ROUT

Main information

  • Trade name:
  • ROUT ORNAMENTAL HERBICIDE
  • Pharmaceutical form:
  • Granular
  • Units in package:
  • 5 kg, 10 kg, 15kg, 20kg, 22.7 kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • EVERRIS AUSTRALIA

Documents

Localization

  • Available in:
  • ROUT ORNAMENTAL HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ACACIA ACINACEA | ALNUS ACUMINATA | AZALEA INDICA | BIRCH | BLUE LAGOON ROSEMARY | BOTTLEBRUSH | BOUGAINVILLIA | CALLIANDRA ROSE
  • Therapeutic area:
  • Group DG Herbicide
  • Therapeutic indications:
  • AMARANTH OR AMARANTHUS | AMSINCKIA,YELLOW BURRWEED OR BURR GRASS | BARLEY GRASS | BARNYARD GRASS OR WATER GRASS | BLACKBERRY NIGHTSHADE | BLADDER KETMIA | BURR | CALTROP OR YELLOW VINE | CAPEWEED | CAUSTIC WEED | CHICKWEED | COMMON BITTERCRESS OR FLICKWEED | COMMON SENSITIVE PLANT | CREEPING OXALIS | CROWSFOOT GRASS | DEADNETTLE | FAT HEN | FLEABANE | GIANT OR BLACK PIGWEED | HEDGE OR WILD MUSTARD | LIVERSEED OR UROCHLOA GRASS | LOVEGRASS | MALLOW | PIGEON GRASS | PIGWEED SPP. | PRICKLY LETTUCE | RED CAUSTIC CREEPER | REDSHANK,SLIM OR SPLEEN AMARANTH | RHODES GRASS | RYEGRASS | SHEPHERD'S PURSE | SOURSOB OR OXALIS | SOW OR MILK THISTLE | STAGGER WEED | STARBURR | STINK GRASS | SUBTERRANEAN CLOVER | SUMMER OR CRAB GRASS | THORNAPPLE | WHITE EYE OR MEXICAN CLOVER | WILD RADISH OR RADISH WEED | WILLOWHERB | WINTER GRASS | WIREWEED, KNOTWEED OR HOGWEED | EUPATORIUM RIPARIA | WOOD SORREL (YELLOW) | AFRICAN WOOD SORREL | CLOVER SORREL | WHITE WEED | PRINCE OF WALES FEATHER | CRAMBLING MUSTARD | PURSLANE | BULL'S HE
  • Product summary:
  • For pre-emergent control of weeds in container & in-ground ornamentals; lasts for up to 3 months.NOT RECOMMENDED FOR USE ON VEGETABLES OR EDIBLE FRUIT CROPS, TURF, BEDDING PLANTS OR GREENHOUSE FLOWERING CROPS. Refer to product label for lists of tolerant and sensitive ornamental species.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 31548/51403
  • Authorization date:
  • 12-11-2010
  • Last update:
  • 15-06-2017

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

ROUT

ORNAMENTAL

HERBICIDE

t above this line is not included

the label.

READ

SAFETY

DIRECTIONS

BEFORE

OPENING

USING

ROUT

ORNAMENTAL

HERBICIDE

CONSTITUENTS:

20g/kg

OXYFLUORFEN

lOg/kg

ORYZALIN

GROUP

HERBICIDE

Page I

Approved

For pre-emergent

contro

weeds in

container

and in-ground

ornamenta l plants. Lasts up

three months

per directions

use.

Scotts

IGHT:

22.7kg*

Text below this line

included

e label

*Or 5kg, I

Okg,

15kg , 20kg

Info

pest

Verified

ROUT

ORNAMENTAL

HERBICIDE

Page Z

Text above this line is not included

the label.

ROUT" Ornamental Herbicide

DIRECTIONS

Restraints

NOT mix

ROUT"'

into potting media

poor weed control will be obtained and 'plant damage

likely.

apply

ROUT\!}

in windy conditions likely

affect good distribution.

broadcast

ROUT

"' over

foliage .

Situation

Weeds Controlled

Application rate

Critical Comments

Container

&

Amsinckia

100 kg/ha

Apply evenly over

area

pots

treated

ground

Barley grass

preferably using a properly calibrated mechanical granule

ornamental

Barnyard grass

l.Okg/100m

spreader. Apply

surface

weed free soil

plants

(See

list

Black nightshade

lOg/m

preferably

after

cultivation

just

after

potting

ROUT

below)

Bladder ketmia

will

control established weeds. Apply

dry foliage

Burr. grass

only and then sprinkler irrigate

hose (10

I Smm)

Caltrop

wash granu

from

foliage and incorporate the herbicide

Capeweed

soil.

Chickweed

Creeping oxalis

apply

ROUT

foliage - should this happen

Crowsfoot grass

irrigate

hose

ediately

remove granules from

Dead

nettle

leaf surface.

Fleabane

Follow

precautions listed

below

avoid unnecessary

Flickweed

plant damage and

obtain

optimum

weed control.

Giant pigweed

Liverseed grass

One application will last

2-3 months depending upon

Love

grass

rainfall, irrigation, soil

(potting

mix), te mperature

Mallow

and weed seed burden. Re-treat when

first signs

Mimosa

weed

growth

are seen

no sooner than 2 months and

Pigeon grass

no later than 3 months

after

first application.

Pigweed

Prickly Lettuce

apply

ROUT

2 weeks

prior

2 weeks after

ustic creeper

bud break

during periods

flush growth. Newly

Redshank (Amaranth)

formed leaves are

nsitive

this product. Spotting

Rhodes grass

drop

may result

from

such applications.

grass

Shepherds purse

apply directly on

bare roots

woody

Soursob

ornamentals

injury may occur.

Sowthistle

Staggerweed

rrburr

ink g

rass

terranean clover

grass

Thornapple

Whit

e eye

Wild mustard

Wild radish

Willowherb

Wint

er grass

Wireweed

USED

ANY PURPOSE

MANNER

CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE

LEGISLATION.

TASMANIA

THIS PRODUCT

MUST

APPLIED

AIRCRAFT

WITHOUT

SPECIFIC APPROVAL

THE REGISTRAR.

!...ABEL

DRAfT

19/ 10/

Back panel

GENERAL

NSTRUCT

ROUT

ORNAMENTAL

HERBICIDE

Text above this line

not included in the label.

Ornamentals on which

ROUP~

be used

Testing has indicated

that

owing

species are

tolerant

ROUT®

when

used

recommended:

Page 3

Abelia x grandiflora 'Francis Mason' (Glossy abelia}, Acacia acinacea, Acacia

ileyana (Cootamundra wattle), Acer palmatum

(Japanese maple}, Alnus acuminata, Arbutus unedo (Strawberry tree), Azalea indica, Betula pendula {Birch}, Bougainvillea spp,

Buxus microphylla v. japonica (Japanese box), Callistemon viminalis 'Captain Cook' (Bottlebrush}, Camellia japonica,

Cassia

bicapsularis,

Cassia

corymbosa, Casuarina littoralis, Casuarina torulosa, Choisya ternata (Mexican orange), Coleonema album,

Cotoneaster sp., Cupressus sempervirens v. (Swanes golden pencil pine}, Diosma ericoides, Eriostemon myoporoides, Eucalyptus

nicholi (Fine leaf peppermint},

Euca

lyptus sideroxylon (Pink iron bark}, Euonymus alata, Ficus benjamina, Fraxinus excelsior {Golden

ash}, Fraxinus pennsylvanica (Red ash}, Gardenia jasminoides, Gardenia magnifica, Gelsemium sempervirens (Carolina jasmine},

Gordonia axillaris, Grevillea 'Ciearview David', Grevillea arenaria, Grevillea robusta (Silky oak), Grevillea 'Poorinda', Hakea laurina,

Hakea

ligna, Hebes buxifolia, Hibiscus

lberis sempervirens, llex vomitoria, Jasminum nitidum, Juniperus chinensis, Juniperus

conferta, Juniperus Sabina, Juniperus squamata, Lagerstroemia indica, Lantana montevidensis, Leptospermum juniperinum

'Horizontalis', Leptospermum petersonii, Ligustrum japonicum, Ligustrum lucidum, Ligustrum sinense,

laleuca armillaris,

Melale'uca decussata, Melia azedarach, Murraya exotica (orange jasmine}, Nandina domestica 'Nana' (Dwarf nandina), Nerium

oleander (Oleander), Photinia robusta, Picea abies (Norway Spruce},

Picea

glauca

(Dwarf

Alberta Spruce}, Pinus elliotii

(Slash

pine},

Pinus radiata, Pinus strobus, Pinus thunbergiana, Pittosporum crassifolium, Pittosporum

tenuifo

lium, Pittosporum

ira,

Podocarpus gracilior, Prunus

(Weeping cherry}, Punica granatum (Pomegranate), Raphiolepis indica, Rhododendron spp.

