Ռեկորմոն

main_info

  • trade_name:
  • Ռեկորմոն
  • dosage:
  • 2000ՄՄ/0,3մլ(6) նախալցված ներարկիչներ 0,3 մլ և (6) ասեղներ
  • pharmaceutical_form:
  • լուծույթ ե/մ և ն/ե ներարկման
  • prescription_type:
  • Դեղատոմսով
  • medicine_domain:
  • Human
  • medicine_type:
  • Allopathic

documents

localization

  • country:
  • Ռեկորմոն
    አርሜኒያ
  • language:
  • አማርኛ

other_info

status

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

6-4-2019

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Fri, 05 Apr 2019 In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the a...

Europe - EFSA - European Food Safety Authority EFSA Journal

29-3-2019

Natugrain®Wheat TS/TS L

Natugrain®Wheat TS/TS L

Published on: Thu, 28 Mar 2019 Natugrain® Wheat TS is the trade name for a feed additive that contains endo‐1,4‐beta‐xylanase produced ■■■■■ The product is currently authorised for use as a feed additive in chickens for fattening, turkeys for fattening or reared for breeding, ducks, ornamental birds and minor avian species (except ducks and laying birds). This scientific opinion concerns the renewal of the authorisation of this additive for those species. The applicant provided evidence that the additiv...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-3-2019

Blokhuis verscherpt regels en toezicht voor internetverkoop alcohol

Blokhuis verscherpt regels en toezicht voor internetverkoop alcohol

Verkopers van alcohol via internet zullen aan strengere regels moeten voldoen om de verkoop aan minderjarigen tegen te gaan. Het toezicht daarop wordt gecentraliseerd naar de Nederlandse Voedsel en Warenautoriteit (NVWA). Staatssecretaris Paul Blokhuis (VWS) start vandaag de consultatie van een wetsvoorstel waarmee deze nieuwe regels worden vastgelegd. Met hetzelfde wetsvoorstel wordt geregeld dat er een einde komt aan stuntaanbiedingen voor alcohol als ‘twee halen, één betalen’. Verkopers moeten aanbied...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Safety and efficacy of Beltherm MP/ML (endo-1,4-betaxylanase) as a feed additive for piglets, pigs for fattening and other porcine species

Published on: Mon, 04 Mar 2019 Beltherm MP/ML contains endo-1,4-beta-xylanase and it is to be used as a zootechnical additive for weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive when used for poultry species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). In that assessment, the safety for the consumers, environment and the users was assessed. The applicant has ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Safety and efficacy of Beltherm MP/ML (endo‐1,4‐beta‐xylanase) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species

Published on: Fri, 01 Mar 2019 Beltherm MP/ML contains endo‐1,4‐beta‐xylanase and is intended to be used as a zootechnical additive for poultry species. The safety and efficacy of the additive have been evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) in 2017. In that assessment, the additive and the production strain, a genetically modified strain of Bacillus subtilis, were characterised in full. No viable cells of the production strain were detecte...

Europe - EFSA - European Food Safety Authority EFSA Journal

27-2-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-12-2018

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Een betaalbare woonplek, voldoende kansen op een opleiding en een baan, financiële zelfredzaamheid en voldoende zorg en ondersteuning. Basisbehoeften voor ieder mens, maar waaraan de 10.700 zwerfjongeren (18 – 27 jaar) in Nederland nog te vaak tekortkomen. Op die vier ‘levensbrede’ prioriteiten zal de staatssecretaris zich richten met zijn actieprogramma Zwerfjongeren, dat hij afgelopen oktober in Tweede Kamer aankondigde. Met het actieprogramma brengt hij lokale partijen en gemeenten, maar ook andere ve...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

6-11-2018

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA Approves Experior for Reduction of Ammonia Gas Released from Beef Cattle Waste

FDA announced today the approval of Experior (lubabegron Type A medicated article), a beta-adrenergic agonist/antagonist drug that, when fed to beef cattle under specific conditions, results in less ammonia gas released as a by-product of their waste.

FDA - U.S. Food and Drug Administration

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Orphan designation:  Recombinant human beta-glucuronidase (vestronidase alfa),  for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

Orphan designation: Recombinant human beta-glucuronidase (vestronidase alfa), for the: Treatment of mucopolysaccharidosis type VII (Sly syndrome)

On 21 March 2012, orphan designation (EU/3/12/973) was granted by the European Commission to NDA Regulatory Science Ltd, United Kingdom, for recombinant human beta-glucuronidase for the treatment of mucopolysaccharidosis type VII (Sly syndrome).

