MCPB-

Main information

  • Trade name:
  • NUFARM MCPB-400 SELECTIVE HERBICIDE
  • Pharmaceutical form:
  • Aqueous
  • Units in package:
  • 20L,110L,200L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical

Documents

Localization

  • Available in:
  • NUFARM MCPB-400 SELECTIVE HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CEREALS | CEREALS UNDERSOWN | CLOVER / MEDIC SEED CROP | CLOVER SEED CROP | COMMERCIAL AREA - GENERAL | FALLOW CROP LAND WEED CO
  • Therapeutic area:
  • Group I Herbicide
  • Therapeutic indications:
  • AMARANTH OR AMARANTHUS | BATHURST BURR | BELLVINE | BLACKBERRY NIGHTSHADE - SEEDLING | CALIFORNIAN THISTLE | CALTROP OR YELLOW VINE | CAT'S EAR OR FLATWEED - SEEDLING | CHARLOCK | COMMON COTULA OR CARROT WEED | COMMON MORNING GLORY | COMMON PIGWEED | CONVOLVULUS GENUS | COTULA OR CARROT WEED - SEEDLING | DOCK | FAT HEN | FUMITORY - RED | FUMITORY - WHITE | HEDGE OR WILD MUSTARD | HOARY CRESS - SEEDLING | INDIAN HEDGE MUSTARD | LESSER SWINECRESS - SEEDLING | NOOGOORA BURR | OPIUM POPPY - SEEDLING | PATERSON'S CURSE | PRICKLY LETTUCE | PRINCE OF WALES FEATHER | REDSHANK | RIBWORT, RIBGRASS OR LAMB'S TONGUE | SAFFRON THISTLE | SHEPHERD'S PURSE | SLENDER OR SHORE THISTLE - SEEDLING | SORREL - SEEDLING | SOW OR MILK THISTLE - SEEDLING | SPEAR OR BLACK THISTLE | SPINY EMEX | STINGING OR DWARF NETTLE | TURNIP WEED | UMBRELLA SEDGE | VARIEGATED THISTLE - SEEDLING | WILD TURNIP | WIREWEED, KNOTWEED OR HOGWEED | AMARANTHUS CRUENTUS | AMARANTHUS POWELLII | AMARANTHUS VIRIDIS | ANNUAL DWARF NETTLE | ANNUAL NETTLE | AUSTR
  • Product summary:
  • For the control of certain weeds in cereals, pea crops, clover and medic seed crops, pastures, peanuts and in industrial and commercial areas.See RESTRAINTS on label

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 31774/0300
  • Authorization date:
  • 03-04-2000
  • Last update:
  • 15-06-2017

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

Nufarm MCPB-400 Selective Herbicide

20 L, 110 L & 200 L label

Date: 07.03.00

Page 1 of 7

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm

MCPB-400

Selective Herbicide

Active constituent: 400 g/L MCPB

present as the sodium salt

For the control of certain weeds in Cereals, Pea Crops, Clover and Medic

Seed Crops, Pastures, Peanuts and in Industrial and Commercial Areas as

stated in the Directions for Use table.

IMPORTANT: READ THE ATTACHED LEAFLET

BEFORE USING THIS PRODUCT.

Contents: 20 Litres

110 Litres

200 Litres

Nufarm Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

GROUP

HERBICIDE

I

Nufarm MCPB-400 Selective Herbicide

20 L, 110 L & 200 L label

Date: 07.03.00

Page 2 of 7

GENERAL INSTRUCTIONS

STORAGE AND DISPOSAL

Store in the closed, original container in a cool, well-

ventilated area. Do not store for prolonged periods in

direct sunlight. Protect from frost. Triple or preferably

pressure rinse containers before disposal . Add

rinsings to spray tank. Do not dispose of undiluted

chemicals on site. If recycling, replace cap and

return clean containers to recycler or designated

collection point.

If not recycling, break, crush or puncture and bury

empty containers in a local authority landfill. If no

landfill is available, bury the containers below 500 mm

in a disposal pit specifically marked and set up for this

purpose clear of waterways, desirable vegetation and

tree roots. Empty containers and product should not

be burnt.

Refillable containers

Empty contents fully into application equipment.

Close all valves and return to point of supply for refill

or storage.

SAFETY DIRECTIONS

Harmful if swallowed. Will irritate the eyes and skin.

Avoid contact with eyes and skin. When preparing

spray, and using the prepared spray wear cotton

overalls buttoned to the neck and wrist, a washable

hat, elbow length PVC gloves and face-shield or

goggles. If product in eyes, wash it out immediately

with water.

After use and before eating, drinking or smoking,

wash hands, arms and face thoroughly with soap and

water. After each day’s use wash gloves, face-shield

or goggles and contaminated clothing.

FIRST AID

If poisoning occurs, contact a doctor or Poisons

Information Centre (13 11 26). If swallowed, and if

more than 15 minutes from a hospital induce vomiting,

preferably using Ipecac Syrup (APF).

MATERIAL SAFETY DATA SHEET

For further information refer to the Material Safety

Data Sheet (MSDS).

CONDITIONS OF SALE

“Nufarm Limited (‘Nufarm’) shall not be liable for any

loss injury damage or death whether consequential or

otherwise whatsoever or howsoever arising whether

through negligence or otherwise in connection with

the sale supply use or application of this product. The

supply of this product is on the express condition that

the purchaser does not rely on Nufarm’s skill or

judgment in purchasing or using the same and every

person dealing with this product does so at his own

risk absolutely. No representative of Nufarm has any

authority to add to or alter these conditions.”

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

NRA Approval No: 31774/0300

Batch No:

Date of Manufacture:

Nufarm MCPB-400 Selective Herbicide

20 L, 110 L & 200 L leaflet

Date: 07.03.00

Page 3 of 7

Nufarm

MCPB-400

Selective Herbicide

Active constituent: 400 g/L MCPB

present as the sodium salt

For the control of certain weeds in Cereals, Pea Crops, Clover and Medic

Seed Crops, Pastures, Peanuts and in Industrial and Commercial Areas as

stated in the Directions for Use table.

READ LEAFLET THOROUGHLY BEFORE USING THIS PRODUCT.

Nufarm Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

GROUP

HERBICIDE

I

Nufarm MCPB-400 Selective Herbicide

20 L, 110 L & 200 L leaflet

Date: 07.03.00

Page 4 of 7

Situation & Crop

Weed Controlled

Cereals

Cereals Undersown

Peas:

Canners 75,

Canners 72,

Emperor,

Green Feast,

Dark Seeded

Perfection,

Dunn Field Peas,

Early Crop 99,

Melb. Market,

Victory Freezer,

Small Sieve

Freezer,

Massey,

Meteor,

Shasta,

Peanuts:

Peanuts,

Virginia Bunch &

Red Spanish

Pastures, seedling:

Clover Red,

White Alsike,

Subterranean,

Strawberry

Clover.

Pastures:

Legume/Grass

Pastures:

Grass only

Seed Crops:Clover

Seed Crops:Clover/Medic

Industrial and Commercial

Areas, Rights of Way,

Fallow Land

Refer weed table

for species of

weeds controlled

DIRECTIONS FOR USE

RESTRAINTS

DO NOT spray if weeds are stressed by cold or dry weather.

DO NOT apply during drought or frosty weather.

DO NOT spray if rain is likely within 12 hours.

DO NOT irrigate within 2 days of spraying.

DO NOT slash or mow pastures within 14 days before or after spraying.

State

Rate/ha

All States

Tas only

NSW, Qld,

SA, Vic, WA,

NT, ACT

All States

All States

NSW, Qld,

Vic, WA, Tas,

NT, ACT only

SA only

All States

Vic, Qld, WA,

Tas, NT only

SA only

NSW, ACT only

NSW, Qld,

WA, Tas, Vic,

NT, ACT only

SA only

All States

4.2 L

4.2 L

4.0 L

4.2 L

2.8 L

2.8 L

1.4 L

4.2 L

4.2 L

2.8-5.6 L

2.8-5 L

2.8-4.2 L

2.8 L

3-5 L

1.4-5.6 L

Critical Comments

Apply after the 3 leaf stage to commencement

of tillering.

Cereals: Apply as above.

Clover: Apply after first trifoliate leaf.

Apply when crop is 100 mm-150 mm tall.

Apply in 3-4 node stage when growth is

strong. DO NOT apply to Gregory’s Surprise.

Contact Nufarm regarding the tolerance of

other varieties to MCPB. Apply when crop is

10-15cm high (6-8 node stage). DO NOT

apply if flowering has begun. Use maximum

amount of water per hectare. MCPB may

delay maturity up to 2 weeks. DO NOT use if

crop is under any sort of stress. See advice

under GENERAL INSTRUCTIONS (PEAS).

Apply from one week after seedlings emerge

but before flowering.

Apply during or following flowering.

Apply after emergence of first trifoliate leaf.

DO NOT apply to Berseem Clover.

Contact Nufarm regarding the tolerance of

clover cultivars.

2-12 th trifoliate leaf. DO NOT apply to

Berseem Clover.

Contact Nufarm regarding the tolerance of

clover cultivars.

Clover: Apply after emergence of first

trifoliate leaf.

Contact Nufarm regarding the tolerance of

clover cultivars.

Grass: Apply after seedlings have 3 or more

leaves. DO NOT use on Lucerne.

Apply after pasture grass seedling have 3 or

more leaves.

DO NOT spray Red or Strawberry Clover in

the year it is to be harvested. Spray well

before flower heads appear.