(Azalea},

Rosa

(Rose}, Rosmarinus folia {'Blue lagoon' rosemary), Schefflera arboricola, Syringa

. (Lilac}, Thuja occidentalis,

Ulmus campestris 'Variegata' (Silver elm), Ulmus procera (English elm), Viburnum plicatum, Weigela spp., Westringia fruticosa.

Ornamentals

on which

ROUT®

Ornamental Herbicide should

be used:

Testing has indicated

that

following

species can be sensitive

ROUT®:

Aesculus pavia, Alnus glutinosa (common alder), Azalea japonica, Cortaderia selloana (pampas), Corynocarpus laevigatus (karaka},

Dietes bicolor, Euonymus fortunei, Euonymus japonicus, Euryops pectinatus,

Ficus

pumila (Creeping fig}, Hardenbergia

spp,

llex

crenata, llex cornuta, Nandina domestica pygmaea, Phoenix roberti, Potentilla fruticosa, Salvia farinacea, Trachelospermum

asiaticum, Wisteria sinensis.

ROUT"

RECOMMENDED

VEGETABLES

EDIBLE

FRUIT

CROPS,

TURF,

BEDDING

PLANTS

GREENHOUSE

FLOWERING

CROPS.

APPLICAT

ROUT

POTS-

ROUT

may be applied individually

each

or pots can be grouped

together

ROUT

distributed using a

granule applicator

GLOVED

hand. FIELD- distribute evenly over

area

be treated using a granule applicator

GLOVED

hand.

Ensure

ROUT

does

stick

plant foliage

remain lodged in leaf axils

other

plant structures.

assist in application/calibration 100 kg/ha

ROUT

equivalent

30/3 2 granules

10 square centimetres [2

x 5 em].

Even

application

important

good weed control.

disturb

the soil surface once

product

been applied

herbicide barrier

will

be broken and weed

growth

occur.

RESISTANT

WEEDS

WARNING

Rout Ornamental Herbicide

member

both

dinitroanaline and diphenylether groups

herbicides. Rout has

a dual

mode

action

inhibitor

tubulin

formation and

inhibitor

protoporphyrinogen oxidase. For weed

resistance management

product

group

D and G herbicide. Some naturally occurring weed biotypes resistant

product and

other

group D and G herbicides may exist through normal genetic variability in any weed

population. The resistant individuals can eventually dominate

weed population

these herbicides are used

repeatedly. These resistant weeds will

be controlled by this.

product

other

group D and G herbicides.

Since the occurrence

resistant weeds

difficult

detect

prior

use, Scotts Australia Pty Ltd accepts

liability

any losses

that

may result

from

failure

this product

control resistant weeds.

Zealand only: Resistance groups are E

&

PRECAUTIONS

apply

pots within 2 weeks

retail sale.

NOT apply in enclosed glasshouse type structures

within 2

weeks

prior

to enclosure in such structures.

PROTECT

CROPS,

NATIVE AND

OTHER

NON-TARGET

PLANTS

apply

whorl

leaved plants

their

leaves channel

herbicide granules

leaf base making removal

granules difficult.

apply

under

weather conditions,

from equipment,

that

may cause

drift

onto

susceptible plants/crops, cropping lands

pastures.

LABEL

DRAFT 19/10/10

Back panel

PROTECTION

LIVESTOCK

ROUT ORNAMENTAL HERBICIDE

Text above this line is

included in the label.

NOT graze any

treated

stockfood

feed

poultry.

contaminate

water

used

livestock.

PROTECTION

WILDLIFE,

FISH,

CRUSTACEANS

AND ENVIRONMENT: Dangerous to wildlife, fish and

other

aquatic

organisms.

NOT contaminate streams, rivers

waterways

with

product

used container,

when cleaning

uipment

NOT use

product

where fauna are foraging and are likely

feed on granules.

SPILLS:

Sweep

spilled material and

return

original container. Wash contaminated

equipment

taking care

that

washings

enter

sewers, drains and

other

waterways. Dispose

waste according

Australian Standard

2507 - Storage and Handling

Pesticides.

NOT allow spilled

product

enter

sewers, drains, creeks

other

waterways.

STORAGE

DISPOSAL

: Keep

reach

children. Store

closed original container, in a dry, cool well

ventilated area

direct sunlight. Shake containers

empty

onto

treatment

site. Puncture or shred and bury

empty

bags

a local

authorit

y landfill.

no landfill

available,

bury

containers

below

500mm

a disposal

specifically marked and set

this purpose clear

waterways, desirable vegetation and

tree

roots. Empty bags

product

should

be burnt.

SAFETY

DIRECTIONS: Avoid

contact

with

eyes and skin. Do

inhale dust, use a dust mask.

product

comes in

contact

with

skin

immediately

wash

area

with

soap and

water.

After

use and before eating, drinking

smoking,

wash hands, arms and face

thoroughly

with

soap and water.

FIRST

AID:

poisoning occurs, contact a

doctor

Poisons

Information

Centre Phone Australia 13 11 26. New

land

phone

0800

POISON

(0800 764 766).

MATERIAL

SAFETY

DATA

SHEET

Further

information

on this

product

is contained in

material safety data sheet [MSDS) available

from

suppliers

manufacturer

NOTICE: The

information

contained,

representations made, in this

document

is based

data

ich,

best

knowledge, was accurate and reliable

time

preparation, however,

responsibility

will

be accepted by

Scotts Australia Pty Limited

errors

and/or

omissions. Users are advised

make

their

determination

suitability

this

information

relation

their

particular purpose

and/or

specific circumstances. Scotts Australia Pty

Limited

liable

any loss

damage

a result

any person acting

refraining

from

acting on any

recommendation

basis

information

contained

printed

this

document

EMERGENCY

INFORMATION

PANEL

DANGEROUS

GOODS

CLASS

product

classified

a Dangerous Good

Code

EMERGENCY

DIAL 000

POLICE

FIRE

GADE

SPECIALIST

ADVICE

EMERGENCY

ONLY

HOURS

1800 033 111.

APVMA Approval No.

31548/~

-5"1~3

NET WEIGHT ZZ.7kg

[Scotts logo)

Scotts Australia Pty Ltd.

31 003 123 162

lumbia Way, Baulkham Hills NSW 2153, Australia

Phone: (02} 8853 7300

: {02) 8853 7310

www.scottsaustra lia.com

2010. Registered to The Scotts Company,

world

rights reserved.

Scotts Product Code 900000

vl.O

DOM:

ROUT ORNAMENTAL HERBICIDE

Page 5

Text

above this line is

cluded

the label.

Rout Ornamental Herbicide

For pre-emergent weed control

weight 22.7kg*

Text below this line

cluded

e label

panels-

.7kg

20kg

only

Text above t

ne is not included in the label

Rout Ornamental Herbicide

22.7kg* pre-emergent herbicide

CAUTION:

-25kg. This product requires a

person

li f t

proper lifting techniques.

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FDA - U.S. Food and Drug Administration

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

17-12-2018

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Een betaalbare woonplek, voldoende kansen op een opleiding en een baan, financiële zelfredzaamheid en voldoende zorg en ondersteuning. Basisbehoeften voor ieder mens, maar waaraan de 10.700 zwerfjongeren (18 – 27 jaar) in Nederland nog te vaak tekortkomen. Op die vier ‘levensbrede’ prioriteiten zal de staatssecretaris zich richten met zijn actieprogramma Zwerfjongeren, dat hij afgelopen oktober in Tweede Kamer aankondigde. Met het actieprogramma brengt hij lokale partijen en gemeenten, maar ook andere ve...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

17-12-2018


Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Draft cabozantinib tablet 20 mg, 40 mg and 60 mg, capsule 20 4 mg and 80 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

17-12-2018


Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Draft ezetimibe tablet 10 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

December 10, 2018: Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

FDA - U.S. Food and Drug Administration

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Madrid, Spain, from 20/05/2019 to 22/05/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, Amsterdam, The Netherlands, from 08/04/2019 to 10/04/2019

Europe - EMA - European Medicines Agency

11-12-2018


The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

The new EudraVigilance system and the electronic reporting of individual case safety reports in the ISO/ICH E2B(R3) format: Hands-on training course, London, United Kingdom, from 11/02/2019 to 20/02/2019

Europe - EMA - European Medicines Agency

10-12-2018


Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Agenda - CHMP agenda of the 10-13 December 2018

Europe - EMA - European Medicines Agency

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

5-12-2018

Public health risks associated with food‐borne parasites

Public health risks associated with food‐borne parasites

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

Europe - EFSA - European Food Safety Authority Publications

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019

Consultation: Good Clinical Practice Inspections Program

Consultation: Good Clinical Practice Inspections Program

The TGA is seeking comments from interested parties on a pilot Good Clinical Practice (GCP) Inspections Program of 12 months duration that will inform a routine GCP Inspections Program. Closing date: 22 February 2019

Therapeutic Goods Administration - Australia

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

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

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

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

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency