CLOUT-S

Main information

  • Trade name:
  • COOPERS CLOUT-S BACKLINE LICE TREATMENT
  • Pharmaceutical form:
  • TOPICAL SOLUTION/SUSPENSION
  • Units in package:
  • 2L, 5L, 20L, 25L
  • Class:
  • Veterinary Pesticide
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • COOPERS CLOUT-S BACKLINE LICE TREATMENT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • GOAT NON LACTATING DAIRY | SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER
  • Therapeutic area:
  • Group 3A Insecticide
  • Therapeutic indications:
  • COMMON GOAT LOUSE | GOATSUCKING LOUSE | SHEEP BODY LOUSE | DAMALINIA CAPRAE (OLD NAME) | DAMALINIA OVIS (PREV. GENUS) | LICE - SYNTHETIC PYRETHROID RE | SHEEP BODY LICE
  • Product summary:
  • Controls pyrethroid susceptible body lice on sheep off-shears and pyrethroid susceptible lice on goats.See RESTRAINTS etc. on label.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36340/0614
  • Authorization date:
  • 10-07-2014
  • Last update:
  • 15-06-2017

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

File Name:

Clout-S 36340 RLP changes

highlighted V1 – 8May14

Prepared By:

L. Wirth

Preparation Date:

08/05/2014

Last Revised:

18/08/2010

Intervet/MSD Animal Health Specification

Version:

(08/05/2014)

Page 1 of 4

CLOUT-S – IMMEDIATE CONTAINER LABELS

2L, 5L, 20L, 25L (MAIN PANEL)

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

FOR ANIMAL TREATMENT ONLY

Coopers®

CLOUT

®

-S

BACKLINE LICE TREATMENT

ACTIVE CONSTITUENT:

10 g/L DELTAMETHRIN

Controls pyrethroid susceptible

body lice on sheep off-shears

and pyrethroid susceptible lice on goats.

2 Litres

[5 Litres

20 Litres

25 Litres]

READ DIRECTIONS FOR USE BEFORE OPENING OR USING THIS PRODUCT.

RLP

APPROVED

File Name:

Clout-S 36340 RLP changes

highlighted V1 – 8May14

Prepared By:

L. Wirth

Preparation Date:

08/05/2014

Last Revised:

18/08/2010

Intervet/MSD Animal Health Specification

Version:

(08/05/2014)

Page 2 of 4

CLOUT-S – IMMEDIATE CONTAINER LABELS

2L, 5L, 20L, 25L (BACK PANEL)

Coopers®

CLOUT

-S

Backline Lice Treatment

CLAIMS

Controls pyrethroid susceptible body lice (Bovicola ovis) on sheep off-shears. Control of lice on sheep is

achieved in up to 6 weeks.

Controls pyrethroid susceptible biting lice (Bovicola caprae) and sucking lice (Linognathus stenopsis) on

goats.

DIRECTIONS FOR USE

RESTRAINTS:

Must only be used within 24 hours after shearing.

DO NOT treat ewes less than 6 weeks before lambing commences, as live lice can persist and

infect the lambs

DO NOT treat lambing ewes or ewes with lambs at foot.

DO NOT mix treated sheep with untreated sheep until 6 weeks after treatment.

DO NOT USE on sheep which have not been cleanly shorn for any reason eg. mycotic dermatitis.

DO NOT USE on female sheep or goats which are producing or may in the future produce milk or

milk products for human consumption.

Dose: 2mL per 10kg liveweight.

Always dose on a liveweight basis. Dose the mob to the heaviest animal by liveweight in each group

(ewes, rams, lambs), do not underdose. The heaviest animals in each group should be weighed.

Check the accuracy of equipment before and during treatment.

Pests

Controlled

Rate

Live

Bodyweight

Critical Comments

Pack

Treats

Pack

Treats

Pack

Treats

Pack

Treats

Sheep

Goats

(not

lactating

dairy

goats)

Body Lice

(Bovicola ovis)

Biting Lice

(Bovicola caprae)

Sucking Lice

(Linognathus

stenopsis)

10mL

12mL

14mL

16mL

Up to 10 kg

11 to 20 kg

21 to 30 kg

31 to 40 kg

41 to 50 kg

51 to 60 kg

61 to 70 kg

71 to 80 kg

Apply to animals in race or

small yard along the

backline using the

recommended applicator

Treatment of sheep must

be carried out within 24

hours of shearing

1,000

2,500

1,250

10,000

5,000

3,333

2,500

2,000

1,666

1,428

1,250

12,500

6,250

4,166

3,125

2,500

2,083

1,785

1,562

2L

5L

20L

25L

NOTE: SEPARATE REAR PANEL

LABELS SHOW REQUIRED PACK

TREAT ONLY FOR EACH PACK

SIZE

Sheep in excess of 80 kg should be treated at the rate of 2 mL per 10 kg bodyweight.

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

UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

WITHHOLDING PERIODS

MEAT : DO NOT USE less than 3 days before slaughter for human consumption.

MILK : DO NOT USE on female sheep or goats which are producing or may in the future produce

milk or milk products for human consumption.

WOOL HARVEST INTERVAL: DO NOT use less than 2 months before shearing or fibre collection.

File Name:

Clout-S 36340 RLP changes

highlighted V1 – 8May14

Prepared By:

L. Wirth

Preparation Date:

08/05/2014

Last Revised:

18/08/2010

Intervet/MSD Animal Health Specification

Version:

(08/05/2014)

Page 3 of 4

CLOUT-S – IMMEDIATE CONTAINER LABELS

2L, 5L, 20L, 25L (BACK PANEL) (continued)

TRADE ADVICE:

EXPORT SLAUGHTER INTERVAL (ESI): SHEEP: DO NOT USE less than 14 days before slaughter

for export. The ESI on this label was correct at the time of label approval. Before using this product,

confirm

current

from

manufacturer

APVMA

website

(www.apvma.gov.au/residues).

Use of this product may result in wool residues that may not comply with European Union environmental

quality standards.

Wool treated with this product may contain detectable residues; adequate treatment records should be

kept and made available, if requested by wool buyers.

GENERAL INSTRUCTIONS

Shake well before use - Replace cap firmly after each use.

Apply a single treatment of ready to use CLOUT-S to control lice on sheep within 24 hours of shearing

and goats at any time. Goats need not be shorn.

To avoid operator insecticide contact when concurrent treatments are carried out, CLOUT-S should be

applied last.

This product should only be applied through the recommended applicator.

Apply along midline from poll to tail. Do not deviate from the spine.

[DIAGRAM

OF

SHEEP]

A scourable red marker dye is included in the product for specific

identification of treated animals.

For further information contact Coopers Customer Service on 1-800-226-511.

PROTECTION OF WILDLIFE, FISH, CRUSTACEA AND ENVIRONMENT

Dangerous to fish. Do not contaminate dams, rivers or streams with the pesticide or used containers.

SAFETY DIRECTIONS

Product is poisonous if swallowed. May irritate the eyes and skin. Facial skin contact may

cause temporary facial numbness. Avoid contact with eyes and skin. When using the product

wear elbow length PVC gloves. If product on 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 wash gloves.

ADDITIONAL USER SAFETY INFORMATION

Sheep Rehandling Interval: Two weeks. If sheep must be handled during this interval, cotton overalls

buttoned to the neck and wrist (or equivalent clothing) should be worn.

Additional Information is listed in the Material Safety Data Sheet.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (Phone 131126).

CLOUT-S – IMMEDIATE CONTAINER LABELS

2L, 5L, 20L, 25L (BACK PANEL) (continued)

SPECIALIST ADVICE IN EMERGENCY ONLY

COOPERS ANIMAL HEALTH

Intervet Australia Pty Limited

1 800 226 511

ALL HOURS - AUSTRALIA WIDE

DRUM

MUSTER

ELIGIBLE

CONTAINER

File Name:

Clout-S 36340 RLP changes

highlighted V1 – 8May14

Prepared By:

L. Wirth

Preparation Date:

08/05/2014

Last Revised:

18/08/2010

Intervet/MSD Animal Health Specification

Version:

(08/05/2014)

Page 4 of 4

WARRANTY

Intervet Australia Pty Limited (IAPL), known as MSD Animal Health, warrants that this product is of

merchantable

quality

intended

purpose.

IAPL’s

liability

loss,

including

consequential losses or injury caused by any act or omission, including negligent acts or omissions,

by IAPL or its agent, is limited to replacing or repairing the product at the option of IAPL. If possible, a

sample of any product causing concern should be retained or delivered to IAPL within 30 days for a

scientific examination.

DISPOSAL

This container can be recycled if it is clean, dry, free of visible residues and has the drumMUSTER

logo visible. Triple or pressure rinse container for disposal. Dispose of rinsate or any undiluted

chemical according to State legislative requirements. Wash outside of the container and the cap.

Store cleaned container in a sheltered place with cap removed. It will then be acceptable for

recycling at any drumMUSTER collection or similar container management program site. The cap

should not be replaced but may be taken separately.

COOPERS ANIMAL HEALTH

Intervet Australia Pty Limited

91-105 Harpin Street, Bendigo East VIC 3550

STORE below 30

C (Room Temperature) in the closed original container in a well ventilated area. Do

not store for prolonged periods in direct sunlight. Avoid contact with food.

APVMA Approval No. 36340/0614

SEE BELOW FOR BATCH AND EXPIRY

® Registered Trademark

® Yellow (PANTONE® 123) the predominant colour of Coopers packaging is a Registered Trademark. PANTONE is

a registered trademark of Pantone, Inc.

© 2014

2L

[5L

To be inserted on relevant rear panel

20L

25L]

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11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

11-1-2019


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

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

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

Europe - EMA - European Medicines Agency

11-1-2019


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

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

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

Europe - EMA - European Medicines Agency

11-1-2019


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

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

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

Europe - EMA - European Medicines Agency

10-1-2019


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

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

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

Europe - EMA - European Medicines Agency

10-1-2019


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

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

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

Europe - EMA - European Medicines Agency

10-1-2019


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

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

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

Europe - EMA - European Medicines Agency

10-1-2019


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

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

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

Europe - EMA - European Medicines Agency

10-1-2019


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

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

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

Europe - EMA - European Medicines Agency

4-1-2019


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

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

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

Europe - EMA - European Medicines Agency

19-12-2018


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

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

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

Europe - EMA - European Medicines Agency

19-12-2018


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

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

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

Europe - EMA - European Medicines Agency

14-12-2018


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

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

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

Europe - EMA - European Medicines Agency

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

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

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

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

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

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

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

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

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

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

Europe -DG Health and Food Safety

7-12-2018


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

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

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

Europe - EMA - European Medicines Agency

7-12-2018


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

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

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

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

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