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Referral: Diclofenac Sodium Spray Gel 4%
diclofenac sodium, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 18/01/2019, Last updated: 14/02/2019Diclofenac Sodium Spray Gel 4% … Diclofenac Sodium Spray Gel 4% following a disagreement … Diclofenac Sodium Spray Gel 4%? Diclofenac Sodium Spray Gel 4% contains the active substance … -
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Human medicine European public assessment report (EPAR): Taltz
ixekizumab, Psoriasis
Date of authorisation: 25/04/2016, Revision: 17, Authorised, Last updated: 22/02/2023weeks. This compares with 4% of those given placebo and … after 12 weeks, compared with 4% of patients given placebo … weeks. This compares with 4% of those given placebo and … -
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Veterinary medicine European public assessment report (EPAR): Apoquel
oclacitinib maleate, Dogs
Date of authorisation: 12/09/2013, Revision: 8, Authorised, Last updated: 21/01/2022study was 66% compared with 4% in placebo-treated dogs using … CADESI scores were 49% and 4%, respectively. The success … study was 66% compared with 4% in placebo-treated dogs using … -
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Human medicine European public assessment report (EPAR): Jorveza
Budesonide, Esophageal Diseases
Date of authorisation: 08/01/2018,
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, Revision: 6, Authorised, Last updated: 06/12/2022
twice a day, compared with 4% in those receiving placebo … -
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Human medicine European public assessment report (EPAR): Hemangiol
propranolol hydrochloride, Hemangioma
Date of authorisation: 23/04/2014, Revision: 6, Authorised, Last updated: 09/02/2023completely compared with around 4% (2 out of 55) in children … completely compared with around 4% (2 out of 55) in children … -
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Human medicine European public assessment report (EPAR): Bonviva
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 29, Authorised, Last updated: 02/08/2022bone density increased by 4% with the monthly tablets … bone density increased by 4% with the monthly tablets … -
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Human medicine European public assessment report (EPAR): Baraclude
Entecavir, Hepatitis B, Chronic
Date of authorisation: 26/06/2006, Revision: 27, Authorised, Last updated: 11/02/2022DNA in their blood, while 4% of those treated with lamivudine … DNA in their blood, while 4% of those treated with lamivudine … -
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Human medicine European public assessment report (EPAR): Conbriza
bazedoxifene, Osteoporosis, Postmenopausal
Date of authorisation: 17/04/2009, Revision: 15, Authorised, Last updated: 23/03/2021new fractures compared with 4% of those receiving placebo … -
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Human medicine European public assessment report (EPAR): Rinvoq (updated)
upadacitinib, Arthritis, Rheumatoid
Date of authorisation: 16/12/2019,
, 
, Revision: 15, Authorised, Last updated: 02/06/2023
compared with almost 5% and 4% for those taking placebo … compared with almost 5% and 4% for those taking placebo … given Rinvoq, compared with 4% and 13% in patients given … -
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Human medicine European public assessment report (EPAR): Jyseleca (updated)
filgotinib maleate, Arthritis, Rheumatoid
Date of authorisation: 24/09/2020,, , Revision: 9, Authorised, Last updated: 30/05/2023
no symptoms compared with 4% of patients who were given … no symptoms compared with 4% of patients who were given … -
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Human medicine European public assessment report (EPAR): Puregon
follitropin beta, Infertility; Hypogonadism
Date of authorisation: 02/05/1996, Revision: 34, Authorised, Last updated: 29/03/2023at the injection site. In 4% of the women treated with … -
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Human medicine European public assessment report (EPAR): Xarelto
rivaroxaban, Arthroplasty, Replacement; Venous Thromboembolism
Date of authorisation: 30/09/2008, Revision: 39, Authorised, Last updated: 23/02/2023of 1,595), compared with 4% of the patients receiving … of 1,595), compared with 4% of the patients receiving … -
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Human medicine European public assessment report (EPAR): Adtralza
Tralokinumab, Dermatitis, Atopic
Date of authorisation: 17/06/2021,, Revision: 2, Authorised, Last updated: 14/12/2022
This compared with around 4% of patients who used a placebo … This compared with around 4% of patients who used a placebo … -
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Human medicine European public assessment report (EPAR): Rayvow
lasmiditan succinate, Migraine Disorders
Date of authorisation: 17/08/2022,, Authorised, Last updated: 03/10/2022
three attacks, compared with 4% of those treated with placebo … three attacks, compared with 4% of those treated with placebo … -
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Human medicine European public assessment report (EPAR): Vaxchora
vibrio cholerae, strain cvd 103-hgr, live, Cholera
Date of authorisation: 01/04/2020,, Revision: 6, Authorised, Last updated: 27/09/2022
received Vaxchora compared with 4% in those who received placebo … received Vaxchora compared with 4% in those who received placebo … -
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Human medicine European public assessment report (EPAR): Nuceiva
Botulinum toxin type A, Skin Aging
Date of authorisation: 27/09/2019,, Revision: 4, Authorised, Last updated: 10/06/2022
botulinum toxin type A and 4% (2 out of 48) of patients … -
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Human medicine European public assessment report (EPAR): Brinavess
Vernakalant hydrochloride, Atrial Fibrillation
Date of authorisation: 01/09/2010, Revision: 16, Authorised, Last updated: 03/03/2022out of 231) compared with 4% (6 out of 159) of those taking … -
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Human medicine European public assessment report (EPAR): Cosentyx (updated)
Secukinumab, Arthritis, Psoriatic; Psoriasis; Spondylitis, Ankylosing
Date of authorisation: 14/01/2015, Revision: 32, Authorised, Last updated: 02/06/2023treated with etanercept and 4% of those receiving placebo … treated with etanercept and 4% of those receiving placebo … -
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Human medicine European public assessment report (EPAR): Olumiant (updated)
Baricitinib, Arthritis, Rheumatoid
Date of authorisation: 13/02/2017,, Revision: 13, Authorised, Last updated: 25/05/2023
of Olumiant, compared with 4% of the participants taking … Olumiant, compared with 4% of the participants taking … -
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Human medicine European public assessment report (EPAR): Skyrizi
Risankizumab, Psoriasis; Arthritis, Psoriatic
Date of authorisation: 26/04/2019,, Revision: 15, Authorised, Last updated: 04/04/2023
receiving ustekinumab and around 4% of those receiving placebo … ustekinumab and around 4% of those receiving placebo … -
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Human medicine European public assessment report (EPAR): CellCept
mycophenolate mofetil, Graft Rejection
Date of authorisation: 14/02/1996, Revision: 38, Authorised, Last updated: 17/03/2023the two groups, at around 4%. What is the risk associated … the two groups, at around 4%. CellCept EMA/741301/2015 … -
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Human medicine European public assessment report (EPAR): Dupixent (updated)
dupilumab, Dermatitis, Atopic; Prurigo; Esophageal Diseases; Asthma; Sinusitis
Date of authorisation: 26/09/2017, Revision: 26, Authorised, Last updated: 25/05/202383 patients) compared with 4% of patients (3 out of 79 … 83 patients) compared with 4% of patients (3 out of 79 … -
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Human medicine European public assessment report (EPAR): Xeljanz
Tofacitinib, Arthritis, Rheumatoid
Date of authorisation: 22/03/2017,
Date of refusal: 25/04/2013,, Revision: 26, Authorised, Last updated: 30/03/2023
of treatment compared with 4% of patients receiving placebo … of treatment compared with 4% of patients receiving placebo … -
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Press release: Over 1000 SMEs now registered with European Medicines Agency SME office
Last updated: 18/09/2012human use under development, 4% are developing medicines … human use under development, 4% are developing medicines … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018
CHMP, Last updated: 16/11/2018Diclofenac sodium spray gel 4% INN diclofenac List item …