PROBAN

Main information

  • Trade name:
  • PROBAN SYSTEMIC INSECTICIDE
  • Pharmaceutical form:
  • ORAL TABLET
  • Units in package:
  • 50Tab,100Tab
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PROBAN SYSTEMIC INSECTICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
  • Therapeutic area:
  • Insecticide
  • Therapeutic indications:
  • DEMODECTIC MANGE | FLEA | PARALYSIS TICK | AUSTRALIAN PARALYSIS TICK | CTENOCEPHALIDES SPP. | GROUND FLEAS | SCRUB TICK
  • Product summary:
  • For the control of fleas on dogs and cats, demodectic mange of dogs and as an aid in the control of tick paralysis/scrub tick (Ixodes holocyclus - not in WA).Do not give to animals that are sick, pregnant, lactating, undergoing treatment with other organophosphates or recovering from surgery.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 35952/0807
  • Authorization date:
  • 13-11-2007
  • Last update:
  • 15-06-2017

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

APVMA 35952/50tab/0807

APVMA 35952/50tab/0807

Store below 25°C (Air Conditioning)

Store below 25°C (Air Conditioning)

L03-076

L03-076

Batch No.

Batch No.

Expiry Date:

Expiry Date:

READ THE ENCLOSED LEAFLET BEFORE USE

DIRECTIONS FOR USE:

This product is contraindicated in animals

that are sick, pregnant, lactating, undergoing

treatment with other organophosphates,

or recovering from surgery.

DOGS: For flea control and the treatment of

demodectic mange: One

One Proban

Proban

tablet

tablet

mouth

mouth for

every

every 10

10 kg

kg bodyweight

bodyweight

twice

twice

a week.

week.

As fleas

fleas

thrive

thrive and

and breed

breed most

most

rapidly

rapidly in

in aa

warm

environment

environment treatment

treatment

should

should

be commenced

commenced

the temperature

temperature starts

starts

wwarmer

armer

and be

continuous

continuous until

until the

cooler

cooler

weathe

weather

r.. T

animal

animal

environment

environment whether

whether kkept

ept inside

inside or

or outside

outside

shoul

should

be treated

treated with

with

appropriate

appropriate insecticid

insecticidee.

For control of paralysis/scrub tick

(Ixodes

holocyclus)

on dogs: 3

3 mg/kg

mg/kg (one

(one

tablet/

tablet/

10kg)

10kg)

bodyweight

bodyweight given

given on

alternate

alternate day

dayss.. T

Treatment

reatment to

be continued

continued through

through

the tick

tick

season

season.. Daily

Daily

searching

searching of

of dogs

dogs for

ticks

ticks and

and their

their remo

removval

al is

recommended

recommended.

. Dogs

Dogs must

must

be accurately

accurately weighed

weighed

and dosed

dosed

according

according

to the

dosage

dosage schedul

schedule

Puppies

Puppies

weight

weight dogs

dogs (under

(under 10kg)

10kg)

more

more susceptible

susceptible to

tick

tick

paralysi

paralysiss,, accurate

accurate dosing

dosing

and daily

daily searching

searching

ticks

ticks

is recommended.

recommended.

CATS: For flea control: One

One quarter

quarter tablet

tablet by

mouth

mouth for

every

every 55 kg

bodyweight

bodyweight

twice

twice

a week.

week.

NOT TO BE USED FOR ANY PURPOSE,

OR IN ANY MANNER, CONTRARY TO THIS

LABEL UNLESS AUTHORISED UNDER

APPROPRIATE LEGISLATION.

FIRST AID: If

If poisoning

poisoning

occur

occurss,, contact

contact aa

doctor

doctor or

or PPoisons

oisons Information

Information Centr

Centree..

Phone

Phone Australia

Australia 131

131 126.

126.

DISPOSAL: Dispose

Dispose of

of empty

empty container

container by

wrapping

wrapping with

with paper

paper and

and putting

putting in

in garbag

garbagee..

Distributed

Distributed by

Boehringer Ingelheim Pty Limited

Vetmedica

etmedica Division

Division

85 WWaterloo

aterloo Road

Road

NORRTH

TH RRYDE

YDE NSW

NSW 2113

2113

SYSTEMIC INSECTICIDE

ACTIVE

ACTIVE CONSTITUENT

CONSTITUENT

TABLET

TABLET CYTHIOATE

CYTHIOATE 30

30 mg

(AN ANTICHOLINESTERASE COMPOUND)

S

T

E

L

B

A

T

control

control o

fflea

leas

s on

on ddooggs

s aan

d cca

demodectic

demodectic

mange

mange

of dogs

dogs

and as

aidd

control

control

of tick

tick paralysis/scrub

paralysis/scrub

tick

tick

(Ixodes

(Ixodes holocyclus)

holocyclus)

Ixodes

Ixodes holocyclus

holocyclus

ticks

ticks

occur

occur in

Western

Western Australia.

Australia.

CAUTION

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

SYSTEMIC INSECTICIDE

ACTIVE

ACTIVE CONSTITUENT

CONSTITUENT

PER TABLET

TABLET CYTHIOATE

CYTHIOATE 30

30 mg

(AN ANTICHOLINESTERASE COMPOUND)

S

T

E

L

B

A

T

For the

the control

control oof

f fflea

leas

on d

doog

gss aanndd ccaats

demodectic

demodectic mange

mange of

dogs

dogs and

as an

an ai

control

control of

tick

tick paralysis/scrub

paralysis/scrub

tick

tick

(Ixodes

(Ixodes holocyclus)

holocyclus)

Ixodes

Ixodes

holocyclus

holocyclus

ticks

ticks do

do not

occur

occur in

in Western

Western

Australia.

Australia.

Die line

CMYK

PMS 375

w/t: 74554

date: 09/10/07

artist: James

file name: Proban 50 tablets Carton

size: 156 x 156.5mm

notes

date

c l

i

e n t

u s e

labelcraft

phone 9550 0999

fax 9550 9734

please

proof

carefully,

errors

overlooked

become

client’s

l i a b i l i t y

E-mail check & Alts artwork: 05/10/07

Alts artwork: 09/10/07

APPROVED

LABEL

Info

pest

Verified

APVMA

APVMA 35952/100tab/0807

35952/100tab/0807

Store

Store below

below 25°C

25°C (Air

(Air Conditioning)

Conditioning)

L03-076

L03-076

Batch

Batch NNoo..

Expiry

Expiry Date:

Date:

NOT TO BE USED FOR ANY PURPOSE,

OR IN ANY MANNER, CONTRARY TO THIS

LABEL UNLESS AUTHORISED UNDER

APPROPRIATE LEGISLATION.

FIRST AID: If

If poisoning

poisoning occur

occurss,, contact

contact aa

doctor

doctor or

or PPoisons

oisons Information

Information Centr

Centree..

Phone

Phone Australia

Australia 131

131 126.

126.

DISPOSAL: Dispose

Dispose of

of empty

empty container

container by

wrapping

wrapping with

with paper

paper and

and putting

putting in

in garbag

garbagee..

Distributed

Distributed by

Boehringer Ingelheim Pty Limited

Vetmedica

etmedica Division

Division

85 WWaterloo

aterloo Road

Road

NORRTH

TH RRYDE

YDE NSW

NSW 2113

2113

READ THE ENCLOSED LEAFLET BEFORE USE

DIRECTIONS FOR USE:

This product is contraindicated in animals

that are sick, pregnant, lactating, undergoing

treatment with other organophosphates,

or recovering from surgery.

DOGS: For flea control and the treatment of

demodectic mange: One

One Proban

Proban tablet

tablet by

mouth

mouth for

for every

every 10

10 kg

kg bodyweight

bodyweight twice

twice aa week.

week.

As fleas

fleas thrive

thrive and

and breed

breed most

most rapidly

rapidly in

in aa wwarm

environment

environment treatment

treatment should

should be

be commenced

commenced as

the temperature

temperature starts

starts to

to get

get wwarmer

armer and

and be

continuous

continuous until

until the

the cooler

cooler weathe

weatherr.. TThe

he animal

animal

eennvir

viroonme

nmenntt wwhhet

ethher

er kkept

ept in

insside

ide or

or ooutside

utside sshhoul

ouldd

be treated

treated with

with the

the appropriate

appropriate insecticid

insecticidee..

For control of paralysis/scrub tick

(Ixodes

holocyclus)

on dogs: 3

3 mg/kg

mg/kg (one

(one tablet/

tablet/ 10kg)

10kg)

bodyweight

bodyweight given

given on

on alternate

alternate day

dayss.. TTreatment

reatment to

be continued

continued through

through the

the tick

tick season

season.. Daily

Daily

searching

searching of

of dogs

dogs for

for ticks

ticks and

and their

their remo

removval

al is

recommended

recommended.. Dogs

Dogs must

must be

be accurately

accurately weighed

weighed

and dosed

dosed according

according to

to the

the dosage

dosage schedul

schedulee..

Puppies

Puppies and

and low

low weight

weight dogs

dogs (under

(under 10kg)

10kg) are

more

more susceptible

susceptible to

to tick

tick paralysi

paralysiss,, accurate

accurate dosing

dosing

and daily

daily searching

searching for

for ticks

ticks is

is recommended.

recommended.

CATS: For flea control: One

One quarter

quarter tablet

tablet by

mouth

mouth for

for every

every 55 kg

kg bodyweight

bodyweight twice

twice aa week.

week.

SYSTEMIC INSECTICIDE

ACTIVE CONSTITUENT

ACTIVE CONSTITUENT

PER TABLET CYTHIOATE 30 mg

PER TABLET CYTHIOATE 30 mg

(AN ANTICHOLINESTERASE COMPOUND)

S

T

E

L

B

A

T

For the control of fleas on dogs and cats,

For the control of fleas on dogs and cats,

demodectic mange of dogs and as an aid

demodectic mange of dogs and as an aid

in the control of tick paralysis/scrub tick

in the control of tick paralysis/scrub tick

(Ixodes

(Ixodes holocyclus)

holocyclus)

Ixodes holocyclus

Ixodes holocyclus

ticks do not occur in Western Australia.

ticks do not occur in Western Australia.

SYSTEMIC INSECTICIDE

ACTIVE CONSTITUENT

ACTIVE CONSTITUENT

PER TABLET CYTHIOATE 30 mg

PER TABLET CYTHIOATE 30 mg

(AN ANTICHOLINESTERASE COMPOUND)

S

T

E

L

B

A

T

For the control of fleas on dogs and cats,

For the control of fleas on dogs and cats,

demodectic mange of dogs and as an aid

demodectic mange of dogs and as an aid

in the control of tick paralysis/scrub tick

in the control of tick paralysis/scrub tick

(Ixodes

(Ixodes holocyclus)

holocyclus)

Ixodes holocyclus

Ixodes holocyclus

ticks do not occur in Western Australia.

ticks do not occur in Western Australia.

CAUTION

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Die line

CMYK

PMS 375

w/t: 74554

date: 09/10/07

artist: James

E-mail check & Alts artwork: 05/10/07

E-mail check & Alts artwork: 09/10/07

file name: Proban 100 Tabs Carton

size: 193.5 x 187.5 mm (78.5 x 44.5 x 44.5 mm)

notes

date

c l

i

e n t

u s e

labelcraft

phone 9550 0999

fax 9550 9734

please

proof

carefully,

errors

overlooked

become

client’s

l i a b i l i t y

APPROVED

LABEL

Date:

Page 1 of 3

PROBAN TABS

35952

25.6.2002

BOTTLE

LABEL

CAUTION

KEEP

REACH

CHILDREN

ANIMAL

TREATMENT

ONLY

PROBAN

SYSTEMIC

INSECTICIDE

ACTIVE

CONSTITUENT

TABLET

CYTHIOATE

ANllCHOLINESTERASE

COMPOUND)

For the control

of fleas on dogs and cats.

demodectic

mange

of dogs and as an aid in the control

of tick

paralysis/scrub tick

(Ixodes ho/ocye/us).

Ixodes ho/ocye/us

ticks do not

occur

Western

Australia.

50/100 tablets

READ

ENCLOSED

LEAFLET

BEFORE

DIREcnONS

FOR USE

give

animals

that

sick,

pregnant,

lactating,

undergoing

treatment

with

other

organophosphates,

recovering

from

surgery.

DOGS:

flea

control

treatment

demodectlc

mange:

One Proban tablet by mouth for every 10 kg

bodyweight twice a week.

control

paralysis/scrub

tick

(Ixodes

holocyclus)

dogs:

mglkg

(one tablet/1 Okg) bodyweight given on

alternate days.

Treatment to be continued through the

tick

season.

CATS

flea

control:

One quarter tablet by mouth

every

kg bodyweight twice a week.

NOT TO

USED

PURPOSE, OR IN

MANNER,

CONTRARY

THiS

LABEL

UNLESS

AUTHORISED

UNDER

APPROPRIATE

LEGISLATION.

FIRST

If poisoning occurs, contact a doctor or Poisons Information Centre.

Phone Australia 131126.

DISPOSAL

Dispose of

empty container by wrapping with paper and putting in garbage.

Boehringer Ingelheim Pty Umited

Vetmedica Division

Waterloo Road

NORTH

RYDE

2113

Store

below

25°C

(Air

Conditioning)

35952/

0

L

Batch

Expiry Date:

APPROVED

LABEL

JTEXT)

Label

~.?:J.?6JP~(}6

....

·\:2:~

Page 3 of 3

PROBAN TABS

NRA35952

25.6.2002

PACKAGING INSERT

CAUTION

KEEP OUT OF REACH OF CHILOREN

FOR ANIMAL

TREATMENT

ONLY

PROBAN

SYSTEMIC INSECTICIDE

ACTIVE CONSTITUENT PER TABLET

CYTHIOATE 30

(AN ANTICHOLINESTIERASE COMPOUND)

For the control

of fleas on dogs and cats,

demodectic mange of dogs and as an aid

in the control

of tick

paralysis/scrub

tick

(Ixodes holocyclus).

Ixodes hoJocyclus

ticks do not occur in Western Australia.

50/100 tablets

DIRECTIONS FOR USE

DO NOT

give

animals

that

sick,

pregnant,

lactating,

undergoing

treatment

with

other

organophosphates,

recovering

from

surgery.

DOGS:

For flea

control

treatment

demodectic

mange:

One Proban tablet

by mouth for every 10 kg

bodyweight

twice a week.

fleas thrive and breed most

rapidly in a warm environment treatment should be

commenced as the temperature starts to get

warmer and be continuous until

the cooler weather.

The animal

environment whether kept

inside or outside should be treated with the appropriate insecticide.

control

paralysis/scrub

tick

(Ixodes

holocyclus)

dogs:

3 mWkg (one tableV10kg)

bodyweight given on

alternate days.

Treatment to be continued through the tick season.

Daily searching of

dogs for ticks and their

removal

is recommended.

Dogs must

be accurately weighed and dosed according to the dosage schedule.

Puppies and low weight

dogs (under 10kg) are more susceptible to tick paralysis,

accurate dosing and daily

searching for ticks is recommended.

CATS:

flea

control:

One quarter tablet

by mouth for every 5 kg bodyweight twice a week.

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

LABEL

UNLESS

AUTHORISED UNDER APPROPRIATIE LEGISLATION.

FIRST AID

If poisoning occurs,

contact a doctor or Poisons Information Centre.

Phone Australia 131126.

DISPOSAL

Dispose of empty container by wrapping with paper and putting in garbage.

Boehringer Ingelheim

Limited

Vetmedica Division

85 Waterloo Road

NORTH RYDE

NSW 2113

Store below 25°C (Air Conditioning)

35952/

GCJ2...

y.

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Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

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

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

6-8-2018

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC Recalls Pat's Cat Turkey, and Ground Lamb Pet Food, because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling 30 1-lb containers of Pat's Cat Turkey Cat Food and 40 2-lb containers of Ground Lamb Dog Food because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in animals eating the products.

FDA - U.S. Food and Drug Administration

31-7-2018

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

FDA - U.S. Food and Drug Administration

19-12-2018

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar:  https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDApic.twitter.com/sHElqFFODy

Join us on January 17, 2019 from 1-2:30 PM EST for a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers. Find out more about the webinar: https://go.usa.gov/xExHX  #MedicalDevice #FDA pic.twitter.com/sHElqFFODy

FDA - U.S. Food and Drug Administration

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Orphan designation: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate (Alirinetide), Treatment of amyotrophic lateral sclerosis, 30/05/2016, Positive

Europe - EMA - European Medicines Agency

30-11-2018

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2018)8149 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8159 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Keppra (UCB Pharma S.A.)

Keppra (UCB Pharma S.A.)

Keppra (Active substance: levetiracetam) - Centralised - Yearly update - Commission Decision (2018)8160 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Teva B.V.)

Pioglitazone Teva Pharma (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8158 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

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

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: 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) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

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

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration

30-8-2018

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Merck Sharp and Dohme B.V.)

Steglatro (Active substance: ertugliflozin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5789 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4315/T/2

Europe -DG Health and Food Safety

30-8-2018

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (AstraZeneca AB)

Fluenz Tetra (Active substance: influenza vaccine (live attenuated, nasal)) - Centralised - Variation - Commission Decision (2018)5815 of Thu, 30 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2617/II/82

Europe -DG Health and Food Safety

3-8-2018

Scandonest and associated names

Scandonest and associated names

Scandonest and associated names (Active substance: mepivacaine) - Community Referrals - Art 30 - Commission Decision (2018)5380 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-30/1455

Europe -DG Health and Food Safety

1-8-2018

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Merck Sharp and Dohme B.V.)

Bridion (Active substance: sugammadex) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5213 of Wed, 01 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/885/T/30

Europe -DG Health and Food Safety

30-7-2018

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Cycle Pharmaceuticals Ltd)

Nityr (Active substance: nitisinone) - Centralised - Authorisation - Commission Decision (2018)5446 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4582

Europe -DG Health and Food Safety

30-7-2018

Esmya (Gedeon Richter Plc.)

Esmya (Gedeon Richter Plc.)

Esmya (Active substance: ulipristal) - Referral - Commission Decision (2018)5101 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2041/A-20

Europe -DG Health and Food Safety