NUGRASS

Main information

  • Trade name:
  • NUFARM NUGRASS SELECTIVE HERBICIDE
  • Pharmaceutical form:
  • Emulsifiable
  • Units in package:
  • 20L,55L,110L,200L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical

Documents

Localization

  • Available in:
  • NUFARM NUGRASS SELECTIVE HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BARLEY | BUFFALO GRASS LAWN OR TURF | CANOLA OILSEED CROP | CARPET GRASS LAWN OR TURF | CEREAL RYE | COMMON COUCH LAWN OR TURF |
  • Therapeutic area:
  • Group A Herbicide
  • Therapeutic indications:
  • ANNUAL OR WIMMERA RYEGRASS | COMMON BARB GRASS | CROWSFOOT GRASS | WILD OR BLACK OAT | CRAB GRASS | RIGID RYEGRASS | SPRING OAT | WIMMERA RYEGRASS
  • Product summary:
  • For post-emergent control of annual ryegrass, common barb grass and wild oats in wheat, linseed, peas and other crops and for the control of crowsfoot grass in turf.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 31671/0704
  • Authorization date:
  • 26-07-2004
  • Last update:
  • 15-06-2017

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

Nufarm Nugrass

20L, 55L, 110L, 200L label

Date: 15.06.04

Page

1 of

6

Selective Herbicide

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm

Nugrass

®

Selective Herbicide

ACTIVE CONSTITUENT: 375 g/L DICLOFOP-METHYL

SOLVENT: 534 g/L LIQUID HYDROCARBON

For post-emergent control of annual rye grass, common barb grass

and wild oats in wheat, linseed, peas and other crops

and for the control of Crowsfoot grass in turf as listed in the

Directions for Use table.

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE

USING THIS PRODUCT.

Contents: 20 Litres

55 Litres

110 Litres

200 Litres

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

® Nugrass is a registered trademark of Nufarm Australia Limited.

GROUP

HERBICIDE

A

Info

pest

Verified

Nufarm Nugrass

20L, 55L, 110L, 200L label

Date: 15.06.04

Page

2 of

6

Selective Herbicide

PROTECTION OF WILDLIFE, FISH,

CRUSTACEANS AND ENVIRONMENT.

DO NOT contaminate streams, rivers or waterways

with the chemical or used container.

STORAGE AND DISPOSAL

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 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 500mm

in a disposal pit specifically marked and set up for

this purpose clear of waterways, desirable vegetation

and tree roots. Empty containers and products should

not be burnt.

SAFETY DIRECTIONS

Will irritate the eyes and skin. Avoid contact with eyes

and skin. DO NOT inhale vapour. When opening the

container, preparing spray and using the prepared

spray, wear cotton overalls buttoned to the neck and

wrist and washable hat, elbow length PVC gloves and

goggles. If product in eyes, wash it out immediately

with water. Wash hands after use. After each day’s

use, wash gloves, goggles and contaminated

clothing.

FIRST AID

If poisoning occurs, contact a doctor or Poisons

Information Centre. Phone Australia 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.: 31671/20L/0704

APVMA Approval No.: 31671/55L/0704

APVMA Approval No.: 31671/110L/0704

APVMA Approval No.: 31671/200L/0704

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

Nufarm Nugrass

label leaflet

Date: 15.06.04

Page

3

of

6

Selective Herbicide

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm

Nugrass

®

Selective Herbicide

ACTIVE CONSTITUENT: 375 g/L DICLOFOP-METHYL

SOLVENT: 534 g/L LIQUID HYDROCARBON

For post-emergent control of annual rye grass, common barb grass

and wild oats in wheat, linseed, peas and other crops

and for the control of Crowsfoot grass in turf as listed in the

Directions for Use table.

READ THOROUGHLY BEFORE USING.

Contents: 20 Litres

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.: 31671/0704

® Nugrass is a registered trademark of Nufarm Australia Limited.

GROUP

HERBICIDE

A

Nufarm Nugrass

label leaflet

Date: 15.06.04

Page

4

of

6

Selective Herbicide

DIRECTIONS FOR USE:

RESTRAINTS: DO NOT apply if rainfall is expected within 2 hours.

DO NOT spray when temperatures are greater than 25˚C.

