156 results
Keyword Meropenem Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): Vaborem, meropenem trihydrate, vaborbactam
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001731-PIP01-14-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 09/07/2021, Last updated: 18/07/2022, Compliance check: XVaborem Active substance meropenem trihydrate vaborbactam Therapeutic … paediatric investigation plan for meropenem (trihydrate) / vaborbactam … paediatric investigation plan for meropenem (trihydrate) / vaborbactam … -
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Human medicine European public assessment report (EPAR): Vaborem
meropenem trihydrate, vaborbactam, Urinary Tract Infections; Bacteremia; Bacterial Infections; Respiratory Tract Infections; Pneumonia; Pneumonia, Ventilator-Associated
Date of authorisation: 20/11/2018,
, Revision: 6, Authorised, Last updated: 29/07/2022
Authorised meropenemvaborbactam Overview Vaborem (previosly Vabomere) is … medicine. active substances meropenem and vaborbactam. How is Vabomere … active substances in Vabomere, meropenem and vaborbactam, work in … -
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Referral: Meronem
meropenem, Article 30 referrals
Status: European Commission final decision, opinion/position date: 23/07/2009, EC decision date: 15/10/2009, Last updated: 12/12/2009contains the active substance meropenem. Meronem is used to treat … active substance in Meronem, meropenem, is an antibiotic that belongs … Meronem and associated names meropenem powder for solution for injection … -
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Opinion/decision on a Paediatric investigation plan (PIP): Meropenem
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-000898-PIP01-10-M02, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection/infusion
Decision date: 18/03/2016, Last updated: 26/04/2016, Compliance check: XKey facts Meropenem Infectious diseasesP/0065/2016EMEA-000898-PIP01-10-M02 … paediatric investigation plan for meropenem (EMEA-000898-PIP01-10-M02 … paediatric investigation plan for meropenem (EMEA-000898-PIP01-10-M02 … -
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Human medicine European public assessment report (EPAR): Zerbaxa
ceftolozane sulfate, tazobactam sodium, Bacterial Infections
Date of authorisation: 18/09/2015, Revision: 15, Authorised, Last updated: 06/09/2022with another antibiotic, meropenem. Both medicines cured 94 … and 375 out of 399 given meropenem). The third study involved … at least as effective as meropenem: the infection had resolved … -
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Human medicine European public assessment report (EPAR): Zavicefta
avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016,, Revision: 14, Authorised, Last updated: 05/07/2022
effective as the antibiotic meropenem in 1,490 patients with complicated … of patients treated with meropenem. In the second study, 94 … of patients treated with meropenem. A third study looked at 332 … -
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Human medicine European public assessment report (EPAR): Xerava
eravacycline, Infection; Bacterial Infections
Date of authorisation: 20/09/2018,, Revision: 4, Authorised, Last updated: 19/08/2021
Xerava was compared with meropenem (another antibiotic). After … of patients treated with meropenem were cured of their infection … -
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Human medicine European public assessment report (EPAR): Recarbrio
imipenem monohydrate, cilastatin sodium, relebactam monohydrate, Gram-Negative Bacterial Infections
Date of authorisation: 13/02/2020,, Revision: 5, Authorised, Last updated: 29/11/2022
antibiotics (such as ertapenem and meropenem) or in patients who have had … antibiotics (such as ertapenem and meropenem) or in patients who have had … -
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Press release: New medicine to treat infections in adults
CHMP, Last updated: 21/09/2018authorisation for Vabomere (meropenem trihydrate/vaborbactam … beta-lactamase inhibitor and meropenem, a broad-spectrum antibiotic … beta-lactamases, vaborbactam protects meropenem from being inactivated and … -
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Opinion/decision on a Paediatric investigation plan (PIP): vaborbactam (updated)
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Infectious diseases
PIP number: EMEA-001740-PIP01-14, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for infusion
Decision date: 22/10/2015, Last updated: 11/01/2023, Compliance check: Xvaborbactam (in combination with meropenem trihydrate) (EMEA-001740-PIP01-14 … vaborbactam (in combination with meropenem trihydrate ) is identical … EMEA-001731-PIP01-14 for meropenem trihydrate (in combination … -
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National expert: Matti Karvanen, Medical Products Agency (updated)
- Declaration of interests - 80.32 KB | PDF
- Curriculum Vitae - 18.71 KB | PDF
early combination effects of colistin and meropenem against Pseudomonas aeruginosa … interaction of colistin and meropenem on a WT and a resistant strain … Effects of Colistin and Meropenem in Vitro against Pseudomonas … -
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National expert: Salvatore Piano, European Medicines Agency (updated)
- Declaration of interests - 82.08 KB | PDF
- Curriculum Vitae - 19.96 KB | PDF
investigator-initiated trial comparing meropenem plus daptomycin versus ceftazidime … -
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Orphan designation: Temocillin sodium for: Treatment of Burkholderia cepacia lung infection in cystic fibrosis
Date of designation: 14/01/2004, Positive, Last updated: 14/07/2014kill micro-organisms) (e.g. meropenem and ceftazidime). At the … kill micro-organisms) (e.g. meropenem and ceftazidime). At the … -
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National expert: Flora Musuamba Tshinanu, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.09 KB | PDF
- Curriculum Vitae - 29.05 KB | PDF
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National expert: Pieter Colin, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 80.41 KB | PDF
- Curriculum Vitae - 30.13 KB | PDF
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2018
CHMP, Last updated: 21/09/2018meropenem trihydrate / vaborbactam … -
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National expert: Mair Powell, Health Products Regulatory Authority (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 20.22 KB | PDF
Haemophilus influenzae to meropenem compared with imipenem, five … -
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National expert: Alicia Rodriguez Gascon, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 44.26 KB | PDF
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National expert: Irja Lutsar, State Agency of Medicines (updated)
- Declaration of interests - 81.68 KB | PDF
- Curriculum Vitae - 65.59 KB | PDF
Free PMC article. Review. Meropenem vs standard of care for treatment … -
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Human medicine European public assessment report (EPAR): Prevymis
Letermovir, Cytomegalovirus Infections
Date of authorisation: 08/01/2018,
, Revision: 13, Authorised, Last updated: 24/11/2022
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Human medicine European public assessment report (EPAR): Invanz
ertapenem sodium, Community-Acquired Infections; Streptococcal Infections; Staphylococcal Infections; Gram-Negative Bacterial Infections; Surgical Wound Infection; Pneumonia, Bacterial
Date of authorisation: 18/04/2002, Revision: 26, Authorised, Last updated: 25/10/2022 -
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Human medicine European public assessment report (EPAR): Fetcroja
cefiderocol sulfate tosilate, Gram-Negative Bacterial Infections
Date of authorisation: 23/04/2020,, Revision: 4, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Xydalba
dalbavancin hydrochloride, Soft Tissue Infections; Skin Diseases, Bacterial
Date of authorisation: 19/02/2015, Revision: 15, Authorised, Last updated: 14/12/2022 -
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Human medicine European public assessment report (EPAR): Cubicin
daptomycin, Gram-Positive Bacterial Infections; Bacteremia; Soft Tissue Infections; Endocarditis, Bacterial
Date of authorisation: 19/01/2006, Revision: 37, Authorised, Last updated: 15/12/2022 -
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Human medicine European public assessment report (EPAR): Lacosamide UCB (updated)
lacosamide, Epilepsies, Partial
Date of authorisation: 26/08/2019, Revision: 5, Authorised, Last updated: 25/01/2023