Պոլիո

main_info

  • trade_name:
  • Պոլիո Սաբին
  • dosage:
  • ոչ պակաս քան-106ԲԿՎԴ50/դեղաչափ+ոչ պակաս քան-105.8ԲԿՎԴ50/դեղաչափ(100) ապակե սրվակներ 1մլ (10 դեղաչափ)
  • pharmaceutical_form:
  • դեղակախույթ ներքին ընդունման
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Պոլիո Սաբին
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

25-4-2019

Software for National Risk Assessment Activities

Software for National Risk Assessment Activities

Published on: Wed, 24 Apr 2019 In specific contract No 9 issued under the framework agreement OC/EFSA/AMU/2015/02, EFSA requested Open Analytics to implement a web application for tracking national risk assessment activities. The web application has three modules: one for visualization of the data, one for editing risk assessment activities and one for managing purposes. Functionalities of the edit module are set according the type of user that has logged into the web application. There are three user t...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-4-2019

Systematic review on health outcomes related to the age of introduction of complementary food

Systematic review on health outcomes related to the age of introduction of complementary food

Published on: Wed, 17 Apr 2019 In 2016, the European Commission gave EFSA a mandate to update its 2009 opinion on the appropriate age for introduction of complementary feeding of infants. In order to retrieve data on health outcomes related to the age of introduction of complementary food, a systematic literature review will be conducted by EFSA. This report presents the preparatory work that is performed by Pallas, with advice of Wageningen University, for the systematic literature review. It provides ...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-4-2019

FDA approves first targeted therapy for metastatic bladder cancer

FDA approves first targeted therapy for metastatic bladder cancer

The FDA granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally advanced or metastatic bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

FDA - U.S. Food and Drug Administration

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

28-3-2019

FDA approves treatment for patients with a type of inflammatory arthritis

FDA approves treatment for patients with a type of inflammatory arthritis

The FDA is approving Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis. This is the first time that the FDA has approved a treatment for non-radiographic axial spondyloarthritis (nr-axSpA). nr-axSpA is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms

FDA - U.S. Food and Drug Administration

25-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2’-fluoro and thirty-five 2’-O-methyl nucleoside

Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2’-fluoro and thirty-five 2’-O-methyl nucleoside

Opinion/decision on a Paediatric investigation plan (PIP): Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2’-fluoro and thirty-five 2’-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues (ALN-65492), decision type: , therapeutic area: , PIP number: P/0015/2019

Europe - EMA - European Medicines Agency

25-4-2019


Orphan designation: Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase), Prevention of arteriovenous access dysfunction in haemodialysis patients, 16/01/2014, Positi

Orphan designation: Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase), Prevention of arteriovenous access dysfunction in haemodialysis patients, 16/01/2014, Positi

Orphan designation: Recombinant human type I pancreatic elastase for the prevention of arteriovenous access dysfunction in haemodialysis patients (vonapanitase), Prevention of arteriovenous access dysfunction in haemodialysis patients, 16/01/2014, Positive

Europe - EMA - European Medicines Agency

25-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): levodopa,carbidopa monohydrate,entacapone, decision type: , therapeutic area: , PIP number: P/0011/2019

Opinion/decision on a Paediatric investigation plan (PIP): levodopa,carbidopa monohydrate,entacapone, decision type: , therapeutic area: , PIP number: P/0011/2019

Opinion/decision on a Paediatric investigation plan (PIP): levodopa,carbidopa monohydrate,entacapone, decision type: , therapeutic area: , PIP number: P/0011/2019

Europe - EMA - European Medicines Agency

25-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Anti-VEGF and anti-DLL4 dual variable domain immunoglobulin (ABT-165), decision type: , therapeutic area: , PIP number: P/0012/2019

Opinion/decision on a Paediatric investigation plan (PIP): Anti-VEGF and anti-DLL4 dual variable domain immunoglobulin (ABT-165), decision type: , therapeutic area: , PIP number: P/0012/2019

Opinion/decision on a Paediatric investigation plan (PIP): Anti-VEGF and anti-DLL4 dual variable domain immunoglobulin (ABT-165), decision type: , therapeutic area: , PIP number: P/0012/2019

Europe - EMA - European Medicines Agency

25-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,Atorvastatin,amlodipine, decision type: , therapeutic area: , PIP number: P/0048/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,Atorvastatin,amlodipine, decision type: , therapeutic area: , PIP number: P/0048/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ramipril,Atorvastatin,amlodipine, decision type: , therapeutic area: , PIP number: P/0048/2019

Europe - EMA - European Medicines Agency

24-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage), decision ty

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage), decision ty

Opinion/decision on a Paediatric investigation plan (PIP): Split influenza virus, inactivated containing antigens equivalent to the A/H1N1-like strain, A/H3N2-like strain, B-like strain (Victoria lineage) and B-like strain (Yamagata lineage), decision type: , therapeutic area: , PIP number: P/0023/2019

Europe - EMA - European Medicines Agency

24-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Bruton’s tyrosine kinase inhibitor, decision type: , therapeutic area: , PIP number: P/0020/2019

Opinion/decision on a Paediatric investigation plan (PIP): Bruton’s tyrosine kinase inhibitor, decision type: , therapeutic area: , PIP number: P/0020/2019

Opinion/decision on a Paediatric investigation plan (PIP): Bruton’s tyrosine kinase inhibitor, decision type: , therapeutic area: , PIP number: P/0020/2019

Europe - EMA - European Medicines Agency

24-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,avapritinib, decision type: , therapeutic area: , PIP number: P/0026/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,avapritinib, decision type: , therapeutic area: , PIP number: P/0026/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,avapritinib, decision type: , therapeutic area: , PIP number: P/0026/2019

Europe - EMA - European Medicines Agency

24-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Germanium (68Ge) chloride / Gallium (68Ga) chloride, decision type: , therapeutic area: , PIP number: P/0019/2019

Opinion/decision on a Paediatric investigation plan (PIP): Germanium (68Ge) chloride / Gallium (68Ga) chloride, decision type: , therapeutic area: , PIP number: P/0019/2019

Opinion/decision on a Paediatric investigation plan (PIP): Germanium (68Ge) chloride / Gallium (68Ga) chloride, decision type: , therapeutic area: , PIP number: P/0019/2019

Europe - EMA - European Medicines Agency

24-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, decision type: , therapeutic area: , PIP number: P/0041/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, decision type: , therapeutic area: , PIP number: P/0041/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ianalumab, decision type: , therapeutic area: , PIP number: P/0041/2019

Europe - EMA - European Medicines Agency

24-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rezafungin acetate, decision type: , therapeutic area: , PIP number: P/0014/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rezafungin acetate, decision type: , therapeutic area: , PIP number: P/0014/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rezafungin acetate, decision type: , therapeutic area: , PIP number: P/0014/2019

Europe - EMA - European Medicines Agency

24-4-2019


Orphan designation: Adeno-associated viral vector serotype 2 containing the human CHM gene encoding human Rab escort protein 1, Treatment of choroideraemia, 04/06/2014, Positive

Orphan designation: Adeno-associated viral vector serotype 2 containing the human CHM gene encoding human Rab escort protein 1, Treatment of choroideraemia, 04/06/2014, Positive

Orphan designation: Adeno-associated viral vector serotype 2 containing the human CHM gene encoding human Rab escort protein 1, Treatment of choroideraemia, 04/06/2014, Positive

Europe - EMA - European Medicines Agency

23-4-2019


Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene, Treatment of X-linked myotubular myopathy, 10/08/2015, Positive

Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene, Treatment of X-linked myotubular myopathy, 10/08/2015, Positive

Orphan designation: Adeno-associated viral vector serotype 8 containing the human MTM1 gene, Treatment of X-linked myotubular myopathy, 10/08/2015, Positive

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic ar

Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic ar

Opinion/decision on a Paediatric investigation plan (PIP): Humenza,Split influenza virus, inactivated containing antigen equivalent to A/California/7/2009 (H1N1)-like strain (A/California/7/2009 (NYMC X-179A)), adjuvanted, decision type: , therapeutic area: , PIP number: P/0022/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan,regadenoson, decision type: , therapeutic area: , PIP number: P/0030/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan,regadenoson, decision type: , therapeutic area: , PIP number: P/0030/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rapiscan,regadenoson, decision type: , therapeutic area: , PIP number: P/0030/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,lacosamide, decision type: , therapeutic area: , PIP number: P/0059/2019

Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,lacosamide, decision type: , therapeutic area: , PIP number: P/0059/2019

Opinion/decision on a Paediatric investigation plan (PIP): Vimpat,lacosamide, decision type: , therapeutic area: , PIP number: P/0059/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tivicay,dolutegravir, decision type: , therapeutic area: , PIP number: P/0017/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tivicay,dolutegravir, decision type: , therapeutic area: , PIP number: P/0017/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tivicay,dolutegravir, decision type: , therapeutic area: , PIP number: P/0017/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Revatio,sildenafil, decision type: , therapeutic area: , PIP number: P/0016/2019

Opinion/decision on a Paediatric investigation plan (PIP): Revatio,sildenafil, decision type: , therapeutic area: , PIP number: P/0016/2019

Opinion/decision on a Paediatric investigation plan (PIP): Revatio,sildenafil, decision type: , therapeutic area: , PIP number: P/0016/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab, decision type: , therapeutic area: , PIP number: P/0028/2019

Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab, decision type: , therapeutic area: , PIP number: P/0028/2019

Opinion/decision on a Paediatric investigation plan (PIP): ocrelizumab, decision type: , therapeutic area: , PIP number: P/0028/2019

Europe - EMA - European Medicines Agency

16-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edarbi,Azilsartan medoxomil, decision type: , therapeutic area: , PIP number: P/0034/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edarbi,Azilsartan medoxomil, decision type: , therapeutic area: , PIP number: P/0034/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edarbi,Azilsartan medoxomil, decision type: , therapeutic area: , PIP number: P/0034/2019

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: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of neurofibromatosis type 2, 26/04/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of neurofibromatosis type 2, 26/04/2012, Positive

Orphan designation: N-Hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide, Treatment of neurofibromatosis type 2, 26/04/2012, Positive

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, decision type: , therapeutic area: , PIP number: P/0042/2019

Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, decision type: , therapeutic area: , PIP number: P/0042/2019

Opinion/decision on a Paediatric investigation plan (PIP): Etripamil, decision type: , therapeutic area: , PIP number: P/0042/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), decision type: , therapeutic area: , PIP number: P/0013/2019

Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), decision type: , therapeutic area: , PIP number: P/0013/2019

Opinion/decision on a Paediatric investigation plan (PIP): bupivacaine,meloxicam (HTX-011), decision type: , therapeutic area: , PIP number: P/0013/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ibrance,palbociclib, decision type: , therapeutic area: , PIP number: P/0005/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ibrance,palbociclib, decision type: , therapeutic area: , PIP number: P/0005/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ibrance,palbociclib, decision type: , therapeutic area: , PIP number: P/0005/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, decision type: , therapeutic area: , PIP number: P/0058/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, decision type: , therapeutic area: , PIP number: P/0058/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pretomanid, decision type: , therapeutic area: , PIP number: P/0058/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, decision type: , therapeutic area: , PIP number: P/0038/2019

Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, decision type: , therapeutic area: , PIP number: P/0038/2019

Opinion/decision on a Paediatric investigation plan (PIP): Givosiran, decision type: , therapeutic area: , PIP number: P/0038/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, decision type: , therapeutic area: , PIP number: P/0044/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, decision type: , therapeutic area: , PIP number: P/0044/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pexidartinib, decision type: , therapeutic area: , PIP number: P/0044/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, decision type: , therapeutic area: , PIP number: P/0050/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, decision type: , therapeutic area: , PIP number: P/0050/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozanimod, decision type: , therapeutic area: , PIP number: P/0050/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0045/2019

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0045/2019

Opinion/decision on a Paediatric investigation plan (PIP): filgotinib, decision type: , therapeutic area: , PIP number: P/0045/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), decision type: , therapeutic area: , PIP number: P/0053/2019

Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), decision type: , therapeutic area: , PIP number: P/0053/2019

Opinion/decision on a Paediatric investigation plan (PIP): Dienogest,ethinyl estradiol (LPRI-424), decision type: , therapeutic area: , PIP number: P/0053/2019

Europe - EMA - European Medicines Agency

12-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, decision type: , therapeutic area: , PIP number: P/0060/2019

Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, decision type: , therapeutic area: , PIP number: P/0060/2019

Opinion/decision on a Paediatric investigation plan (PIP): Crizanlizumab, decision type: , therapeutic area: , PIP number: P/0060/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Braftovi,Encorafenib, decision type: , therapeutic area: , PIP number: P/0049/2019

Opinion/decision on a Paediatric investigation plan (PIP): Braftovi,Encorafenib, decision type: , therapeutic area: , PIP number: P/0049/2019

Opinion/decision on a Paediatric investigation plan (PIP): Braftovi,Encorafenib, decision type: , therapeutic area: , PIP number: P/0049/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,guselkumab, decision type: , therapeutic area: , PIP number: P/0025/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,guselkumab, decision type: , therapeutic area: , PIP number: P/0025/2019

Opinion/decision on a Paediatric investigation plan (PIP): Tremfya,guselkumab, decision type: , therapeutic area: , PIP number: P/0025/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Mektovi,binimetinib, decision type: , therapeutic area: , PIP number: P/0037/2019

Opinion/decision on a Paediatric investigation plan (PIP): Mektovi,binimetinib, decision type: , therapeutic area: , PIP number: P/0037/2019

Opinion/decision on a Paediatric investigation plan (PIP): Mektovi,binimetinib, decision type: , therapeutic area: , PIP number: P/0037/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,Ibrutinib, decision type: , therapeutic area: , PIP number: P/0021/2019

Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,Ibrutinib, decision type: , therapeutic area: , PIP number: P/0021/2019

Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica,Ibrutinib, decision type: , therapeutic area: , PIP number: P/0021/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, decision type: , therapeutic area: , PIP number: P/0007/2019

Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, decision type: , therapeutic area: , PIP number: P/0007/2019

Opinion/decision on a Paediatric investigation plan (PIP): semaglutide, decision type: , therapeutic area: , PIP number: P/0007/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Opinion/decision on a Paediatric investigation plan (PIP): Turoctocog alfa pegol, decision type: , therapeutic area: , PIP number: P/0046/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, decision type: , therapeutic area: , PIP number: P/0009/2019

Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, decision type: , therapeutic area: , PIP number: P/0009/2019

Opinion/decision on a Paediatric investigation plan (PIP): Bilastine, decision type: , therapeutic area: , PIP number: P/0009/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,rilpivirine, decision type: , therapeutic area: , PIP number: P/0039/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,rilpivirine, decision type: , therapeutic area: , PIP number: P/0039/2019

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,rilpivirine, decision type: , therapeutic area: , PIP number: P/0039/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ozempic,semaglutide, decision type: , therapeutic area: , PIP number: P/0036/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozempic,semaglutide, decision type: , therapeutic area: , PIP number: P/0036/2019

Opinion/decision on a Paediatric investigation plan (PIP): Ozempic,semaglutide, decision type: , therapeutic area: , PIP number: P/0036/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta,darunavir,cobicistat, decision type: , therapeutic area: , PIP number: P/0006/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta,darunavir,cobicistat, decision type: , therapeutic area: , PIP number: P/0006/2019

Opinion/decision on a Paediatric investigation plan (PIP): Rezolsta,darunavir,cobicistat, decision type: , therapeutic area: , PIP number: P/0006/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,dolutegravir,abacavir,lamivudine, decision type: , therapeutic area: , PIP number: P/0018/2019

Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,dolutegravir,abacavir,lamivudine, decision type: , therapeutic area: , PIP number: P/0018/2019

Opinion/decision on a Paediatric investigation plan (PIP): Triumeq,dolutegravir,abacavir,lamivudine, decision type: , therapeutic area: , PIP number: P/0018/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Moventig,Naloxegol, decision type: , therapeutic area: , PIP number: P/0056/2019

Opinion/decision on a Paediatric investigation plan (PIP): Moventig,Naloxegol, decision type: , therapeutic area: , PIP number: P/0056/2019

Opinion/decision on a Paediatric investigation plan (PIP): Moventig,Naloxegol, decision type: , therapeutic area: , PIP number: P/0056/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), decision type: , therapeutic area: , PIP number: P/0035/2019

Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), decision type: , therapeutic area: , PIP number: P/0035/2019

Opinion/decision on a Paediatric investigation plan (PIP): Sodium sulphate,potassium sulphate,magnesium sulphate heptahydrate (BLI800), decision type: , therapeutic area: , PIP number: P/0035/2019

Europe - EMA - European Medicines Agency

11-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, decision type: , therapeutic area: , PIP number: P/0029/2019

Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, decision type: , therapeutic area: , PIP number: P/0029/2019

Opinion/decision on a Paediatric investigation plan (PIP): Birch pollen extract, decision type: , therapeutic area: , PIP number: P/0029/2019

Europe - EMA - European Medicines Agency

9-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, decision type: , therapeutic area: , PIP number: P/0010/2019

Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, decision type: , therapeutic area: , PIP number: P/0010/2019

Opinion/decision on a Paediatric investigation plan (PIP): Entrectinib, decision type: , therapeutic area: , PIP number: P/0010/2019

Europe - EMA - European Medicines Agency

9-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto,Venetoclax, decision type: , therapeutic area: , PIP number: P/0001/2019

Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto,Venetoclax, decision type: , therapeutic area: , PIP number: P/0001/2019

Opinion/decision on a Paediatric investigation plan (PIP): Venclyxto,Venetoclax, decision type: , therapeutic area: , PIP number: P/0001/2019

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

8-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, decision type: , therapeutic area: , PIP number: P/0004/2019

Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, decision type: , therapeutic area: , PIP number: P/0004/2019

Opinion/decision on a Paediatric investigation plan (PIP): axicabtagene ciloleucel, decision type: , therapeutic area: , PIP number: P/0004/2019

Europe - EMA - European Medicines Agency

8-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, decision type: , therapeutic area: , PIP number: P/0003/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, decision type: , therapeutic area: , PIP number: P/0003/2019

Opinion/decision on a Paediatric investigation plan (PIP): Pimodivir, decision type: , therapeutic area: , PIP number: P/0003/2019

Europe - EMA - European Medicines Agency

8-4-2019


Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, decision type: , therapeutic area: , PIP number: P/0055/2019

Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, decision type: , therapeutic area: , PIP number: P/0055/2019

Opinion/decision on a Paediatric investigation plan (PIP): Gadopiclenol, decision type: , therapeutic area: , PIP number: P/0055/2019

Europe - EMA - European Medicines Agency

27-3-2019


Orphan designation: miglustat, Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Positive

Orphan designation: miglustat, Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Positive

Orphan designation: miglustat, Treatment of glycogen storage disease type II (Pompe's disease), 11/01/2019, Positive

Europe - EMA - European Medicines Agency

27-3-2019


Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine: List of nationally authorised medicinal products - PSUSA/00010339/201807

Europe - EMA - European Medicines Agency

22-3-2019

On March 18th, the @US_FDA identified a Class I Recall, the most serious  type of recall: Cook Medical Inc. Recalls Transseptal Needle Due to  Risk of Detached Plastic Fragments. Find out more about the recall:  https://go.usa.gov/xEtdg  #FDA #MedicalDevi

On March 18th, the @US_FDA identified a Class I Recall, the most serious type of recall: Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments. Find out more about the recall: https://go.usa.gov/xEtdg  #FDA #MedicalDevi

On March 18th, the @US_FDA identified a Class I Recall, the most serious type of recall: Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments. Find out more about the recall: https://go.usa.gov/xEtdg  #FDA #MedicalDevice pic.twitter.com/JasosItjFN

FDA - U.S. Food and Drug Administration

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


Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Poliovirus type 1 / poliovirus type 3 (oral, live, attenuated) vaccine - List of nationally authorised medicinal products - PSUSA/00010642/201807

Europe - EMA - European Medicines Agency

15-3-2019


Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Orphan designation: Adenovirus serotype 5 containing partial E1A deletion and an integrin-binding domain, Treatment of glioma, 16/12/2014, Positive

Europe - EMA - European Medicines Agency

15-3-2019


Orphan designation: Hydroxy-propyl-beta-cyclodextrin, Treatment of Niemann-Pick disease, type C, 30/08/2011, Positive

Orphan designation: Hydroxy-propyl-beta-cyclodextrin, Treatment of Niemann-Pick disease, type C, 30/08/2011, Positive

Orphan designation: Hydroxy-propyl-beta-cyclodextrin, Treatment of Niemann-Pick disease, type C, 30/08/2011, Positive

Europe - EMA - European Medicines Agency