2219 results
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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): Wegovy
semaglutide, Obesity; Overweight
Date of authorisation: 06/01/2022,
, Revision: 2, Authorised, Last updated: 26/08/2022
them achieving at least a 5% weight reduction. Three of … Wegovy group were able to lose 5% of their weight compared … Wegovy group lost at least 5% of their weight compared … -
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Human medicine European public assessment report (EPAR): Mysimba (updated)
bupropion hydrochloride, naltrexone hydrochloride, Obesity; Overweight
Date of authorisation: 26/03/2015,, Revision: 24, Authorised, Last updated: 03/03/2023
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): Saxenda
liraglutide, Obesity; Overweight
Date of authorisation: 23/03/2015, Revision: 12, Authorised, Last updated: 29/06/2022patients 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): 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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Human medicine European public assessment report (EPAR): Beyfortus
nirsevimab,
Date of authorisation: 31/10/2022,, Authorised, Last updated: 30/01/2023
medical attention compared with 5% 1 (25 out of 496) in the … 2.6% has been amended to 5% (25 out of 496) What are … 2.6 % has been amended to 5% (25 out of 496) http://www.ema.europa.eu/how-to-find-us http://www.ema.europa.eu/contact … -
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Human medicine European public assessment report (EPAR): Bimzelx
bimekizumab, Psoriasis
Date of authorisation: 20/08/2021,, Revision: 2, Authorised, Last updated: 05/12/2022
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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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): Ilumetri (updated)
tildrakizumab, Psoriasis
Date of authorisation: 17/09/2018,, Revision: 8, Authorised, Last updated: 22/02/2023
48% given etanercept and 5% given placebo. What are the … -
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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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Human medicine European public assessment report (EPAR): Synagis
palivizumab, Respiratory Syncytial Virus Infections
Date of authorisation: 13/08/1999, Revision: 44, Authorised, Last updated: 14/07/2022RSV-related hospitalisations: 5% of the children who received … RSV-related hospitalisations: 5% of the children who received … -
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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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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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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): Xelevia
sitagliptin, Diabetes Mellitus, Type 2
Date of authorisation: 21/03/2007, Revision: 37, Authorised, Last updated: 31/01/2023generally 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): Stelara
Ustekinumab, Psoriasis; Arthritis, Psoriatic; Crohn Disease; Colitis, Ulcerative
Date of authorisation: 15/01/2009, Revision: 42, Authorised, Last updated: 18/01/2023or minimal, compared with 5% of patients receiving placebo … -
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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: 02/08/2022injections, compared with 5% with the daily tablets. In … injections, compared with 5% with the daily tablets. In … -
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Human medicine European public assessment report (EPAR): Otezla
apremilast, Arthritis, Psoriatic; Psoriasis
Date of authorisation: 15/01/2015, Revision: 19, Authorised, Last updated: 21/07/2022treatment. This compared with 5% (15 of 282) and 6% (8 of … treatment. This compared with 5% (15 of 282) and 6% (8 of … -
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Human medicine European public assessment report (EPAR): Ventavis
iloprost, Hypertension, Pulmonary
Date of authorisation: 15/09/2003, Revision: 29, Authorised, Last updated: 13/12/2021out 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): Tamiflu
oseltamivir, Influenza, Human
Date of authorisation: 20/06/2002, Revision: 40, Authorised, Last updated: 05/10/2021after contact, compared with 5% of those taking placebo … -
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Human medicine European public assessment report (EPAR): Tecentriq (updated)
atezolizumab, Carcinoma, Transitional Cell; Carcinoma, Non-Small-Cell Lung; Urologic Neoplasms; Breast Neoplasms; Small Cell Lung Carcinoma
Date of authorisation: 20/09/2017, Revision: 21, Authorised, Last updated: 07/03/2023have a PD-L1 expression ≥ 5% (see section 5.1 … -
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Human medicine European public assessment report (EPAR): Imjudo (updated)
Tremelimumab, Carcinoma, Hepatocellular
Date of authorisation: 15/12/2022,, Authorised, Last updated: 02/03/2023
months on average. About 5% of patients who received … months on average. About 5% of patients who received … -
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Human medicine European public assessment report (EPAR): Byfavo
remimazolam, Conscious Sedation
Date of authorisation: 26/03/2021,, Revision: 4, Authorised, Last updated: 16/02/2023
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): Zyclara
imiquimod, Keratosis; Keratosis, Actinic
Date of authorisation: 23/08/2012, Revision: 14, Authorised, Last updated: 13/02/2023which contains imiquimod at 5% strength. How is Zyclara … which contains imiquimod at 5% strength. How is Zyclara … -
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Human medicine European public assessment report (EPAR): Arixtra
fondaparinux sodium, Venous Thrombosis; Pulmonary Embolism; Myocardial Infarction; Angina, Unstable
Date of authorisation: 20/03/2002, Revision: 34, Authorised, Last updated: 11/11/2022ST-segment elevation, with around 5% of the patients in each group … segment elevation, with around 5% of the patients in each …