Պոլիո

main_info

  • trade_name:
  • Պոլիո Սաբին
  • dosage:
  • ոչ պակաս քան-106ԲԿՎԴ50/դեղաչափ+ոչ պակաս քան-105.8ԲԿՎԴ50/դեղաչափ(100) ապակե սրվակներ 2մլ (20դեղաչափ)
  • 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

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

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

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

8-3-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Opinion/decision on a Paediatric investigation plan (PIP): Rolofylline, decision type: , therapeutic area: , PIP number: P/87/2009

Europe - EMA - European Medicines Agency

1-3-2019


New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

New add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Domagrozumab, decision type: , therapeutic area: , PIP number: P/0327/2017

Opinion/decision on a Paediatric investigation plan (PIP): Domagrozumab, decision type: , therapeutic area: , PIP number: P/0327/2017

Opinion/decision on a Paediatric investigation plan (PIP): Domagrozumab, decision type: , therapeutic area: , PIP number: P/0327/2017

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface ant

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface ant

Opinion/decision on a Paediatric investigation plan (PIP): Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H1N1Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/H3N2Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain B, decision type: , therapeutic area: , PIP number: P/208/2010

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066)

Opinion/decision on a Paediatric investigation plan (PIP): (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) ( LIK066), decision type: , therapeutic area: , PIP number: P/0183/2014

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145)

Opinion/decision on a Paediatric investigation plan (PIP): Optaflu,Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains: A/Solomon Islands/3/2006 (H1N1)-like strain (A/Solomon Islands/3/2006, IVR-145); A/Wisconsin/67/2005 (H3N2)-like strain (A/Wisconsin/67/2005, NYMC X161B); B/Malaysia/2506/2004-like strain (B/Malaysia/2506/2004), decision type: , therapeutic area: , PIP number: P/0210/2012

Europe - EMA - European Medicines Agency

27-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Opinion/decision on a Paediatric investigation plan (PIP): Covalently closed DNA plasmids coding for cytomegalovirus phosphoprotein 65 and glycoprotein B genes (ASP0113), decision type: , therapeutic area: , PIP number: P/0338/2014

Europe - EMA - European Medicines Agency

26-2-2019


Procedural update on submission of Type I variations to EMA in March, April and May 2019

Procedural update on submission of Type I variations to EMA in March, April and May 2019

Procedural update on submission of Type I variations to EMA in March, April and May 2019

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

21-2-2019


Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Prevymis,Letermovir, decision type: , therapeutic area: , PIP number: P/0385/2018

Opinion/decision on a Paediatric investigation plan (PIP): Prevymis,Letermovir, decision type: , therapeutic area: , PIP number: P/0385/2018

Opinion/decision on a Paediatric investigation plan (PIP): Prevymis,Letermovir, decision type: , therapeutic area: , PIP number: P/0385/2018

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Peanut flour, decision type: , therapeutic area: , PIP number: P/0377/2018

Opinion/decision on a Paediatric investigation plan (PIP): Peanut flour, decision type: , therapeutic area: , PIP number: P/0377/2018

Opinion/decision on a Paediatric investigation plan (PIP): Peanut flour, decision type: , therapeutic area: , PIP number: P/0377/2018

Europe - EMA - European Medicines Agency