1411 results
Keyword Acido Folico SF Remove keyword
-
List item
Orphan designation: Obiltoxaximab for: Treatment of anthrax
Date of designation: 24/08/2018, Positive, Last updated: 27/11/2020the European Commission to SFL Regulatory Services GmbH … sponsorship was transferred to SFL Pharmaceuticals Deutschland … in the EU as Obiltoxaximab SFL since 18 November 2020. Expand … -
List item
Human medicine European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL)
nyxthracis, Anthrax
Date of authorisation: 18/11/2020,
, 
, 
, Revision: 3, Authorised, Last updated: 15/12/2022
previously Obiltoxaximab SFL) Infections Bacterial Infections Bacterial … obiltoxaximab Overview Obiltoxaximab SFL is a medicine used with antibiotic … available. Obiltoxaximab SFL contains the The substance … -
List item
Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of designation: 16/01/2014, Positive, Last updated: 23/01/2014Lactobacillus acidophilus and Bifidobacterium bifidum … Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic acid (diphenylmethyl)-amide, polysodium salt
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Other
PIP number: EMEA-001354-PIP01-12, Route(s) of administration: Vaginal use, Pharmaceutical form(s): Vaginal gel
Decision date: 26/02/2013, Last updated: 23/04/2013, Compliance check: X2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … 2,6-bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2 … 2,6-Bis-{(1-napthalenyl-3,6-disulfonic acid)-oxyacetamido}-2,6-bis-2,6-bis-2,6-bis-(2,6-diamino-hexanoylamino)-2,6-diamino-hexanoic … -
List item
Human medicine European public assessment report (EPAR): Sibnayal
Potassium citrate monohydrated, Potassium hydrogen carbonate, Acidosis, Renal Tubular
Date of authorisation: 30/04/2021, Revision: 1, Authorised, Last updated: 26/04/2022Diseases Acid-Base Imbalance Acidosis Acidosis, Renal Tubular … with distal renal tubular acidosis (dRTA), a disease in which … with distal renal tubular acidosis (dRTA), a disease in which … -
List item
Press release: Updated advice on body fat changes and lactic acidosis with HIV medicines
CHMP, Last updated: 23/10/2015body fat changes and lactic acidosis with HIV medicines … body fat changes and lactic acidosis with medicines for the treatment … require a warning about lactic acidosis. … -
List item
Human medicine European public assessment report (EPAR): Bondenza (previously Ibandronic Acid Roche)
ibandronic acid, Osteoporosis, Postmenopausal
Date of authorisation: 23/02/2004, Revision: 16, Withdrawn, Last updated: 13/05/2013Roche)EMEA/H/C/000502ibandronic acidibandronic acidOsteoporosis, PostmenopausalM05BA06 Publication … -
List item
Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of designation: 20/06/2017, Withdrawn, Last updated: 03/05/2021treatment of distal renal tubular acidosis. The sponsor’s address was … What is distal renal tubular acidosis? Distal renal tubular acidosis is a kidney disease in which … type of distal renal tubular acidosis, usually first detected in … -
List item
Human medicine European public assessment report (EPAR): Ebymect
dapagliflozin propanediol monohydrate, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 15/11/2015, Revision: 17, Authorised, Last updated: 28/01/2022any form of acute metabolic acidosis (build up of acid in the … called ketones) or lactic acidosis (build-up of lactic acid … increase the risk of lactic acidosis (see section 4.4) should … -
List item
Human medicine European public assessment report (EPAR): Xigduo
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 18, Authorised, Last updated: 28/01/2022any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid … -
List item
National expert: Shawgi Fiseifis, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.81 KB | PDF
- Curriculum Vitae - 17.33 KB | PDF
PDF icon application/pdf sfiseifis_CV_en.pdf Declaration of interests … PDF icon application/pdf sfiseifis_DI_en.pdf … -
List item
Orphan designation: 5-(4,6-dimorpholino-1,3,5-triazin-2-yl)-4-(trifluoromethyl)pyridin-2-amine (bimiralisib) for: Treatment of diffuse large B-cell lymphoma
Date of designation: 27/02/2017, Positive, Last updated: 10/06/2021sponsorship was transferred to SFL Pharmaceuticals Deutschland … -
List item
Human medicine European public assessment report (EPAR): Stribild (updated)
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate, HIV Infections
Date of authorisation: 24/05/2013, Revision: 25, Authorised, Last updated: 02/02/2023been seen including lactic acidosis (excess lactic acid in the … been seen including lactic acidosis (excess lactic acid in the … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): Obiltoxaximab
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-002144-PIP01-17, Route(s) of administration: Solution for infusion, Pharmaceutical form(s): Intravenous drip use
Decision date: 30/01/2018, Last updated: 17/04/2018, Compliance check: Xinfection Solution for infusion SFL Pharmaceuticals Deutschland … 7621 5500 250 E-mail: RA@sfl-services.com P: decision … application submitted by SFL Regulatory Affairs Consulting … -
List item
Opinion/decision on a Paediatric investigation plan (PIP): N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl) cyclobutyl)-3-phenylisoxazole-5-
Decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Therapeutic area: Pneumology-allergology
PIP number: EMEA-002398-PIP01-18, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral dosage form, Capsule, hard
Decision date: 17/05/2019, Last updated: 12/10/2020, Compliance check: Xcystic fibrosis Oral use SFL Pharmaceuticals Deutschland … 7621 5500 250 E-mail: RA@sfl-services.com P: decision … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Teva Generics
zoledronic acid monohydrate, Osteoporosis; Osteitis Deformans
Date of authorisation: 27/03/2014,
, Revision: 2, Withdrawn, Last updated: 08/08/2016
acid monohydratezoledronic acidOsteoporosisOsteitis DeformansM05BA08 This is … -
List item
Orphan designation: Sodium (4-{(E)-3-(4-fluorophenyl)-3-[4-(3-morpholin-4-yl-prop1ynyl)phenyl]allyloxy}-2-methylphenoxy)acetate for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 21/08/2020, Positive, Last updated: 25/11/2020encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
List item
Human medicine European public assessment report (EPAR): Zoledronic acid Teva Pharma
zoledronic acid, Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal
Date of authorisation: 15/08/2012,, Revision: 11, Withdrawn, Last updated: 12/12/2018
-
List item
Orphan designation: (S)-6-hydroxy-2,5,7,8-tetramethyl-N-((R)-piperidin-3-yl)chroman-2-carboxamide hydrochloride for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 10/08/2015, Positive, Last updated: 02/10/2015encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … -
List item
Orphan designation: Vatiquinone for: Treatment of mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes
Date of designation: 24/02/2022, Positive, Last updated: 28/04/2022encephalomyopathy, lactic acidosis, and stroke-like episodes … encephalomyopathy, lactic acidosis, and stroke-like episodes … -
List item
Orphan designation: 2-isopropyl-3H-naphtho[1,2-d]imidazole-4,5-dione for: Treatment of mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes
Date of designation: 12/12/2017, Positive, Last updated: 03/02/2021encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … encephalomyopathy, lactic acidosis and stroke-like episodes … -
List item
News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020
CHMP, Last updated: 18/09/2020Obiltoxaximab SFL* … -
List item
Human medicine European public assessment report (EPAR): Icandra (previously Vildagliptin / metformin hydrochloride Novartis)
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 30/11/2008, Revision: 25, Authorised, Last updated: 09/11/2022who could develop metabolic acidosis (build-up of acid in the … who could develop metabolic acidosis (build-up of acid in the … -
List item
Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 5, Authorised, Last updated: 12/09/2022
of infection), metabolic acidosis (imbalance in the body’s … of infection), metabolic acidosis (imbalance in the body’s … -
List item
Human medicine European public assessment report (EPAR): Eucreas
vildagliptin, metformin hydrochloride, Diabetes Mellitus, Type 2
Date of authorisation: 14/11/2007, Revision: 22, Authorised, Last updated: 08/11/2022who could develop metabolic acidosis (build-up of acid in the … who could develop metabolic acidosis (build-up of acid in the … information on the risk of lactic acidosis. These patients form a large …