TRIFORINE ROSE FUNGICIDE

Main information

  • Trade name:
  • KENDON TRIFORINE ROSE FUNGICIDE
  • Pharmaceutical form:
  • Emulsifiable
  • Units in package:
  • 250mL,500mL,1L,5L,20L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • KENDON CHEMS & MNFG

Documents

Localization

  • Available in:
  • KENDON TRIFORINE ROSE FUNGICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ROSE | STURT'S DESERT ROSE
  • Therapeutic area:
  • Group 3 Fungicide
  • Therapeutic indications:
  • BLACK SPOT ON ROSE | POWDERY MILDEW ON ROSE | ROSE RUST
  • Product summary:
  • Controls black spot, powdery mildew and rust.DO NOT apply during abnormally hot, cold or slow drying conditions. DO NOT use a wetting agent as it may cause excessive run off.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 30517/0702
  • Authorization date:
  • 30-07-2002
  • Last update:
  • 15-06-2017

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

16/07/02

DIRECTIONS

FOR

USE

Page I

CAUTION

KEEP

OUTOF

REACH

OF

CHILDREN

READ

SAFETY

DIRECTIONS

BEFORE

OPENING

ORUSING

Kendon

Triforine

Rose

Fungicide

ACTIVE

CONSTITUENT'

199/L TRIFOR!NE

SOLVENT, 23.8g/L DIMETIIYL FORMAMIDE

GROUP

FUNGICIDE

Controls Black Spot

Powdery Mildew

&

Rust

CONTENTS:

5L / 20L

Kendon Chemical

&

Mnfg Co

71 McClure St, Thornbury Vic 3071

(03)94972822

AN AUSTRALIAN OWNED COMPANY EST 1950

N.R.A.

APPROVED

LABEL

(TEXT)

Label

~.':E~2i.?2.::.:::

Dale:

.

~Q..J

..

Q]::/.£\t,

Signature:."c;

DO NOT

apply during abnormally hot, cold, or slow

drying

conditions.

DONOT

use a

wetting

agent

as

it

may causeexcessive

run

off.

CROP

DISEASE

RATE

TO APPLY

Roses all types

Black Spot,

15mL per Litre

Apply at intervals

of?·1

0 days

Powdery Mildew,

afwater

for

as long as diseases

are

active

Rust

NOTTO BE

USED

FORANY

PURPOSE

OR IN ANY

MANNER

CONTRARY

TOTHIS

LABEL

UNLESS

AUTHORISED

UNDER

APPROPRIATELEGI~LATION

GENERAL

INSTRUCTIONS

MIXING:

Slowly add desired amount to water wbile stirring

MEmOD

OF

APPLICATION:

Spray

plants

to the point

of

run-off to

ensure

thorough

wetting

coverage.

COMPATIBILITY:

combined with either

Carbaryl,

or Pirimor

mixing with both or other

products

may

cause

serious

damage.

APPLY

PREPARED

MIXTURE

IMMEDIATELY

16/07/02 .

FUNGICIDERESISTANCE WARNING:

Page 2

GROUP

FUNGICIDE

Triforine is a member of the DMI group offungicides. For fungicide resistance management triforine is a Group C fungicide.

Some naturally occurring individual fungi resistant to triforine and other Group C fungicides may exist through normal

genetic variability

any fungal population. The resistant individuals can eventually dominate the fungi population

these

fungicides are used repeatedly. These resistant fungi

will

not be controlled by triforine and other Group C fungicides, thus

resulting

a reduction

efficacy and possible yield loss.

Since the occurrence

resistant

fungi

is difficult to detect Kendon Chemical

&

lvfNFG

Co Pty Ltd accepts no liability for

any losses that may result from failure oftriforine to control resistantfungi.

PROTECTION

WaDLIFE,

FISH,

CRUSTACEANS

ENVIRONMENT

CAUTION:

DO NOT

contaminate streams, rivers

waterways

with

the chemical or used containers.

STORAGE

DISPOSAL.-

Store

the closed original container in a cool, well ventilated area out of

direct sunlight. Triple or preferably pressure rinse containers before disposal. Add rinsings to spray tank.

Do not dispose

undiluted chemicals on site. Break, crush or puncture and bury empty containers below

500mm

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.

SAFETY

DIRECTIONS

Avoid contact

with

eyes and skin. Do not inhale spray mist. When preparing spray wear elbow length

PVC gloves and face shield.

product contacts with skin, immediately wash area

with

soap and water.

