BOTULINUM VACCINE BIVALENT

Main information

  • Trade name:
  • BOTULINUM VACCINE BIVALENT
  • Pharmaceutical form:
  • PARENTERAL LIQUID/SOLUTION/SUSPENSION
  • Units in package:
  • 100mL, 500mL
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • ZOETIS AUSTRALIA

Documents

Localization

  • Available in:
  • BOTULINUM VACCINE BIVALENT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER
  • Therapeutic area:
  • vaccine
  • Therapeutic indications:
  • BOTULISM
  • Product summary:
  • For the prevention of botulism in cattle and sheep.See CAUTION - AVOID CARCASS DAMAGE on label.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 36586/60192
  • Authorization date:
  • 30-10-2013
  • Last update:
  • 15-06-2017

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

APPENDIX 2

Australian Government

Australian Pesticides

Veterinary Medicines Authority

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPs)

(Veterinary

Products)

Select appropriate:

New Product (include all applicable RLPs)

Variation (highlight instructions that are being varied). Approval

label being varied: 36586/1[2]/1105

Signal heading:

Product name:

Active constituent/s:

Statement

claims:

Net contents:

Directions for

Heading:

Restraints:

Contraindications:

Precautions:

Side effects:

Dosage

&

administration:

Approved

FOR ANIMAL TREATMENT ONLY

Botulinum

Vaccine Bivalent

;, 6

IU/ml

botulinum

Type

;,1.5

IU/ml

botulinum

Type D

Thiomersal

mg/ml

added as

antiseptic

For the prevention

botulism in cattle and sheep

Botulinum

Vaccine

Bivalent

contains

toxoids

prepared

from

cultures

both

Clostridium botulinum

Type C

("

IU/ml)

Clostridium botulinum

Type D

("

IU/ml).

The aluminium salt acts as

adjuvant and thereby increases the level and

duration

immunity

conferred

vaccines.

type

adjuvant and

purification procedures

used

ensure maximum protection

stock with minimum risk

local reactions at the site of injection.

Thiomersal

mg/ml

is added as

antiseptic.

100mL and 500mL

DIRECTIONS FOR USE

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT

Contents must

left

outer package until immediately before use

Shake

well

before use and keep

thoroughly

mixed

during

Localised swelling may develop

the site

injection and a

firm

nodular

lump

may persist

some weeks, even months. There may

some

temporary

lameness.

The recommended dose

cattle

all ages is 5 mL, and

sheep

ages

is 2

route

inoculation

subcutaneous

uust

under

skin).

recommended site

injection is high on the neck, behind the ear.

DEVELOPMENT

IMMUNITY

One dose of vaccine

sufficient to confer moderately

good

protection

but,

whenever

possible, each animal should

given a second dose

vaccine of the same volume

the first with

interval of four

six weeks between doses.

Thereafter, one dose

(2ml

for sheep or

for cattle) each year

sufficient

maintain immunity.

Wormald Street, symonston ACT 2609

PO Box 6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au ABN 19 495 043 447

General directions:

As maximum immunity develops about four weeks after vaccination, the best time to

vaccinate

three

four weeks before

date at which deaths usually occur.

INDICATIONS FOR USE:

Botulism occurs when animals, usually cattle and sheep, eat bones, carrion, fodder or

decaying vegetation that have been contaminated by the toxins elaborated

either

or both types

botulinum.

Animals tend

eat carrion when suffering from

phosphorus deficiency or protein hunger.

As it is not always possible

supply either

adequate diet or suitable fodder, the only practical means

controlling botulism

to vaccinate with the appropriate Botulinum Vaccine.

The most common type

botulism

cattle and sheep throughout Australia

that

caused

botulinum

Type

However,

Northern Australia

botulinum

Type

D may occur.

some northern areas stock, particularly cattle can

affected

both types.

The use of

Botulinum Vaccine Bivalent

warranted

some areas where

stock can

affected

both types.

A.

Single Doses

Single doses

the vaccine may

withdrawn from the pack using a sterilised

hypodermic needle and syringe after disinfecting the stopper of the vaccine pack

B.

Use with Automatic Vaccinator

automatic vaccinator may be attached to

pack

follows:

Remove the sterilised plastic cap and tube from

pack

Connect

tube

the automatic vaccinator

Disinfect the stopper with a suitable antiseptic, e.g. methylated

spirits

Screw the cap

to the plastic bottle of

vaccine which

will

cause

needle

penetrate the stopper

Prime the automatic vaccinator

depressing

plunger several times and

vaccine will flow to the needle

NOTE: Before attachment, used metal automatic vaccinators should

resterilized

taking

apart and

boiling

water for at least

minutes.

careful not to

contaminate the vaccinator during re-assembly.

RESEALING

A partially used pack

kept for use the next day if the following steps are taken

Unscrew the delivery tube from the vaccine pack

Empty the delivery tube

vaccinator

depressing the plunger several times

Disinfect the stopper

Store the vaccine

the refrigerator.

Do not freeze

Before re-use, the delivery tube and

should

sterilised

boiling for at least

ten minutes

NOTE: The plastic delivery tube may become opaque.

Frequent attachment of the

connecting tube may cause the stopper to leak.

Therefore, the tube should not be attached more than twice

Opened packs should be used as quickly as possible

Re-opening increases the risk

vaccine contamination

18

Wormald

Street,

Symonston

ACT

2609

PO

Box

6182,

Kingston

ACT

2604

Australia

Tel:

2 6210 4700

Fax:

2 6210 4874

www.apvma.gov.au

495 043 447

Withholding

Period/s:

Trade

Advice:

Safety

Directions:

First

Aid:

This

pack

compatible

with

Quickshot

Vaccinator

CAUTION AVOID CARCASE DAMAGE

Sterilise

injection apparatus

boiling

water for

minutes (or

equivalent) before

use.

Avoid use of strong disinfectants

apparatus.

Maintain cleanliness at all times during vaccination.

Great care must be

taken to avoid contamination of the vaccine, needle

internal parts of

syringe

contact with unsterile surfaces or unwashed hands.

Keep needles sharp and clean. Replace frequently.

Use the shortest possible needle, not exceeding

length.

As far

possible avoid injection of animals during wet weather or under

dusty conditions. Animals should preferably be inoculated

temporary

yards

clean grass,

fixed mustering yards are likely to

heavily

contaminated with clostridial spores.

This product must

injected only under the skin (subcutaneously).

If possible inject

high

the neck behind the

ear,

i.e.

under the skin

the side of the neck oust behind

below the base of the ear).

Before vaccine

injected, the proposed site of inoculation

the animal's

skin may

cleaned

swabbing with cotton-wool soaked

antiseptic

solution, such

methylated spirits.

Unused vaccine may

held over for use the next

day,

provided instructions

for resealing are followed.

vaccine

been

fully

tested

found

conform

accepted

standards

potency,

safety

sterility.

NOTE

This vaccine has been fully tested for sterility and safety before issue, but it

must

stressed that correct vaccination procedure

the field

equally

important

if secondary

infection

prevented.

Very

occasionally,

pathogenic organisms lying dormant

the animal's tissues are activated at

the time of vaccination.

This may lead to losses of stock, but fortunately

rare

occurrence.

above

factors

beyond

control

of the

manufacturer, Zoetis cannot accept responsibility for any disability or loss

stock following vaccination.

Zero

days

N/A

N/A

poisoning occurs, contact a doctor or Poisons Information Centre.

Phone

Australia

131126.

This

material

cause

mild

allergic

reaction

sensitive individuals

skin contact.

Avoid skin contact.

If skin

or hair

contact occurs, remove contaminated clothing and flush skin and hair with

18 Wormald Street. Symonston

2609

PO Box 6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700 Fax:

2 6210 4874

www.apvma.gov.au

ABN

19 495 043 447

running

water.

splashed

eyes

wash

immediately

with water.

Additional user

Take care to avoid accidental self-injection.

safety:

In the event

self-injection,

seek

medical attention

you are concerned

show

the package leaflet

label, to the

Medical

Practitioner.

Environmental

N/A

statements:

Disposal:

Dispose of empty containers

wrapping

paper

putting

garbage.

Discarded

needles should

immediately placed

a designated

and appropriately labelled

'sharps' container

Storage:

Store between

(Refrigerate.

not freeze). Protect from light.

Name

&

address:

Zoetis Australia Ply

38-42

Wharf

Road

West Ryde NSW

2114

AUSTRALIA

Australian Technical Services Toll Free

1800 814 883

www.zoetis.com.au

The following

for APVMA use only:

;;:vMA

approval

APVMA

No:

36586/60192

18

Wormald

Street,

Symonston

ACT

2609

PO Box 6182, Kingston ACT 2604 Australia

Tel:

2 6210 4700 Fax:

2 6210 4874

www.apvma.gov.au ABN

495 043 447

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17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Opinion/decision on a Paediatric investigation plan (PIP): Autologous cartilage derived cultured chondrocytes, decision type: , therapeutic area: , PIP number: P/0282/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Opinion/decision on a Paediatric investigation plan (PIP): Lynparza,Olaparib, decision type: , therapeutic area: , PIP number: P/0262/2018

Europe - EMA - European Medicines Agency

14-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of retinitis pigmentosa, 28/07/2015, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Orphan designation: Adenovirus-associated viral vector serotype 2 containing the human RPE65 gene (voretigene neparvovec), Treatment of leber's congenital amaurosis, 02/04/2012, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Opinion/decision on a Paediatric investigation plan (PIP): Olumiant,baricitinib, decision type: , therapeutic area: , PIP number: P/0291/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Opinion/decision on a Paediatric investigation plan (PIP): Kevzara,sarilumab, decision type: , therapeutic area: , PIP number: P/0335/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Opinion/decision on a Paediatric investigation plan (PIP): Adcetris,Brentuximab vedotin, decision type: , therapeutic area: , PIP number: P/0327/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Opinion/decision on a Paediatric investigation plan (PIP): Veliparib, decision type: , therapeutic area: , PIP number: P/0256/2018

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

Opinion/decision on a Paediatric investigation plan (PIP): navitoclax, decision type: , therapeutic area: , PIP number: P/0255/2018

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

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: 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

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

19-12-2018

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall:  https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/

On 12/12/18 GE Healthcare Recalled CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA has identified this as a Class I Recall, the most serious type recall. Read more about the recall: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/S2EbMdmwpe

FDA - U.S. Food and Drug Administration

19-12-2018


Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Orphan designation: adeno-associated viral vector serotype hu68 containing the human SMN1 gene, Treatment of spinal muscular atrophy, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Orphan designation: autologous glioma tumour cells treated with antisense molecule directed against the insulin-like growth factor type 1 receptor, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Opinion/decision on a Paediatric investigation plan (PIP): Abraxane,paclitaxel, decision type: , therapeutic area: , PIP number: P/0257/2018

Europe - EMA - European Medicines Agency

18-12-2018


Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein, Treatment of Friedreich's ataxia, 23/08/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here:  https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE38

GE Healthcare Recalls CareScape R860 Inspiratory Safety Guard Due to Risk of Disconnection from Breathing Circuit. @US_FDA @US has identified this as a Class I Recall, the most serious type recall. Read more about the recall here: https://go.usa.gov/xE383  #MedicalDevice #FDA pic.twitter.com/X4IprwU8R2

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall:  https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

.@US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevicepic.twitter.com/YU9Iq

. @US_FDA issues class I recall, the most serious type pf recall: Synaptive Medical Recalls BrightMatter Guide with SurfaceTrace Registration Due to Software Defect. Read more about the recall: https://go.usa.gov/xPMEn  #MedicalDevice pic.twitter.com/YU9Iq3Yw0b

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer  Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack  of Adequate Validation and Controls to Ensure Product Cleanliness. Read  more about the recall:  https://go.us

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.us

. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW

FDA - U.S. Food and Drug Administration

30-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0230/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0230/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0230/2018

Europe - EMA - European Medicines Agency

30-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0231/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0231/2018

Opinion/decision on a Paediatric investigation plan (PIP): Risankizumab, decision type: , therapeutic area: , PIP number: P/0231/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, decision type: , therapeutic area: , PIP number: P/0152/2018

Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, decision type: , therapeutic area: , PIP number: P/0152/2018

Opinion/decision on a Paediatric investigation plan (PIP): Emapalumab, decision type: , therapeutic area: , PIP number: P/0152/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Opinion/decision on a Paediatric investigation plan (PIP): lamivudine,dolutegravir, decision type: , therapeutic area: , PIP number: P/0151/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, decision type: , therapeutic area: , PIP number: P/0182/2018

Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, decision type: , therapeutic area: , PIP number: P/0182/2018

Opinion/decision on a Paediatric investigation plan (PIP): Larotrectinib, decision type: , therapeutic area: , PIP number: P/0182/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, decision type: , therapeutic area: , PIP number: P/0186/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, decision type: , therapeutic area: , PIP number: P/0186/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rimiducid, decision type: , therapeutic area: , PIP number: P/0186/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, decision type: , therapeutic area: , PIP number: P/0198/2018

Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, decision type: , therapeutic area: , PIP number: P/0198/2018

Opinion/decision on a Paediatric investigation plan (PIP): gabapentin, decision type: , therapeutic area: , PIP number: P/0198/2018

Europe - EMA - European Medicines Agency