Ակտրապիդ

main_info

  • trade_name:
  • Ակտրապիդ Փենֆիլ
  • dosage:
  • 100ՄՄ/մլ(5) ապակե փամփուշտներ 3մլ
  • pharmaceutical_form:
  • լուծույթ ներարկման
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Ակտրապիդ Փենֆիլ
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

  • source:
  • Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում - Armenia
  • last_update:
  • 31-05-2018

17-4-2019

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Assessment of the application for renewal of authorisation of GalliPro® (Bacillus subtilis DSM 17299) for chickens for fattening

Published on: Tue, 16 Apr 2019 GalliPro® is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. Bacillus subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the t...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-4-2019

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Nutrimune and immune defence against pathogens in the gastrointestinal and upper respiratory tracts: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Mon, 15 Apr 2019 Following an application from H.J. Heinz Supply Chain Europe B.V. submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Nutrimune and immune defence against pathogens in the gastrointestinal (GI) tract and upper respirator...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-4-2019

Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Evaluation of the health risks related to the presence of cyanogenic glycosides in foods other than raw apricot kernels

Published on: Thu, 11 Apr 2019 In 2016, the EFSA Panel on Contaminants in the Food Chain (CONTAM) published a scientific opinion on the acute health risks related to the presence of cyanogenic glycosides (CNGs) in raw apricot kernels in which an acute reference dose (ARfD) of 20 μg/kg body weight (bw) was established for cyanide (CN). In the present opinion, the CONTAM Panel concluded that this ARfD is applicable for acute effects of CN regardless the dietary source. To account for differences in cyanid...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-4-2019

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

EFSA Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment

Published on: Thu, 11 Apr 2019 The European Union (EU) pesticides Regulation established that in vitro comparative metabolism studies shall be performed. At present an Organisation for Economic Co‐operation and Development (OECD) test guideline for this kind of studies is not available. The European Food Safety Authority (EFSA) Workshop on in vitro comparative metabolism studies in regulatory pesticide risk assessment discussed the use of these studies to identify human metabolites and to support the as...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-4-2019

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283

Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283

Published on: Tue, 09 Apr 2019 In 2018, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that whey basic protein isolate obtained by ion exchange chromatography from skimmed cow's milk is safe for human consumption under the proposed conditions of use as infant and follow on formula, meal replacement beverages, foods for special medical purposes and food supplements. Following a request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion ...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-4-2019

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment

FDA today approved Dovato (dolutegravir and lamivudine), as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This is the first FDA-approved two-drug, fixed-dose, complete regimen for HIV-infected adults who have never received antiretroviral treatment for HIV.

FDA - U.S. Food and Drug Administration

6-4-2019

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Assessment of genetically modified maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 and subcombinations, for food and feed uses, under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2011‐103)

Published on: Fri, 05 Apr 2019 Maize Bt11 × MIR162 × MIR604 × 1507 × 5307 × GA21 (six‐event stack maize) was produced by conventional crossing to combine six single events: Bt11, MIR162, MIR604, 1507, 5307 and GA21. The GMO Panel previously assessed the six single events and 22 of their combinations and did not identify safety concerns. No new data on the maize single events or their 22 combinations that could lead to modification of the original conclusions on their safety have been identified. The mol...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-4-2019

FDA expands approved use of metastatic breast cancer treatment to include male patients

FDA expands approved use of metastatic breast cancer treatment to include male patients

The FDA is extending the indication of Ibrance (palbociclib) capsules in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in male patients.

FDA - U.S. Food and Drug Administration

2-4-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

FDA is announcing a public hearing to discuss access to affordable insulin products.

FDA - U.S. Food and Drug Administration

29-3-2019

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Final Report: Applying a tested procedure for the identification of potential emerging chemical risks in the food chain to the substances registered under REACH ‐ REACH 2

Published on: Thu, 28 Mar 2019 This study applied a procedure for the identification of potential emerging chemical risks in the food chain to substances registered under the REACH Regulation that was previously developed and tested in an EFSA‐sponsored pilot study. The selection was limited to substances that (a) were registered with a full registration, (b) met eligibility criteria (e.g. availability of a CAS number and a SMILES notation) and (c) were considered to be inside the applicability domain o...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-3-2019