After use and before eating, drinking or smoking

wash

hands

arms

and face thoroughly with soap and

water. After each days use was gloves, face shield and contaminated clothing.

FIRST

poisoning occurs contact a doctor or Poisons Information Centre Ph.131126.

MATERIAL

SAFETY

DATA

SHEET

For further information refer to

Material Safety Data Sheet

Notice - This product as supplied

high

grade and believedto be suitable for any purpose for which it is expressly supplied

and must be used

accordance

with

the directions for use given on this label. No responsibility is accepted

respect of this

product, save those non excludable conditions implied

the TradePractices Act and any applicable State Legislation.

U.N.

No :

1993

HAZCHEM

2(Y)E

PACKAGINGGROUP

EMERGENCY PHONE

Police or

Fire

Brigade

Specialist Advice

Kendon Chemical

&

MFNG Co

(03) 94972822

Approval

30517/

070~t.-

16/07/02

Page 3

CAUTION

KEEP

our

OF

REACH

OF

CHILDREN

READ

SAFETY

DIRECTIONS

BEFORE

OPENING

OR

USING

Kendon

Triforine

Rose Fungicide

ACTIVE

CONSTITUENT:

199IL

TRlFORINE

SOLVENT:

23.8gIL

DIMETHYL FORMAMIDE

Controls

Black

Spot

Powdery Mildew

&

Rust

CONTENTS:

250mL / 500mL /

Kendon Chemical

&

Mnfg

72 McClure St, Thornbury Vic 3071

(03)94972822

AN

AUSTRALIAN

OWNED

COMPANY

EST1950

DO

NOT

apply

during

abnonna11y

hot,

cold, orslow

drying

conditions.

DONOT

use a wetting

agent

as

it

maycause excessive

run

CROP

DISEASE

RATE

TO APPLY

Roses all types

Black Spot,

15mL

Litre

Apply

at intervals

of7-10

days

PowderyMildew,

water

for as long as diseases are

active

Rust

NOTTO BE USEDFORANY

PURPOSE

DR INANY

MANNER

CONTRARY

TOTHISLABEL

UNLESS

AUTHORISED.

CAUTION:

DO

NOT

allow chemical

containers

or

spray

to

get into

drains,

sewers,

streams

orponds

HOW TO PREPARE

MIXING:

Slowly

desired amount to water while stirring

METHOD OF APPLICATION:

Spray plants

to the point

run-off to

ensure

thorough

wetting

and coverage.

COMPATIBILITY:

Maybe

combined

with

either

Carbaryl,

or

Pirimor

but

mixing

with

both

or

other

products

may cause serious

damage.

APPLY PREPARED

MIXTURE

IMMEDIATELY

16/07/02

Page

STORAGE AND

DISPOSAL.-

Store

the closed original container in a

cool,

place out

the reach of

children. Do not store

direct sunlight. Dispose

empty container by wrapping

paper, placing in

plastic bag and putting

garbage.

SAFETY DIRECTIONS

Avoid contact

with

eyes and skin. Do not inhale spray mist. After use and before eating,

drinking

smoking, wash hands, arms and face thoroughly

with

soap and water.

FIRST

poisoning occurs contact a doctor or Poisons Information Centre Ph. 131126.

Notice - This product as suppliedis of

high

grade and believed

be suitable for any purpose for

which

is expressly supplied

and mustbe used

accordance withthe directions for use given on this

label.

No responsibility is accepted

respectof

this

product, save those non excludable conditions

implied

by the Trade Practices Act and any applicable State Legislation.

U.N.

1993

HAZCHEM

2(Y)E

PACKAGING

GROUP

EMERGENCY PHONE

Police or Fire Brigade

Specialist Advice

Kendon Chemical

&

MFNG Co Pty Ltd

(03) 94972822

NRAApproval No:

30517/07o'L--

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Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

3-10-2018

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Sportminister Bruno Bruins brengt verrassingsbezoek aan Talent TeamNL in Buenos Aires

Van 6 tot 18 oktober wordt in Buenos Aires, Argentinië, de derde editie van de Jeugd Olympische Spelen gehouden. Toptalenten uit 206 landen tussen de 15 en 18 jaar oud doen hieraan mee. Talent TeamNL bestaat uit 41 sporters die uitkomen in  19 disciplines. Minister voor Sport Bruno Bruins bracht vandaag een verrassingsbezoek aan de Nederlandse ploeg. Hij bezocht het Olympisch Dorp waar de talenten onder leiding van Chef de Mission Mark Huizinga zich voorbereiden op de Spelen die zaterdag beginnen. 

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

September 19, 2018: Springfield Doctor Sentenced for Illegally Sharing Patient Medical Files

FDA - U.S. Food and Drug Administration

19-9-2018

Enforcement Report for the Week of September 19, 2018

Enforcement Report for the Week of September 19, 2018

Recently Updated Records for the Week of September 19, 2018 Last Modified Date: Tuesday, September 18, 2018

FDA - U.S. Food and Drug Administration

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

3-1-2019

South Australian man faces criminal charges for dealing with counterfeit and unapproved medicines

South Australian man faces criminal charges for dealing with counterfeit and unapproved medicines

Dealing countefeit and unapproved medicines is a serious offence as shown in recent TGA prosecution outcome in South Australia

Therapeutic Goods Administration - Australia

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

Perlinring and associated names

Perlinring and associated names

Perlinring and associated names (Active substance: etonogestrel/ethinylestradiol) - Community Referrals - Art 29 - Commission Decision (2018)9141 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1473

Europe -DG Health and Food Safety

12-12-2018

TGA operations over the holiday period 2018-19

TGA operations over the holiday period 2018-19

The TGA will have limited operations from Monday 24 December 2018 until Wednesday 2 January 2018

Therapeutic Goods Administration - Australia

30-11-2018

Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

Public submissions on scheduling matters referred to the ACMS #24 and Joint ACMS-ACCS #19 meetings held in June 2018

Public submissions on the delegate's interim decision for alkyl nitrites

Therapeutic Goods Administration - Australia

26-11-2018

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Pfizer Europe MA EEIG)

Levetiracetam Hospira (Active substance: levetiracetam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7985 of Mon, 26 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2783/T/19

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Opinion/decision on a Paediatric investigation plan (PIP): Velphoro,Sucroferric oxyhydroxide (mixture of iron (III)-oxyhydroxide, sucrose, starch) (PA21), decision type: , therapeutic area: , PIP number: P/0196/2018

Europe - EMA - European Medicines Agency

22-11-2018

Brintellix (H. Lundbeck A/S)

Brintellix (H. Lundbeck A/S)

Brintellix (Active substance: vortioxetine) - Centralised - Renewal - Commission Decision (2018)7896 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2717/R/19

Europe -DG Health and Food Safety

22-10-2018

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Vifor Fresenius Medical Care Renal Pharma France)

Velphoro (Active substance: mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) - Centralised - Yearly update - Commission Decision (2018)6972 of Mon, 22 Oct 2018

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

2-10-2018

Uptravi (Janssen-Cilag International NV)

Uptravi (Janssen-Cilag International NV)

Uptravi (Active substance: selexipag) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6470 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3774/T/19

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

19-9-2018

Ilumetri (Almirall, S.A.)

Ilumetri (Almirall, S.A.)

Ilumetri (Active substance: tildrakizumab) - Centralised - Authorisation - Commission Decision (2018)6106 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4514

Europe -DG Health and Food Safety

19-9-2018

Hulio (Mylan S.A.S.)

Hulio (Mylan S.A.S.)

Hulio (Active substance: adalimumab) - Centralised - Authorisation - Commission Decision (2018)6107 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004429/0000

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

19-9-2018

Fortacin (Recordati Ireland Ltd)

Fortacin (Recordati Ireland Ltd)

Fortacin (Active substance: lidocaine / prilocaine) - Centralised - Renewal - Commission Decision (2018)6103 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2693/R/23

Europe -DG Health and Food Safety

19-9-2018

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Eli Lilly Nederland B.V.)

Lartruvo (Active substance: olaratumab) - Centralised - Annual renewal - Commission Decision (2018)6105 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4216/R/10

Europe -DG Health and Food Safety

19-9-2018

Stelara (Janssen-Cilag International NV)

Stelara (Janssen-Cilag International NV)

Stelara (Active substance: ustekinumab) - PSUSA - Modification - Commission Decision (2018)6102 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/00003085/201712

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

CRYSVITA (Kyowa Kirin Holdings B.V.)

CRYSVITA (Kyowa Kirin Holdings B.V.)

CRYSVITA (Active substance: Burosumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6096 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4275/T/01

Europe -DG Health and Food Safety

19-9-2018

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Mylan S.A.S.)

Memantine Mylan (Active substance: Memantine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5972 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2660/T/12

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency