LVE MCPA

Main information

  • Trade name:
  • NUFARM L.V.E. MCPA LOW-VOLATILE ESTER HERBICIDE
  • Pharmaceutical form:
  • Emulsifiable
  • Units in package:
  • 5L,20L,110L,200L,1000L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical

Documents

Localization

  • Available in:
  • NUFARM L.V.E. MCPA LOW-VOLATILE ESTER HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BARLEY | CEREAL RYE | GRASS PASTURE | OATS | PASTURE GRASS SEED CROP | TRITICALE | WHEAT
  • Therapeutic area:
  • Group I Herbicide
  • Therapeutic indications:
  • BATHURST BURR | CAPEWEED | CHARLOCK | DANDELION - TARAXACUM OFFICINALE | FAT HEN | FUMITORY | HEDGE OR WILD MUSTARD | LINCOLN WEED, SAND ROCKET OR MUSTARD | LONDON ROCKET | NOOGOORA BURR | PATERSON'S CURSE | SAFFRON THISTLE | SCOTCH THISTLE | SKELETON WEED | SLENDER, SHORE OR SHEEP THISTLE | SPEAR OR BLACK THISTLE | STINKWORT | TURNIP WEED | VARIEGATED THISTLE | VOLUNTEER CANOLA OR RAPESEED | VOLUNTEER SAFFLOWER | VOLUNTEER SUNFLOWER | WILD RADISH OR RADISH WEED | WILD SAGE | WILD TURNIP | BLESSED THISTLE | BRASSICA CAMPESTRIS | BRASSICA KABER | BRASSICA RAPA SSP. SYLVESTRIS | BRASSICA RAPA VAR. SYLVESTRIS | BRASSICA SINAPISTRUM | BULL THISTLE | CABBAGE THISTLE | CARDUUS MARIANUS | COCKLEBURR | COMMON DANDELION | COTTON THISTLE | CRAMBLING MUSTARD | ECHIUM LYCOPSIS | ECHIUM SPP. | ENGLISH DANDELION | EUROPEAN DANDELION | FALSE STAR THISTLE | GIANT MUSTARD | HEDGE MUSTARD | HERALDIC THISTLE | HOLY THISTLE | JOINTED CHARLOCK | LADY'S THISTLE | MILK THISTLE | PINK WEED | PURPLE BUGLOSS | PURPLE VIPER'S BUGLOSS |
  • Product summary:
  • For selective control of certain weeds in agricultural crops.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 31521/0604
  • Authorization date:
  • 16-07-2004
  • Last update:
  • 15-06-2017

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

Nufarm L.V.E. MCPA

5L, 20L,110L, 200L,1000L label

Date: 25.06.04

Page

1

of

6

Low-Volatile Ester Herbicide

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm

L.V.E. MCPA

Low-Volatile Ester Herbicide

ACTIVE CONSTITUENT: 500 g/L MCPA present as the iso-octyl ester

For selective control of certain weeds in agricultural crops as

listed in the Directions for Use.

IMPORTANT: READ THE ATTACHED LEAFLET

BEFORE USING THIS PRODUCT.

Contents: 5 Litres

20 Litres

110 Litres

200 Litres

1000 Litres

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

GROUP

HERBICIDE

I

Info

pest

Verified

STORAGE AND DISPOSAL (5L, 20L, 200L only)

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

ventilated area. DO NOT store for prolonged periods

in direct sunlight. Triple or preferably pressure rinse

containers before disposal. Add rinsings to spray

tank. DO NOT dispose of undiluted chemical 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

available, bury the containers below 500mm 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 (1000L only):

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

ventilated area. DO NOT store for prolonged periods

in direct sunlight. Empty contents fully into application

equipment. Close all valves and return to point of sale

for refill or storage.

Envirodrum 110L Mini Bulk Returnable Container:

Store the original sealed Envirodrum™ in a cool, well

ventilated area. DO NOT store for prolonged periods

in direct sunlight. DO NOT tamper with the Micro

Matic valve or the security seal. DO NOT contaminate

the Envirodrum with water or any foreign matter.

After each use of the product, please ensure that the

Micro Matic coupler, delivery system and hoses are

disconnected, triple rinsed with clean water and

drained accordingly. When the contents of the

Envirodrum have been used, please return the empty

Envirodrum to the point of purchase. The Envirodrum

remains the property of Nufarm Australia Limited.

SAFETY DIRECTIONS

Harmful if swallowed. Attacks eyes. Will irritate the

skin. When preparing spray and using the prepared

spray wear cotton overalls buttoned to the neck and

wrist and a washable hat, elbow-length PVC gloves

and 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, goggles and contaminated clothing.

FIRST AID

If poisoning occurs, contact a Doctor or Poisons

Information Centre (Phone 13 11 26).

MATERIAL SAFETY DATA SHEET

For further information refer to the Material Safety

Data Sheet (MSDS).

CONDITIONS OF SALE

“Nufarm Australia 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.”

APVMA Approval No.: 31521/5L/0604

APVMA Approval No.: 31521/20L/0604

APVMA Approval No.: 31521/110L/0604

APVMA Approval No.: 31521/200L/0604

APVMA Approval No.: 31521/1000L/0604

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

Batch No.

Date of Manufacture

(5L, 20L, 200L only)

Barcode

Nufarm L.V.E. MCPA

5L, 20L,110L, 200L,1000L label

Date: 25.06.04

Page

2

of

6

Low-Volatile Ester Herbicide

Nufarm L.V.E. MCPA

Label leaflet for all pack sizes

Date: 25.06.04

Page

3

of

6

Low-Volatile Ester Herbicide

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm

L.V.E. MCPA

Low-Volatile Ester Herbicide

ACTIVE CONSTITUENT: 500 g/L MCPA present as the iso-octyl ester

For selective control of certain weeds in agricultural crops as

listed in the Directions for Use.

READ COMPLETE DIRECTIONS FOR USE

BEFORE USING THE PRODUCT.

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

APVMA Approval No.: 31521/0604

GROUP

HERBICIDE

I

DIRECTIONS FOR USE:

Situation &

Crop

Weeds

Rate/ha

Critical Comments

Wheat

(up to early flag

leaf (Z37) only)

Oats, Barley,

Triticale and

Cereal Rye

(up to early flag

leaf (Z37) only)

Grass Pastures

and Grass

Seed Crops

CEREALS

Wheat, barley,

oats, triticale,

cereal rye

Refer Weed Table

Wild radish

Stage of weed growth

Up to the 4 leaf stage and not

more than 120mm in diameter

Up to the 6 leaf stage and not

more than 150mm in diameter

Up to the 8 leaf stage and not

more than 180mm in

diameter*

500mL-2.1L

500mL-1.6L

500mL-2.1L

L.V.E. MCPA

200mL plus

Nugrex 350mL

L.V.E. MCPA

200mL plus

Nugrex 500mL

L.V.E. MCPA

400mL plus

Nugrex 500mL

Use the lower rate (500mL/ha) when crop is at 3-5 leaf stage

(Z13-Z15). Apply higher rates from 5 leaf stage through to flag

leaf just visible (Z15-Z37). Kulin: Use only from Z15-Z37

(WA only).

Use lower rate (500mL/ha) when crop is at 3-5 leaf stage (Z13-

Z15). Apply higher rates from 5 leaf stage through to flag leaf

just visible (Z15-Z37). Barley: Use only from 5 leaf stage to flag

leaf just visible (Z15-Z37).

Apply to established grass based pastures. Damage may occur

to Legumes if present. See Legume Tolerance under Protection

of Crops. NOTE: Capeweed, Paterson’s Curse (Salvation Jane)

and Variegated Thistle may be poisonous to stock after spraying.

*Reduced efficacy (suppression only) may be achieved on wild

radish larger than 8 leaf or greater than 180mm in diameter.

DO NOT use this tank-mix if cereals are undersown with lucerne

or annual medics.

Crop Stage

Nugrex 350mL + L.V.E. MCPA 200mL:

Apply from 3 leaf to fully tillered (Zadok’s Z13 to Z30).

Nugrex 500mL + L.V.E. MCPA 200mL:

Apply from 3 leaf to fully tillered (Zadok’s Z13 to Z30).

Nugrex 500mL + L.V.E. MCPA 400mL:

Apply from 5 leaf stage to fully tillered (Zadok’s Z16 to Z30).

Optimum results are achieved when sprayed at 3-5 leaf crop

stage (generally 4-8 weeks post-sowing).

WA only: DO NOT apply to Barley or Kulin Wheat before the 5

leaf stage (Z15).

Warning: Nugrex may cause transient crop yellowing of cereals.

Some varieties of oats have not been tested. (Refer to “Crop

Tolerance” section of General Instructions on the Nugrex label).

Nufarm L.V.E. MCPA

Label leaflet for all pack sizes

Date: 25.06.04

Page

4

of

6

Low-Volatile Ester Herbicide

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

AUTHORISED UNDER APPROPRIATE LEGISLATION.

WITHHOLDING PERIOD:

FOR HARVESTING: NOT REQUIRED WHEN USED AS DIRECTED.

DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 7 DAYS AFTER APPLICATION.

GENERAL INSTRUCTIONS

Before opening, carefully read Directions for Use,

Precautionary Statements, Safety Directions and First

Aid Instructions. Weeds should be sprayed while actively

growing and at their most susceptible stage. As a general

guide, annuals should be sprayed when young and

perennials just prior to appearance of bud stage.

Extremes of cold or drought are unfavourable. The best

conditions are when soil is moist, weather fine and

rain unlikely within 6 hours following application. DO NOT

spray weeds outside the stages indicated in “Critical

Comments” as damage, loss of yield or inadequate

weed control may result. DO NOT spray in high winds.

APPLICATION/MIXING INFORMATION

This product mixes readily with water. Half fill the spray

tank with clean water and add the required amount of

roduct. Agitate thoroughly before adding remainder of water.

BOOM SPRAYING - Use 30-120 L/ha of water.

AERIAL SPRAYING - Use 10-90 L/ha of water.

EQUIPMENT MAINTENANCE AND USAGE

Equipment that has been used for this chemical

should not be used for the application of other

materials to sensitive plants unless it has been well

washed out with Spraymate Tank & Equipment

Cleaner followed by several clear water rinses.

COMPATIBILITY / TANK MIXES

This product can be mixed with Ally*/Associate*, Kamba

Bromicide

, Flowable Diuron, Flowable Terbutryn,

Glean*/Siege*, Glyphosate, Roundup^, Grasp*,

Nugrass

/Hoegrass*, Nugran/Logran*, Nugrex/Tigrex*,

Lontrel*/Archer™, Propon, Puma*. When tank mixing

add the required amount of compatible product when the

spray tank is nearly full and while continuously agitating.

If left overnight, agitate thoroughly before spraying. When

mixing with Nugrass or Hoegrass, add an approved

surfactant and do not exceed 700mL of L.V.E. MCPA

per hectare. For consistent results, use a minimum of

80L water per ha by ground and 30L by air, and if wild

oats are present, use 2L Nugrass per hectare.

RESISTANT WEEDS WARNING

Nufarm L.V.E. MCPA Low-Volatile Ester Herbicide

(‘L.V.E. MCPA’) is a member of the Phenoxys group

of herbicides. L.V.E. MCPA has the Disruptors of

plant cell growth mode of action. For weed resistance

management L.V.E. MCPA is a Group I herbicide.

Some naturally-occurring weed biotypes resistant to

L.V.E. MCPA and other Group I herbicides may exist

hrough 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 L.V.E.

MCPA or other Group I herbicides.

Since the occurrence of resistant weeds is difficult to

detect prior to use, Nufarm Australia Limited accepts

no liability for any losses that may result from the

failure of L.V.E. MCPA to control resistant weeds.

PROTECTION OF CROPS, NATIVE AND OTHER

NON-TARGET PLANTS

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. Avoid spray drift and vapour movement onto

susceptible crops such as cotton, vines, tomatoes,

vegetables, fruit trees, lucerne, legume crops and

pastures, oilseed crops or other susceptible crops or

trees (eg. kurrajongs, belahs, eucalypts).

Legume Tolerance: The tolerance of pasture

legumes to this product can vary with species, variety,

growing conditions, stage of growth and companion

crop cover. While MCPA is preferable to 2,4-D in most

situations, this product will cause greater damage than

MCPA amine formulations. Lucerne and medics

should not be sprayed under any circumstances with

this product as severe damage will result.

PROTECTION OF WILDLIFE, FISH, CRUSTACEA

AND ENVIRONMENT

DO NOT contaminate streams, rivers or waterways

with the chemical or used container.

STORAGE AND DISPOSAL (5L, 20L, 200L only)

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

ventilated area. DO NOT store for prolonged periods

in direct sunlight. Triple or preferably pressure rinse

containers before disposal. Add rinsings to spray tank.

DO NOT dispose of undiluted chemical 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 available, bury

the containers below 500mm 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 (1000L only):

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

ventilated area. DO NOT store for prolonged periods

in direct sunlight. Empty contents fully into application

equipment. Close all valves and return to point of sale

for refill or storage.

Envirodrum 110L Mini Bulk Returnable Container:

Store the original sealed Envirodrum™ in a cool, well

ventilated area. DO NOT store for prolonged periods

in direct sunlight. DO NOT tamper with the Micro Matic

valve or the security seal. DO NOT contaminate the

Envirodrum with water or any foreign matter.