Europe - EMA - European Medicines Agency

1-8-2018

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Unauthorized skin creams and lotions sold at various retailers in Quebec may pose serious health risks

Health Canada seized eight unauthorized skin lotions and creams from Ayotai Canada because they are labelled to contain a prescription drug (clobetasol propionate or betamethasone dipropionate). The unauthorized lotions and creams were distributed by Ayotai and sold by various retailers in Quebec.

Health Canada

27-7-2018

Pending EC decision:  Abseamed, epoetin alfa, Opinion date: 26-Jul-2018

Pending EC decision: Abseamed, epoetin alfa, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

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: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues, Treatment of beta-thalassaemia intermedia and major, 11/01/2019, Positive

Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues, Treatment of beta-thalassaemia intermedia and major, 11/01/2019, Positive

Orphan designation: Synthetic double-stranded siRNA oligonucleotide directed against TMPRSS6 mRNA and covalently linked to a ligand containing three N-acetylgalactosamine residues, Treatment of beta-thalassaemia intermedia and major, 11/01/2019, Positive

Europe - EMA - European Medicines Agency

27-3-2019

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Boyd Consultants Limited)

EU/3/16/1664 (Active substance: Polyethylene glycol-modified human recombinant truncated cystathionine beta-synthase) - Transfer of orphan designation - Commission Decision (2019)2383 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004883

Europe -DG Health and Food Safety

18-3-2019


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

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

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

Europe - EMA - European Medicines Agency

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

15-3-2019

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Active substance: Hydroxy-propyl-beta-cyclodextrin) - Transfer of orphan designation - Commission Decision (2019)2108 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005321

Europe -DG Health and Food Safety

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

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

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

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

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

Europe -DG Health and Food Safety

21-2-2019

Rebif (Merck Europe B.V.)

Rebif (Merck Europe B.V.)

Rebif (Active substance: Interferon beta-1a) - Corrigendum - Commission Decision (2019)1535 of Thu, 21 Feb 2019

Europe -DG Health and Food Safety

19-2-2019


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

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

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

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/17/1969 (Maria Livadiotis)

EU/3/17/1969 (Maria Livadiotis)

EU/3/17/1969 (Active substance: Recombinant adeno-associated viral vector serotype 2/1 encoding human beta-hexosaminidase alpha and beta subunits) - Transfer of orphan designation - Commission Decision (2019)1357 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003568

Europe -DG Health and Food Safety

25-1-2019

Biopoin (Teva  GmbH)

Biopoin (Teva GmbH)

Biopoin (Active substance: epoetin theta) - Centralised - Yearly update - Commission Decision (2019)682 of Fri, 25 Jan 2019

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Opinion/decision on a Paediatric investigation plan (PIP): interferon beta-1a, decision type: , therapeutic area: , PIP number: P/0305/2018

Europe - EMA - European Medicines Agency

20-12-2018


Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1319 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9010 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002648

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1316 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9011 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002649

Europe -DG Health and Food Safety

19-12-2018

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1312 (Active substance: Recombinant factor VIIa modified with three terminal repeats derived from the beta chain of human chorionic gonadotropin) - Transfer of orphan designation - Commission Decision (2018)9012 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002650

Europe -DG Health and Food Safety

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

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

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

31-10-2018

Eporatio (ratiopharm GmbH)

Eporatio (ratiopharm GmbH)

Eporatio (Active substance: epoetin theta) - Centralised - Yearly update - Commission Decision (2018)7336 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86

Europe -DG Health and Food Safety

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

4-9-2018

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5857 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/726/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

27-8-2018

Aranesp (Amgen Europe B.V.)

Aranesp (Amgen Europe B.V.)

Aranesp (Active substance: darbepoetin alfa) - Centralised - Yearly update - Commission Decision (2018)5707 of Mon, 27 Aug 2018

Europe -DG Health and Food Safety

6-8-2018

Avonex (Biogen Netherlands B.V.)

Avonex (Biogen Netherlands B.V.)

Avonex (Active substance: Interferon Beta - 1a) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5392 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/102/T/178

Europe -DG Health and Food Safety

2-8-2018

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Orchard Therapeutics Ltd)

EU/3/16/1660 (Active substance: Autologous CD34+ cells transduced with lentiviral vector encoding the human beta globin gene) - Transfer of orphan designation - Commission Decision (2018)5288 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/024/16/T/02

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5035 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/13/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (bluebird bio (Germany) GmbH)

EU/3/12/1091 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human betaA-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5032 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/146/12/T/01

Europe -DG Health and Food Safety