Contact Nufarm regarding the tolerance of

clover cultivars.

Spray from 2-12 th trifoliate leaf.

Contact Nufarm regarding the tolerance of

clover/medic cultivars.

Apply in autumn and early winter.

Apply to weeds as early as possible.

Resistance increases with age.

Nufarm MCPB-400 Selective Herbicide

20 L, 110 L & 200 L leaflet

Date: 07.03.00

Page 5 of 7

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

AUTHORISED UNDER APPROPRIATE LEGISLATION.

WITHHOLDING PERIOD: DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 7 DAYS AFTER APPLICATION

NOTE

The rate tolerated by the crop/pasture limits the range of weeds and efficacy of the product (see the

Directions for Use table, above).

WEEDS TABLE

The following table lists the weeds controlled by this product. In general, spray weeds when actively growing and

at as early a stage as possible.

Weeds Controlled

Amaranths

Bathurst Burr

Bellvine (White Flowers)

Black Nightshade

Caltrop (Tribulls Terrestris)

Carrot weed

Cats Ear

Charlock

Common Cotula

Common Morning Glory

Common Pigweed

Convolvulus

Dock

Fat Hen

Fumitory (red and white)

Hoary Cress

Indian Hedge Mustard

Lesser Swinecress

Nettles, Dwarf/Annual Stinging

Noogoora Burr

Opium Poppy

Paterson’s Curse (Salvation Jane)

Plantains (Ribgrass, Lamb’s tongue,

Ribwort)

Prickly Lettuce

Prince of Wales Feather

Redshank

Shepherd’s Purse

Sorrell

Sow (Milk) Thistle

Rate/ha

4.2 L

4.2-5.6 L

1.4 L

2.8 L

4.2-5.6 L

4.2-5.6 L

1.4 L

4.2-5.6 L

1.4 L

4.2 L

2.8 L

4.2-5.6 L

4.2 L

2.8 L

4.2 L

4.2 L

4.2 L

4.2 L

4.2 L

4.2 L

4.2-5.6 L

4.2 L

4.2 L

4.2 L

Critical Comments

Growth Stage: Apply to young actively

growing weeds.

NSW only: Use the higher rate for spot

spraying only.

Seedlings only controlled.

Apply to young actively growing weeds.

Seedlings only: moderately susceptible

NSW only: use the higher rate for spot

spraying only.

Seedling only controlled.

Apply to young actively growing weeds.

Older docks may require 2-3 resprays.

Apply to young actively growing weeds.

NSW only: Use the higher rate for spot

spraying only.

Seedlings only.

Apply to young actively growing weeds.

NSW only: Use the higher rate for spot

spraying only.

Seedling only controlled.

Apply to young actively growing weeds.

Seedling only controlled.

Apply to young actively growing weeds.

Seedlings only.

Spiny Emex (Doublegee)

Thistles:

Black/Spear

California

Saffron

Slender

Variegated

Turnip Weed (Rapistrum Rugosum)

Umbrella Sedge

Wild or Hedge Mustard

Wild Turnip

Wireweed (Hogweed)

4.2-5.6 L

4.2 L

4.2-5.6 L

4.2-5.6 L

2.8 L

4.2 L

2.8 L

2.8 L

4.2 L

Apply to young actively growing weeds.

Spray when 10-15 cm or early bud stage at

higher rate for control of top growth and some

root growth.

Apply to young actively growing weeds.

Seedlings only controlled.

Seedlings only controlled.

Apply to young, actively growing weeds.

Pasture should not be slashed or burnt 14

days before or after spraying.

Apply to young actively growing weeds.

NSW only: Use the higher rate for spot

spraying only.

Apply to young, actively growing weeds.

Nufarm MCPB-400 Selective Herbicide

20 L, 110 L & 200 L leaflet

Date: 07.03.00

Page 6 of 7

Nufarm MCPB-400 Selective Herbicide

20 L, 110 L & 200 L leaflet

Date: 07.03.00

Page 7 of 7

GENERAL INSTRUCTIONS

MIXING

To ensure even mixing, half fill the spray tank with

clean water, add the required amount of chemical,

and stir thoroughly. Add the remainder of the water

and mix again before spraying. Apply with equipment

with nozzle tips designed to apply 110-330 L/ha. A

volume of at least 220 L/ha is required in sub-tropical

areas. Ensure correct calibration so that the correct rate

of application is maintained. Set height of boom to give

even coverage over weeds. DO NOT use hard water.

EQUIPMENT MAINTENANCE AND USAGE

After use thoroughly clean equipment and rinse out

several times prior to re-use.

CROP SAFETY

DO NOT exceed recommended rates to avoid crop

damage.

PEAS: Do not use if crops are under

drought/water/disease stress. Will possibly compound

existing problems. MCPB usually causes twisting and

a reduction in plant growth, 2-3 weeks after spraying.

Peas recover and grow normally if not sujected to

stress when sprayed, or during the post-application

recovery period.

RESISTANT WEEDS WARNING

Nufarm MCPB-400 Selective Herbicide (‘MCPB-400’)

is a member of the Phenoxys group of herbicides.

MCPB-400 has the disruptors of plant cell growth

mode of action. For weed resistance management

MCPB-400 is a Group I herbicide.

Some naturally-occurring weed biotypes resistant to

MCPB-400 and other disruptors of plant cell growth

herbicides may exist through normal genetic

variability in any weed population. The resistant

individuals can eventually dominate the weed

population if these herbicides are used repeatedly.

These resistant weeds will not be controlled by

MCPB-400 or other disruptors of plant cell growth

herbicides.

Since the occurrence of resistant weeds is difficult to

detect prior to use, Nufarm Limited accepts no liability

for any losses that may result from the failure of

MCPB-400 to control resistant weeds.

PROTECTION OF CROPS, NATIVE AND OTHER

NON-TARGET PLANTS

DO NOT allow spray drift over or onto susceptible

crops such as cotton, tobacco, flowers, vegetables,

fruit trees, bananas, pineapples, tomatoes, vines,

kurrajongs, lupins, ornamentals or other susceptible

crops.

DO NOT apply under weather conditions or from

spraying equipment that may cause spray to drift onto

nearby susceptible plants/crops, cropping lands or

pastures.

PROTECTION OF WILDLIFE, FISH,

CRUSTACEANS AND ENVIRONMENT

DO NOT contaminate dams, rivers or streams with

the product or used containers.

STORAGE AND DISPOSAL

Store in the closed, original container in a cool, well-

ventilated area. Do not store for prolonged periods in

direct sunlight. Protect from frost. Triple or preferably

pressure rinse containers before disposal . Add rinsings

to spray tank. Do not dispose of undiluted chemicals

on site. If recycling, replace cap and return clean

containers to recycler or designated collection point.

If not recycling, break, crush or puncture and bury

empty containers in a local authority landfill. If no

landfill is available, bury the containers below 500 mm

in a disposal pit specifically marked and set up for this

purpose clear of waterways, desirable vegetation and

tree roots. Empty containers and product should not

be burnt.

Refillable containers

Empty contents fully into application equipment.

Close all valves and return to point of supply for refill

or storage.

SAFETY DIRECTIONS

Harmful if swallowed. Will irritate the eyes and skin.

Avoid contact with eyes and skin. When preparing

spray and using the prepared spray wear cotton

overalls buttoned to the neck and wrist, a washable

hat, elbow length PVC gloves and face shield or

goggles. If product in eyes, wash it out immediately

with water.

After use and before eating, drinking or smoking,

wash hands, arms and face thoroughly with soap and

water. After each day’s use wash gloves, face-shield

or goggles and contaminated clothing.

FIRST AID

If poisoning occurs, contact a doctor or Poisons

Information Centre (13 11 26). If swallowed, and if

more than 15 minutes from a hospital induce vomiting,

preferably using Ipecac Syrup (APF).

MATERIAL SAFETY DATA SHEET

For further information refer to the Material Safety

Data Sheet (MSDS).

CONDITIONS OF SALE

“Nufarm Limited (‘Nufarm’) shall not be liable for any

loss injury damage or death whether consequential or

otherwise whatsoever or howsoever arising whether

through negligence or otherwise in connection with

the sale supply use or application of this product. The

supply of this product is on the express condition that

the purchaser does not rely on Nufarm’s skill or

judgment in purchasing or using the same and every

person dealing with this product does so at his own

risk absolutely. No representative of Nufarm has any

authority to add to or alter these conditions.”

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

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Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

8-9-2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use PremierZen Gold 4000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

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

14-6-2018

Blokhuis: maak postnatale depressie bespreekbaar

Blokhuis: maak postnatale depressie bespreekbaar

In Nederland ontwikkelen jaarlijks ruim 23.400 vrouwen een depressie na de bevalling. Dat is 1 op de 8 moeders. Velen van hen durven hun situatie niet aan te kaarten. Zij zijn bang om gezien te worden als een slechte moeder (47,4%) en willen anderen niet belasten (52,2%), blijkt uit een peiling onder vrouwen die (signalen van) een postnatale depressie hebben gehad. Hierdoor blijft postnatale depressie, ook wel postpartum depressie (PPD) genoemd, te vaak onbesproken. Daarom geeft staatssecretaris Paul Blo...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

19-6-2015

Global operation against illicit medicines completed

Global operation against illicit medicines completed

A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.

Danish Medicines Agency

20-12-2018


Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

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

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

25-7-2018

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist.  https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

FDA - U.S. Food and Drug Administration

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety