Medicine

Main information

  • Trade name:
  • Medicine chamber spacer
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Medicine chamber spacer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221299
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221299

Disposable Medical Supplies Pty Ltd - Medicine chamber spacer

ARTG entry for

Medical Device Included Class 1

Sponsor

Disposable Medical Supplies Pty Ltd

Postal Address

PO Box 8617,PERTH BC, WA, 6849

Australia

ARTG Start Date

14/03/2014

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

Disposable Medical Supplies Pty Ltd

Unit 3 / 267 Rokeby Road

SUBIACO, WA, 6008

Australia

Products

1. Medicine chamber spacer

Product Type

Single Device Product

Effective date

14/03/2014

GMDN

38018 Medicine chamber spacer

Intended purpose

A device in the form of a small container that is placed between a nebulizer or a metered dose inhaler

(MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in

order to minimize delivery of large aerosolized particles.This is a reusable device.

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 01:31:14 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

14-3-2019

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

Statement by FDA Commissioner Scott Gottlieb, M.D., on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

FDA issues statement on new strategies to modernize clinical trials to advance precision medicine, patient protections and more efficient product development

FDA - U.S. Food and Drug Administration

14-3-2019

Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries

Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries

Today, the Danish Medicines Agency signed an agreement with WHO to help build up drug regulatory authorities in low- and middle-income countries, including Africa.

Danish Medicines Agency

12-3-2019

Public consultation on electronic package leaflets and summaries of product characteristics across the EU

Public consultation on electronic package leaflets and summaries of product characteristics across the EU

What should the package leaflets and labels of medicines for citizens and the summaries of product characteristics for healthcare professionals look like in the future? A public consultation on key principles about this has been launched throughout the EU, with comments to be submitted by 31 July.

Danish Medicines Agency

8-3-2019

Common European recommendations establish a framework for testing medicines of the future

Common European recommendations establish a framework for testing medicines of the future

The common European subgroup for complex clinical trials with trial subjects, which is headed by Denmark, has just published a set of recommendations for the development of personalised medicine.

Danish Medicines Agency

7-3-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s steps on naming of biological medicines to balance competition and safety for patients receiving these products

FDA updates draft guidance to set a clear path for the nonproprietary naming of interchangeable biosimilars.

FDA - U.S. Food and Drug Administration

1-3-2019

New EU report on big data paves the way for action

New EU report on big data paves the way for action

A taskforce on big data in the pharmaceutical area, the HMA-EMA Joint Big Data Taskforce, has just published its first report. The report offers a definition of big data and several recommendations for European authorities that regulate medicines and medical devices.

Danish Medicines Agency

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

14-3-2019


Human medicines European public assessment report (EPAR): Lusutrombopag Shionogi, lusutrombopag, Thrombocytopenia, Date of authorisation: 18/02/2019, Status: Authorised

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Europe - EMA - European Medicines Agency

14-3-2019

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (Active substance: Tylvalosin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2091 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/83/T/77

Europe -DG Health and Food Safety

14-3-2019

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Active substance: Fluoxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2089 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/T/31

Europe -DG Health and Food Safety

14-3-2019

Webinar: Permitted indications for listed medicines

Webinar: Permitted indications for listed medicines

Webinar for small to medium businesses, start-ups, researchers and those new to regulation

Therapeutic Goods Administration - Australia

13-3-2019

Luminity (Lantheus EU Limited)

Luminity (Lantheus EU Limited)

Luminity (Active substance: perflutren) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2049 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/654/T/27

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

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety

13-3-2019

Varuby (TESARO Bio Netherlands B.V.)

Varuby (TESARO Bio Netherlands B.V.)

Varuby (Active substance: rolapitant) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2068 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4196/T/15

Europe -DG Health and Food Safety

13-3-2019

Senshio (Shionogi B.V.)

Senshio (Shionogi B.V.)

Senshio (Active substance: ospemifene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2066 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2780/T/26

Europe -DG Health and Food Safety

13-3-2019

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (RAD Neurim Pharmaceuticals EEC SARL)

Slenyto (Active substance: melatonin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2064 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425/T/04

Europe -DG Health and Food Safety

12-3-2019

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use

Quinolone and fluoroquinolone medicinal products for systemic and inhalation use (Active substance: nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequine) - Community Referrals - Art 31 - Commission Decision (2019)2050 of Tue, 12 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1452/C/2789

Europe -DG Health and Food Safety

11-3-2019

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (ESPL Regulatory Consulting Limited)

EU/3/14/1337 (Active substance: Acamprosate calcium) - Transfer of orphan designation - Commission Decision (2019)1944 of Mon, 11 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004283

Europe -DG Health and Food Safety

8-3-2019

Today is the last day to provide comments to the #DigitalHealth #FDAPrecertPilot working model. Input will help shape the @US_FDA's next steps to build the #Pre-Cert program. Submit comments to the docket:  https://www.regulations.gov/docket?D=FDA-2017-N-

