Նիզորալ

main_info

  • trade_name:
  • Նիզորալ
  • dosage:
  • 20մգ/գալյումինե պարկուճ 15գ
  • pharmaceutical_form:
  • նրբաքսուք արտաքին կիրառման
  • prescription_type:
  • Առանց դեղատոմսի
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Նիզորալ
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

2-4-2019

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Safety and efficacy of Hemicell®‐L (endo‐1,4‐β‐mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

Published on: Mon, 01 Apr 2019 The additive Hemicell®‐L is a liquid preparation of endo‐1,4‐β‐mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and cons...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses

Assessment of the application for renewal of authorisation of Levucell SC (Saccharomyces cerevisiae CNCM I‐1077) as a feed additive for lambs and horses

Published on: Thu, 21 Mar 2019 Levucell® SC is the trade name for a feed additive based on viable cells of a strain Saccharomyces cerevisiae. The product is currently authorised for use in feed for horses, lambs, dairy sheep and dairy goats, dairy cows and cattle for fattening. This opinion concerns the renewal of the authorisation of Levucell® SC as a zootechnical additive for lambs and horses. S. cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

12-2-2019

Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased...

Health Canada

21-12-2018

FDA approves first treatment for rare blood disease

FDA approves first treatment for rare blood disease

The FDA approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.

FDA - U.S. Food and Drug Administration

20-12-2018

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

FDA sends warning letter to Genetech, Inc. and letters to other companies to reiterate the FDA’s compliance and enforcement policy regarding stem cells.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

FDA - U.S. Food and Drug Administration

26-11-2018

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries

Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling six lots of ThermaCare® HeatWrap product to the consumer level. Pfizer Consumer Healthcare initiated this recall because product from these lots has a potential to leak ingredients that are contained in the heat cell wrap.

FDA - U.S. Food and Drug Administration

16-11-2018

Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

The U.S. Department of Agriculture and U.S. Food and Drug Administration are announcing that USDA and FDA should jointly oversee the production of cell-cultured food products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

30-10-2018

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

Danish Medicines Agency

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

FDA - U.S. Food and Drug Administration

13-9-2018

FDA approves new kind of treatment for hairy cell leukemia

FDA approves new kind of treatment for hairy cell leukemia

FDA approves Lumoxiti (moxetumomab pasudotox-tdfk) for the treatment of adult patients with relapsed or refractory hairy cell leukemia

FDA - U.S. Food and Drug Administration

10-9-2018

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

WASHINGTON, Sept. 10, 2018 – U.S. Secretary of Agriculture Sonny Perdue, DVM and U.S. Food and Drug Administration Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018 to discuss the use of cell culture technology to develop products derived from livestock and poultry.

FDA - U.S. Food and Drug Administration

9-4-2019


Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Orphan designation: Lurbinectedin, Treatment of small cell lung cancer, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

8-4-2019


Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, Positive

Orphan designation: Autologous stromal vascular cell fraction from adipose tissue, Treatment of systemic sclerosis, 28/04/2016, 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

5-4-2019

Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)

Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)

Update to BIA-ALCL health professional web page following banning of macro-textured and polyurethane-coated breast implants in France

Therapeutic Goods Administration - Australia

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

2-4-2019

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Global Stem cell Technology (G.S.T.) NV)

Arti-Cell Forte (Active substance: Chondrogenic induced equine allogeneic peripheral blood-derived mesenchymal stem cells) - Centralised - Authorisation - Commission Decision (2019)2625 of Tue, 02 Apr 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/4727

Europe -DG Health and Food Safety

29-3-2019


Summary of opinion: Zynteglo,autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene,  28/03/2019,  Positive

Summary of opinion: Zynteglo,autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, 28/03/2019, Positive

Summary of opinion: Zynteglo,autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, 28/03/2019, Positive

Europe - EMA - European Medicines Agency

27-3-2019


Orphan designation: Benserazide hydrochloride, The treatment of sickle cell disease, 11/01/2019, Positive

Orphan designation: Benserazide hydrochloride, The treatment of sickle cell disease, 11/01/2019, Positive

Orphan designation: Benserazide hydrochloride, The treatment of sickle cell disease, 11/01/2019, Positive

Europe - EMA - European Medicines Agency

27-3-2019

EU/3/16/1643 (Clinical Network Services (NL) B.V.)

EU/3/16/1643 (Clinical Network Services (NL) B.V.)

EU/3/16/1643 (Active substance: Autologous stromal vascular cell fraction from adipose tissue) - Transfer of orphan designation - Commission Decision (2019)2405 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005318

Europe -DG Health and Food Safety

22-3-2019


Summary of opinion: Innovax-ND-IBD,cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus,  21/03/2019,  Positive

Summary of opinion: Innovax-ND-IBD,cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus, 21/03/2019, Positive

Summary of opinion: Innovax-ND-IBD,cell-associated live recombinant turkey herpesvirus expressing the fusion protein of ND virus and the VP2 protein of IBD virus, 21/03/2019, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo, Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Positive

Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo, Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Positive

Orphan designation: Adenovirus-specific T-cells derived from allogeneic donor leukocytes, expanded ex vivo, Treatment of adenovirus infection in allogeneic haematopoietic stem cell transplant recipients, 16/01/2014, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, Positive

Orphan designation: Autologous Epstein-Barr virus specific T cells derived from peripheral blood mononuclear cells, expanded ex vivo-, Treatment of extranodal NK/T-cell lymphoma, nasal type, 14/07/2016, 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

14-3-2019


Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Orphan designation: Itraconazole, Treatment of naevoid basal-cell carcinoma syndrome (Gorlin syndrome), 23/08/2017, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, Positive

Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 14/12/2018, Positive

Orphan designation: Allogeneic ABCB5-positive limbal stem cells, Treatment of limbal stem cell deficiency, 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

25-2-2019


Orphan designation: Lisocabtagene maraleucel, Treatment of primary mediastinal large-B-cell lymphoma, 19/11/2018, Positive

Orphan designation: Lisocabtagene maraleucel, Treatment of primary mediastinal large-B-cell lymphoma, 19/11/2018, Positive

Orphan designation: Lisocabtagene maraleucel, Treatment of primary mediastinal large-B-cell lymphoma, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of diffuse large B-cell lymphoma, 17/07/2017, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of diffuse large B-cell lymphoma, 17/07/2017, Positive

Orphan designation: Autologous CD4+ and CD8+ T cells expressing a CD19-specific chimeric antigen receptor, Treatment of diffuse large B-cell lymphoma, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Orphan designation: Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes, Prevention of cytomegalovirus disease in patients with impaired cell-mediated immunity deemed at..., 09/08/2012, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Obinutuzumab, Treatment of diffuse large B-cell lymphoma, 22/08/2014, Withdrawn

Orphan designation: Obinutuzumab, Treatment of diffuse large B-cell lymphoma, 22/08/2014, Withdrawn

Orphan designation: Obinutuzumab, Treatment of diffuse large B-cell lymphoma, 22/08/2014, Withdrawn

Europe - EMA - European Medicines Agency

28-1-2019


Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Sulfonated monophosphorylated mannose oligosaccharide, Treatment of hepatocellular carcinoma, 21/06/2011, Positive

Orphan designation: Sulfonated monophosphorylated mannose oligosaccharide, Treatment of hepatocellular carcinoma, 21/06/2011, Positive

Orphan designation: Sulfonated monophosphorylated mannose oligosaccharide, Treatment of hepatocellular carcinoma, 21/06/2011, Positive

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem

Orphan designation: Allogeneic ex-vivo-expanded umbilical cord blood-derived haematopoietic CD34+ progenitor cells and allogeneic non-expanded umbilical cord blood-derived haematopoietic mature myeloid and lymphoid cells, Treatment in haematopoietic stem cell transplantation, 20/03/2017, Positive

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cell-free solution of lysed Escherichia coli culture, strain Laves, decision type: , therapeutic area: , PIP number: P/0328/2018

Europe - EMA - European Medicines Agency

18-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous dendritic cells pulsed with allogeneic tumour cell lysate, decision type: , therapeutic area: , PIP number: P/0334/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Opinion/decision on a Paediatric investigation plan (PIP): Anti-mucosal addressin cell adhesion molecule antibody (SHP647), decision type: , therapeutic area: , PIP number: P/0281/2018

Europe - EMA - European Medicines Agency

16-1-2019

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Active substance: Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)196 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2089/T/19

Europe -DG Health and Food Safety

21-12-2018

Breast implant associated cancer (or BIA-ALCL)

Breast implant associated cancer (or BIA-ALCL)

Breast implant associated cancer, or breast implant associated anaplastic large cell lymphoma (BIA-ALCL), is a rare cancer of the immune system

Therapeutic Goods Administration - Australia

19-12-2018


Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Orphan designation: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2, Treatment in haematopoietic stem cell transplantation, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2112 (Merck Europe B.V.)

EU/3/18/2112 (Merck Europe B.V.)

EU/3/18/2112 (Active substance: 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) - Orphan designation - Commission Decision (2018)9027 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/154/18

Europe -DG Health and Food Safety

18-12-2018

Pandemic influenza vaccine H5N1 BAXTER (Ology Bioservices Ireland LTD)

Pandemic influenza vaccine H5N1 BAXTER (Ology Bioservices Ireland LTD)

Pandemic influenza vaccine H5N1 BAXTER (Active substance: Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8926 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1200/T/26

Europe -DG Health and Food Safety

14-12-2018

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Active substance: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - Centralised - Authorisation - Commission Decision (2018)8911 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4814

Europe -DG Health and Food Safety

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous anti-BCMA (B-cell maturation antigen) chimeric antigen receptor (CAR) T-cells

Europe - EMA - European Medicines Agency

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Scientific recommendation on classification of advanced therapy medicinal products: Autologous ex vivo expanded regulatory T lymphocytes with the cell marker profile of CD3+, CD4+, CD25high, CD127-, FoxP3+

Europe - EMA - European Medicines Agency

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

29-11-2018


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of blastic plasmacytoid dendritic cell neoplasm, 11/11/2015, Positive

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area:

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area:

Opinion/decision on a Paediatric investigation plan (PIP): Autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence (GSK2696274), decision type: , therapeutic area: , PIP number: P/0212/2018

Europe - EMA - European Medicines Agency

26-11-2018


Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Alunbrig, brigatinib, Carcinoma, Non-Small-Cell Lung, Date of authorisation: 22/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

18-10-2018

#FDA is committed to supporting women’s health. We know mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact of medical device innovations

#FDA is committed to supporting women’s health. We know mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact of medical device innovations

#FDA is committed to supporting women’s health. We know mammography is an important tool for detecting breast cancer in its early, most treatable stages and an excellent example of the meaningful and positive impact of medical device innovations

FDA - U.S. Food and Drug Administration

5-9-2018

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medica

FDA's Center for Devices and Radiological Health, along with the University of Maryland Center of Excellence in Regulatory Science and Innovation will be hosting a workshop on #PatientEngagement in Real-World Evidence Lessons and Best Practices for medical devices on Sept. 9th

FDA - U.S. Food and Drug Administration