DOMINO LIQUID CHLORINE

Main information

  • Trade name:
  • DOMINO LIQUID CHLORINE
  • Class:
  • AgChem
  • Medicine domain:
  • Plants
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DOMINO LIQUID CHLORINE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • ALGICIDE

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Archived
  • Authorization number:
  • 30984
  • Last update:
  • 09-08-2016

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 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 vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

29-11-2018

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

FDA warns company for selling e-liquids that resemble kid-friendly foods as part of the agency’s ongoing Youth Tobacco Prevention Plan

FDA issued a warning letter to Electric Lotus LLC for selling nicotine-containing e-liquids used in e-cigarettes with labeling and/or advertising that cause them to resemble kid-friendly food products.

FDA - U.S. Food and Drug Administration

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

24-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

23-8-2018

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

FDA announced that all 17 manufacturers, distributors, and retailers that were warned in May have stopped selling the e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

8-8-2018

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Product Quest Manufacturing LLC Issues Voluntary Nationwide Recall of CVS Health 12 Hour Sinus Relief Nasal Mist Due to Microbiological Contamination

Holly Hill, FL, Product Quest Manufacturing (“Product Quest”) is voluntarily recalling Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist, a clear, colorless liquid, to the consumer level. The product was found to have had microbiological contamination identified as Pseudomonas aeruginosa.

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

21-7-2018

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

FDA - U.S. Food and Drug Administration

20-7-2018

J2Labz recalls Sugar Shack Vaping Liquid

J2Labz recalls Sugar Shack Vaping Liquid

Health Canada's sampling and evaluation program has determined that these vaping products do not meet the packaging and labelling requirements of the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA - U.S. Food and Drug Administration

4-6-2018

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks

FDA has approved new labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices.

FDA - U.S. Food and Drug Administration

15-1-2019

A warning to consumers about the serious health risks relating to e-cigarette liquid

A warning to consumers about the serious health risks relating to e-cigarette liquid

The TGA is alerting consumers to the potential risks of purchasing electronic cigarette liquid

Therapeutic Goods Administration - Australia

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

29-6-2018

EU/3/18/2031 (Air Liquide SantE (International))

EU/3/18/2031 (Air Liquide SantE (International))

EU/3/18/2031 (Active substance: Argon) - Orphan designation - Commission Decision (2018)4176 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/031/18

Europe -DG Health and Food Safety

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

4-6-2018

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports-  https://go.usa.gov/xQGf8  #FDA #MedicalDevice

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports- https://go.usa.gov/xQGf8  #FDA #MedicalDevice

UPDATE to Letter to Health Care Providers: Potential risks with liquid-filled intragastric balloons – Additional Information Regarding Death Reports- https://go.usa.gov/xQGf8  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration