Ցերոտեքս

main_info

  • trade_name:
  • Ցերոտեքս
  • dosage:
  • 400մգ(14/1x14/), (28/2x14/), (42/3x14/) և (56/4x14/) բլիստերում
  • pharmaceutical_form:
  • դեղապատիճներ
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

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  • country:
  • Ցերոտեքս
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

8-3-2019

Safety assessment of the process ‘Jász‐Plasztik’, based on Vacurema Prime technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘Jász‐Plasztik’, based on Vacurema Prime technology, used to recycle post‐consumer PET into food contact materials

Published on: Thu, 07 Mar 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the recycling process Jász‐Plasztik (EU register number RECYC0157). The input are hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers and containing no more than 5% PET from non‐food applications. They are heated in a batch reactor under vacuum and then heated in a continuous reactor under vacuum...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

ANSES 2017 Annual report: The Maisons-Alfort Laboratory for Animal Health

ANSES 2017 Annual report: The Maisons-Alfort Laboratory for Animal Health

France - Agence Nationale du Médicament Vétérinaire

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

9-4-2019


Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Orphan designation: Poly(N-acetyl, N-arginyl)glucosamine, Treatment of cystic fibrosis, 26/02/2019, Positive

Europe - EMA - European Medicines Agency

4-3-2019

EU/3/19/2144 (Accelsiors CRO And Consultancy Services Ltd.)

EU/3/19/2144 (Accelsiors CRO And Consultancy Services Ltd.)

EU/3/19/2144 (Active substance: Poly(N-acetyl, N-arginyl)glucosamine) - Orphan designation - Commission Decision (2019)1736 of Mon, 04 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002552

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Celecoxib, Treatment of familial adenomatous polyposis (FAP), 21/11/2001, Withdrawn

Orphan designation: Celecoxib, Treatment of familial adenomatous polyposis (FAP), 21/11/2001, Withdrawn

Orphan designation: Celecoxib, Treatment of familial adenomatous polyposis (FAP), 21/11/2001, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


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

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

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

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Serotype 26 adenovirus encoding mosaic 1 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos1.Gag-Pol) / serotype 26 adenovirus encoding mosaic 2 HIV-1 group-specific antigen and polym

Opinion/decision on a Paediatric investigation plan (PIP): Serotype 26 adenovirus encoding mosaic 1 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos1.Gag-Pol) / serotype 26 adenovirus encoding mosaic 2 HIV-1 group-specific antigen and polym

Opinion/decision on a Paediatric investigation plan (PIP): Serotype 26 adenovirus encoding mosaic 1 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos1.Gag-Pol) / serotype 26 adenovirus encoding mosaic 2 HIV-1 group-specific antigen and polymerase proteins (Ad26.Mos2.Gag-Pol) / serotype 26 adenovirus encoding mosaic 1 HIV-1 envelope protein (Ad26.Mos1.Env) / serotype 26 adenovirus encoding mosaic 2S HIV-1 envelope protein (Ad26.Mos2S.Env) [Ad26.Mos4.HIV], decision type: , therapeutic area: ,...

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197

Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197

Opinion/decision on a Paediatric investigation plan (PIP): pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate,pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate,pneumococcal polysaccharide serotyp...

Europe - EMA - European Medicines Agency

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

29-10-2018

Synflorix (GlaxoSmithKline Biologicals S.A.)

Synflorix (GlaxoSmithKline Biologicals S.A.)

Synflorix (Active substance: Pneumococcal polysaccharide conjugate vaccine (adsorbed)) - Centralised - Yearly update - Commission Decision (2018)7257 of Mon, 29 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

18-5-2018

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (IQVIA RDS Ireland Limited)

EU/3/13/1220 (Active substance: Poly[2-[(4-{[1-carboxy-2-(hexadecylcarbamoyl)ethyl]sulfanyl}-2,3-bis({2-[((2S)-2-(2-{[(2R)-2-carbamoyl-(2-{[(2S)-1-ethoxy-3-(3-hydroxy-4oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}ethyl]sulfanyl}-3-{[(2S)-1-ethoxy-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)-1-oxopropan-2-yl]carbamoyl}propanamido)-3-(3-hydroxy-4-oxo-1,4-dihydropyridin-1-yl)propanoyl Ethyl ester) )-methoxy]acetyl}oxy)butyl)sulfanyl]-3-(hexadecylcarbamoyl)propanoic acid]-poly(ethylene glycol)-este...

Europe -DG Health and Food Safety