DO NOT apply to weeds or turf under stress due to, for example, very dry, very wet, nutrient deficient,

frosty or diseased conditions.

DO NOT use on rye-grass turf.

State

Weed

Stage

Rate

All States

NSW only

NSW, Vic, SA,

Tas, WA only

NSW only

All States

NSW, Vic, SA,

Tas, WA only

All States

All States

Tas only

Qld, NSW,

ACT only

2 - 4 leaf

2 - 4 leaf

2 - 4 leaf

2 - 4 leaf

2 - 3 leaf

3 - 4 leaf

2 - 3 leaf

3 - 4 leaf

2 - 4 leaf

2 - 4 leaf

See critical

comments

1L/ha

1.25L/ha

1L/ha

1.25L/ha

1.5L/ha

2L/ha

(not barley)

1.5L/ha

2L/ha

1L/ha

1.5 - 2L/ha

0.5 - 3L/ha

1L/ha or

100mL in

100L of water

per 1000m

1L/ha or 100

to 150mL in

100L of water

per 1000m

1 to 2.5L/ha

or 100 to

250mL in

100L of water

per 1000m

Crop

Weeds

Wheat, Linseed,

Triticale, Canola and

associated Oilseed

Rape, Safflower, Rye,

Barley

Lupins, Peas

Wheat, Linseed,

Triticale, Canola and

associated Oilseed

Rape, Safflower, Rye,

Barley

Lupins, Peas

Pasture, Legume

Seed Crops

Oilseed Poppies

Turf: kikuyu, hybrid

couch cv. Tifdwarf

Queensland blue

couch

Common couch,

Buffalo, Hybrid

couch cv. Tifway,

Carpet grass, Salt

couch

Annual

(Wimmera)

Rye Grass

Common

Barb Grass

Annual Rye

Grass

Common

Barb Grass

Wild Oats

Wild Oats

Annual Rye

Grass

Wild Oats

Wild Oats,

Annual Rye

Grass

(refer critical

comments)

Crowsfoot

grass

(Eleusine

indica)

Critical Comments

Apply generally 3-6 weeks after sowing, when

cereals usually 2-5 leaves.

For barley, apply only when crop is 4-5 leaf

stage. Add wetting agent to water in spray

tank – i.e. 150mL Activator/ 100L water. This

is irrespective of volume of water/ha or rate of

Nugrass. Do not add wetting agent if mixing

with some other sprays (refer compatibility).

For barley, apply only when crop is 4-5 leaf.

Avoid double spraying (overlap) at the

maximum rate of 1.5L/ha. In crops other than

barley, use 2L rate if most weeds 3-4 leaf and

if spraying 4-6 weeks after sowing, especially

in N. NSW and Qld.

Add wetting agent as above. Use 1.5L rate

only if growing conditions are very favourable

and weeds 2-3 leaf, 3-4 weeks after sowing,

and cereals usually 2-3 leaf.

Add wetting agent as above. Ensure thorough

coverage of weeds.

Do not add wetting agent. Apply in

accordance with recommendations made by

the Department of Primary Industry or the

poppy contracting company.

Apply to weeds between the seedling and

tillering stage for best results. Use lower rates

for seedlings and higher rates for established

grass weeds. A repeat spray may be needed

in 2 to 4 weeks.

Results are best when Nugrass is applied

under good growing conditions and weeds

have sufficient leaf area ie. 2 to 3 days after

mowing.

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 STOCKFEED FOR 7 WEEKS AFTER APPLICATION.

TURF: DO NOT ALLOW TREATED AREAS OR CLIPPINGS TO BE GRAZED BY OR FED TO

LIVESTOCK.

GENERAL INSTRUCTIONS

Results are best under good growing conditions, when the weeds are actively growing. Application

to weeds under stress eg. due to continuous severe frosts, dry and waterlogged conditions,

nutrient deficiency or disease should be avoided.

If spraying cannot be completed spray mixtures of Chipco Illoxan in clean water may be left

overnight without significant loss of efficacy. The mixture should be well agitated before spraying

re-commences. It is not recommended that this be general practice.

Nufarm Nugrass

label leaflet

Date: 15.06.04

Page

5

of

6

Selective Herbicide

GENERAL INSTRUCTIONS

Before opening, carefully read Directions for Use,

Precautionary Statements, Safety Directions and First

Aid Instructions.

Results are best under good growing conditions and

application to weeds under stress (eg. due to

continuous severe frost, dry or waterlogged

conditions) should be avoided. Wild oats germinating

after application will often be stunted and will not

seriously compete with the crop. Application to crops

with a covering of frost or dew has been successful

but should be avoided in general. Nugrass does not

affect undersown clovers or medics or other broadleaf

crops and has no activity against broadleaf weeds.

Current indications are that spray mixture may be left

overnight without loss of efficiency, if spraying cannot

be completed. However, it is not recommended that

this be general practice.

CROP SAFETY

Do not plant susceptible crops (eg. maize, sorghum,

rice) for 10 weeks after application.

APPLICATION

Aim to apply this product to base of weeds and

ensure penetration.

MIXING

Add the required quantity of this product directly to

the spray tank when about two-thirds full. Top up with

water to required volume, with agitators in motion.

Where wetting agents are recommended, add just

before tank is full of water to avoid excessive frothing.

EQUIPMENT

Ground Sprayers: Standard boom sprays only are

recommended and must be fitted with bypass or

mechanical agitation. It is recommended to use

approximately 50 to 150L water/ha and a droplet size

of 200-300 microns. DO NOT apply with boomless jets

or misters. With ground boom sprays, better coverage

and penetration may be obtained by setting nozzles at

45˚ angle forward, particularly in dense crops.

Knapsack Equipment: Nugrass should be applied at

label rates in adequate water to thoroughly wet

weeds being sprayed, ie. 5 to 10L/100m

Aircraft: Best results have been obtained using

20-30L water/ha with a steady cross wind and a

swath width of 15-18 metres. Aim for a droplet size

of 200-300 microns. DO NOT exaggerate swath

width. Aircraft operators should consult manufacturer

for details.

COMPATIBILITY

1. Nugrass may be tank mixed with Afalon

Bromoxynil, Bromoxynil + MCPA,

methabenzthiazuron

, Tigrex (max. 800mL/ha) or

MCPA LVE (max. 700mL/ha) for broadleaf weed

control in wheat and barley; and with Dimethoate,

Omethoate and Phosmet. DO NOT add wetting agent

to Afalon

, Bromoxynil or methabenzthiazuron

mixtures.

2. When mixing with bromoxynil + MCPA, Tigrex or

MCPA LVE add non-ionic surfactant at the rate

recommended on the label eg. Activator surfactant

at the rate of 150mL per 100L water. Some

reduction in grass weed control and speed of action

can be expected with these mixtures but to

minimise this, use a minimum of 80L water per ha

by ground and 30L by air, and if wild oats are

present, use 2.0L Nugrass/ha (except barley). DO

NOT use Bromoxynil + MCPA at rates above

1.4L/ha when mixing with Nugrass.

3. Nugrass and Du Pont Ally are physically

compatible but when this mixture is used a

significant reduction in grass weed control can be

expected. Add wetting agent to this mixture as for

Nugrass at recommended rates. Consult company

representatives for further advice.

4. Allow at least 10 days between any application of

Nugrass and other herbicides containing 2, 4-D,

MCPA, dicamba or other similar sprays, which

should preferably follow Nugrass.

5. For use in oilseed poppies in Tasmania only:

Nugrass may be mixed with pesticides as

recommended by the Department of Primary

Industry or the poppy contracting company.

6. Where Phalaris is present, Nugrass and Puma may

be applied together at the respective recommended

rates. Wetting agent should be added to this

mixture at the rate recommended on the Nugrass

label.

RESISTANT WEEDS WARNING

Nufarm Nugrass Selective Herbicide (“Nugrass”) is a

member of the Aryloxyphenoxypropionates (“Fops”)

group of herbicides. Nugrass has the inhibitors of acetyl

coA carboxylase mode of action. For weed resistance

management Nugrass is a Group A herbicide.

Some naturally occurring weed biotypes resistant to

Nugrass and other inhibitors of acetyl coA carboxylase

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 Nugrass or other

inhibitors of acetyl coA carboxylase 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 Nugrass to control resistant weeds.

PROTECTION OF CROPS, NATIVE AND OTHER

NON-TARGET PLANTS.

DO NOT apply under meteorological conditions or

from spraying equipment which could be expected to

cause spray to drift onto nearby susceptible plants,

adjacent crops, crop lands or pastures. Crops

particularly susceptible include maize, sorghum and

rice. DO NOT plant maize, sorghum and rice for 10

weeks after application.

PROTECTION OF WILDLIFE, FISH,

CRUSTACEANS AND ENVIRONMENT.

DO NOT contaminate streams, rivers or waterways

with the chemical or used container.

Nufarm Nugrass

label leaflet

Date: 15.06.04

Page

6

of

6

Selective Herbicide

STORAGE AND DISPOSAL

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 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 500mm

in a disposal pit specifically marked and set up for

this purpose clear of waterways, desirable vegetation

and tree roots. Empty containers and products should

not be burnt.

SAFETY DIRECTIONS

Will irritate the eyes and skin. Avoid contact with eyes

and skin. DO NOT inhale vapour. When opening the

container, preparing spray and using the prepared

spray, wear cotton overalls buttoned to the neck and

wrist and washable hat, elbow length PVC gloves and

goggles. If product in eyes, wash it out immediately

with water. Wash hands after use. After each day’s

use, wash gloves, goggles and contaminated

clothing.

FIRST AID

If poisoning occurs, contact a doctor or Poisons

Information Centre. Phone Australia 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.: 31671/0704

Hoegrass, Afalon and Puma are registered trademarks of Hoechst AG.

Tigrex is a registered trademark of Rhone-Poulenc Netherlands.

Ally is a registered trademark of E.I. DuPont de Nemours & Co. Inc.,

Wilmington, Delaware, USA.

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

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Europe - EMA - European Medicines Agency

22-11-2018


Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lymphocytic leukaemia, 06/12/2012, Withdrawn

Europe - EMA - European Medicines Agency

22-11-2018

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Active substance: (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) - Transfer of orphan designation - Commission Decision (2018)7813 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000001966

Europe -DG Health and Food Safety

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 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) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 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) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (IQVIA RDS Ireland Limited)

EU/3/18/2055 (Active substance: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate) - Orphan designation - Commission Decision (2018)5727 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/060/18

Europe -DG Health and Food Safety

6-8-2018

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Sanofi-Aventis groupe)

Insulin lispro Sanofi (Active substance: insulin lispro) - Centralised - Yearly update - Commission Decision (2018)5375 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/18/2019 (Reata UK Limited)

EU/3/18/2019 (Reata UK Limited)

EU/3/18/2019 (Active substance: Bardoxolone methyl) - Transfer of orphan designation - Commission Decision (2018)5055 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/18/T/01

Europe -DG Health and Food Safety

27-7-2018

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Pfizer Europe MA EEIG)

EU/3/06/401 (Active substance: N-methyl D-(2,3,4,5,6-pentahydroxy-hexyl)-ammonium; 2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylate) - Transfer of orphan designation - Commission Decision (2018)5038 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/06/T/03

Europe -DG Health and Food Safety

19-7-2018

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Reglntel Ltd)

EU/3/16/1783 (Active substance: N-(5-(6-chloro-2,2-difluorobenzo[d][1,3]dioxol-5-yl)pyrazin-2-yl)-2-fluoro-6-methylbenzamide) - Transfer of orphan designation - Commission Decision (2018)4810 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/138/16/T/02

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2029 (Klinikum der UniversitAt MUnchen)

EU/3/18/2029 (Klinikum der UniversitAt MUnchen)

EU/3/18/2029 (Active substance: 2-[(2S)-2-methyl-1,4-dioxa-8-azaspiro[4.5]dec-8-yl]-8-nitro-6-trifluoromethyl-4H-1,3-benzothiazin-4-one) - Orphan designation - Commission Decision (2018)4174 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/004/18

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

11-6-2018

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Gilead Sciences Ireland UC)

Harvoni (Active substance: ledipasvir/sofosbuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3759 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3850/T/67

Europe -DG Health and Food Safety

11-6-2018

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Novartis Europharm Limited)

Exforge HCT (Active substance: amlodipine besylate / valsartan / hydrochlorothiazide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3752 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1068/T/66

Europe -DG Health and Food Safety

11-6-2018

Dafiro (Novartis Europharm Limited)

Dafiro (Novartis Europharm Limited)

Dafiro (Active substance: amlodipine / valsartan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3753 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/776/T/99

Europe -DG Health and Food Safety

11-6-2018

Cerdelga (Genzyme Europe B.V.)

Cerdelga (Genzyme Europe B.V.)

Cerdelga (Active substance: eliglustat) - Centralised - 2-Monthly update - Commission Decision (2018)3754 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3724/II/15/G

Europe -DG Health and Food Safety

11-6-2018

TAGRISSO (AstraZeneca AB)

TAGRISSO (AstraZeneca AB)

TAGRISSO (Active substance: osimertinib) - Centralised - 2-Monthly update - Commission Decision (2018)3757 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4124/II/19

Europe -DG Health and Food Safety

11-6-2018

Pradaxa (Boehringer Ingelheim International GmbH)

Pradaxa (Boehringer Ingelheim International GmbH)

Pradaxa (Active substance: dabigatran etexilate mesilate) - Centralised - 2-Monthly update - Commission Decision (2018)3755 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/829/II/108

Europe -DG Health and Food Safety

11-6-2018

Quinsair (Chiesi Farmaceutici S.p.A.)

Quinsair (Chiesi Farmaceutici S.p.A.)

Quinsair (Active substance: levofloxacin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3756 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2789/T/16

Europe -DG Health and Food Safety

11-6-2018

Zykadia (Novartis Europharm Limited)

Zykadia (Novartis Europharm Limited)

Zykadia (Active substance: ceritinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3758 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3819/T/24

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Alnylam UK Limited)

EU/3/18/2026 (Active substance: Synthetic double-stranded siRNA oligonucleotide targeted against transthyretin mRNA, with six phosphorothioate linkages in the backbone, and nine 2'-fluoro and thirty-five 2'-O-methyl nucleoside residues in the sequence, which is covalently linked via a phosphodiester group to a ligand containing three N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)3394 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Pharma Gateway AB)

EU/3/18/2025 (Active substance: Modified mRNA encoding human methylmalonyl-coenzyme A mutase encapsulated into lipid nanoparticles) - Orphan designation - Commission Decision (2018)3393 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/017/18

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2019 (Dr Stefan Blesse)

EU/3/18/2019 (Dr Stefan Blesse)

EU/3/18/2019 (Active substance: Bardoxolone methyl) - Orphan designation - Commission Decision (2018)3386 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/18

Europe -DG Health and Food Safety

24-5-2018

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3265 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3755/R/27

Europe -DG Health and Food Safety

21-5-2018

EU/3/09/715 (Incyte Biosciences Distribution B.V.)

EU/3/09/715 (Incyte Biosciences Distribution B.V.)

EU/3/09/715 (Active substance: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]) - Transfer of orphan designation - Commission Decision (2018)3139 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/09/T/02

Europe -DG Health and Food Safety

21-5-2018

EU/3/09/716 (Incyte Biosciences Distribution B.V.)

EU/3/09/716 (Incyte Biosciences Distribution B.V.)

EU/3/09/716 (Active substance: Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]) - Transfer of orphan designation - Commission Decision (2018)3140 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/09/T/02

Europe -DG Health and Food Safety

18-5-2018

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Pharma Gateway AB)

EU/3/17/1936 (Active substance: 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea) - Transfer of orphan designation - Commission Decision (2018)3133 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/06/375 (Novartis Europharm Limited)

EU/3/06/375 (Novartis Europharm Limited)

EU/3/06/375 (Active substance: Nilotinib) - Transfer of orphan designation - Commission Decision (2018)3033 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/06/T/01

Europe -DG Health and Food Safety

3-4-2018

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (AbbVie Deutschland GmbH and Co. KG)

EU/3/12/1080 (Active substance: 4-(4-{[2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide) - Transfer of orphan designation - Commission Decision (2018)2056 of Tue, 03 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/124/12/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/14/1363 (IQVIA RDS Ireland Limited)

EU/3/14/1363 (IQVIA RDS Ireland Limited)

EU/3/14/1363 (Active substance: 4-[[(1S,4S)-5-[[4-[4-(oxazol-2-yl)phenoxy]phenyl]methyl]-2,5-diazabicyclo[2.2.1]hept-2-yl]methyl]benzoic acid) - Transfer of orphan designation - Commission Decision (2018)1818 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/14/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

Europe -DG Health and Food Safety