1955 results
Keyword Albiomin 5% Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pain
PIP number: EMEA-002668-PIP01-19, Route(s) of administration: Oral use, Pharmaceutical form(s): Oral solution
Decision date: 18/03/2020, Last updated: 30/07/2020, Compliance check: XActive substance 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract … 5%-Δ9-tetrahydrocannabinol standardised Cannabis extract … -
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Human medicine European public assessment report (EPAR): Mysimba
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,
, Revision: 19, Authorised, Last updated: 13/07/2021
patients have not lost at least 5% of their initial body weight … patients who achieved at least a 5% weight reduction; the studies … Mysimba-treated patients who achieved 5% weight loss ranged from 28 … -
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Human medicine European public assessment report (EPAR): Xenical
orlistat, Obesity
Date of authorisation: 29/07/1998, Revision: 24, Authorised, Last updated: 07/05/2020been unable to lose at least 5% of their body weight since … -
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Referral: Baytril injectable
enrofloxacin, Article 34
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/20142.5% injectable, Baytril 5% injectable and Baytril 10 … 2.5% injectable, Baytril 5% injectable and Baytril 10 … 2.5% injectable, Baytril 5% injectable and Baytril 10 … -
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Human medicine European public assessment report (EPAR): Saxenda
liraglutide, Obesity; Overweight
Date of authorisation: 23/03/2015, Revision: 10, Authorised, Last updated: 10/06/2021patients have not lost at least 5% of their initial body weight … patients have not lost at least 5% of their initial body weight … -
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Human medicine European public assessment report (EPAR): Qsiva
phentermine, topiramate, Obesity
Date of refusal: 14/05/2013, Refused, Last updated: 13/06/2013of patients with at least 5% weight loss after 28 or 56 … -
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Referral: Baytril injectable and generics
enrofloxacin, Article 35
Status: European Commission final decision, opinion/position date: 09/04/2014, EC decision date: 01/09/2014, Last updated: 10/12/20142.5% injectable, Baytril 5% injectable, Baytril 10% injectable … 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable … 2.5% injectable, Baytril 5% injectable and Baytril 10 … -
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Human medicine European public assessment report (EPAR): Nustendi
Bempedoic acid, Ezetimibe, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 27/03/2020,, Revision: 4, Authorised, Last updated: 06/07/2021
with an increase of around 5% in patients taking placebo … -
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Human medicine European public assessment report (EPAR): Nilemdo
Bempedoic acid, Hypercholesterolemia; Dyslipidemias
Date of authorisation: 01/04/2020,, Revision: 4, Authorised, Last updated: 21/06/2021
of 1% and an increase of 5% respectively in patients … -
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Human medicine European public assessment report (EPAR): Cufence
trientine dihydrochloride, Hepatolenticular Degeneration
Date of authorisation: 25/07/2019, Revision: 3, Authorised, Last updated: 17/06/2021had deteriorating symptoms: 5% with worsening liver symptoms … -
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Human medicine European public assessment report (EPAR): Ilumetri
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 4, Authorised, Last updated: 18/05/2021
48% given etanercept and 5% given placebo. What are the … -
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Human medicine European public assessment report (EPAR): Bonviva
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 28, Authorised, Last updated: 29/03/2021injections, compared with 5% with the daily tablets. In … injections, compared with 5% with the daily tablets. In … -
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Veterinary medicine European public assessment report (EPAR): Mirataz
mirtazapine, Cats
Date of authorisation: 10/12/2019, Revision: 2, Authorised, Last updated: 02/02/2021in cats who had at least 5% weight loss due to an underlying … -
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Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 28, Authorised, Last updated: 01/02/2021out of 101), compared with 5% of the patients taking placebo … out of 101), compared with 5% of the patients taking placebo … -
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Human medicine European public assessment report (EPAR): Bimzelx
Bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Authorised, Last updated: 24/08/2021
weeks. This compares with 1 to 5% of patients receiving placebo … weeks, compared with 1 to 5% of patients receiving placebo … weeks. This compares with 1 to 5% of patients receiving placebo … -
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Veterinary medicine European public assessment report (EPAR): Stelfonta
tigilanol tiglate, Dogs
Date of authorisation: 15/01/2020, Revision: 1, Authorised, Last updated: 13/05/2020complete response) compared to 5% of dogs that received a dummy … -
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Human medicine European public assessment report (EPAR): Selincro
Nalmefene hydrochloride dihydrate, Alcohol-Related Disorders
Date of authorisation: 24/02/2013, Revision: 11, Authorised, Last updated: 15/05/2019a bottle of beer (330 ml; 5% alcohol by volume) contains … a bottle of beer (330 ml; 5% alcohol by volume) contains … -
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Human medicine European public assessment report (EPAR): Byfavo
remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021,, Authorised, Last updated: 20/04/2021
out of 310) with Byfavo, 5% (3 out of 63) with placebo … out of 310) with Byfavo, 5% (3 out of 63) with placebo … -
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Human medicine European public assessment report (EPAR): Stelara
Ustekinumab, Psoriasis; Arthritis, Psoriatic; Crohn Disease
Date of authorisation: 15/01/2009, Revision: 37, Authorised, Last updated: 16/09/2021or minimal, compared with 5% of patients receiving placebo … -
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Human medicine European public assessment report (EPAR): Klisyri
tirbanibulin, Keratosis, Actinic
Date of authorisation: 16/07/2021,, Authorised, Last updated: 21/07/2021
using Klisyri compared with 5% of those using placebo. Similarly … using Klisyri compared with 5% of those using placebo. Similarly … -
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Human medicine European public assessment report (EPAR): Tecentriq
atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017,, Revision: 15, Authorised, Last updated: 09/09/2021
have a PD-L1 expression ≥ 5% (see section 5.1 … -
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Human medicine European public assessment report (EPAR): Diacomit
stiripentol, Myoclonic Epilepsy, Juvenile
Date of authorisation: 03/01/2007,
Date of refusal: 11/02/2009, Revision: 17, Authorised, Last updated: 15/06/2021out of 21), compared with 5% of the placebo group (1 out … out of 21), compared with 5% of the placebo group (1 … -
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Human medicine European public assessment report (EPAR): Forsteo
teriparatide, Osteoporosis; Osteoporosis, Postmenopausal
Date of authorisation: 10/06/2003, Revision: 23, Authorised, Last updated: 18/03/2021reducing vertebral fractures: 5% of the women who received … reducing vertebral fractures: 5% of the women who received … -
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Human medicine European public assessment report (EPAR): Xelevia
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 31, Authorised, Last updated: 24/02/2021generally seen in more than 5% of patients) include pancreatitis … generally seen in more than 5% of patients) include pancreatitis … -
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Human medicine European public assessment report (EPAR): Nplate
romiplostim, Purpura, Thrombocytopenic, Idiopathic
Date of authorisation: 04/02/2009, Revision: 24, Authorised, Last updated: 03/02/2021out of 41) compared with 5% receiving placebo (1 out … out of 41) compared with 5% receiving placebo (1 out …