REV-WASH

Main information

  • Trade name:
  • REV-WASH HEAVY DUTY LIQUID ALKALI DETERGENT
  • Pharmaceutical form:
  • LIQUID CONCENTRATE
  • Units in package:
  • 5L, 20L, 25L, 100L, 200L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical

Documents

Localization

  • Available in:
  • REV-WASH HEAVY DUTY LIQUID ALKALI DETERGENT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • DAIRY EQUIPMENT STAINLESS STEEL | DAIRY PLANT STAINLESS STEEL | MILKING EQUIPMENT | BUILDING | MILKING MACHINE
  • Therapeutic area:
  • dairy cleanser
  • Therapeutic indications:
  • MILKSTONE REMOVAL | MILK FAT | MILK PROTEIN | MINERAL DEPOSITS
  • Product summary:
  • Heavy duty liquid alkali detergent.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 30075/0707
  • Authorization date:
  • 08-01-2008
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Heavy Duty

Liquid Alkali Detergent

5 L

Manufactured by :

DASCO Pty Ltd

Phone 03-9459-7004

24 HELEN STREET, WEST HEIDELBERG, VIC3081

REV-WASH

DIRECTION FOR USE

DIRECTIONS—MILKING MACHINES– EVENING ALKALI CLEANING

AFTER MILKING RINSE PLANT USING ALKA RINSE AS PER LABEL DIRECTIONS WITH COLD WA-

TER (20

C-30

C) USE 10 LITRES PER UNIT.

Use REV-WASH detergent at the rate of 40ml per 10 litres of hot water (60

). Use a minimum of 10 litres

per set of cups.

Use a rinse of very hot water (80

C) to complete the cleaning program..

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO

THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT:

Dangerous to fish. DO NOT contaminate streams, rivers, or water ways with the chemical or used containers.

STORAGE INSTRUCTIONS: Store below 30

C (Room Temperature), away from direct sunlight. Store in

closed original container in a well ventilated area as cool as possible out of direct sunlight.

DISPOSAL: Triple or (preferably) pressure rinse containers before disposal. Add rinsings to prepared product.

DO NOT dispose of undiluted chemicals on site. If not recycling break, crush, puncture and bury empty con-

tainers in a local authority landfill. If not available bury the containers below 500mm in a disposal pit specifically

marked and set up for this purpose clear of waterways, vegetation and roots. Empty containers and products

should not be burnt.

SAFETY DIRECTIONS:

Corrosive. May produce severe burns. Attacks skin and eyes. The

product is poisonous if swallowed. The product is alkaline. Avoid contact with eyes, skin

and clothing. When preparing and using the product wear elbow length PVC gloves and a

face shield or goggles. Do not mix with hot water. If product on skin immediately wash area

with soap and water. Wash hands after use. After each days use wash gloves, face shield

or goggles. And contaminated clothing.

FIRST AID:

If poisoning occurs. Contact a doctor or Poisons Information Centre. Phone Australia

13-1126: New Zealand 03-474-7000. If swallowed, do NOT induce vomiting. Give a glass of water. If

skin contact occurs, remove contaminated clothing and wash skin thoroughly. If in eyes, hold eyes

open, flood with water for at least 15 minutes.

For further information see product MSDS

APVMA Approval Number: 30075 / 5 / 0707

Un Number: 1824

SODIUM HYDROXIDE SOLUTION

Class: 8, Pack Grp: II

HAZCHEM: 2R

POISON

READ SAFETY DIRECTION BEFORE OPENING OR USING

KEEP OUT OF REACH OF CHILDREN

Active Constituent :

403g/L SODIUM HYDROXIDE

Lo Foaming

Date of Manufacture

Batch Number

APPROVED

LABEL

Info

pest

Verified

Heavy Duty

Liquid Alkali Detergent

20 L

Manufactured by :

DASCO Pty Ltd

Phone 03-9459-7004

24 HELEN STREET, WEST HEIDELBERG, VIC3081

REV-WASH

DIRECTION FOR USE

DIRECTIONS—MILKING MACHINES– EVENING ALKALI CLEANING

AFTER MILKING RINSE PLANT USING ALKA RINSE AS PER LABEL DIRECTIONS WITH COLD WA-

TER (20

C-30

C) USE 10 LITRES PER UNIT.

Use REV-WASH detergent at the rate of 40ml per 10 litres of hot water (60

). Use a minimum of 10 litres

per set of cups.

Use a rinse of very hot water (80

C) to complete the cleaning program..

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO

THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT:

Dangerous to fish. DO NOT contaminate streams, rivers, or water ways with the chemical or used containers.

STORAGE INSTRUCTIONS: Store below 30

C (Room Temperature), away from direct sunlight. Store in

closed original container in a well ventilated area as cool as possible out of direct sunlight.

DISPOSAL: Triple or (preferably) pressure rinse containers before disposal. Add rinsings to prepared product.

DO NOT dispose of undiluted chemicals on site. If not recycling break, crush, puncture and bury empty con-

tainers in a local authority landfill. If not available bury the containers below 500mm in a disposal pit specifically

marked and set up for this purpose clear of waterways, vegetation and roots. Empty containers and products

should not be burnt.

SAFETY DIRECTIONS:

Corrosive. May produce severe burns. Attacks skin and eyes. The

product is poisonous if swallowed. The product is alkaline. Avoid contact with eyes, skin

and clothing. When preparing and using the product wear elbow length PVC gloves and a

face shield or goggles. Do not mix with hot water. If product on skin immediately wash area

with soap and water. Wash hands after use. After each days use wash gloves, face shield

or goggles. And contaminated clothing.

FIRST AID:

If poisoning occurs. Contact a doctor or Poisons Information Centre. Phone Australia

13-1126: New Zealand 03-474-7000. If swallowed, do NOT induce vomiting. Give a glass of water. If

skin contact occurs, remove contaminated clothing and wash skin thoroughly. If in eyes, hold eyes

open, flood with water for at least 15 minutes.

For further information see product MSDS

APVMA Approval Number: 30075 / 20 / 0707

Un Number: 1824

SODIUM HYDROXIDE SOLUTION

Class: 8, Pack Grp: II

HAZCHEM: 2R

POISON

READ SAFETY DIRECTION BEFORE OPENING OR USING

KEEP OUT OF REACH OF CHILDREN

Active Constituent :

403g/L SODIUM HYDROXIDE

Lo Foaming

Date of Manufacture

Batch Number

APPROVED

LABEL

Heavy Duty

Liquid Alkali Detergent

25 L

Manufactured by :

DASCO Pty Ltd

Phone 03-9459-7004

24 HELEN STREET, WEST HEIDELBERG, VIC3081

REV-WASH

DIRECTION FOR USE

DIRECTIONS—MILKING MACHINES– EVENING ALKALI CLEANING

AFTER MILKING RINSE PLANT USING ALKA RINSE AS PER LABEL DIRECTIONS WITH COLD WA-

TER (20

C-30

C) USE 10 LITRES PER UNIT.

Use REV-WASH detergent at the rate of 40ml per 10 litres of hot water (60

). Use a minimum of 10 litres

per set of cups.

Use a rinse of very hot water (80

C) to complete the cleaning program..

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO

THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT:

Dangerous to fish. DO NOT contaminate streams, rivers, or water ways with the chemical or used containers.

STORAGE INSTRUCTIONS: Store below 30

C (Room Temperature), away from direct sunlight. Store in

closed original container in a well ventilated area as cool as possible out of direct sunlight.

DISPOSAL: Triple or (preferably) pressure rinse containers before disposal. Add rinsings to prepared product.

DO NOT dispose of undiluted chemicals on site. If not recycling break, crush, puncture and bury empty con-

tainers in a local authority landfill. If not available bury the containers below 500mm in a disposal pit specifically

marked and set up for this purpose clear of waterways, vegetation and roots. Empty containers and products

should not be burnt.

SAFETY DIRECTIONS:

Corrosive. May produce severe burns. Attacks skin and eyes. The

product is poisonous if swallowed. The product is alkaline. Avoid contact with eyes, skin

and clothing. When preparing and using the product wear elbow length PVC gloves and a

face shield or goggles. Do not mix with hot water. If product on skin immediately wash area

with soap and water. Wash hands after use. After each days use wash gloves, face shield

or goggles. And contaminated clothing.

FIRST AID:

If poisoning occurs. Contact a doctor or Poisons Information Centre. Phone Australia

13-1126: New Zealand 03-474-7000. If swallowed, do NOT induce vomiting. Give a glass of water. If

skin contact occurs, remove contaminated clothing and wash skin thoroughly. If in eyes, hold eyes

open, flood with water for at least 15 minutes.

For further information see product MSDS

APVMA Approval Number: 30075 / 25 / 0707

Un Number: 1824

SODIUM HYDROXIDE SOLUTION

Class: 8, Pack Grp: II

HAZCHEM: 2R

POISON

READ SAFETY DIRECTION BEFORE OPENING OR USING

KEEP OUT OF REACH OF CHILDREN

Active Constituent :

403g/L SODIUM HYDROXIDE

Lo Foaming

Date of Manufacture

Batch Number

APPROVED

LABEL

Heavy Duty

Liquid Alkali Detergent

100 L

Manufactured by :

DASCO Pty Ltd

Phone 03-9459-7004

24 HELEN STREET, WEST HEIDELBERG, VIC3081

REV-WASH

DIRECTION FOR USE

DIRECTIONS—MILKING MACHINES– EVENING ALKALI CLEANING

AFTER MILKING RINSE PLANT USING ALKA RINSE AS PER LABEL DIRECTIONS WITH COLD WA-

TER (20

C-30

C) USE 10 LITRES PER UNIT.

Use REV-WASH detergent at the rate of 40ml per 10 litres of hot water (60

). Use a minimum of 10 litres

per set of cups.

Use a rinse of very hot water (80

C) to complete the cleaning program..

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO

THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT:

Dangerous to fish. DO NOT contaminate streams, rivers, or water ways with the chemical or used containers.

STORAGE INSTRUCTIONS: Store below 30

C (Room Temperature), away from direct sunlight. Store in

closed original container in a well ventilated area as cool as possible out of direct sunlight.

DISPOSAL: Triple or (preferably) pressure rinse containers before disposal. Add rinsings to prepared product.

DO NOT dispose of undiluted chemicals on site. If not recycling break, crush, puncture and bury empty con-

tainers in a local authority landfill. If not available bury the containers below 500mm in a disposal pit specifically

marked and set up for this purpose clear of waterways, vegetation and roots. Empty containers and products

should not be burnt.

SAFETY DIRECTIONS:

Corrosive. May produce severe burns. Attacks skin and eyes. The

product is poisonous if swallowed. The product is alkaline. Avoid contact with eyes, skin

and clothing. When preparing and using the product wear elbow length PVC gloves and a

face shield or goggles. Do not mix with hot water. If product on skin immediately wash area

with soap and water. Wash hands after use. After each days use wash gloves, face shield

or goggles. And contaminated clothing.

FIRST AID:

If poisoning occurs. Contact a doctor or Poisons Information Centre. Phone Australia

13-1126: New Zealand 03-474-7000. If swallowed, do NOT induce vomiting. Give a glass of water. If

skin contact occurs, remove contaminated clothing and wash skin thoroughly. If in eyes, hold eyes

open, flood with water for at least 15 minutes.

For further information see product MSDS

APVMA Approval Number: 30075 / 100 / 0707

Un Number: 1824

SODIUM HYDROXIDE SOLUTION

Class: 8, Pack Grp: II

HAZCHEM: 2R

POISON

READ SAFETY DIRECTION BEFORE OPENING OR USING

KEEP OUT OF REACH OF CHILDREN

Active Constituent :

403g/L SODIUM HYDROXIDE

Lo Foaming

Date of Manufacture

Batch Number

APPROVED

LABEL

Heavy Duty

Liquid Alkali Detergent

200 L

Manufactured by :

DASCO Pty Ltd

Phone 03-9459-7004

24 HELEN STREET, WEST HEIDELBERG, VIC3081

REV-WASH

DIRECTION FOR USE

DIRECTIONS—MILKING MACHINES– EVENING ALKALI CLEANING

AFTER MILKING RINSE PLANT USING ALKA RINSE AS PER LABEL DIRECTIONS WITH COLD WA-

TER (20

C-30

C) USE 10 LITRES PER UNIT.

