152 results
Keyword Albumina Grifols Remove keyword
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Opinion/decision on a Paediatric investigation plan (PIP): VeraSeal, human fibrinogen, human thrombin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001598-PIP01-13-M03, Route(s) of administration: Epilesional use, Pharmaceutical form(s): Solution for sealant
Decision date: 27/01/2021, Last updated: 06/10/2021, Compliance check: Xpublic enquiries Instituto Grifols, S.A. E-mail: areatecnica.instituto@grifols.com … application submitted by Instituto Grifols, S.A. on 10 September 2020 … is addressed to Instituto Grifols, S.A., Can Guasc, 2 Parets … -
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Opinion/decision on a Paediatric investigation plan (PIP): Flebogamma DIF (previously Flebogammadif), Human normal immunoglobulin
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-003121-PIP01-21, Route(s) of administration: All routes of administration, Pharmaceutical form(s): All pharmaceutical forms
Decision date: 11/03/2022, Last updated: 20/04/2023, Compliance check: Xadministration Instituto Grifols, S.A. E-mail: areatecnica.instituto@grifols.com … application submitted by Instituto Grifols, S.A. on 14 October 2021 under … is addressed to Instituto Grifols, S.A., 2 Can Guasch St, Poligono … -
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Opinion/decision on a Paediatric investigation plan (PIP): human fibrinogen
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-002769-PIP01-20, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 15/07/2020, Last updated: 16/06/2021, Compliance check: XIntravenous use Instituto Grifols, S.A. E-mail: areatecnica.instituto@grifols.com … application submitted by Instituto Grifols, S.A. on 24 February 2020 … is addressed to Instituto Grifols, S.A., 2 Can Guasch St., Polígono … -
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Human medicine European public assessment report (EPAR): VeraSeal
human fibrinogen, human thrombin, Hemostasis, Surgical
Date of authorisation: 10/11/2017, Revision: 7, Authorised, Last updated: 12/01/2023 -
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Opinion/decision on a Paediatric investigation plan (PIP): Human normal immunoglobulin
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001853-PIP01-15-M02, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/11/2019, Last updated: 16/09/2021, Compliance check: V, 13/11/2020Contact for public enquiries Grifols Therapeutics Inc. Tel. +49 … -
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Orphan designation: Human plasmin for: Treatment of acute peripheral arterial occlusion
Date of designation: 23/02/2011, Withdrawn, Last updated: 12/03/2018Biotherapeutics GmbH changed name to Grifols Deutschland GmbH. Expand … -
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Orphan designation: for: Treatment of congenital alpha-1 antitrypsin deficiency
Date of designation: 03/06/2008, Positive, Last updated: 17/10/2013Biotherapeutics GmbH changed name to Grifols Deutschland GmbH. Expand … Biotherapeutics GmbH changed name to Grifols Deutschland GmbH. What … Sponsor’s contact details: Grifols Deutschland GmbH … -
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Orphan designation: Alpha-1 proteinase inhibitor for: Treatment of cystic fibrosis
Date of designation: 10/10/2012, Positive, Last updated: 16/11/2012the European Commission to Grifols Deutschland GmbH, Germany … European Commission to Grifols Deutschland GmbH, Germany … Sponsor’s contact details: Grifols Deutschland GmbH Lyoner … -
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Plasma master file certificates (updated)
Last updated: 17/05/2023Behring (ref. EMA/H/PMF/000001/04) Grifols (ref. EMA/H/PMF/000002/04) Takeda …
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Human medicine European public assessment report (EPAR): Tavlesse
Fostamatinib disodium, Thrombocytopenia
Date of authorisation: 09/01/2020,
, Revision: 5, Authorised, Last updated: 12/09/2022
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Human medicine European public assessment report (EPAR): Flebogamma DIF (previously Flebogammadif)
Human normal immunoglobulin, Mucocutaneous Lymph Node Syndrome; Guillain-Barre Syndrome; Bone Marrow Transplantation; Purpura, Thrombocytopenic, Idiopathic; Immunologic Deficiency Syndromes
Date of authorisation: 23/07/2007, Revision: 18, Authorised, Last updated: 04/02/2022 -
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National expert: Raffaella Sardelli, Italian Medicines Agency (updated)
- Declaration of interests - 39.64 KB | PDF
- Curriculum Vitae - 31.8 KB | PDF
alluminio in soluzioni di albumina umana: un monitoraggio italiano” … precallicreina in soluzioni di albumina umana” (Abs) La trasfusione … -
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European Medicines Agency's workshop on stem cell-based therapies
London, UK, 10/05/2010, Last updated: 16/02/2010applications: Dr Dirk Buscher, Grifols PDF icon application/pdf … applications Dr Dirk Buscher, Grifols Haematopoietic stem cells … -
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News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019
CHMP, Last updated: 28/06/2019Marketing-authorisation holder Instituto Grifols, S.A. More information … -
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National expert: Pere Soler Palacin, The Spanish Agency Of Medicines And Medical Devices (updated)
- Declaration of interests - 46.93 KB | PDF
- Curriculum Vitae - 24.25 KB | PDF
vaccine Past 01-07- 2016 01-12- 2020 Grifols IGSC 20% Subcutaneous immunoglobulin … therapeutic drug monitoring Grifols Genetic basis of common variable … therapeutic drug monitoring Grifols Genetic basis of common variable … -
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National expert: Maria Luisa Casini, Italian Medicines Agency (updated)
- Declaration of interests - 39.31 KB | PDF
- Curriculum Vitae - 39.53 KB | PDF
della stabilizzazione dell’albumina sierica da parte di sostanze … -
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Human medicine European public assessment report (EPAR): Renvela
sevelamer carbonate, Hyperphosphatemia; Renal Dialysis
Date of authorisation: 09/06/2009, Revision: 25, Authorised, Last updated: 05/01/2023 -
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Human medicine European public assessment report (EPAR): Renagel (updated)
sevelamer, Renal Dialysis; Hyperphosphatemia
Date of authorisation: 28/01/2000, Revision: 35, Authorised, Last updated: 24/05/2023 -
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Human medicine European public assessment report (EPAR): Eladynos (updated)
abaloparatide, Osteoporosis, Postmenopausal; Osteoporosis, Revision: 1, Authorised, Last updated: 22/05/2023
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,
, Revision: 9, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Farydak (updated)
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,, Revision: 12, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Prolia
denosumab, Bone Resorption; Osteoporosis, Postmenopausal
Date of authorisation: 26/05/2010, Revision: 26, Authorised, Last updated: 06/10/2022 -
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Human medicine European public assessment report (EPAR): NeuroBloc
botulinum toxin type B, Torticollis
Date of authorisation: 22/01/2001, Revision: 33, Withdrawn, Last updated: 04/05/2023 -
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , 
, Revision: 23, Authorised, Last updated: 14/04/2023
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Human medicine European public assessment report (EPAR): Xgeva
denosumab, Fractures, Bone; Neoplasm Metastasis
Date of authorisation: 13/07/2011, Revision: 23, Authorised, Last updated: 21/07/2022