NIAGLOBIN

Κύριές Πληροφορίες

  • Εμπορική ονομασία:
  • NIAGLOBIN 5G/VIAL LY.P.IV.IN
  • Δοσολογία:
  • 5G/VIAL
  • Φαρμακοτεχνική μορφή:
  • ΕΝΕΣΙΜΟ ΛΥΟΦΙΛΟ ΓΙΑ ΕΝΔΟΦΛΕΒΙΑ ΕΓΧΥΣΗ
  • Χρήση για:
  • Οι άνθρωποι
  • Τύπος φάρμακου:
  • αλλοπαθητική των ναρκωτικών

Έγγραφα

  • για το ευρύ κοινό:
  • Το ενημερωτικό φυλλάδιο για το προϊόν αυτό δεν είναι άμεσα διαθέσιμα, μπορείτε να στείλετε ένα αίτημα στην εξυπηρέτηση πελατών μας και εμείς θα σας ενημερώσουμε το συντομότερο είμαστε σε θέση να το αποκτήσει.


    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.

Εντοπισμός

  • Διατίθεται σε:
  • NIAGLOBIN 5G/VIAL LY.P.IV.IN
    Ελλάδα
  • Γλώσσα:
  • Ελληνικά

Θεραπευτικές πληροφορίες

  • Θεραπευτική περιοχή:
  • ΠΡΟΙΟΝ ΑΙΜΑΤΟΣ (ΠΑ)

Άλλες πληροφορίες

Κατάσταση

  • Πηγή:
  • Εθνικός Οργανισμός Φαρμάκων
  • τελευταία ενημέρωση:
  • 09-08-2016
  • Το ενημερωτικό φυλλάδιο για το προϊόν αυτό δεν είναι άμεσα διαθέσιμα, μπορείτε να στείλετε ένα αίτημα στην εξυπηρέτηση πελατών μας και εμείς θα σας ενημερώσουμε το συντομότερο είμαστε σε θέση να το αποκτήσει.

    Ζητήστε το ενημερωτικό φυλλάδιο για το ευρύ κοινό.

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

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

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

15-3-2019

Peer review of the pesticide risk assessment of the active substance thiacloprid

Peer review of the pesticide risk assessment of the active substance thiacloprid

Published on: Thu, 14 Mar 2019 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance thiacloprid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of thiaclopr...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Pest categorisation of Phymatotrichopsis omnivora

Pest categorisation of Phymatotrichopsis omnivora

Published on: Tue, 12 Mar 2019 The Panel on Plant Health performed a pest categorisation of Phymatotrichopsis omnivora, the causal agent of Phymatotrichum root rot of more than 2,000 dicotyledonous plant species, for the EU. The pest is listed as Trechispora brinkmannii in Annex IAI of Directive 2000/29/EC. P. omnivora is a well‐defined fungal species and reliable methods exist for its detection and identification. It is present in south‐western USA, northern Mexico, Libya and Venezuela. The pest is not...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Safety and efficacy of Probion forte® (Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) for chickens for fattening

Published on: Tue, 12 Mar 2019 In 2017, the EFSA Panel on Additive and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Probion Forte®(Bacillus subtilis KCCM 10941P and Bacillus coagulans KCCM 11093P) as a feed additive for chickens for fattening. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment provided that the identity of the strains is established and the lack ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry

USDA’s Food Safety and Inspection Service and FDA announce a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry

FDA - U.S. Food and Drug Administration

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. Initiates a Voluntary Nationwide Consumer Level Recall Expansion of 38 Lots of Amlodipine Valsartan Tablets USP and Valsartan Tablets, USP due to the detection of NDEA (N-Nitrosodiethylamine) Impurity.

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial proc...