Today is the last day to provide comments to the #DigitalHealth #FDAPrecertPilot working model. Input will help shape the @US_FDA's next steps to build the #Pre-Cert program. Submit comments to the docket: https://www.regulations.gov/docket?D=FDA-2017-N-

Today is the last day to provide comments to the #DigitalHealth #FDAPrecertPilot working model. Input will help shape the @US_FDA's next steps to build the #Pre-Cert program. Submit comments to the docket: https://www.regulations.gov/docket?D=FDA-2017-N-4301 … #DigitalMedicine #HealthTech pic.twitter.com/iUsLNtkjTx

FDA - U.S. Food and Drug Administration

8-3-2019

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Clinical Network Services (NL) B.V.)

EU/3/12/968 (Active substance: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin) - Transfer of orphan designation - Commission Decision (2019)1940 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004447

Europe -DG Health and Food Safety

8-3-2019

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Granzer Regulatory Consulting and Services)

EU/3/17/1894 (Active substance: Recombinant human antibody directed against misfolded human superoxide dismutase 1) - Transfer of orphan designation - Commission Decision (2019)1943 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004025

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/14/1281 (Active substance: 1-(2,2-difluoro-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropanecarboxamide) - Transfer of orphan designation - Commission Decision (2019)1953 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004132

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/08/563 (Active substance: Recombinant derivative of C3 transferase) - Transfer of orphan designation - Commission Decision (2019)1952 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004115

Europe -DG Health and Food Safety

8-3-2019

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Leadiant GmbH)

EU/3/15/1487 (Active substance: Reduced oxydised N-acetyl heparin) - Transfer of orphan designation - Commission Decision (2019)1951 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004452

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Imago BioSciences B.V.)

EU/3/16/1757 (Active substance: N-[(2S)-5-{[(1R,2S)-2-(4-fluorophenyl)cyclopropyl]amino}-1-(4-methylpiperazin-1-yl)-1-oxopentan-2-yl]-4-(1H-1,2,3-triazol-1-yl)benzamide, bis-tosylate salt) - Transfer of orphan designation - Commission Decision (2019)1954 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003424

Europe -DG Health and Food Safety

8-3-2019

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Clinical Network Services (NL) B.V.)

EU/3/06/381 (Active substance: Human monoclonal antibody against Pseudomonas aeruginosa serotype O11) - Transfer of orphan designation - Commission Decision (2019)1941 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004486

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1285 (Clinuvel Europe Limited)

EU/3/14/1285 (Clinuvel Europe Limited)

EU/3/14/1285 (Active substance: Afamelanotide) - Transfer of orphan designation - Commission Decision (2019)1950 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004300

Europe -DG Health and Food Safety

8-3-2019

EU/3/09/648 (Clinuvel Europe Limited)

EU/3/09/648 (Clinuvel Europe Limited)

EU/3/09/648 (Active substance: Afamelanotide) - Transfer of orphan designation - Commission Decision (2019)1949 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004299

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Clinuvel Europe Limited)

EU/3/08/545 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1948 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004293

Europe -DG Health and Food Safety

8-3-2019

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Clinuvel Europe Limited)

EU/3/08/541 (Active substance: [Nle4, D-Phe7]-alpha-melanocyte stimulating hormone) - Transfer of orphan designation - Commission Decision (2019)1947 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004019

Europe -DG Health and Food Safety

8-3-2019

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Richardson Associates Regulatory Affairs Ltd)

EU/3/14/1404 (Active substance: 1-(2-isopropoxyethyl)-2-thioxo-1,2,3,5-tetrahydro-pyrrolo[3,2-d]pyrimidin-4-one) - Transfer of orphan designation - Commission Decision (2019)1942 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004496

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (F2G Biotech GmbH)

EU/3/16/1738 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1946 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004537

Europe -DG Health and Food Safety

8-3-2019

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (F2G Biotech GmbH)

EU/3/16/1713 (Active substance: 2-(1,5-dimethyl-3-phenyl-1H-pyrrol-2-yl)-N-{4-[4-(5-fluoro-pyrimidin-2-yl)piperazin-1-yl]-phenyl}-2-oxo-acetamide) - Transfer of orphan designation - Commission Decision (2019)1945 of Fri, 08 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004529

Europe -DG Health and Food Safety

7-3-2019

DaTSCAN (GE Healthcare B.V.)

DaTSCAN (GE Healthcare B.V.)

DaTSCAN (Active substance: Ioflupane (123I)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1908 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/266/T/57

Europe -DG Health and Food Safety

7-3-2019

Kiovig (Baxter AG)

Kiovig (Baxter AG)

Kiovig (Active substance: Human normal immunoglobulin (IVIg)) - Centralised - 2-Monthly update - Commission Decision (2019)1909 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/628/IB/88

Europe -DG Health and Food Safety

7-3-2019

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Accord Healthcare S.L.U.)