Use REV-WASH detergent at the rate of 40ml per 10 litres of hot water (60

). Use a minimum of 10 litres

per set of cups.

Use a rinse of very hot water (80

C) to complete the cleaning program..

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER, CONTRARY TO

THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT:

Dangerous to fish. DO NOT contaminate streams, rivers, or water ways with the chemical or used containers.

STORAGE INSTRUCTIONS: Store below 30

C (Room Temperature), away from direct sunlight. Store in

closed original container in a well ventilated area as cool as possible out of direct sunlight.

DISPOSAL: Triple or (preferably) pressure rinse containers before disposal. Add rinsings to prepared product.

DO NOT dispose of undiluted chemicals on site. If not recycling break, crush, puncture and bury empty con-

tainers in a local authority landfill. If not available bury the containers below 500mm in a disposal pit specifically

marked and set up for this purpose clear of waterways, vegetation and roots. Empty containers and products

should not be burnt.

SAFETY DIRECTIONS:

Corrosive. May produce severe burns. Attacks skin and eyes. The

product is poisonous if swallowed. The product is alkaline. Avoid contact with eyes, skin

and clothing. When preparing and using the product wear elbow length PVC gloves and a

face shield or goggles. Do not mix with hot water. If product on skin immediately wash area

with soap and water. Wash hands after use. After each days use wash gloves, face shield

or goggles. And contaminated clothing.

FIRST AID:

If poisoning occurs. Contact a doctor or Poisons Information Centre. Phone Australia

13-1126: New Zealand 03-474-7000. If swallowed, do NOT induce vomiting. Give a glass of water. If

skin contact occurs, remove contaminated clothing and wash skin thoroughly. If in eyes, hold eyes

open, flood with water for at least 15 minutes.

For further information see product MSDS

APVMA Approval Number: 30075 / 200 / 0707

Un Number: 1824

SODIUM HYDROXIDE SOLUTION

Class: 8, Pack Grp: II

HAZCHEM: 2R

POISON

READ SAFETY DIRECTION BEFORE OPENING OR USING

KEEP OUT OF REACH OF CHILDREN

Active Constituent :

403g/L SODIUM HYDROXIDE

Lo Foaming

Date of Manufacture

Batch Number

APPROVED

LABEL

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19-12-2018

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Europe - EFSA - European Food Safety Authority EFSA Journal

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

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

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

17-12-2018

 Occupational health: aiming to take better account of multiple exposure

Occupational health: aiming to take better account of multiple exposure

Workers can potentially be exposed to numerous health risk factors through their occupations. The question of multiple exposure is a major challenge for all those active in the field of occupational health, safety and prevention. As part of the 2016-2020 National Occupational Health Plan, a review of the measures taken by the main players to address the question of multiple exposure in France and abroad is being published today. This work has helped determine the state of knowledge and the issues surroun...

France - Agence Nationale du Médicament Vétérinaire

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Published on: Thu, 13 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State France for the pesticide active substance bromoxynil are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to bromoxynil can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions w...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

Nettoyants Lemieux recalls Concentrated Dishwasher Powder

Nettoyants Lemieux recalls Concentrated Dishwasher Powder

Health Canada has determined that the recalled product does not comply with Canadian packaging and labeling regulations.

Health Canada

6-12-2018

Bee health: ANSES reviews the latest scientific developments

Bee health: ANSES reviews the latest scientific developments

ANSES is holding its annual scientific conference on bee health. This event is an opportunity for the Agency to review the latest major developments in research and surveillance in this field. For this seventh edition, ANSES is inviting the various stakeholders involved in the issue to discuss the latest scientific advances, technological innovations and international and local initiatives contributing to adequate prevention and protection of the health of pollinating insects.

France - Agence Nationale du Médicament Vétérinaire

5-12-2018

Public health risks associated with food‐borne parasites

Public health risks associated with food‐borne parasites

Published on: Tue, 04 Dec 2018 Parasites are important food‐borne pathogens. Their complex lifecycles, varied transmission routes, and prolonged periods between infection and symptoms mean that the public health burden and relative importance of different transmission routes are often difficult to assess. Furthermore, there are challenges in detection and diagnostics, and variations in reporting. A Europe‐focused ranking exercise, using multicriteria decision analysis, identified potentially food‐borne ...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018


Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products - Revision 3

Europe - EMA - European Medicines Agency

30-11-2018


Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2

Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2

Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2

Europe - EMA - European Medicines Agency

30-11-2018

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Data collection for the estimation of ecological data (specific focal species, time spent in treated areas collecting food, composition of diet), residue level and residue decline on food items to be used in the risk assessment for birds and mammals

Published on: Thu, 29 Nov 2018 The study described in this report was conducted with the aim of developing an unified database of ecological data and residue data to be used for the risk assessment of plant protection products for birds and mammals. The main sources of data were the information submitted in the context of approval of active substances and authorization of products and and additional information retrieved through a systematic literature review. The data were screened and organised in thr...

Europe - EFSA - European Food Safety Authority Publications

26-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of

FDA provides updates on two elements in medical device safety action plan: modernizing 510(k) program and new process for establishing special controls.

FDA - U.S. Food and Drug Administration

18-1-2019


Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - veterinary

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

16-1-2019

Product Quality Reviews (PQRs) for listed and complementary medicines

Product Quality Reviews (PQRs) for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

9-1-2019


Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), Bluetongue (BT) and Foot-and-Mouth disease (FMD) - Revision 1

Europe - EMA - European Medicines Agency

20-12-2018

Review of the Narcotic Drugs Act 1967 - Public meetings

Review of the Narcotic Drugs Act 1967 - Public meetings

The TGA will be hosting public meetings in February 2019 in Sydney, Brisbane and Melbourne

Therapeutic Goods Administration - Australia

19-12-2018


Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Overview of comments received on 'Guideline on the conduct of bioequivalence studies for veterinary medicinal products' (EMA/CVMP/016/00-Rev.3) - Revision 3

Europe - EMA - European Medicines Agency

19-12-2018


Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Guideline on the conduct of bioequivalence studies for veterinary medicinal products - Revision 3

Europe - EMA - European Medicines Agency

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

18-12-2018

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

Consultation: Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidance

TGA is seeking comments on the expansion and amendment of TGO 54. Closing date: 12 February 2019

Therapeutic Goods Administration - Australia

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


Final Guideline on Active Substance Master File Procedure - Revision 4

Final Guideline on Active Substance Master File Procedure - Revision 4

Final Guideline on Active Substance Master File Procedure - Revision 4

Europe - EMA - European Medicines Agency

14-12-2018


EudraVigilance access policy for medicines for veterinary use - Revision 1

EudraVigilance access policy for medicines for veterinary use - Revision 1

EudraVigilance access policy for medicines for veterinary use - Revision 1

Europe - EMA - European Medicines Agency

14-12-2018

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8927 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2745/T/38

Europe -DG Health and Food Safety

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

14-12-2018

Review of the Narcotic Drugs Act 1967

Review of the Narcotic Drugs Act 1967

Professor John McMillan AO appointed to review and report on the operation of the Narcotic Drugs Act 1967

Therapeutic Goods Administration - Australia

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

4-12-2018


Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Europe - EMA - European Medicines Agency

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

30-11-2018

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more:  https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk pic.twitter.com/6rRnfSyLy4

Selected participants will work directly with the FDA to accelerate the development of and eventual review of marketing applications for these innovative products. Read more: https://go.usa.gov/xPMPk  pic.twitter.com/6rRnfSyLy4

FDA - U.S. Food and Drug Administration

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

26-11-2018

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

Today #FDA announced the most significant modernization of the 510(k) medical device review process in a generation. https://www.wsj.com/articles/fda-is-revamping-clearance-procedures-for-medical-devices-1543234015 …

FDA - U.S. Food and Drug Administration

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration