7208 results
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Orphan designation: Lactobacillus acidophilus and Bifidobacterium bifidum for: Prevention of necrotising enterocolitis
Date of first decision: 16/01/2014, Positive, Last updated: 23/01/2014Italy, for Lactobacillus acidophilus and Bifidobacterium bifidum … expected to work? Lactobacillus acidophilus and Bifidobacterium bifidum … designation Lactobacillus acidophilus and Bifidobacterium bifidum … -
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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-(2,6-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-(2,6-diamino-hexanoylamino)- 2,6-diamino-hexanoic … -
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Opinion/decision on a Paediatric investigation plan (PIP): gallium (68Ga) chloride, germanium (68Ge) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-001102-PIP01-10, Route(s) of administration: Other use, Pharmaceutical form(s): Radionuclide generator
Decision date: 08/06/2011, Last updated: 14/07/2011, Compliance check: Xsubstance gallium (68Ga) chloride germanium (68Ge) chloride Therapeutic … regaffairs.radiopharma@ezag.de Germany +49 30941084282 +49 30941084160 … Gallium [68 Ga] Chloride / Germanium [68 Ge] Chloride (EMEA-001102-PIP01-10 … -
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Opinion/decision on a Paediatric investigation plan (PIP): germanium (68Ge) chloride, gallium (68Ga) chloride
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Other
PIP number: EMEA-002436-PIP01-18, Pharmaceutical form(s): Radionuclide generator
Decision date: 03/01/2019, Last updated: 24/04/2019, Compliance check: XActive substance germanium (68Ge) chloride gallium (68Ga … germanium (68Ge) chloride gallium … -
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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 HIV medicines … body fat changes and lactic acidosis with HIV medicines 23 … -
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National expert: Katarzyna Germel, The Office for Registration of Medicinal Products, Medical Devices and Biocides (updated)
- Declaration of interests - 79.8 KB | PDF
- Curriculum Vitae - 16.45 KB | PDF
Vitae PERSONAL INFORMATION Katarzyna Germel WORK EXPERIENCE March 2020 … Germel 2020-12-11 Classified as … of interests I, Katarzyna Germel Organisation/Company: The … -
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Non-clinical testing for inadvertent germline transmission of gene transfer vectors
Last updated: 17/11/2005ical testing for inadvertent germline transmission of gene transfer … ical testing for inadvertent germline transmission of gene transfer … NfG - nonclinical testing - germline transmission European …
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ICH Considerations: general principles to address the risk of inadvertent germline integration of gene therapy vectors
Last updated: 01/11/2006address the risk of inadvertent germline integration of gene therapy … address the risk of inadvertent germline integration of gene therapy …
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News: European Medicines Agency and German Society for Transfusion Medicine and Immunohaematology to co-organise workshop on advanced therapies
Last updated: 19/05/2014European Medicines Agency and German Society for Transfusion Medicine … European Medicines Agency and German Society for Transfusion Medicine … -
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The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Berlin, Germany
one-by-one EDV-GmbH, Berlin, Germany, from 24/09/2018 to 26/09/2018, Last updated: 14/06/2018training course, Berlin, Germany … training course, Berlin, Germany … one-by-one EDV-GmbH, Berlin, Germany Course # 18515 OVERVIEW EudraVigilance … -
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Committee for Advanced Therapies (CAT) and the German Society for Transfusion Medicine and Immunohaematology (DGTI) workshop on advanced-therapy medicinal products: How to bring cell-based medicinal products successfully to the market
Dresden, Germany, 11/09/2014, Last updated: 21/10/2014Advanced Therapies (CAT) and the German Society for Transfusion Medicine … Advanced Therapies (CAT) and the German Society for Transfusion Medicine … Congress Centrum, Dresden, GERMANY Introduction … -
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Human medicine European public assessment report (EPAR): Xigduo
metformin hydrochloride, dapagliflozin propanediol monohydrate, Diabetes Mellitus, Type 2
Date of authorisation: 16/01/2014, Revision: 16, Authorised, Last updated: 12/02/2020any form of acute metabolic acidosis (build up of acid in the … ‘ketones’) or lactic acidosis (build-up of lactic acid … -
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Orphan designation: tripotassium citrate monohydrate, Potassium hydrogen carbonate for: Treatment of distal renal tubular acidosis
Date of first decision: 20/06/2017, Positive, Last updated: 17/07/2017treatment of distal renal tubular acidosis. Expand section Collapse section … 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 … -
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Human medicine European public assessment report (EPAR): Azarga
brinzolamide, timolol maleate, Glaucoma, Open-Angle, Ocular Hypertension
Date of authorisation: 25/11/2008, Revision: 13, Authorised, Last updated: 17/08/2020airways); have hyperchloraemic acidosis (excess acid in the blood … • have hyperchloraemic acidosis (excess acid in the blood … -
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Human medicine European public assessment report (EPAR): Simbrinza
brinzolamide, brimonidine tartrate, Ocular Hypertension, Glaucoma, Open-Angle
Date of authorisation: 18/07/2014, Revision: 7, Authorised, Last updated: 11/06/2020patients with hyperchloraemic acidosis (excess acid in the blood … patients with hyperchloraemic acidosis (excess acid in the blood … -
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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 first decision: 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 … -
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Human medicine European public assessment report (EPAR): Synjardy
empagliflozin, metformin, Diabetes Mellitus, Type 2
Date of authorisation: 27/05/2015,
, Revision: 17, Authorised, Last updated: 21/10/2020
patients with: metabolic acidosis (when the body produces more … patients with: • metabolic acidosis (when the body produces more … -
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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 first decision: 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 … -
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Human medicine European public assessment report (EPAR): Kaletra
lopinavir, ritonavir, HIV Infections
Date of authorisation: 19/03/2001, Revision: 55, Authorised, Last updated: 25/11/2020PDF/79.64 KB) (PDF/79.64 KB) German (PDF/80.1 KB) (PDF/80.1 KB … -
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Human medicine European public assessment report (EPAR): Trizivir (updated)
abacavir (as sulfate), lamivudine, zidovudine, HIV Infections
Date of authorisation: 27/12/2000, Revision: 36, Authorised, Last updated: 25/02/2021PDF/129.75 KB) (PDF/129.75 KB) German (PDF/130.91 KB) (PDF/130.91 … readily available. Lactic acidosis Lactic acidosis, usually associated with hepatomegaly … -
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Human medicine European public assessment report (EPAR): Ziagen (updated)
abacavir, HIV Infections
Date of authorisation: 08/07/1999, Revision: 42, Authorised, Last updated: 24/02/2021PDF/128.61 KB) (PDF/128.61 KB) German (PDF/130.23 KB) (PDF/130.23 … -
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Human medicine European public assessment report (EPAR): Kivexa (updated)
abacavir, lamivudine, HIV Infections
Date of authorisation: 16/12/2004, Revision: 33, Authorised, Last updated: 25/02/2021PDF/131.01 KB) (PDF/131.01 KB) German (PDF/131.62 KB) (PDF/131.62 … -
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Human medicine European public assessment report (EPAR): Stocrin (updated)
efavirenz, HIV Infections
Date of authorisation: 28/05/1999, Revision: 45, Authorised, Last updated: 18/02/2021PDF/84.38 KB) (PDF/84.38 KB) German (PDF/84.78 KB) (PDF/84.78 … -
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Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated, Potassium hydrogen carbonate
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Uro-nephrology
PIP number: EMEA-001357-PIP01-12-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Prolonged-release granules
Decision date: 07/12/2018, Last updated: 19/02/2019, Compliance check: XTreatment of renal tubular acidosis Oral use Advicenne Pharma … treatment of renal tubular acidosis PDF icon application/pdf … treatment of renal tubular acidosis On 15 August 2014, the … -
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National expert: Silvia Berkner, Federal Institute for Drugs and Medical Devices (updated)
- Declaration of interests - 79.76 KB | PDF
- Curriculum Vitae - 18.55 KB | PDF
Assessor Federal Environment Agency (Germany) EDUCATION AND TRAINING March … Biochemistry University of Bayreuth (Germany) Biochemistry, Molecular … Sciences University of Bayreuth (Germany) Hydrology, Environmental …