Pharmaceutical

Main information

  • Trade name:
  • Pharmaceutical information system application software
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Pharmaceutical information system application software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221842
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221842

Cerner Corporation Pty Ltd - Pharmaceutical information system application software

ARTG entry for

Medical Device Included Class 1

Sponsor

Cerner Corporation Pty Ltd

Postal Address

PO Box 311,NORTH SYDNEY, NSW, 2059

Australia

ARTG Start Date

1/04/2014

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

Cerner Corporation

8779 Hillcrest Road

Kansas City, MO, 64138

United States Of America

Products

1. Pharmaceutical information system application software

Product Type

Single Device Product

Effective date

1/04/2014

GMDN

58842 Pharmaceutical information system application software

Intended purpose

An application , routine, and/or algorithm intended for use as or in an information system to receive,

collect, store, manage,assist in analysis of, display, output and distribute data within or between healthcare

facilities, to assist with therapeutic pharmaceutical prescription and management

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 09.11.2017 at 11:37:22 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

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC.

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer).

FDA - U.S. Food and Drug Administration

4-3-2019

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.

FDA - U.S. Food and Drug Administration

1-3-2019

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of Losartan potassium/ hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

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

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

12-2-2019

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

February 7, 2019: Three Federal Cases Allege Illegal Importation and Sale of ‘Herbal’ Sexual Enhancement Pills that Contained Pharmaceutical Drugs

FDA - U.S. Food and Drug Administration

8-2-2019

New data analysis centre to open at the Danish Medicines Agency

New data analysis centre to open at the Danish Medicines Agency

The Danish government today announced its decision to support the establishment of a new data analysis centre in the Danish Medicines Agency. The centre is to handle the analysis of large data quantities in the pharmaceutical and medical devices areas and will set new standards for the monitoring of the safety and efficacy of medicines and medical devices after their marketing.

Danish Medicines Agency

31-1-2019

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

January 18, 2019: Medical Company Executive Sentenced for Smuggling $18 Million in Misbranded Pharmaceuticals into United States

FDA - U.S. Food and Drug Administration

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

18-1-2019

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products

-- Prinston Pharmaceutical Inc., dba Solco Healthcare LLC., has initiated a voluntary recall of one (1) lot of Irbesartan and seven (7) lots of Irbesartan HCTZ Tablets to the consumer level due to the detection of trace amount of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

FDA - U.S. Food and Drug Administration

8-1-2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass.

FDA - U.S. Food and Drug Administration

6-1-2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Lupin Pharmaceuticals, Inc. is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials.

FDA - U.S. Food and Drug Administration

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

20-12-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinog...

FDA - U.S. Food and Drug Administration

18-12-2018


Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Draft guideline on safety and residue data requirements for pharmaceutical veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Revision 2

Europe - EMA - European Medicines Agency

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

3-12-2018

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

November 28, 2018: Former Vice President of Insys Pharmaceuticals Pleads Guilty to Racketeering Scheme

FDA - U.S. Food and Drug Administration

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

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

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

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

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

27-2-2019

Zavicefta (Pfizer Ireland Pharmaceuticals)

Zavicefta (Pfizer Ireland Pharmaceuticals)

Zavicefta (Active substance: ceftazidime/avibactam) - Centralised - Yearly update - Commission Decision (2019)1673 of Wed, 27 Feb 2019

Europe -DG Health and Food Safety

27-2-2019

Hetlioz (Vanda Pharmaceuticals Germany GmbH)

Hetlioz (Vanda Pharmaceuticals Germany GmbH)

Hetlioz (Active substance: tasimelteon) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1668 of Wed, 27 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3870/T/13

Europe -DG Health and Food Safety

25-2-2019

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Taro Pharmaceuticals Europe B.V.)

EU/3/05/301 (Active substance: Chimeric monoclonal antibody to shiga-toxin 1 and 2) - Transfer of orphan designation - Commission Decision (2019)1636 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003835

Europe -DG Health and Food Safety

22-2-2019

Bortezomib SUN (Sun Pharmaceutical Industries Europe BV)

Bortezomib SUN (Sun Pharmaceutical Industries Europe BV)

Bortezomib SUN (Active substance: bortezomib) - PSUSA - Modification - Commission Decision (2019)1586 of Fri, 22 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4076/PSUSA/424/201804

Europe -DG Health and Food Safety

19-2-2019

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (AOP Orphan Pharmaceuticals AG)

Besremi (Active substance: ropeginterferon alfa-2b) - Centralised - Authorisation - Commission Decision (2019)1455 of Tue, 19 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4128/00

Europe -DG Health and Food Safety

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

15-2-2019


HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry

HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry

HMA/EMA Joint Task Force on big data – Survey for pharmaceutical industry

Europe - EMA - European Medicines Agency

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

11-2-2019

Raxone (Santhera Pharmaceuticals (Deutschland) GmbH)

Raxone (Santhera Pharmaceuticals (Deutschland) GmbH)

Raxone (Active substance: idebenone) - Centralised - Yearly update - Commission Decision (2019)1074 of Mon, 11 Feb 2019

Europe -DG Health and Food Safety

11-2-2019

Manufacture of sterile radiopharmaceuticals labelled with fluorine-18

Manufacture of sterile radiopharmaceuticals labelled with fluorine-18

Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13

Therapeutic Goods Administration - Australia

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

Resolor (Shire Pharmaceuticals Ireland Limited)

Resolor (Shire Pharmaceuticals Ireland Limited)

Resolor (Active substance: prucalopride) - Centralised - Yearly update - Commission Decision (2019)840 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

25-1-2019

Revestive (Shire Pharmaceuticals Ireland Limited)

Revestive (Shire Pharmaceuticals Ireland Limited)

Revestive (Active substance: teduglutide) - Centralised - Yearly update - Commission Decision (2019)681 of Fri, 25 Jan 2019

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

22-1-2019

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Allergan Pharmaceuticals Ireland)

Lumigan (Active substance: Bimatoprost) - PASS - Modification - Commission Decision (2019)586 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/413/201803

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

18-1-2019


Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Overview of comments received on ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management

Europe - EMA - European Medicines Agency

17-1-2019

Natpar (Shire Pharmaceuticals Ireland Limited)

Natpar (Shire Pharmaceuticals Ireland Limited)

Natpar (Active substance: parathyroid hormone) - PSUSA - Modification - Commission Decision (2019)269 of Thu, 17 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10591/201804

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2133 (TLC Biopharmaceuticals B.V.)

EU/3/18/2133 (TLC Biopharmaceuticals B.V.)

EU/3/18/2133 (Active substance: Vinorelbine tartrate) - Orphan designation - Commission Decision (2019)227 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001988

Europe -DG Health and Food Safety

15-1-2019

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Arena Pharmaceuticals Limited)

EU/3/18/2130 (Active substance: Ralinepag) - Orphan designation - Commission Decision (2019)239 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002037

Europe -DG Health and Food Safety

15-1-2019

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Vertex Pharmaceuticals (Ireland) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)188 of Tue, 15 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/004682/T/0003

Europe -DG Health and Food Safety

20-12-2018


Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Europe - EMA - European Medicines Agency

20-12-2018

Ledaga (Helsinn Birex Pharmaceuticals Ltd.)

Ledaga (Helsinn Birex Pharmaceuticals Ltd.)

Ledaga (Active substance: chlormethine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)9124 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2826/T/8

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2118 (Eiger Biopharmaceuticals Europe Limited)

EU/3/18/2118 (Eiger Biopharmaceuticals Europe Limited)

EU/3/18/2118 (Active substance: Lonafarnib) - Orphan designation - Commission Decision (2018)9033 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/159/18

Europe -DG Health and Food Safety

18-12-2018

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

EU/3/18/2117 (Vertex Pharmaceuticals (Europe) 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) - Orphan designation - Commission Decision (2018)9032 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/137/18

Europe -DG Health and Food Safety

18-12-2018

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

EU/3/18/2116 (Vertex Pharmaceuticals (Europe) 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) - Orphan designation - Commission Decision (2018)9031 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/139/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2115 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2115 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2115 (Active substance: Human anti-promyostatin monoclonal antibody) - Orphan designation - Commission Decision (2018)9030 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/136/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2114 (Shire Pharmaceuticals Ireland Limited)

EU/3/18/2114 (Shire Pharmaceuticals Ireland Limited)

EU/3/18/2114 (Active substance: C1 esterase inhibitor (human)) - Orphan designation - Commission Decision (2018)9029 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/173/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/17/1828 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/17/1828 (Vertex Pharmaceuticals (Ireland) Limited)

EU/3/17/1828 (Active substance: 1-(2,2-difluoro-2H-1,3-benzodioxol-5-yl)-N-{1-[(2R)-2,3-dihydroxypropyl]-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl}cyclopropane-1-carboxamide and ivacaftor) - Transfer of orphan designation - Commission Decision (2018)9017 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002757

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2109 (Yes Pharmaceutical Development Services GmbH)

EU/3/18/2109 (Active substance: Adeno-associated virus serotype HSC15 expressing human phenylalanine hydroxylase) - Orphan designation - Commission Decision (2018)9024 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/153/18

Europe -DG Health and Food Safety

18-12-2018

EU/3/12/963 (Helsinn Birex Pharmaceuticals Ltd)

EU/3/12/963 (Helsinn Birex Pharmaceuticals Ltd)

EU/3/12/963 (Active substance: Chlormethine) - Transfer of orphan designation - Commission Decision (2018)9016 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002753

Europe -DG Health and Food Safety