SYSTAMEX CONCENTRATED DRENCH

Main information

  • Trade name:
  • COOPERS SYSTAMEX CONCENTRATED DRENCH FOR BEEF DAIRY CATTLE & HORSES
  • Pharmaceutical form:
  • ORAL SOLUTION/SUSPENSION
  • Units in package:
  • 1L,5L
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • COOPERS SYSTAMEX CONCENTRATED DRENCH FOR BEEF DAIRY CATTLE & HORSES
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CATTLE | HORSE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COLT | COW | DAIRY COW | DONKEY |
  • Therapeutic area:
  • anthelmintic
  • Therapeutic indications:
  • BARBER'S POLE WORM - HAEMONCHUS PLACEI | BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP. | HOOKWORM - BUNOSTOMUM PHLEBOTOMUM | LARGE ROUNDWORM - PARASCARIS EQUORUM | LARGE STRONGYLES - STRONGYLUS EDENTATUS | LARGE STRONGYLES - STRONGYLUS SPP. | LARGE STRONGYLES - STRONGYLUS VULGARIS | LUNGWORM - DICTYOCAULUS VIVIPARUS | NODULE WORM - OESOPHAGOSTOMUM RADIATUM | PINWORM - OXYURIS EQUI | ROUNDWORM - EGGS | SMALL BROWN STOMACH WORM - O. OSTERTAGI | SMALL INTESTINAL WORM - COOPERIA SPP. | SMALL STRONGYLES | STOMACH HAIR WORM | TAPEWORM - MONIEZIA SPP. | THIN NECKED INTESTINAL WORM | BLOODWORM | CORONOCYCLUS SPP. | CYALOCEPHALUS SPP. | CYATHOSTOMUM SPP. | CYLICOCYCLUS SPP. | CYLICODONTOPHORUS SPP. | CYLICOSTEPHANUS SPP. | GYALOCEPHALUS SPP. | HAIR WORM | INCLUDING INHIBITED STAGES | INTESTINAL HAIR WORM | LARGE LUNGWORM | LARGE WHITE ROUNDWORM | PARAPOTERIOSTOMUM SPP. | PETROVINEMA SPP. | POTERIOSTOMUM SPP. | SMALL HAIR WORM | STRONGYLE | STRONGYLUS EDENTATUS | STRONGYLUS EQUINUS | STRONGYLUS VULGARIS | TAPEWORM - HEADS/S
  • Product summary:
  • For the control of all important gastrointestinal roundworms (including inhibited Ostertagia larvae in cattle and at least 50% of migrating Strongyle larvae in horses) lungworm, tapeworm (in cattle) and sterilisation of roundworm eggs.See Restraints on label

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36099/0503
  • Authorization date:
  • 10-06-2003
  • Last update:
  • 15-06-2017

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

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 1 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

5L LABEL – FRONT PANEL

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

COOPERS®

Systamex ®

CONCENTRATED DRENCH FOR BEEF

AND DAIRY CATTLE AND HORSES

ACTIVE CONSTITUENT: 90.6 g/L OXFENDAZOLE

For the control of ALL IMPORTANT GASTROINTESTINAL

ROUNDWORMS (including inhibited OSTERTAGIA larvae

in cattle and at least 50% of migrating STRONGYLE larvae

in horses), LUNGWORM, TAPEWORM (in cattle) and

STERILISATION of ROUNDWORM EGGS.

5 Litres

COOPERS LOGO

Picture may be inserted.

Printer codes to be assigned.

DRUMMUSTER

ELIGIBLE

CONTAINER

TREATS

250

400KG CATTLE

Info

pest

Verified

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 2 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

5L – REAR PANEL

COOPERS®

Systamex ®

CONCENTRATED DRENCH

DIRECTIONS FOR USE

Restraints

Do not treat within 7 days of administering FASCOL# (bromsalans). (# Trade Mark Lane Ltd.)

Normal care should be taken with handling of weak and pregnant animals.

Copper Sulfate must not be mixed with Systamex.

Do not administer with Carbon Bisulphide.

SHAKE CONTAINER BEFORE USE.

Before commencing drenching read the label carefully.

Systamex should be administered orally using accurate drenching equipment.

Clean equipment thoroughly before and after use.

CATTLE: Systamex is a benzimidazole drench and is an effective treatment for susceptible strains of

Small Brown Stomach Worm (Ostertagia ostertagi), (including inhibited larvae), Stomach Hair Worm

(Trichostrongylus axei), Barber’s Pole Worm (Haemonchus placei), Small intestinal Worm (Cooperia

spp), Thin necked Intestinal Worm (Nematodirus spp), Nodule Worm (Oesophagostomum radiatum),

Black Scour Worm (Trichostrongylus spp),

Hookworm (Bunostomum phlebotomum), Tapeworm

(Moniezia spp) and Lungworm (Dictyocaulus viviparus) in cattle.

Systamex efficacy trials indicate a consistently effective level of activity against all stages of

Ostertagia, including inhibited (Hypobiotic) larvae in cattle.

Systamex sterilises roundworm eggs – except those from Nematodirus spp.

Internal parasites may develop resistance to drenches (anthelmintics). If drench (anthelmintic) failure

with this preparation is suspected, seek veterinary confirmation and notify the manufacturer.

DOSE RATE: CATTLE 5 mL per 100 kg Liveweight.

Always dose on a liveweight basis. The heaviest animals in a mob should be weighed with scales or

a weigh band used. Dose the mob according to the weight of the heaviest animals. Check the

accuracy of drenching equipment before and during drenching procedures.

DOSE RATE EXAMPLE TABLE

LIVEWEIGHT (kg)

DOSE (mL)

12.5

17.5

22.5

27.5

32.5

PACK TREATS

1000

Animals heavier than 650 kg should be treated at the rate of 5 mL/100kg liveweight.

Systamex may be given to cattle concurrently with most spray or pour-on lice treatments, growth

promotant implants, treatment with selenium (oral or injection), copper injection and cobalt pellets,

vaccination against clostridial diseases and Leptospira.

The ovicidal activity of Systamex ensures that 4-6 hours after dosing, virtually all roundworm eggs

passed

dung

rendered

infertile,

thus

reducing

potential

further

pasture

contamination.

To be fully effective, a period of 6 hours should elapse before drenched cattle are moved onto clean

pasture.

Larvicidal activity ensures that no significant numbers of immature worms remain within the animal to

subsequently develop into adults.

HORSES: Systamex is effective for the control of adult and immature forms of Stomach Hair Worm

(Trichostrongylus

axei).

Roundworm

(Parascaris),

Pinworm

(Oxyuris),

Strongylus

spp.

susceptible small strongyles of horses. It kills the tissue stages of Strongylus adentatus and at least

50% (59-88% activity) of the migrating stages of Strongylus vulgaris with corresponding reduction in

arterial lesions. A reduction in the prevalence of associated colic could be expected.

DOSE RATE: HORSES 11mL per 100kg liveweight.

The ovicidal activity of Systamex ensures that 24 hours after dosing, virtually all roundworm eggs

passed

dung

rendered

infertile,

thus

reducing

potential

further

pasture

contamination.

To be fully effective, a period of 24 hours should elapse before drenched horses are moved onto

clean pasture. Systamex may be administered to horses at the same time as boticides containing

trichlorfon.

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 3 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

5L – REAR PANEL (continued)

WITHHOLDING PERIODS

CATTLE: MEAT - DO NOT USE less than 8 days before slaughter for human consumption.

MILK: WITHHOLDING PERIOD NIL.

HORSES: MEAT – DO NOT USE less than 28 days before slaughter for human consumption.

For further information contact Coopers Customer Service on 1 800 226 511.

SAFETY DIRECTIONS

Harmful if absorbed by skin contact or swallowed. Avoid contact with skin. Wash hands after

use.

FIRST AID

If poisoning occurs, contact a Doctor or Poisons Information Centre (Phone 131126)

Additional information is listed in the Material Safety Data Sheet.

SPECIALIST ADVICE IN EMERGENCY ONLY

Schering-Plough Pty Ltd

1 800 226 511

ALL HOURS - AUSTRALIA-WIDE

WARRANTY

Schering-Plough Pty Ltd (SPPL) warrants that this product is of merchantable quality and fit for its

intended purpose. SPPL’s liability for any loss, including consequential losses or injury caused by any

act or omission, including negligent acts or omissions, by SPPL or its agent is limited to replacing or

repairing the product at the option of SPPL. If possible, a sample of any product causing concern

should be retained or delivered to SPPL within 30 days for a scientific examination.

DISPOSAL

Triple or (preferably) pressure rinse containers. Dispose of rinsate in a disposal pit specifically

marked and set up for this purpose clear of waterways, vegetation and roots. Do not dispose of

undiluted chemicals on site.

Return clean container for recycling where this is an option or for disposal at a landfill authorised to

accept that waste. If neither of these options are 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 product should not be burnt.

Containers should be taken after cleaning as indicated to an approved collection centre.

STORAGE

Store below 30

C (Room Temperature) in the closed, original container in a well ventilated area.

Do not store for prolonged periods in direct sunlight.

BATCH

EXPIRY

COOPERS ANIMAL HEALTH

A division of Schering-Plough Pty Ltd

11 Gibbon Road, Baulkham Hills NSW 2153

APVMA Approval No. 36099/0503

® Coopers is a Schering-Plough Pty Ltd Registered Trademark

® Systamex is a Syntex (USA) Inc. Registered Trademark

© Schering-Plough Pty Ltd 2003

5L

Printer codes to be assigned

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 4 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

1L ZIPSEAL LABEL/LEAFLET – FRONT PANEL

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

COOPERS®

Systamex ®

CONCENTRATED DRENCH FOR BEEF

AND DAIRY CATTLE AND HORSES

ACTIVE CONSTITUENTS:

90.6 g/L OXFENDAZOLE

For the control of ALL IMPORTANT GASTROINTESTINAL

ROUNDWORMS (including inhibited OSTERTAGIA larvae

in cattle and at least 50% of migrating STRONGYLE larvae

in horses), LUNGWORM, TAPEWORM (in cattle) and

STERILISATION of ROUNDWORM EGGS.

SAFETY DIRECTIONS: Harmful if absorbed by skin contact or swallowed.

Avoid contact with

skin. Wash hands after use.

FIRST AID: If poisoning occurs, contact a doctor or Poisons

Information Centre (Phone 131126).

Additional information is listed in the material safety data sheet.

1 Litre

COOPERS LOGO

Picture may be inserted.

Printer codes to be assigned.

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 5 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

1L ZIPSEAL LEAFLET – OUTSIDE LABEL VISIBLE WHEN ZIP SEAL IS CLOSED

TO OPEN PEEL HERE

COOPERS®

Systamex ®

CONCENTRATED DRENCH

FOR BEEF AND DAIRY CATTLE AND HORSES

READ ENCLOSED DIRECTIONS FOR USE.

For the control of ALL IMPORTANT GASTROINTESTINAL ROUNDWORMS (including inhibited

OSTERTAGIA larvae in cattle and at least 50% of migrating STRONGYLE larvae in horses),

LUNGWORM, TAPEWORM (in cattle) and STERILISATION of ROUNDWORM EGGS.

Dispose of empty container by wrapping with paper and putting in garbage.

STORAGE: Store below 30

C (Room Temperature) in the closed, original container in a well

ventilated area. Do not store for prolonged periods in direct sunlight.

APVMA Approval No. 36099/0503

® Coopers is a Schering-Plough Pty Ltd

COOPERS ANIMAL HEALTH

Registered Trademark

A division of Schering-Plough Pty Ltd

® Systamex is a Syntex (USA) Inc. Registered Trademark

11 Gibbon Road, Baulkham Hills NSW 2153

© Schering-Plough Pty Ltd 2003

(B)

EXP.

Printer codes and barcodes to

be assigned

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 6 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

1L ZIPSEAL LEAFLET – INTERNAL PAGES

CATTLE: Systamex is a benzimidazole drench and is an effective treatment for susceptible strains of

Small Brown Stomach Worm (Ostertagia ostertagi), (including inhibited larvae), Stomach Hair Worm

(Trichostrongylus axei), Barber’s Pole Worm (Haemonchus placei), Small intestinal Worm (Cooperia

spp), Thin necked Intestinal Worm (Nematodirus spp), Nodule Worm (Oesophagostomum radiatum),

Black Scour Worm (Trichostrongylus spp),

Hookworm (Bunostomum phlebotomum), Tapeworm

(Moniezia spp) and Lungworm (Dictyocaulus viviparus) in cattle.

Systamex efficacy trials indicate a consistently effective level of activity against all stages of

Ostertagia, including inhibited (Hypobiotic) larvae in cattle.

Systamex sterilises roundworm eggs – except those from Nematodirus spp.

Internal parasites may develop resistance to drenches (anthelmintics). If drench (anthelmintic) failure

with this preparation is suspected, seek veterinary confirmation and notify the manufacturer.

HORSES: Systamex is effective for the control of adult and immature forms of Stomach Hair Worm

(Trichostrongylus

axei).

Roundworm

(Parascaris),

Pinworm

(Oxyuris),

Strongylus

spp.

susceptible small strongyles of horses. It kills the tissue stages of Strongylus adentatus and at least

50% (59-88% activity) of the migrating stages of Strongylus vulgaris with corresponding reduction in

arterial lesions. A reduction in the prevalence of associated colic could be expected.

DIRECTIONS FOR USE: SHAKE CONTAINER BEFORE USE

Restraints

Do not treat within 7 days of administering FASCOL# (bromsalans). (# Trade Mark Lane Ltd.)

Normal care should be taken with handling of weak and pregnant animals.

Copper Sulfate must not be mixed with Systamex.

Do not administer with Carbon Bisulphide.

Before commencing drenching read the label carefully. Systamex should be administered orally using

accurate drenching equipment. Clean equipment thoroughly before and after use.

DOSE RATE: CATTLE 5 mL per 100 kg Liveweight.

Always dose on a liveweight basis. The heaviest animals in a mob should be weighed with scales or

a weigh band used. Dose the mob according to the weight of the heaviest animals. Check the

accuracy of drenching equipment before and during drenching procedures.

LIVEWEIGHT (kg)

DOSE (mL)

PACK TREATS

10.0

12.5

15.0

17.5

20.0

22.5

25.0

27.5

30.0

32.5

Animals heavier than 650 kg should be treated at the rate of 5 mL/100kg liveweight.

Systamex may be given to cattle concurrently with most spray or pour-on lice treatments, growth

promotant implants, treatment with selenium (oral or injection), copper injection and cobalt pellets,

vaccination against clostridial diseases and Leptospira.

The ovicidal activity of Systamex ensures that 4-6 hours after dosing, virtually all roundworm eggs

passed

dung

rendered

infertile,

thus

reducing

potential

further

pasture

contamination.

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 7 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

1L ZIP SEAL LEAFLET

INTERNAL PAGES (CONTINUED)

To be fully effective, a period of 6 hours should elapse before drenched cattle are moved onto clean

pasture. Larvicidal activity ensures that no significant numbers of immature worms remain within the

animal to subsequently develop into adults.

DOSE RATE: HORSES 11mL per 100kg liveweight.

The ovicidal activity of Systamex ensures that 24 hours after dosing, virtually all roundworm eggs

passed

dung

rendered

infertile,

thus

reducing

potential

further

pasture

contamination.

To be fully effective, a period of 24 hours should elapse before drenched horses are moved onto

clean pasture. Systamex may be administered to horses at the same time as boticides containing

trichlorfon.

WITHHOLDING PERIODS

CATTLE: MEAT - DO NOT USE less than 8 days before slaughter for human consumption.

MILK: WITHHOLDING PERIOD NIL.

HORSES: MEAT – DO NOT USE less than 28 days before slaughter for human consumption.

For further information contact Coopers Customer Service on 1 800 226 511.

File Name:

36099_0503c.doc

Prepared By:

L. Wirth

Preparation Date:

28/4/2003

Last Revised:

11/2/2000

Schering-Plough Label & Printer

Specifications:

Version:

(28/4/2003

Page 8 of 8

SYSTAMEX CONCENTRATE – IMMEDIATE CONTAINER

1L ZIPSEAL LEAFLET – PANEL ADHERING DIRECTLY TO CONTAINER

COOPERS®

Systamex ®

CONCENTRATED DRENCH

FOR BEEF AND DAIRY CATTLE AND HORSES

WARRANTY

Schering-Plough Pty Ltd (SPPL) warrants that this product is of merchantable quality and fit for its

intended purpose. SPPL’s liability for any loss, including consequential losses or injury caused by any act

or omission, including negligent acts or omissions, by SPPL or its agent, is limited to replacing or

repairing the product at the option of SPPL. If possible, a sample of any product causing concern should

be retained or delivered to SPPL within 30 days for a scientific examination.

For further information contact Coopers Customer Service on 1 800 226 511.

SPECIALIST ADVICE IN EMERGENCY ONLY

Schering-Plough Pty Ltd

1 800 226 511

ALL HOURS – AUSTRALIA-WIDE

Dispose of empty container by wrapping with paper and putting in garbage.

Storage: Store below 30

C (Room Temperature) in the closed, original container in a well ventilated

area. Do not store for prolonged periods in direct sunlight.

COOPERS ANIMAL HEALTH

A division of Schering-Plough Pty Ltd

11 Gibbon Road, Baulkham Hills NSW 2153

NRA Approval No. 36099/0503

® Coopers is a Schering-Plough Pty Ltd Registered Trademark

® Systamex is a Syntex USA Inc. Registered Trademark

© Schering-Plough Pty Ltd 2003

(B)

EXP.

Printer codes to be assigned

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1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Europe - EMA - European Medicines Agency

15-11-2018

alitretinoin

alitretinoin

alitretinoin (Active substance: alitretinoin) - Centralised - Art 28 - (PSUR - Commission Decision (2018)7675 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/90/201801

Europe -DG Health and Food Safety

25-9-2018

Zonegran (Eisai GmbH)

Zonegran (Eisai GmbH)

Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90

Europe -DG Health and Food Safety

5-9-2018

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments:  h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: h

#FDA announces draft guidance: Consideration of Uncertainty in Making Benefit-Risk Determinations in #MedicalDevice Premarket Approvals. The document is now open for comment for 90 days. Click the link to review the draft guidance and provide comments: https://go.usa.gov/xPcpT  pic.twitter.com/hAuLWaIYiK

FDA - U.S. Food and Drug Administration

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Aerius (Merck Sharp and Dohme B.V.)

Aerius (Merck Sharp and Dohme B.V.)

Aerius (Active substance: desloratadine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4255 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/313/T/90

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

22-6-2018

First continuous glucose monitoring system that includes a fully implantable glucose sensor that can be worn up to 90 days approved today.  #cgm #diabetes #fda #medicaldevice  https://go.usa.gov/xUqg5 pic.twitter.com/6zs99z2Dlz

First continuous glucose monitoring system that includes a fully implantable glucose sensor that can be worn up to 90 days approved today. #cgm #diabetes #fda #medicaldevice https://go.usa.gov/xUqg5 pic.twitter.com/6zs99z2Dlz

First continuous glucose monitoring system that includes a fully implantable glucose sensor that can be worn up to 90 days approved today. #cgm #diabetes #fda #medicaldevice https://go.usa.gov/xUqg5  pic.twitter.com/6zs99z2Dlz

FDA - U.S. Food and Drug Administration