176 results
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Opinion/decision on a Paediatric investigation plan (PIP): Ceftriaxone, Sulbactam
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-001568-PIP03-14, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection or infusion
Decision date: 09/03/2015, Last updated: 24/03/2015, Compliance check: XKey facts Ceftriaxone Sulbactam Infectious diseasesP/0054/2015EMEA-001568-PIP03-14 … deferral for ceftriaxone / sulbactam (EMEA-001568-PIP03-14) PDF … investigation plan: Ceftriaxone / sulbactam for treatment of bacterial … -
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Opinion/decision on a Paediatric investigation plan (PIP): Durlobactam / sulbactam (SUL-DUR)
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-002807-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for solution for injection
Decision date: 22/12/2020, Last updated: 20/09/2021, Compliance check: Xtive substance Durlobactam / sulbactam (SUL-DUR) Therapeutic area … deferral for durlobactam / sulbactam (SUL-DUR) (EMEA-002807-PIP01-20 … deferral for durlobactam / sulbactam (SUL-DUR) (EMEA-002807-PIP01-20 … -
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National expert: Irene Bidault, National Agency For The Safety Of Medicine And Health Products (updated)
- Declaration of interests - 80.05 KB | PDF
- Curriculum Vitae - 16.41 KB | PDF
PDF icon application/pdf ibidault_CV_en.pdf Declaration of interests … PDF icon application/pdf ibidault_DI_en.pdf … -
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Orphan designation: Acetylleucine for: Treatment of GM2 gangliosidosis
Date of designation: 12/12/2017, Positive, Last updated: 25/04/2019acetylleucine (also known as IBI1000) for the treatment of GM2 … acetylleucine (also known as IBI1000) for the treatment of GM2 … -
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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
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, Revision: 13, Authorised, Last updated: 09/07/2021
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Press release: Two new medicines for advanced kidney cancer
CHMP, Last updated: 22/07/2016recommendation is based is a Phase Ib/II trial involving 153 patients … complement data from the phase Ib/II trial. The opinions adopted … recommendation is based is a Phase Ib/II trial involving 153 patients … -
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National expert: Simona Kudeliene, Lithuania States Medicines Control Agency (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 17.14 KB | PDF
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National expert: Maria Grazia Evandri, Italian Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 25.26 KB | PDF
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National expert: Maria Teresa Herdeiro, European Medicines Agency (updated)
- Declaration of interests - 79.78 KB | PDF
- Curriculum Vitae - 29.22 KB | PDF
Present Principal investigator iBiMED - University of Aveiro (Portugal) Research … Herdeiro Organisation/Company: iBiMED University of Aveiro Country … -
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National expert: Raúl J. Andrade, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 85.79 KB | PDF
- Curriculum Vitae - 38.52 KB | PDF
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National expert: Piyush Jain, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.04 KB | PDF
- Curriculum Vitae - 29.81 KB | PDF
Gianluca Matteoli, Sales Ibiza Martinez, Cintya Lopez-Lopez … Mondelaers, S.U., Matteoli, G., Ibiza Martinez, S., Lopez-Lopez … -
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National expert: Ulrich Nordheim, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 81.66 KB | PDF
- Curriculum Vitae - 18.34 KB | PDF
Cannabinoid Antagonist Ibipinabant (SLV319) Obesity, Diabetes … -
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National expert: Anna Wachnik-Święcicka, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 80.09 KB | PDF
- Curriculum Vitae - 18.93 KB | PDF
of infants2-12 months old (ibid.). 3. Wachnik A., Nagy K … zsiranyagcserere, patkanyban (ibid.). 8. Biro L., Rodics K … aktiyitasara patkany szerumban (ibid.). 11. Antal M., Wachnik … -
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National expert: Ewa Widy Tyszkiewicz, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 26.02 KB | PDF
II. Anticholinergic drugs, ibid, 393-399. E. Widy-Tyszkiewicz … Drugs and autonomic Ganglia, ibid, 401-404. [polish] E. Widy-Tyszkiewicz … neuromuscular transduction, ibid, 406-409 [polish] E. Widy-Tyszkiewicz … -
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National expert: María José Torres, European Medicines Agency (updated)
- Declaration of interests - 84.86 KB | PDF
- Curriculum Vitae - 18.81 KB | PDF
Present Head of Research Group IBIMA - Hospital Regional Universitario … Biomedical Research in Málaga (IBIMA). In the latter, I am coordinator … -
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Human medicine European public assessment report (EPAR): Wakix
pitolisant, Narcolepsy
Date of authorisation: 31/03/2016,, 
, Revision: 11, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, , Revision: 3, Authorised, Last updated: 20/08/2021
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National expert: Monica Bartolomei, Italian Medicines Agency (updated)
- Declaration of interests - 79.87 KB | PDF
- Curriculum Vitae - 23.95 KB | PDF
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National expert: Maria Francesca Cometa, Italian Medicines Agency (updated)
- Declaration of interests - 80.13 KB | PDF
- Curriculum Vitae - 24.38 KB | PDF
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National expert: Massimiliano Filosto, European Medicines Agency (updated)
- Declaration of interests - 82.21 KB | PDF
- Curriculum Vitae - 25.05 KB | PDF
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Human medicine European public assessment report (EPAR): Zavicefta (updated)
avibactam sodium, ceftazidime pentahydrate, Pneumonia, Bacterial; Soft Tissue Infections; Pneumonia; Urinary Tract Infections; Gram-Negative Bacterial Infections
Date of authorisation: 23/06/2016,, Revision: 12, Authorised, Last updated: 26/10/2021
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Human medicine European public assessment report (EPAR): Vaxzevria (previously COVID-19 Vaccine AstraZeneca) (updated)
ChAdOx1-SARS-COV-2, COVID-19 virus infection
Date of authorisation: 29/01/2021,, 
, Revision: 14, Authorised, Last updated: 28/10/2021
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Human medicine European public assessment report (EPAR): Tygacil (updated)
Tigecycline, Bacterial Infections; Skin Diseases, Bacterial; Soft Tissue Infections
Date of authorisation: 24/04/2006, Revision: 33, Authorised, Last updated: 26/10/2021 -
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Human medicine European public assessment report (EPAR): Lenalidomide Mylan
lenalidomide, Multiple Myeloma
Date of authorisation: 18/12/2020,
, Revision: 3, Authorised, Last updated: 01/09/2021
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National expert: Wei Zhao, European Medicines Agency (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 29.36 KB | PDF