FDA - U.S. Food and Drug Administration

27-2-2019

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

The European Union summary report on antimicrobial resistance in zoonotic and indicator bacteria from humans, animals and food in 2017

Published on: Tue, 26 Feb 2019 The data on antimicrobial resistance in zoonotic and indicator bacteria in 2017, submitted by 28 EU Member States (MSs), were jointly analysed by EFSA and ECDC. Resistance in zoonotic Salmonella and Campylobacter from humans, animals and food, and resistance in indicator Escherichia coli as well as meticillin-resistant Staphylococcus aureus in animals and food were addressed, and temporal trends assessed. ‘Microbiological’ resistance was assessed using epidemiological cut-...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Giant hogweed: limit its proliferation in order to reduce risks to human health and the environment

Giant hogweed: limit its proliferation in order to reduce risks to human health and the environment

Placed on the European Union's list of invasive species of concern, giant hogweed presents risks both to the flora of the environments it colonises and to human health. In response to this observation, ANSES was asked to summarise knowledge regarding this plant and make risk management recommendations. With its expert assessment work completed, the Agency recommends the creation of a monitoring system and the use of available control methods to eradicate giant hogweed populations in high-priority areas.

France - Agence Nationale du Médicament Vétérinaire

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-2-2019

Salmonella control in poultry flocks and its public health impact

Salmonella control in poultry flocks and its public health impact

Published on: Mon, 18 Feb 2019 An increase in confirmed human salmonellosis cases in the EU after 2014 triggered investigation of contributory factors and control options in poultry production. Reconsideration of the five current target serovars for breeding hens showed that there is justification for retaining Salmonella Enteritidis, Salmonella Typhimurium (including monophasic variants) and Salmonella Infantis, while Salmonella Virchow and Salmonella Hadar could be replaced by Salmonella Kentucky and ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

19-3-2019


Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2148 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003801

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2147 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003809

Europe -DG Health and Food Safety

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

18-3-2019


Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Orphan designation: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene, Treatment of beta thalassaemia intermedia and major, 24/01/2013, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Orphan designation: Human haptoglobin, Treatment of sickle cell disease, 09/12/2011, Positive

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

EU/3/11/936 (Active substance: Human haptoglobin) - Transfer of orphan designation - Commission Decision (2019)2106 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004485

Europe -DG Health and Food Safety

14-3-2019


Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Actrapid (Novo Nordisk A/S)

Actrapid (Novo Nordisk A/S)

Actrapid (Active substance: Insulin human (rDNA)) - Centralised - Yearly update - Commission Decision (2019)2070 of Wed, 13 Mar 2019

Europe -DG Health and Food Safety

12-3-2019


Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Orphan designation: C1 esterase inhibitor (human), Treatment in solid organ transplantation, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract ca

Orphan designation: Bifunctional fusion protein composed of two extracellular domains of transforming growth factor beta receptor II fused with a human immunoglobulin G1 monoclonal antibody against programmed death ligand 1, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Active substance: Human monoclonal antibody against Pseudomonas aeruginosa serotype O11) - Transfer of orphan designation - Commission Decision (2019)1941 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004486

Europe -DG Health and Food Safety

8-3-2019


Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Orphan designation: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase, Treatment of phenylalanine hydroxylase deficiency, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019

Kiovig (Baxter AG)

Kiovig (Baxter AG)

Kiovig (Active substance: Human normal immunoglobulin (IVIg)) - Centralised - 2-Monthly update - Commission Decision (2019)1909 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/628/IB/88

Europe -DG Health and Food Safety

7-3-2019


Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Orphan designation: Adeno-associated viral vector expressing human 21- hydroxylase, Treatment of congenital adrenal hyperplasia, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

7-3-2019


Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Orphan designation: Human anti-promyostatin monoclonal antibody, Treatment of spinal muscular atrophy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

6-3-2019


Human medicines highlights - March 2019

Human medicines highlights - March 2019

Human medicines highlights - March 2019

Europe - EMA - European Medicines Agency

6-3-2019

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media

This consultation paper considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

4-3-2019


Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Orphan designation: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA, Treatment of adrenoleukodystrophy, 06/06/2012, Positive

Europe - EMA - European Medicines Agency

1-3-2019


Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2019)1751 of Fri, 01 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003921

Europe -DG Health and Food Safety

1-3-2019


Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Referral: Syner-Kinase and associated names, urokinase, Article 29(4) referrals, Opinion provided by Committee for Medicinal Products for Human Use, 28/02/2019

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Fondazione Telethon)

EU/3/19/2141 (Active substance: Lentiviral vector encoding human coagulation factor IX) - Orphan designation - Commission Decision (2019)1733 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002293

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2140 (Artemida Pharma Europe Limited)

EU/3/19/2140 (Artemida Pharma Europe Limited)

EU/3/19/2140 (Active substance: Humanised IGg1 monoclonal antibody targeting human transferrin receptor conjugated to human iduronate-2-sulfatase) - Orphan designation - Commission Decision (2019)1732 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001793

Europe -DG Health and Food Safety

26-2-2019


Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Macimorelin Aeterna Zentaris, macimorelin, Diagnostic Techniques, Endocrine, Date of authorisation: 11/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

26-2-2019

Survey of human insulin products

Survey of human insulin products

The TGA has tested a range of human insulin products and all met the applicable quality standards

Therapeutic Goods Administration - Australia

25-2-2019


Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast, Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast, Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast, Treatment of Duchenne muscular dystrophy, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

25-2-2019

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (bluebird bio (Netherlands) B.V.)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2019)1626 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003556

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (bluebird bio (Netherlands) B.V.)

EU/3/12/1003 (Active substance: Autologous haematopoietic stem cells transduced with lentiviral vector Lenti-D encoding the human ABCD1 cDNA) - Transfer of orphan designation - Commission Decision (2019)1634 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003636

Europe -DG Health and Food Safety

25-2-2019

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Novartis Europharm Limited)

EU/3/15/1518 (Active substance: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1628 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003549

Europe -DG Health and Food Safety

25-2-2019

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Novartis Europharm Limited)

EU/3/12/981 (Active substance: Adenovirus associated viral vector serotype 2 containing the human RPE65 gene) - Transfer of orphan designation - Commission Decision (2019)1627 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003485

Europe -DG Health and Food Safety

25-2-2019


Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Orphan designation: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor, Treatment of Duchenne muscular dystrophy, 19/11/2019, Positive

Europe - EMA - European Medicines Agency

25-2-2019


Orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised, Treatment of neuroblastoma, 19/11/2018, Positive

Orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised, Treatment of neuroblastoma, 19/11/2018, Positive

Orphan designation: Anti-GD2 monoclonal antibody 3F8 humanised, Treatment of neuroblastoma, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells, Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive

Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells, Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive

Orphan designation: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells, Treatment of thromboangiitis obliterans (Buerger's disease), 21/05/2015, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide), Treatment of achondroplasia, 24/01/2013, Positive

Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide), Treatment of achondroplasia, 24/01/2013, Positive

Orphan designation: Modified recombinant human C-type natriuretic peptide (Vosoritide), Treatment of achondroplasia, 24/01/2013, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Orphan designation: Pegylated recombinant human hyaluronidase PH20(pegvorhyaluronidase alfa), Treatment of pancreatic cancer, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan), Treatment of growth-hormone deficiency, 05/08/2013, Withdrawn

Orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan), Treatment of growth-hormone deficiency, 05/08/2013, Withdrawn

Orphan designation: Recombinant human growth hormone modified by fusion with two hydrophilic polypeptide chains (somavaratan), Treatment of growth-hormone deficiency, 05/08/2013, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Opinion/decision on a Paediatric investigation plan (PIP): Nanobody directed towards the fusion protein of human respiratory syncytial virus (ALX-0171), decision type: , therapeutic area: , PIP number: P/0367/2018

Europe - EMA - European Medicines Agency

20-2-2019

Silgard (Merck Sharp and Dohme Limited)

Silgard (Merck Sharp and Dohme Limited)

Silgard (Active substance: Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)) - Centralised - Withdrawal - Commission Decision (2019)1516 of Wed, 20 Feb 2019

Europe -DG Health and Food Safety

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/20

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ hematopoietic stem cells transduced ex vivo with EFS lentiviral vector encoding for the human adenosine deaminase gene, decision type: , therapeutic area: , PIP number: P/0400/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Orphan designation: autologous human adipose perivascular stromal cells genetically modified to secrete soluble tumour necrosis factor-related apoptosis-inducing ligand, The treatment of pancreatic cancer, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

Orphan designation: human apotransferrin, Treatment of beta-thalassaemia intermedia and major, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Orphan designation: Salmonella typhi Ty21a strain transfected with a plasmid vector encoding the human vascular endothelial growth factor receptor 2, Treatment of glioma, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

18-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Opinion/decision on a Paediatric investigation plan (PIP): Holoclar,Ex-vivo expanded human autologous epithelium containing stem cells, decision type: , therapeutic area: , PIP number: P/0370/2018

Europe - EMA - European Medicines Agency