fri 28 Nov 2025🇪🇺 EU approval (EC decision)

Imaavy (nipocalimab) approved in the EU

Marketing authorisation to Janssen Cilag International NV; Additional monitoring · source

Mon 03 Nov 2025🇪🇺 CHMP positive opinion

Imaavy (nipocalimab): CHMP positive opinion

Janssen Cilag International NV; Additional monitoring · source

Products

ProductStatusApproved
🇪🇺Plivensia
sirukumab
Application withdrawn
🇪🇺Comfyde
carisbamate
Application withdrawn
🇪🇺Zeftera (previously Zevtera)
ceftobiprole
Refused
🇪🇺Icotyde
icotrokinra hydrochloride
Authorised2026-09-18
🇪🇺Imaavy
nipocalimab
Authorised2025-11-28
🇪🇺Lazcluze
lazertinib
Authorised2025-01-20
🇪🇺Yuvanci
macitentan;tadalafil
Authorised2024-09-27
🇪🇺Carvykti
ciltacabtagene autoleucel
Authorised2022-05-25
🇪🇺Jcovden (previously COVID-19 Vaccine Janssen)
COVID-19 vaccine (Ad26.COV2-S [recombinant])
Withdrawn2021-03-11
🇪🇺Rekambys
rilpivirine
Authorised2020-12-17
🇪🇺Spravato
esketamine
Authorised2019-12-18
🇪🇺Erleada
apalutamide
Authorised2019-01-14
🇪🇺Tremfya
guselkumab
Authorised2017-11-10
🇪🇺Symtuza
darunavir;cobicistat;emtricitabine;tenofovir alafenamide
Authorised2017-09-21
🇪🇺Uptravi
selexipag
Authorised2016-05-12
🇪🇺Trevicta (previously Paliperidone Janssen)
paliperidone
Authorised2014-12-05
🇪🇺Imbruvica
ibrutinib
Authorised2014-10-21
🇪🇺Olysio
simeprevir
Withdrawn2014-05-14
🇪🇺Vokanamet
canagliflozin;metformin
Authorised2014-04-23
🇪🇺Invokana
canagliflozin
Authorised2013-11-15
🇪🇺Stayveer
bosentan monohydrate
Authorised2013-06-24
🇪🇺Incivo
telaprevir
Expired2011-09-19
🇪🇺Zytiga
abiraterone
Authorised2011-09-05
🇪🇺Xeplion
paliperidone
Authorised2011-03-04
🇪🇺Simponi
golimumab
Authorised2009-10-01
🇪🇺Stelara
ustekinumab
Authorised2009-01-16
🇪🇺Intelence
etravirine
Authorised2008-08-28
🇪🇺Doribax
doripenem
Withdrawn2008-07-25
🇪🇺Invega
paliperidone
Authorised2007-06-24
🇪🇺Prezista
darunavir
Authorised2007-02-11
🇪🇺Ionsys
fentanyl
Withdrawn2006-01-24
🇪🇺Velcade
bortezomib
Authorised2004-04-26
🇪🇺Remicade
infliximab
Authorised1999-08-13
🇪🇺Regranex
becaplermin
Withdrawn1999-03-29

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.