CLORURO

Informació principal

  • Denominació comercial:
  • CLORURO DE TALIO(201TL) COVIDIEN 370MBq vial 10ml
  • Vía de administración:
  • Forma: Viales
  • Utilitza per:
  • Humans
  • Tipo de medicina:
  • medicament al·lopàtic

Documents

Localització

  • Disponible en:
  • CLORURO DE TALIO(201TL) COVIDIEN 370MBq vial 10ml
    Andorra
  • Idioma:
  • català

Altres dades

Estat

  • Font:
  • CedimCat - Centre d'Informació de Medicaments de Catalunya
  • Número d'autorització:
  • 661580
  • última actualització:
  • 09-06-2018

Prospecte: composició, indicacions, interacció, posologia, embaràs, lactància, reaccions adverses

CLORURO DE TALIO(201TL) COVIDIEN

370MBq vial 10ml

talio (Tl-201), cloruro

Indicacions

Medicament que serveix per diagnosticar determinades malalties.

Consideracions

Aquest medicament ha de preparar-se abans de la seva administraci

Ha de rebutjar el medicament 7 dies despr

s de l'obertura de l'env

Aquest medicament ha de ser administrat per via intravenosa.

Aquest medicament ha de ser administrat per un metge o un altre professional sanitari amb experi

ncia.

Aquest medicament

s d'un sol

s; rebutgi qualsevol resta de medicament que pugui quedar a l'env

s una vegada utilitzat.

NO heu de menjar res 4 hores abans d`administrar-vos aquest medicament.

Avisi el seu metge si pateix o ha patit problemes de rony

Alguns medicaments poden modificar l`efic

cia d`aquest f

rmac. NO preneu altres medicaments

sense consultar abans el vostre metge o farmac

utic.

Informi immediatament al seu metge si est

embarassada o creu que pot estar-ho.

Avisi al seu metge si t

algun fill a qui estigui alletant.

Efectes adversos

Aquest medicament pot produir envermelliment o mol

sties al punt d'aplicaci

Si not

s qualsevol altre s

mptoma que creu que pot ser causat per aquest medicament, digui-li-ho al

seu metge.

Posologia

Li administraran aquest medicament a un centre sanitari.

VIA INTRAVENOSA.

22-3-2019

Benoeming voorzitter Raad voor Volksgezondheid en Samenleving

Benoeming voorzitter Raad voor Volksgezondheid en Samenleving

Mevrouw prof. dr. M. (Jet) Bussemaker wordt voorzitter van de Raad voor Volksgezondheid en Samenleving (RVS). De ministerraad heeft met deze voordracht ingestemd op voorstel van minister De Jonge van Volksgezondheid, Welzijn en Sport. De benoeming gaat in op 1 juni 2019.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

22-3-2019

Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species

Safety and efficacy of l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 for all animal species

Published on: Thu, 21 Mar 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 l‐lysine monohydrochloride and l‐lysine sulfate produced using Corynebacterium glutamicum CCTCC M 2015595 when used as nutritional additive in feed and water for drinking for all animal species. The active substance is l‐lysine and it is produced in two different forms (monohydrochloride or sulfate). O...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across

Evaluation of the applicability of existing (Q)SAR models for predicting the genotoxicity of pesticides and similarity analysis related with genotoxicity of pesticides for facilitating of grouping and read across

Published on: Thu, 21 Mar 2019 To facilitate the practical implementation of the guidance on the residue definition for dietary risk assessment, EFSA has organized an evaluation of applicability of existing in silico models for predicting the genotoxicity of pesticides and their metabolites, including analysis of the impact on genotoxicity of the metabolic structural changes. The prediction ability of (Q)SARs for in vitro and in vivo tests were evaluated. For the Ames test, all (Q)SAR models generated s...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Safety and efficacy of l‐tryptophan produced with Escherichia coli CGMCC 11674 for all animal species

Safety and efficacy of l‐tryptophan produced with Escherichia coli CGMCC 11674 for all animal species

Published on: Thu, 21 Mar 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 l‐tryptophan produced by fermentation with Escherichia coli CGMCC 11674 when used as a nutritional additive in feed and water for drinking for all animal species and categories. The production strain did not raise safety concerns. The FEEDAP Panel cannot conclude on the safety of l‐tryptophan produced ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-3-2019

Lumpy skin disease III. Data collection and analysis

Lumpy skin disease III. Data collection and analysis

Published on: Thu, 21 Mar 2019 In 2018, no lumpy skin disease (LSD) outbreaks were reported in the Balkan region, after the decline reported in 2017 (385) compared to 2016 (7,483). This confirms the effectiveness of the vaccination campaign based on the LSD homologous vaccine strain which continued throughout 2018 with over 2.5 million animals vaccinated, keeping the mean vaccination coverage above 70%. In 2018, LSD outbreaks were reported in Russia, Turkey and Georgia. In Russia, the LSD epidemics expa...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips.

FDA - U.S. Food and Drug Administration

21-3-2019

FDA Announces New Date for Webinar on Genome Editing in Animals

FDA Announces New Date for Webinar on Genome Editing in Animals

On April 25, 2019, FDA CVM, with participation from the CBER, will hold a public webinar about genome editing in animals, an innovative and rapidly evolving technology that offers significant public health benefits.

FDA - U.S. Food and Drug Administration

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Modification of the existing maximum residue level for cyprodinil in Florence fennel

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the FPS Health, Food chain safety and Environment of Belgium, submitted an application to modify the existing maximum residue level (MRL) for the active substance cyprodinil in Florence fennel to accommodate the intended use in the northern Europe. The submitted data were found sufficient to derive an MRL proposal of 4 mg/kg for cyprodinil in Florence fennel. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-3-2019

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Safety and efficacy of Cinergy® Life B3 HiCon (Bacillus amyloliquefaciens NRRL B‐50508, B. amyloliquefaciens NRRL B‐50509 and Bacillus subtilis NRRL B‐50510) as a feed additive for pigs for fattening and minor porcine species

Published on: Wed, 20 Mar 2019 The additive contains viable spores of two strains of Bacillus amyloliquefaciens and a single strain of Bacillus subtilis and is intended to be used with pigs for fattening and minor porcine species at a minimum inclusion level of 1.5 × 108 colony forming units (CFU)/kg complete feedingstuffs. The two bacterial species are considered suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strains to be establ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

March 19, 2019: Chinese Citizen Sentenced in Scheme to Sell Mislabeled Dietary Supplements

March 19, 2019: Chinese Citizen Sentenced in Scheme to Sell Mislabeled Dietary Supplements

March 19, 2019: Chinese Citizen Sentenced in Scheme to Sell Mislabeled Dietary Supplements

FDA - U.S. Food and Drug Administration

20-3-2019

March 14, 2019: Haverhill Nurse Charged with Drug Tampering

March 14, 2019: Haverhill Nurse Charged with Drug Tampering

March 14, 2019: Haverhill Nurse Charged with Drug Tampering

FDA - U.S. Food and Drug Administration

20-3-2019


Management Board meeting: 21 March 2019, European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2019 to 21/03/2019

Management Board meeting: 21 March 2019, European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2019 to 21/03/2019

Management Board meeting: 21 March 2019, European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2019 to 21/03/2019

Europe - EMA - European Medicines Agency

20-3-2019


Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 19/03/2019 to 21/03/2019

Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 19/03/2019 to 21/03/2019

Committee for Medicinal Products for Veterinary Use (CVMP): 19-21 March 2019 , European Medicines Agency, Amsterdam, the Netherlands, from 19/03/2019 to 21/03/2019

Europe - EMA - European Medicines Agency

20-3-2019


Agenda - COMP agenda of the 19-21 March 2019 meeting

Agenda - COMP agenda of the 19-21 March 2019 meeting

Agenda - COMP agenda of the 19-21 March 2019 meeting

Europe - EMA - European Medicines Agency

20-3-2019

Enforcement Report for the Week of March 20, 2019

Enforcement Report for the Week of March 20, 2019

Recently Updated Records for the Week of March 20, 2019 Last Modified Date: Monday, March 18, 2019

FDA - U.S. Food and Drug Administration

20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

Published on: Tue, 19 Mar 2019 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 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

Published on: Tue, 19 Mar 2019 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 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(c...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Probiotic Lactina® for chickens and rabbits

Probiotic Lactina® for chickens and rabbits

Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the European Food Safety Authority 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 Probiotic Lactina® for chickens for fattening and rabbits. The additive is a preparation containing viable cells of six strains of lactic acid bacteria intended for use in feed at the proposed dose of 2.5 × 109CFU/kg complete feedingstuffs. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-3-2019

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Assessment of the application for renewal of authorisation of Bonvital® (Enterococcus faecium DSM 7134) as a feed additive for weaned piglets and pigs for fattening

Published on: Tue, 19 Mar 2019 Bonvital® is the trade name for a feed additive based on Enterococcus faecium DSM 7134 currently authorised for use in piglets, pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. This opinion concerns the renewal of the authorisation of Bonvital® as a zootechnical additive for weaned piglets and pigs for fattening. The applicant is proposing to increase the minimum and maximum inclusion level of the additive in feed for ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

March 13, 2019: Five Individuals and Two Companies Plead Guilty to Felony Charges in Multimillion Dollar Scheme to Fraudulently Sell Popular Dietary Supplements

March 13, 2019: Five Individuals and Two Companies Plead Guilty to Felony Charges in Multimillion Dollar Scheme to Fraudulently Sell Popular Dietary Supplements

March 13, 2019: Five Individuals and Two Companies Plead Guilty to Felony Charges in Multimillion Dollar Scheme to Fraudulently Sell Popular Dietary Supplements

FDA - U.S. Food and Drug Administration

18-3-2019

Nieuwe ambities voor aanpak laaggeletterdheid

Nieuwe ambities voor aanpak laaggeletterdheid

Om laaggeletterdheid aan te pakken, trekt het kabinet € 425 miljoen uit in de periode 2020-2024. Dat is ruim € 35 miljoen méér dan in de periode 2015-2019. Onderdeel van de nieuwe aanpak is onder andere om meer mensen te bereiken die Nederlands als moedertaal hebben. Ook komt er geld beschikbaar om mensen te leren omgaan met een computer of smartphone. Minister Van Engelshoven (OCW), minister De Jonge (VWS), staatssecretaris Van Ark (SZW) en staatssecretaris Knops (BZK) schrijven dat vandaag in een gezam...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-3-2019

Marian Kaljouw herbenoemd als voorzitter van de NZa

Marian Kaljouw herbenoemd als voorzitter van de NZa

Dr. M.J. (Marian) Kaljouw wordt herbenoemd als bestuursvoorzitter van de Nederlandse Zorgautoriteit (NZa). De benoeming geldt voor een periode van vier jaar en gaat in op 1 juni 2019. Minister Hugo de Jonge van Volksgezondheid, Welzijn en Sport heeft de ministerraad hierover vandaag geïnformeerd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

27-3-2019

Pemetrexed Accord (Accord Healthcare S.L.U.)

Pemetrexed Accord (Accord Healthcare S.L.U.)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1669 of Wed, 27 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4072/T/06

Europe -DG Health and Food Safety

22-3-2019


Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019

Europe - EMA - European Medicines Agency

22-3-2019


Summary of opinion: Vectra 3D,dinotefuran, permethrin, and pyriproxyfen,  21/03/2019,  Positive

Summary of opinion: Vectra 3D,dinotefuran, permethrin, and pyriproxyfen, 21/03/2019, Positive

Summary of opinion: Vectra 3D,dinotefuran, permethrin, and pyriproxyfen, 21/03/2019, Positive

Europe - EMA - European Medicines Agency

22-3-2019


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

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

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

Europe - EMA - European Medicines Agency

22-3-2019


Summary of opinion: Afoxolaner Merial,afoxolaner,  21/03/2019,  Positive

Summary of opinion: Afoxolaner Merial,afoxolaner, 21/03/2019, Positive

Summary of opinion: Afoxolaner Merial,afoxolaner, 21/03/2019, Positive

Europe - EMA - European Medicines Agency

22-3-2019


Summary of opinion: ProZinc,insulin human,  21/03/2019,  Positive

Summary of opinion: ProZinc,insulin human, 21/03/2019, Positive

Summary of opinion: ProZinc,insulin human, 21/03/2019, Positive

Europe - EMA - European Medicines Agency

22-3-2019


Summary of opinion: Baycox Iron,toltrazuril / iron(iii) ion,  21/03/2019,  Positive

Summary of opinion: Baycox Iron,toltrazuril / iron(iii) ion, 21/03/2019, Positive

Summary of opinion: Baycox Iron,toltrazuril / iron(iii) ion, 21/03/2019, Positive

Europe - EMA - European Medicines Agency

22-3-2019


EMA Management Board: highlights of March 2019 meeting

EMA Management Board: highlights of March 2019 meeting

EMA Management Board: highlights of March 2019 meeting

Europe - EMA - European Medicines Agency

22-3-2019

ACSS public statement, 14-15 May 2018

ACSS public statement, 14-15 May 2018

Public statement for the Generic Medicines Working Group face-to-face meeting in Switzerland, May 2018

Therapeutic Goods Administration - Australia

21-3-2019

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast:  https://bit.ly/2WgkmGC   March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0   #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevicepic.twitter.com/zvhd7

In addition, the FDA is providing a live feed of the meeting for those who cannot attend in person: March 25, 2019 (Day 1) Webcast: https://bit.ly/2WgkmGC  March 26, 2019 (Day 2) Webcast: https://bit.ly/2TnAKU0  #FDA #MedicalDevice pic.twitter.com/zvhd72SyxX

FDA - U.S. Food and Drug Administration

20-3-2019

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Diamond ROC EOOD)

EU/3/13/1154 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2145 of Wed, 20 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003817

Europe -DG Health and Food Safety

20-3-2019

Pharmacovigilance Inspection Program metrics report: Sep 2017 - Dec 2018

Pharmacovigilance Inspection Program metrics report: Sep 2017 - Dec 2018

Statistics from inspections conducted from 1 September 2017 to 31 December 2018

Therapeutic Goods Administration - Australia

19-3-2019


Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Erleada, apalutamide, Prostatic Neoplasms, Date of authorisation: 14/01/2019, Status: Authorised

Europe - EMA - European Medicines Agency

19-3-2019

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Norbrook Laboratories (Ireland) Limited)

Loxicom (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2179 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/141/T/32

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2155 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004764

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (TMC Pharma (EU) Limited)

EU/3/16/1703 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2154 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004730

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (TMC Pharma (EU) Limited)

EU/3/16/1688 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2153 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004734

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)2156 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004770

Europe -DG Health and Food Safety

19-3-2019

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

EU/3/10/823 (Active substance: Lomitapide) - Transfer of orphan designation - Commission Decision (2019)2152 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004233

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Diamond ROC EOOD)

EU/3/16/1633 (Active substance: Fosbretabulin tromethamine) - Transfer of orphan designation - Commission Decision (2019)2151 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003815

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Diamond ROC EOOD)

EU/3/15/1587 (Active substance: Combretastatin A1 diphosphate) - Transfer of orphan designation - Commission Decision (2019)2149 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003811

Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Diamond ROC EOOD)

EU/3/15/1584 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2148 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003801

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Diamond ROC EOOD)

EU/3/14/1329 (Active substance: Variant of recombinant human fibroblast growth factor 19) - Transfer of orphan designation - Commission Decision (2019)2147 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003809

Europe -DG Health and Food Safety

18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Diamond ROC EOOD)

EU/3/14/1247 (Active substance: Autologous dendritic cells pulsed with tumour antigen-derived synthetic peptides (MAGE-1, HER-2, AIM-2, TRP-2, gp-100, and interleukin-13 receptor alpha)) - Transfer of orphan designation - Commission Decision (2019)2146 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003818

Europe -DG Health and Food Safety

18-3-2019

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Diamond ROC EOOD)

EU/3/04/195 (Active substance: 2-Methoxy-5-[(1Z)-2-(3,4,5-trimethoxyphenyl)ethenyl]-phenol) - Transfer of orphan designation - Commission Decision (2019)2144 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003813

Europe -DG Health and Food Safety

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Worphmed Srl)

EU/3/16/1742 (Active substance: Acebutolol hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2157 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004715

Europe -DG Health and Food Safety

18-3-2019


Orphan designation: Triheptanoin, Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of carnitine palmitoyltransferase II deficiency, 28/07/2015, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues, Treatment of primary hyperoxalu

Orphan designation: synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues, Treatment of primary hyperoxalu

Orphan designation: synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues, Treatment of primary hyperoxaluria, 31/07/2018, Positive

Europe - EMA - European Medicines Agency

18-3-2019

Consultations on adoption of European Union guidelines in Australia

Consultations on adoption of European Union guidelines in Australia

Consultation on proposed adoption of European Union guidelines. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

15-3-2019


Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 12-15 March 2019

Europe - EMA - European Medicines Agency

15-3-2019

Ongentys (Bial - Portela and Ca, SA)

Ongentys (Bial - Portela and Ca, SA)

Ongentys (Active substance: opicapone) - Centralised - Yearly update - Commission Decision (2019)2113 of Fri, 15 Mar 2019

Europe -DG Health and Food Safety

15-3-2019

Intrarosa (Endoceutics S.A.)

Intrarosa (Endoceutics S.A.)

Intrarosa (Active substance: prasterone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2063 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004138/T/0005

Europe -DG Health and Food Safety

15-3-2019

NovoMix (Novo Nordisk A/S)

NovoMix (Novo Nordisk A/S)

NovoMix (Active substance: Insulin aspart) - Centralised - 2-Monthly update - Commission Decision (2019)2114 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/000308/II/0095

Europe -DG Health and Food Safety

15-3-2019

Zoledronic acid Accord (Accord Healthcare S.L.U.)

Zoledronic acid Accord (Accord Healthcare S.L.U.)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2071 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002667/T/0007

Europe -DG Health and Food Safety

15-3-2019

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Akcea Therapeutics Ireland Limited)

EU/3/14/1249 (Active substance: Phosphorothioate oligonucleotide targeted to apolipoprotein C-III) - Transfer of orphan designation - Commission Decision (2019)2104 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004954

Europe -DG Health and Food Safety

15-3-2019

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Active substance: Autologous adult live cultured osteoblasts) - Transfer of orphan designation - Commission Decision (2019)2105 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004280

Europe -DG Health and Food Safety

15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Active substance: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate) - Transfer of orphan designation - Commission Decision (2019)2107 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004914

Europe -DG Health and Food Safety