EU Insights Chemical mixtures awareness, understanding and risk perceptions

EU Insights Chemical mixtures awareness, understanding and risk perceptions

Published on: Mon, 25 Mar 2019 EFSA defines ‘chemical mixtures’ as ‘several substances which may have combined effects on the body from their combined exposures’. There are already some methodologies for assessing risks from combined exposure to groups of chemicals, and EFSA together with European partners is developing methodologies to assess the risk from exposure to combinations of chemicals in food. However, consumers' understanding and views on this topic have not been documented. This poses signif...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-3-2019

Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals

Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals

Published on: Mon, 25 Mar 2019 This Guidance document describes harmonised risk assessment methodologies for combined exposure to multiple chemicals for all relevant areas within EFSA's remit, i.e. human health, animal health and ecological areas. First, a short review of the key terms, scientific basis for combined exposure risk assessment and approaches to assessing (eco)toxicology is given, including existing frameworks for these risk assessments. This background was evaluated, resulting in a harmoni...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-3-2019

Technical report of the public consultation on the draft ‘Guidance on harmonised risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals’

Technical report of the public consultation on the draft ‘Guidance on harmonised risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals’

Published on: Mon, 25 Mar 2019 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft guidance of the working group of the Scientific Committee ‘Harmonised risk assessment methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals’. The background and the Terms of Reference were prepared by EFSA staff and the working group of the Scienti...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across

Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across

Published on: Thu, 21 Mar 2019 To facilitate the practical implementation of the guidance on the residue definition for dietary risk assessment, EFSA has organized an evaluation of applicability of existing in silico models for predicting the genotoxicity of pesticides and their metabolites, including analysis of the impact on genotoxicity of the metabolic structural changes. The prediction ability of (Q)SARs for in vitro and in vivo tests were evaluated. For the Ames test, all (Q)SAR models generated s...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Published on: Wed, 20 Mar 2019 The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be establ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-3-2019

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

ANSES and University of Rennes 1 strengthen their scientific cooperation dedicated to "One Health"

Roger Genet, Director General of ANSES, and David Alis, President of the University of Rennes 1, today signed a scientific framework agreement aimed at strengthening their cooperation on environmental health, focused primarily on the "One Health" concept covering human, animal and plant health for the benefit of all. To mark this occasion, a conference and round table were organised on the theme of the exposome, one of the key issues at the heart of this new partnership between the two institutions.  

France - Agence Nationale du Médicament Vétérinaire

17-4-2019


Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Ajovy, fremanezumab, Migraine Disorders, Date of authorisation: 28/03/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-4-2019


Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Tobramycin PARI, tobramycin, Respiratory Tract Infections,Cystic Fibrosis, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

17-4-2019


Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease,

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease,

Human medicines European public assessment report (EPAR): Idacio, adalimumab, Arthritis, Rheumatoid,Arthritis, Juvenile Rheumatoid,Psoriasis,Arthritis, Psoriatic,Spondylitis, Ankylosing,Uveitis,Hidradenitis Suppurativa,Colitis, Ulcerative,Crohn Disease, Date of authorisation: 02/04/2019, Status: Authorised

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene, Treatment of choroideraemia, 04/07/2014, Positive

Orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene, Treatment of choroideraemia, 04/07/2014, Positive

Orphan designation: Adeno-associated viral vector serotype 2 containing the human REP1 gene, Treatment of choroideraemia, 04/07/2014, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Orphan designation: Recombinant human monoclonal antibody to insulin receptor, Treatment of congenital hyperinsulinism, 14/07/2016, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5 fused with RGD-motif, Prevention of the ischaemia/reperfusion injury associated with solid organ transplantation, 20/01/2009, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of primary membranoproliferative glomerulonephritis, 27/10/2011, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Orphan designation: Recombinant human minibody against complement component C5, Treatment of atypical haemolytic uraemic syndrome (aHUS), 22/09/2008, Withdrawn

Europe - EMA - European Medicines Agency

12-4-2019


Human medicines highlights - April 2019

Human medicines highlights - April 2019

Human medicines highlights - April 2019

Europe - EMA - European Medicines Agency

12-4-2019

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Diamond ROC EOOD)

EU/3/16/1665 (Active substance: Recombinant adeno-associated viral vector containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)2934 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005876

Europe -DG Health and Food Safety

12-4-2019

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Diamond ROC EOOD)

EU/3/15/1556 (Active substance: Recombinant adeno-associated viral vector containing human CNGA3 gene) - Transfer of orphan designation - Commission Decision (2019)2933 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005873

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Diamond ROC EOOD)

EU/3/13/1107 (Active substance: Recombinant adeno-associated viral vector containing the human retinoschisin gene) - Transfer of orphan designation - Commission Decision (2019)2932 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005875

Europe -DG Health and Food Safety

12-4-2019

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Diamond ROC EOOD)

EU/3/13/1099 (Active substance: Recombinant adeno-associated viral vector containing the human CNGB3 gene) - Transfer of orphan designation - Commission Decision (2019)2931 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005874

Europe -DG Health and Food Safety

12-4-2019

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Diamond ROC EOOD)

EU/3/07/440 (Active substance: Recombinant adeno-associated viral vector containing human alpha-1 antitrypsin gene) - Transfer of orphan designation - Commission Decision (2019)2930 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005871

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (JVM Europe B.V.)

EU/3/18/2126 (Active substance: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision (2019)2922 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005194

Europe -DG Health and Food Safety

12-4-2019

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (JVM Europe B.V.)

EU/3/18/2022 (Active substance: Glucagon analogue linked to a human immunoglobulin Fc fragment) - Transfer of orphan designation - Commission Decision 2920 of Fri, 12 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005277

Europe -DG Health and Food Safety

10-4-2019

Lantus (Sanofi-Aventis Deutschland GmbH)

Lantus (Sanofi-Aventis Deutschland GmbH)

Lantus (Active substance: insulin glargine) - Centralised - Yearly update - Commission Decision (2019)2815 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

10-4-2019

Actraphane (Novo Nordisk A/S)

Actraphane (Novo Nordisk A/S)

Actraphane (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2813 of Wed, 10 Apr 2019

Europe -DG Health and Food Safety

9-4-2019


Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Orphan designation: Lentiviral vector encoding human coagulation factor IX, Treatment of haemophilia B, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

9-4-2019


Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Orphan designation: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase, Treatment of mucopolysaccharidosis type II (Hunter’s syndrome), 26/02/2019, Positive

Europe - EMA - European Medicines Agency

5-4-2019


Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Orphan designation: Recombinant human club cell 10 KDa protein, Treatment of bronchiolitis obliterans syndrome, 27/02/2017, Positive

Europe - EMA - European Medicines Agency

4-4-2019

Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world’s smallest heart v

Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world’s smallest heart v

Under Dr. Gottlieb, CDRH continued bringing innovative devices to market using a total product life-cycle approach. For example, expanded approval of an automated insulin dosing system for people age 7 and up with diabetes and the world’s smallest heart valve for newborns. pic.twitter.com/SNokx8QVXW

FDA - U.S. Food and Drug Administration

3-4-2019


VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2

VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2

VICH GL36(R2): Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI - Revision 2

Europe - EMA - European Medicines Agency

3-4-2019

EU/3/17/1842 (EUDRAC GmbH)

EU/3/17/1842 (EUDRAC GmbH)

EU/3/17/1842 (Active substance: Recombinant human club cell 10 KDa protein) - Transfer of orphan designation - Commission Decision (2019)2668 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004449

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Real Regulatory Limited)

EU/3/19/2150 (Active substance: Codon-optimised human cystic fibrosis transmembrane conductance regulator messenger ribonucleic acid complexed with lipid-based nanoparticles) - Orphan designation - Commission Decision (2019)2666 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002333

Europe -DG Health and Food Safety

3-4-2019

EU/3/19/2149 (Brainvectis)

EU/3/19/2149 (Brainvectis)

EU/3/19/2149 (Active substance: Adeno-associated viral vector serotype rh10 containing the human cholesterol 24-hydroxylase gene) - Orphan designation - Commission Decision (2019)2665 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002264

Europe -DG Health and Food Safety

3-4-2019

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Tracon Pharma International Limited)

EU/3/16/1648 (Active substance: Human/murine chimeric monoclonal antibody against endoglin) - Transfer of orphan designation - Commission Decision (2019)2677 of Wed, 03 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004633

Europe -DG Health and Food Safety

1-4-2019

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Amicus Therapeutics Europe Limited)

EU/3/18/2000 (Active substance: Recombinant human acid alpha-glucosidase) - Transfer of orphan designation - Commission Decision (2019)2423 of Mon, 01 Apr 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004425

Europe -DG Health and Food Safety

1-4-2019

NovoRapid (Novo Nordisk A/S)

NovoRapid (Novo Nordisk A/S)

NovoRapid (Active substance: Insulin aspart) - Centralised - Yearly update - Commission Decision (2019)2596 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

Mixtard (Novo Nordisk A/S)

Mixtard (Novo Nordisk A/S)

Mixtard (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2598 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

1-4-2019

Insulatard (Novo Nordisk A/S)

Insulatard (Novo Nordisk A/S)

Insulatard (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2597 of Mon, 01 Apr 2019

Europe -DG Health and Food Safety

29-3-2019


Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia,Gout, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia,Gout, Date of authorisation: 28/03/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Febuxostat Krka, febuxostat, Hyperuricemia,Gout, Date of authorisation: 28/03/2019, Status: Authorised

Europe - EMA - European Medicines Agency

29-3-2019


International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 1

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 1

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q3D on elemental impurities - Step 5 - Revision 1

Europe - EMA - European Medicines Agency

29-3-2019

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Orchard Therapeutics (Europe) Limited)

EU/3/14/1280 (Active substance: Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene) - Transfer of orphan designation - Commission Decision (2019)2432 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003985

Europe -DG Health and Food Safety

29-3-2019

EU/3/13/1134 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/13/1134 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/13/1134 (Active substance: Autologous CD34+ cells transduced with a lentiviral vector containing the human ADA gene) - Transfer of orphan designation - Commission Decision (2019)2431 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003982

Europe -DG Health and Food Safety

29-3-2019

EU/3/07/446 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/07/446 (Orchard Therapeutics (Netherlands) B.V.)

EU/3/07/446 (Active substance: Autologous CD34+ cells transfected with lentiviral vector containing the human arylsulfatase A cDNA) - Transfer of orphan designation - Commission Decision (2019)2430 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003632

Europe -DG Health and Food Safety

29-3-2019

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (BPL Bioproducts Laboratory GmbH)

Coagadex (Active substance: human coagulation factor X) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2577 of Fri, 29 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3855/T/14

Europe -DG Health and Food Safety

29-3-2019


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 March 2019

Europe - EMA - European Medicines Agency

29-3-2019


Referral: Basiron AC and associated names, benzoyl peroxide, Article 13 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/03/2019

Referral: Basiron AC and associated names, benzoyl peroxide, Article 13 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/03/2019

Referral: Basiron AC and associated names, benzoyl peroxide, Article 13 referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/03/2019

Europe - EMA - European Medicines Agency

28-3-2019

EU/3/15/1467 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1467 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1467 (Active substance: Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL17A1-encoding retroviral vector) - Transfer of orphan designation - Commission Decision (2019)2414 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004602

Europe -DG Health and Food Safety

28-3-2019

EU/3/15/1466 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1466 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1466 (Active substance: Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a COL7A1-encoding retroviral vector) - Transfer of orphan designation - Commission Decision (2019)2413 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004603

Europe -DG Health and Food Safety

28-3-2019

EU/3/15/1465 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1465 (Holostem Terapie Avanzate S.r.l.)

EU/3/15/1465 (Active substance: Ex-vivo-expanded autologous human keratinocytes containing epidermal stem cells transduced with a LAMB3-encoding retroviral vector) - Transfer of orphan designation - Commission Decision (2019)2412 of Thu, 28 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004545

Europe -DG Health and Food Safety

27-3-2019

Levemir (Novo Nordisk A/S)

Levemir (Novo Nordisk A/S)

Levemir (Active substance: insulin detemir) - Centralised - Yearly update - Commission Decision (2019)2389 of Wed, 27 Mar 2019

Europe -DG Health and Food Safety

27-3-2019

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Active substance: Polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase) - Transfer of orphan designation - Commission Decision (2019)2383 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004883

Europe -DG Health and Food Safety

27-3-2019


Orphan designation: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment, Treatment of short bowel syndrome, 11/01/2019, Positive

Orphan designation: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment, Treatment of short bowel syndrome, 11/01/2019, Positive

Orphan designation: Human glucagon-like peptide-2 analogue linked to a human immunoglobulin Fc fragment, Treatment of short bowel syndrome, 11/01/2019, Positive

Europe - EMA - European Medicines Agency

26-3-2019


Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Orphan designation: Human coagulation factor X, Treatment of hereditary factor X deficiency, 14/09/2007, Positive

Europe - EMA - European Medicines Agency

22-3-2019


Summary of opinion: ProZinc,insulin human,  21/03/2019,  Positive

Summary of opinion: ProZinc,insulin human, 21/03/2019, Positive

Summary of opinion: ProZinc,insulin human, 21/03/2019, Positive

Europe - EMA - European Medicines Agency