Granpidam (Active substance: sildenafil) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1914 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4289/T/02

Europe -DG Health and Food Safety

7-3-2019

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

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

Pregabalin Accord (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1913 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4024/T/10

Europe -DG Health and Food Safety

7-3-2019

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

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

Aripiprazole Accord (Active substance: aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1915 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4021/T/13

Europe -DG Health and Food Safety

7-3-2019

EU/3/18/2091 (S-cubed Pharmaceutical Services ApS)

EU/3/18/2091 (S-cubed Pharmaceutical Services ApS)

EU/3/18/2091 (Active substance: Glucagon) - Transfer of orphan designation - Commission Decision (2019)1740 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004177

Europe -DG Health and Food Safety

6-3-2019


Human medicines highlights - March 2019

Human medicines highlights - March 2019

Human medicines highlights - March 2019

Europe - EMA - European Medicines Agency

6-3-2019

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation

This consultation considers the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification. Closing date: 29 April 2019

Therapeutic Goods Administration - Australia

5-3-2019

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

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

Palonosetron Accord (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1825 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4129/T/04

Europe -DG Health and Food Safety

5-3-2019

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

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

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1829 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2539/T/41

Europe -DG Health and Food Safety

5-3-2019

Tegsedi (Akcea Therapeutics Ireland Ltd)

Tegsedi (Akcea Therapeutics Ireland Ltd)

Tegsedi (Active substance: inotersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1826 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004782/T/0003

Europe -DG Health and Food Safety

5-3-2019

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

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

Lacosamide Accord (Active substance: lacosamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1831 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4443/T/02

Europe -DG Health and Food Safety

5-3-2019

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

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

Levetiracetam Accord (Active substance: levetiracetam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1828 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2290/T/22

Europe -DG Health and Food Safety

5-3-2019

Melosus (CP-Pharma Handelsgesellschaft mbH)

Melosus (CP-Pharma Handelsgesellschaft mbH)

Melosus (Active substance: Meloxicam) - Centralised - 2-Monthly update - Commission Decision (2019)1824 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/2001/IB/07

Europe -DG Health and Food Safety

5-3-2019

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

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

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1827 of Tue, 05 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857/T/01

Europe -DG Health and Food Safety

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

1-3-2019


Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Human medicines European public assessment report (EPAR): Rizmoic, naldemedine, Constipation, Date of authorisation: 18/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019


Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Evant, Coccidiosis vaccine live for chickens, Date of authorisation: 05/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (TMC Pharma (EU) Limited)

EU/3/15/1563 (Active substance: Recombinant human interleukin-3 truncated diphtheria toxin fusion protein) - Transfer of orphan designation - Commission Decision (2019)1751 of Fri, 01 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003921

Europe -DG Health and Food Safety

1-3-2019

EU/3/15/1607 (TMC Pharma (EU) Limited)

EU/3/15/1607 (TMC Pharma (EU) Limited)

EU/3/15/1607 (Active substance: Entolimod) - Transfer of orphan designation - Commission Decision (2019)1738 of Fri, 01 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004004

Europe -DG Health and Food Safety

1-3-2019


Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Veterinary medicines European public assessment report (EPAR): Kriptazen, halofuginone, Date of authorisation: 08/02/2019, Status: Authorised

Europe - EMA - European Medicines Agency

1-3-2019

Medicines Advisory Statements Specification updates

Medicines Advisory Statements Specification updates

The new Therapeutic Goods (Medicines Advisory Statements) Specification 2019 commences 1 March 2019

Therapeutic Goods Administration - Australia

28-2-2019

EU/3/19/2135 (Enzyvant Therapeutics Ireland Limited)

EU/3/19/2135 (Enzyvant Therapeutics Ireland Limited)

EU/3/19/2135 (Active substance: Allogeneic cultured postnatal thymus-derived tissue) - Orphan designation - Commission Decision (2019)1727 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002975

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (FGK Representative Service GmbH)

EU/3/19/2134 (Active substance: 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester) - Orphan designation - Commission Decision (2019)1726 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002279

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Sinus Regulatory Consulting EU Limited)

EU/3/12/997 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1750 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004372

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Sinus Regulatory Consulting EU Limited)

EU/3/12/996 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1749 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004369

Europe -DG Health and Food Safety

28-2-2019

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Sinus Regulatory Consulting EU Limited)

EU/3/12/993 (Active substance: N-hydroxy-4-(3-methyl-2-(S)-phenyl-butyrylamino) benzamide) - Transfer of orphan designation - Commission Decision (2019)1748 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004343

Europe -DG Health and Food Safety

28-2-2019

EU/3/19/2145 (Roche Registration GmbH)

EU/3/19/2145 (Roche Registration GmbH)

EU/3/19/2145 (Active substance: Risdiplam) - Orphan designation - Commission Decision (2019)1737 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001899

Europe -DG Health and Food Safety