219 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 - 80.07 KB | PDF
- Curriculum Vitae - 16.59 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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Human medicine European public assessment report (EPAR): Tagrisso
osimertinib mesilate, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 01/02/2016,
, Revision: 17, Authorised, Last updated: 29/11/2022
adult patients with stage IB-IIIA non-small cell lung cancer … adult patients with stage IB-IIIA non-small cell lung cancer … -
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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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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 - 17.67 KB | PDF
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National expert: Paola Minghetti, Italian Medicines Agency (updated)
- Declaration of interests - 81.41 KB | PDF
- Curriculum Vitae - 62.13 KB | PDF
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National expert: Raúl J. Andrade, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 85.81 KB | PDF
- Curriculum Vitae - 38.85 KB | PDF
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National expert: Maria Teresa Herdeiro, European Medicines Agency (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 31.39 KB | PDF
Principal investigator /Professor iBiMED - University of Aveiro (Portugal) Research … Herdeiro Organisation/Company: iBiMED /Medical Science Department … -
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National expert: Anna Wachnik-Święcicka, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 79.84 KB | PDF
- Curriculum Vitae - 19.15 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: Maria Grazia Evandri, Italian Medicines Agency (updated)
- Declaration of interests - 79.83 KB | PDF
- Curriculum Vitae - 26.75 KB | PDF
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National expert: Piyush Jain, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 81.03 KB | PDF
- Curriculum Vitae - 30.18 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 - 81.68 KB | PDF
- Curriculum Vitae - 18.54 KB | PDF
Cannabinoid Antagonist Ibipinabant (SLV319) Obesity, Diabetes … -
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National expert: Valentina Di Giovanni, Italian Medicines Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 19.31 KB | PDF
company belonging to the IBIGEN group) (Italy) Implementation … company belonging to the IBIGEN group) (Italy) Involvment … -
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National expert: María Isabel Lucena, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.82 KB | PDF
- Curriculum Vitae - 32.33 KB | PDF
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Human medicine European public assessment report (EPAR): Kisqali (updated)
ribociclib succinate, Breast Neoplasms
Date of authorisation: 22/08/2017, Revision: 12, Authorised, Last updated: 11/01/2023 -
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National expert: Guoda Radaviciute, Lithuania States Medicines Control Agency (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 17.34 KB | PDF
evaluation of variations of type IB/IA and validation of type II … -
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National expert: Marta de Vicente, Spanish Agency of Medicines and Medical Devices (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 17.63 KB | PDF
Constituted by Antibióticos, S.A., Ibys, S.A., Alergía e Inmunología Abelló … -
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Human medicine European public assessment report (EPAR): Supemtek
Influenza A virus subtype H1N1 haemagglutinin, recombinant, Influenza A virus subtype H3N2 haemagglutinin, recombinant, Influenza B virus Victoria lineage haemagglutinin, recombinant, Influenza B virus Yamagata lineage haemagglutinin, recombinant, Influenza, Human
Date of authorisation: 16/11/2020,
, Revision: 2, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Polivy
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, 
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, Revision: 4, Authorised, Last updated: 22/09/2022
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, , Revision: 5, Authorised, Last updated: 28/04/2022
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National expert: Christian Mayer, Austrian Medicines and Medical Devices Agency (updated)
- Declaration of interests - 79.79 KB | PDF
- Curriculum Vitae - 18.22 KB | PDF
cyanobacterial cytochrome c oxidase. Ibidem pp.341-355 Projects Memberships Other … -
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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: 20, Authorised, Last updated: 24/08/2022 -
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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