After each use of the product, please ensure that the

Micro Matic coupler, delivery system and hoses are

disconnected, triple rinsed with clean water and

drained accordingly. When the contents of the

Envirodrum have been used, please return the empty

Envirodrum to the point of purchase. The Envirodrum

remains the property of Nufarm Australia Limited.

SAFETY DIRECTIONS

Harmful if swallowed. Attacks eyes. Will irritate the

skin. When preparing spray and using the prepared

spray wear cotton overalls buttoned to the neck and

wrist and a washable hat, elbow length PVC gloves

and 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, goggles and contaminated clothing.

FIRST AID

If poisoning occurs, contact a Doctor or Poisons

Information Centre (Phone 13 11 26).

MATERIAL SAFETY DATA SHEET

For further information refer to the Material Safety

Data Sheet (MSDS).

CONDITIONS OF SALE

“Nufarm Australia 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

at his own risk absolutely. No representative of Nufarm

has any authority to add to or alter these conditions.”

™ Trademark Pending

® Kamba, Bromicide, Credit, Bonus, Weedmaster

and Nugrass are registered trade marks of Nufarm

Australia Limited.

^ Roundup is a registered trademark of Monsanto

Technology LLC used under licence by Nufarm

Australia Limited.

* Other registered trade marks

APVMA Approval No.: 31521/0604

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

Nufarm L.V.E. MCPA

Label leaflet for all pack sizes

Date: 25.06.04

Page

5

of

6

Low-Volatile Ester Herbicide

WEED TABLE: Specific Weed Control Recommendations.

Where weeds are to be sprayed in a crop or pasture, use only the rates given for the particular crop or

situation indicated under the Directions of Use table.

In most cases this will give control, however some hard to kill weeds or those in advanced stages of

growth may only be suppressed.

The rates listed in the weeds table below are for use where weeds only are present and crop or pasture is

not involved. Use at these rates in a crop or pasture other than for spot spraying may cause damage.

Nufarm L.V.E. MCPA

Label leaflet for all pack sizes

Date: 25.06.04

Page

6

of

6

Low-Volatile Ester Herbicide

Weeds

Rate/ha

Critical Comments

Bathurst Burr

(Xanthium spinosum)

Capeweed

(Arctotheca calendula)

Charlock

(Sinapis arvensis)

Dandelion

(Taraxacum officinale)

Fat Hen

(Chenopodium album)

Fumitory

(Fumaria)

Hedge Mustards

(Sisymbrium

spp

)

Lincoln Weed

(Diplotaxis tenuifolia)

London Rocket

(Sismybrium irio)

Noogoora Burr

(Xanthium occidentale)

Paterson’s Curse

(Echium plantagineum)

Saffron Thistle

(Carthamus lanatus)

Scotch (Cotton) Thistle

(Onopordum acanthium)

Skeleton Weed

(Chondrilla juncea)

Slender Thistle

(Carduus tenuiflorus)

Spear Thistle

(Cirsium vulgare)

Stinkwort

(Dittrichia graveolens)

Turnip Weed

(Rapistrum rugosum)

Volunteer Canola

(Brassica napus)

Variegated Thistle

(Silybum marianum)

Volunteer Safflower

(Carthamus tinctorius)

Volunteer Sunflower

(Helianthus annuus)

Wild Radish

(Raphanus

raphanistrum)

Wild Sage

(Salvia verbenaca)

Wild Turnip

(Brassica

spp

)

1.6L

1.7L

500mL-1.6L

1.6L

1-1.6L

1.1L

560mL-1L

700mL

1.1L

1.6L

1.7L

1.1-1.9L

700mL-1.7L

1.1-1.6L

2.1L

1.5-2.1L

1.6L

700mL-1.1L

1.5L

840mL-1.1L

1.5L

1.1-1.6L

1.1L

500mL-1.5L

Moderately susceptible. Spray young seedlings.

Apply up to 2-4 leaf stage only when plants are no larger than 5cm in diameter.

Young rosettes very susceptible.

Apply in early rosette stage.

Tolerance increases with age. Use lower rate only on seedlings.

Moderately susceptible. Spray up to first true leaf stage. (Not Tas).

Apply at rosette stage.

Apply up to rosette stage only.

Spray at young stage.

Tolerance increases with age. Spray young seedlings only.

Apply at 2 to 4 leaf stage only.

Spray young rosettes before leaves become spiny.

Spray young rosettes.

Moderately susceptible. Spray rosettes before aerial growth commences.

Moderately susceptible. Spray young rosettes.

Moderately susceptible. Spray young rosettes.

Spray very young before plants 15cm high.

Apply up to rosette stage. Apply lower rates to seedlings.

Apply to seedlings only.

