Transfer

Main information

  • Trade name:
  • Transfer aid, person,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Transfer aid, person,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218207
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218207

Alpha Rehabilitation Equipment - Transfer aid, person, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Alpha Rehabilitation Equipment

Postal Address

PO Box 384,CARDIFF, NSW, 2285

Australia

ARTG Start Date

6/12/2013

Product category

Medical Device Class 1

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Acime Frame

1 Avenue de L'Europe

ZA de le Maie

, Rinxent, 62720

France

Products

1. Transfer aid, person, <specify>

Product Type

Single Device Product

Effective date

6/12/2013

GMDN

15693 Transfer aid, person, <specify>

Intended purpose

Intended to assist with the transfer between locations in a facility.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 11:25:20 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

1-2-2019

EFSA statement on the risk posed to humans by a vitamin B2 produced by a genetically modified strain of Bacillus subtilis used as a feed additive

EFSA statement on the risk posed to humans by a vitamin B2 produced by a genetically modified strain of Bacillus subtilis used as a feed additive

Published on: Thu, 31 Jan 2019 The detection of recombinant DNA in a vitamin B2 used as feed additive was notified by the Belgian national authorities on 2 October 2018 via the Rapid Alert System for Food and Feed (RASFF). The European Commission requested scientific advice from EFSA on the risk posed to humans by the presence of genetically modified material in the feed additive, particularly with regard to antimicrobial resistance (AMR). EFSA assessed the analytical data from RASFF regarding the prese...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Guidelines for reporting 2018 prevalence sample‐based data in accordance with SSD2 data model

Guidelines for reporting 2018 prevalence sample‐based data in accordance with SSD2 data model

Published on: Wed, 30 Jan 2019 Prevalence sample‐based data should be transmitted from Member States to the European Food Safety Authority (EFSA) using the EFSA Standard Sample Description version 2 (SSD2) standard. To support reporting countries in data submission using eXtensible Markup Language (XML) data transfer, specific guidelines are given in this report covering the reporting of sample‐based zoonoses and zoonotic agent data. These guidelines are specifically aimed at guiding the reporting of in...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Data dictionaries‐guidelines for reporting 2018 data on zoonoses, antimicrobial resistance and food‐borne outbreaks

Data dictionaries‐guidelines for reporting 2018 data on zoonoses, antimicrobial resistance and food‐borne outbreaks

Published on: Wed, 30 Jan 2019 This technical report of the European Food Safety Authority (EFSA) presents guidance to reporting European Union (EU) Member States and non‐Member States in data submission using extensible markup language (XML) data transfer covering the reporting of isolate‐based quantitative antimicrobial resistance data, as well as reporting of prevalence data on zoonoses and food‐borne contaminants, food‐borne outbreak data, animal population data and disease status data. For data col...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-2-2019

EU/3/18/2116 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2116 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2116 (Active substance: Ivacaftor, N-(1,3-dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1362 of Mon, 18 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003732

Europe -DG Health and Food Safety

15-2-2019

Circadin (RAD Neurim Pharmaceuticals EEC SARL)

Circadin (RAD Neurim Pharmaceuticals EEC SARL)

Circadin (Active substance: Melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1079 of Fri, 15 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/695/T/58

Europe -DG Health and Food Safety

14-2-2019

Yargesa (Piramal Critical Care B.V.)

Yargesa (Piramal Critical Care B.V.)

Yargesa (Active substance: miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1329 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004016/T/0005

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Nightstar Europa Limited)

EU/3/18/1975 (Active substance: Adenovirus-associated viral vector serotype 8 containing the human RPGR gene) - Transfer of orphan designation - Commission Decision (2019)1376 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003405

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (AstraZeneca AB)

EU/3/12/1051 (Active substance: Recombinant human lecithin cholesterol acyltransferase) - Transfer of orphan designation - Commission Decision (2019)1365 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003174

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1478 (Florence Porte ThomE)

EU/3/15/1478 (Florence Porte ThomE)

EU/3/15/1478 (Active substance: Rimeporide) - Transfer of orphan designation - Commission Decision (2019)1364 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003005

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (BioMarin International Limited)

EU/3/12/1094 (Active substance: Modified recombinant human C-type natriuretic peptide) - Transfer of orphan designation - Commission Decision (2019)1348 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003587

Europe -DG Health and Food Safety

14-2-2019

EU/3/11/914 (Quality Regulatory Clinical Ireland Limited)

EU/3/11/914 (Quality Regulatory Clinical Ireland Limited)

EU/3/11/914 (Active substance: Smilagenin) - Transfer of orphan designation - Commission Decision (2019)1374 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003741

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/2117 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2117 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/18/2117 (Active substance: Ivacaftor, potassium(benzenesulfonyl)({[6-(3-{2-[1-(trifluoromethyl) cyclopropyl]ethoxy}-1H-pyrazol-1-yl)-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridin-3-yl]carbonyl})azanide, tezacaftor) - Transfer of orphan designation - Commission Decision (2019)1363 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003788

Europe -DG Health and Food Safety

14-2-2019

EU/3/18/2011 (Kyowa Kirin Holdings B.V.)

EU/3/18/2011 (Kyowa Kirin Holdings B.V.)

EU/3/18/2011 (Active substance: Burosumab) - Transfer of orphan designation - Commission Decision (2019)1344 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003746

Europe -DG Health and Food Safety

14-2-2019

EU/3/16/1656 (Sellas Life Sciences Limited)

EU/3/16/1656 (Sellas Life Sciences Limited)

EU/3/16/1656 (Active substance: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly) - Transfer of orphan designation - Commission Decision (2019)1346 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003557

Europe -DG Health and Food Safety

14-2-2019

EU/3/16/1655 (Sellas Life Sciences Limited)

EU/3/16/1655 (Sellas Life Sciences Limited)

EU/3/16/1655 (Active substance: Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu, Ser-Gly-Gln-Ala-Tyr-Met-Phe-Pro-Asn-Ala-Pro-Tyr-Leu-Pro-Ser-Cys-Leu-Glu-Ser, Arg-Ser-Asp-Glu-Leu-Val-Arg-His-His-Asn-Met-His-Gln-Arg-Asn-Met-Thr-Lys-Leu and Pro-Gly-Cys-Asn-Lys-Arg-Tyr-Phe-Lys-Leu-Ser-His-Leu-Gln-Met-His-Ser-Arg-Lys-His-Thr-Gly) - Transfer of orphan designation - Commission Decision (2019)1345 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003572

Europe -DG Health and Food Safety

14-2-2019

EU/3/17/1840 (LSK Biopharma Limited)

EU/3/17/1840 (LSK Biopharma Limited)

EU/3/17/1840 (Active substance: N-(4-(1-cyanocyclopentyl)phenyl)-2-(4-pyridinylmethyl)amino-3-pyridinecarboxamide methanesulfonate) - Transfer of orphan designation - Commission Decision (2019)1347 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003244

Europe -DG Health and Food Safety

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

14-2-2019

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Clinical Network Services (NL) B.V.)

EU/3/16/1702 (Active substance: Recombinant human monoclonal antibody to insulin receptor) - Transfer of orphan designation - Commission Decision (2019)1372 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003601

Europe -DG Health and Food Safety

14-2-2019

EU/3/12/1089 (Alexion Europe SAS)

EU/3/12/1089 (Alexion Europe SAS)

EU/3/12/1089 (Active substance: Choline tetrathiomolybdate) - Transfer of orphan designation - Commission Decision (2019)1373 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003805

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Voisin Consulting S.A.R.L.)

EU/3/15/1499 (Active substance: Adult human bone-marrow-derived, ex-vivo-expanded, pooled allogeneic mesenchymal stromal cells) - Transfer of orphan designation - Commission Decision (2019)1375 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003671

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1525 (Ultragenyx Netherlands B.V.)

EU/3/15/1525 (Ultragenyx Netherlands B.V.)

EU/3/15/1525 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1368 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003845

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1524 (Ultragenyx Netherlands B.V.)

EU/3/15/1524 (Ultragenyx Netherlands B.V.)

EU/3/15/1524 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1367 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003772

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1508 (Ultragenyx Netherlands B.V.)

EU/3/15/1508 (Ultragenyx Netherlands B.V.)

EU/3/15/1508 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1366 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003846

Europe -DG Health and Food Safety

14-2-2019

EU/3/14/1394 (Pharma Gateway AB)

EU/3/14/1394 (Pharma Gateway AB)

EU/3/14/1394 (Active substance: Pegylated recombinant human hyaluronidase PH20) - Transfer of orphan designation - Commission Decision (2019)1343 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002720

Europe -DG Health and Food Safety

14-2-2019

EU/3/14/1290 (Nightstar Europa Limited)

EU/3/14/1290 (Nightstar Europa Limited)

EU/3/14/1290 (Active substance: Adeno-associated viral vector serotype 2 containing the human REP1 gene) - Transfer of orphan designation - Commission Decision (2019)1361 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003290

Europe -DG Health and Food Safety

11-2-2019

Lenvima (Eisai GmbH)

Lenvima (Eisai GmbH)

Lenvima (Active substance: lenvatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1076 of Mon, 11 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3727/T/24

Europe -DG Health and Food Safety

11-2-2019

Kisplyx (Eisai GmbH)

Kisplyx (Eisai GmbH)

Kisplyx (Active substance: lenvatinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1077 of Mon, 11 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4224/T/22

Europe -DG Health and Food Safety

8-2-2019

Accofil (Accord Healthcare S.L.U.)

Accofil (Accord Healthcare S.L.U.)

Accofil (Active substance: Filgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1033 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3956/T/27

Europe -DG Health and Food Safety

8-2-2019

Axumin (Blue Earth Diagnostics Ireland Ltd)

Axumin (Blue Earth Diagnostics Ireland Ltd)

Axumin (Active substance: fluciclovine (18F)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1046 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004197/T/0012

Europe -DG Health and Food Safety

8-2-2019

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

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

Eptifibatide Accord (Active substance: eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1036 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4104/T/05

Europe -DG Health and Food Safety

8-2-2019

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

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

Ivabradine Accord (Active substance: ivabradine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1034 of Fri, 08 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4241/T/03

Europe -DG Health and Food Safety

6-2-2019

Zycortal (Dechra Regulatory B.V.)

Zycortal (Dechra Regulatory B.V.)

Zycortal (Active substance: desoxycortone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)914 of Wed, 06 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/3782/T/02

Europe -DG Health and Food Safety

4-2-2019

On January 28th, @US_FDA  identified a Class I Recall, the most serious  type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid  Transfer Systems Due to Potential Malfunctions. Find out more about the recall here:  https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEX

On January 28th, @US_FDA identified a Class I Recall, the most serious type of recall: West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions. Find out more about the recall here: https://go.usa.gov/xEXHM  #FDA #MedicalDevice pic.twitter.com/0l5O1bSaUy

FDA - U.S. Food and Drug Administration

4-2-2019

EU/3/17/1951 (Clinical Network Services (NL) B.V.)

EU/3/17/1951 (Clinical Network Services (NL) B.V.)

EU/3/17/1951 (Active substance: Agammaglobulinaemia tyrosine kinase) - Transfer of orphan designation - Commission Decision (2019)817 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002857

Europe -DG Health and Food Safety

4-2-2019

EU/3/16/1758 (Clinical Network Services (NL) B.V.)

EU/3/16/1758 (Clinical Network Services (NL) B.V.)

EU/3/16/1758 (Active substance: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide) - Transfer of orphan designation - Commission Decision (2019)816 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003048

Europe -DG Health and Food Safety

4-2-2019

EU/3/15/1498 (Clinical Network Services (NL) B.V.)

EU/3/15/1498 (Clinical Network Services (NL) B.V.)

EU/3/15/1498 (Active substance: 2-(7-ethoxy-4-(3-fluorophenyl)-1-oxophthalazin-2(1H)-yl)-N-methyl-N-(2-methylbenzo[d]oxazol-6-yl)acetamide) - Transfer of orphan designation - Commission Decision (2019)815 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003040

Europe -DG Health and Food Safety

4-2-2019

EU/3/17/1930 (Cymabay Ireland Limited)

EU/3/17/1930 (Cymabay Ireland Limited)

EU/3/17/1930 (Active substance: Seladelpar) - Transfer of orphan designation - Commission Decision (2019)812 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002516

Europe -DG Health and Food Safety

4-2-2019

Zoely (Theramex Ireland Limited)

Zoely (Theramex Ireland Limited)

Zoely (Active substance: nomegestrol / estradiol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)850 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1213/T/47

Europe -DG Health and Food Safety

4-2-2019

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

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

Memantine Accord (Active substance: memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)844 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/T/12

Europe -DG Health and Food Safety

4-2-2019

Olanzapine Glenmark (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)853 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1085/T/29

Europe -DG Health and Food Safety

4-2-2019

Olanzapine Glenmark Europe (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark Europe (Glenmark Arzneimittel GmbH)

Olanzapine Glenmark Europe (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)856 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1086/T/27

Europe -DG Health and Food Safety

4-2-2019

Feraccru (Norgine B.V.)

Feraccru (Norgine B.V.)

Feraccru (Active substance: ferric maltol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)857 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2733/T/20

Europe -DG Health and Food Safety

4-2-2019

Combivir (ViiV Healthcare BV)

Combivir (ViiV Healthcare BV)

Combivir (Active substance: lamivudine / zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)858 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/190/T/94

Europe -DG Health and Food Safety

4-2-2019

Xaluprine (Nova Laboratories Ireland Limited)

Xaluprine (Nova Laboratories Ireland Limited)

Xaluprine (Active substance: Mercaptopurine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)846 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002022/T/0020

Europe -DG Health and Food Safety

4-2-2019

EU/3/12/1083 (Voisin Consulting S.A.R.L.)

EU/3/12/1083 (Voisin Consulting S.A.R.L.)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2019)814 of Mon, 04 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003624

Europe -DG Health and Food Safety

1-2-2019

EU/3/12/1068 (StEphane Gibaud)

EU/3/12/1068 (StEphane Gibaud)

EU/3/12/1068 (Active substance: Melarsoprol) - Transfer of orphan designation - Commission Decision (2019)813 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003439

Europe -DG Health and Food Safety

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

25-1-2019

Luxturna (Novartis Europharm Limited)

Luxturna (Novartis Europharm Limited)

Luxturna (Active substance: voretigene neparvovec) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)675 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4451/T/01

Europe -DG Health and Food Safety

25-1-2019

Juluca (ViiV Healthcare BV)

Juluca (ViiV Healthcare BV)

Juluca (Active substance: dolutegravir / rilpivirine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)679 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4427/T/07

Europe -DG Health and Food Safety

25-1-2019

Bronchitol (Pharmaxis Europe Limited)

Bronchitol (Pharmaxis Europe Limited)

Bronchitol (Active substance: Mannitol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)687 of Fri, 25 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/1252/T/35

Europe -DG Health and Food Safety

23-1-2019

Lonquex (Teva B.V.)

Lonquex (Teva B.V.)

Lonquex (Active substance: lipegfilgrastim) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)623 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/002556/T/0046

Europe -DG Health and Food Safety

23-1-2019

EU/3/15/1490 (S-cubed Pharmaceutical Services ApS)

EU/3/15/1490 (S-cubed Pharmaceutical Services ApS)

EU/3/15/1490 (Active substance: Triamcinolone acetonide) - Transfer of orphan designation - Commission Decision (2019)579 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003126

Europe -DG Health and Food Safety

23-1-2019

EU/3/14/1342 (S-cubed Pharmaceutical Services ApS)

EU/3/14/1342 (S-cubed Pharmaceutical Services ApS)

EU/3/14/1342 (Active substance: Glucagon) - Transfer of orphan designation - Commission Decision (2019)578 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003128

Europe -DG Health and Food Safety

23-1-2019

EU/3/13/1204 (S-cubed Pharmaceutical Services ApS)

EU/3/13/1204 (S-cubed Pharmaceutical Services ApS)

EU/3/13/1204 (Active substance: Sirolimus) - Transfer of orphan designation - Commission Decision (2019)577 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003156

Europe -DG Health and Food Safety

23-1-2019

EU/3/11/872 (S-cubed Pharmaceutical Services ApS)

EU/3/11/872 (S-cubed Pharmaceutical Services ApS)

EU/3/11/872 (Active substance: Sulfonated monophosphorylated mannose oligosaccharide) - Transfer of orphan designation - Commission Decision (2019)576 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003129

Europe -DG Health and Food Safety

23-1-2019

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Active substance: Cyclic pyranopterin monophosphate) - Transfer of orphan designation - Commission Decision (2019)574 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003164

Europe -DG Health and Food Safety

22-1-2019

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (BioMarin International Limited)

EU/3/14/1422 (Active substance: Chimeric fusion protein of recombinant human alpha-N-acetylglucosaminidase and human insulin-like growth factor 2) - Transfer of orphan designation - Commission Decision (2019)575 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003313

Europe -DG Health and Food Safety

22-1-2019

EU/3/16/1812 (FGK Representative Service GmbH)

EU/3/16/1812 (FGK Representative Service GmbH)

EU/3/16/1812 (Active substance: Antroquinonol) - Transfer of orphan designation - Commission Decision (2019)581 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003324

Europe -DG Health and Food Safety

22-1-2019

EU/3/05/325 (Pharmaxis Europe Limited)

EU/3/05/325 (Pharmaxis Europe Limited)

EU/3/05/325 (Active substance: Mannitolum) - Transfer of orphan designation - Commission Decision (2019)580 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002786

Europe -DG Health and Food Safety

22-1-2019

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Active substance: Tasimelteon) - Transfer of orphan designation - Commission Decision (2019)573 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002557

Europe -DG Health and Food Safety

17-1-2019

Savene (Clinigen Healthcare B.V.)

Savene (Clinigen Healthcare B.V.)

Savene (Active substance: Dexrazoxane) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)206 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/000682/T/0038

Europe -DG Health and Food Safety

16-1-2019

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (EUSA Pharma (Netherlands) B.V.)

EU/3/12/1062 (Active substance: Chimeric monoclonal antibody against GD2) - Transfer of orphan designation - Commission Decision (2019)238 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003198

Europe -DG Health and Food Safety

16-1-2019

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Ology Bioservices Ireland LTD)

Vepacel (Active substance: Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)196 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2089/T/19

Europe -DG Health and Food Safety