Spray at pre-cabbage stage.

Apply to seedlings only.

Apply to seedlings only.

Apply up to 2 to 3 leaf stage only.

Spray young seedlings.

Spray young rosettes. Lower rates for seedlings.

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FDA - U.S. Food and Drug Administration

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA Proposes Study with Intent of Eliminating Use of Dogs in Certain Types of Research

FDA Proposes Study with Intent of Eliminating Use of Dogs in Certain Types of Research

In keeping with the goals of reducing, replacing, and/or refining the use of animals in research, the U.S. Food and Drug Administration today released for public comment proposed research to validate an alternative approach for bioequivalence studies for certain animal drugs.

FDA - U.S. Food and Drug Administration

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

22-10-2018

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

October 22, 2018: Medical Equipment Company Agrees to Pay $5.25 Million to Resolve Allegations of Fraudulent Claims for Compounded Medical Creams

FDA - U.S. Food and Drug Administration

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

14-9-2018

Minister van Sport Bruno Bruins aanwezig bij MXGP Assen

Minister van Sport Bruno Bruins aanwezig bij MXGP Assen

Dit weekend staat de Motorcross Grand Prix (MXGP) op het TT circuit van Assen op de agenda. Dit jaar kan een bijzondere editie worden, omdat Jeffrey Herlings de mogelijkheid heeft om de eerste Nederlandse wereldkampioen in de MXGP-categorie te worden.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

6-8-2018

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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

3-8-2018

Scientific guideline:  Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Agomelatine tablet 25 mg product-specific bioequivalence guidance, adopted

Agomelatine tablet 25 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Vismodegib hard capsule 150 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Vismodegib hard capsule 150 mg product-specific bioequivalence guidance, adopted

Vismodegib hard capsule 150 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

2-8-2018

Minister Bruno Bruins bij start Skûtsjesilen

Minister Bruno Bruins bij start Skûtsjesilen

Minister van Sport Bruno Bruins bezoekt zaterdag 4 augustus de start van het jaarlijkse Sintrale Kommisje Skûtsjesilen (SKS) kampioenschap. Hierbij strijden 14 ‘Skûtsjes’ om de felbegeerde kampioenswimpel en de wisseltrofee: het Sulveren Skûtsje.  In totaal worden de komende twee weken 11 wedstrijden gezeild. De eerste wedstrijd start zaterdag op het Pikmeer bij Grou.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

31-7-2018

Public Notification: Black Rhino 25000 contains hidden drug ingredient

Public Notification: Black Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Black Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

Public Notification: Krazzy Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Krazzy Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

Public Notification: Gold Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Gold Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

31-7-2018

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

Public Notification: Platinum Rhino 25000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Platinum Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

19-7-2018

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

July 18, 2018: Medical Device Maker AngioDynamics Agrees to Pay $12.5 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

11-7-2018

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

OCOOW LLC recalls Odie's Solvent-Free Super Penetrating Oil and Odie's Safer Solvent

The recalled products do not have proper consumer chemical hazard packaging and labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

10-7-2018

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

Preventieve HIV-remmers (PrEP) worden verstrekt voor een periode van vijf jaar

PrEP wordt binnen een onderzoekssetting voor een periode van vijf jaar verstrekt aan de hoogrisicogroep van mannen die seks hebben met mannen (MSM). Dat heeft minister Bruno Bruins (Medische Zorg) vandaag bekend gemaakt. Op basis van schattingen van het RIVM zullen ongeveer 6500 mannen hiervan gebruik gaan maken en kunnen hiermee  250 hiv-infecties per jaar worden voorkomen. Voor gebruikers gaat een eigen bijdrage gelden van maximaal 25%, dat komt overeen met ongeveer 12 euro per maand. Ook wordt hen gev...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

10-1-2019


Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

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

17-12-2018


Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, Date of authorisation: 22/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Takhzyro, lanadelumab, Angioedemas, Hereditary, Date of authorisation: 22/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

17-12-2018


Ezetimibe product-specific bioequivalence guidance

Ezetimibe product-specific bioequivalence guidance

Ezetimibe product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Overview of comments received on draft dimethyl fumarate gastro-resistant capsules 120 mg and 240 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

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

Europe -DG Health and Food Safety

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

16-11-2018

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Samsung Bioepis NL B.V.)

Ontruzant (Active substance: trastuzumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7553 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004323/T/0012

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

15-11-2018

Benepali (Samsung Bioepis NL B.V.)

Benepali (Samsung Bioepis NL B.V.)

Benepali (Active substance: etanercept) - Centralised - Yearly update - Commission Decision (2018) 7557 of Thu, 15 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency