Ovuprost Beta

New Zealand - English - Ministry for Primary Industries

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Active ingredient:
cloprostenol present as cloprostenol sodium
Available from:
Elanco New Zealand
Composition:
cloprostenol present as cloprostenol sodium 0.25 g/litre
Authorization number:
A011733
Authorization date:
2019-09-09

100 mL Flexipack label

Issue date: 18 Jul 2019

The information above this line is not included in the label

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE

Ovuprost Beta

100 mL

For luteolysis of functional corpora lutea in cows, mares and sows.

ACTIVE CONSTITUENT

Each mL contains 250 µg cloprostenol (sodium).

DIRECTIONS FOR USE

Read package insert prior to use.

Intramuscular injection into the anterior half of the neck.

DOSE RATE

Cows

2 mL

Mares < 400 kg

0.5 – 1 mL

> 400 kg

1 – 2 mL

Sows

0.7 mL

WITHHOLDING PERIODS

Milk and meat: Nil

STORAGE

Store below 25 °C. Protect from light. Store locked up.

Use within 28 days of withdrawing the first dose.

If mixed with PREGNECOL (ACVM No A5279), store mixed product below 25 °C and use

within 21 days of mixing. Protect from light. Store locked up.

ACVM No. A011733

See www.foodsafety.govt.nz for registration conditions.

BAYER NEW ZEALAND LTD

3 Argus Place, Hillcrest, Auckland 0627, New Zealand.

Customer Info Line: 0800 927 733

Manufactured at: Corner of Wiri Station Road and Hobill Avenue, Manukau City, Auckland,

New Zealand

Batch

Unit carton label – 100 mL packs

(main panel)

Issue date: 18 Jul 2019

The information above this line is not included in the label

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE

Ovuprost Beta

100 mL

Cloprostenol Sterile Injection

For luteolysis of functional corpora lutea in cows, mares and sows.

For use with Prosynch and Oestrus synchrony programmes.

Unit carton label – 100 mL packs

(side panels)

Issue date: 18 Jul 2019

The information above this line is not included in the label

ACTIVE CONSTITUENT

Each mL contains 250 µg cloprostenol (as cloprostenol sodium).

INDICATIONS

For luteolysis of functional corpora lutea in cows, mares and sows

CONTRAINDICATIONS

Do not administer by the intravenous route.

Do not use in pregnant animals when abortion or induced parturition is not the objective. Do

not use in mares suffering from acute or subacute disorders of the gastrointestinal or

respiratory system.

DIRECTIONS FOR USE

Read package insert prior to use.

By intramuscular injection into the anterior half of the neck.

DOSE RATE

Cows

Single or repeat doses of 2 mL

Mares

< 400 kg bodyweight 0.5 – 1 mL

> 400 kg bodyweight 1 – 2 mL

Sows

0.7 mL within 3 days of expected farrowing date

Unit carton label – 100 mL packs

(side panels cont’d)

Issue date: 18 Jul 2019

The information above this line is not included in the label

WITHHOLDING PERIODS

Milk and meat: Nil

STORAGE

Store below 25 °C (room temperature). Protect from light. Store locked up.

Use within 28 days of withdrawing the first dose.

If mixed with PREGNECOL (ACVM No A5279), store mixed product below 25 °C, and use

within 21 days of mixing.

DISPOSAL

Preferably dispose of the product by use. Otherwise dispose of product and packaging in an

approved landfill or other approved facility.

READ ENTIRE LABEL BEFORE USE.

May damage fertility or the unborn child from repeated oral exposure. Presumed to/may

cause organ damage from repeated oral exposure at high doses.

HANDLING PRECAUTIONS:

Use personal protective equipment as required. Do not eat, drink or smoke when using this

product.

FIRST AID:

For advice contact the National Poisons Centre – 0800 POISON (0800 764 766) – or a

doctor, immediately.

ADDITIONAL SAFETY INFORMATION

Women of child-bearing age, asthmatics or other people with bronchial disease should use

extreme caution when handling cloprostenol as the drug may induce abortion or acute

bronchoconstriction. Gloves should be worn when handling or administering the drug. As

cloprostenol is readily absorbed through the skin, any cloprostenol contacting skin must be

washed off immediately using soap and water.

Registered pursuant to the ACVM Act 1997, No. A011733

See www.foodsafety.govt.nz for registration conditions.

BAYER NEW ZEALAND LTD

3 Argus Place, Hillcrest, Auckland 0627, New Zealand.

Customer Info Line: 0800 927 733

Manufactured at: Corner of Wiri Station Road and Hobill Avenue, Manukau City, Auckland,

New Zealand

Batch

20 mL vial label

Issue date: 18 Jul 2019

The information above this line is not included in the label

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

RVM

Ovuprost Beta

20 mL

Cloprostenol Sterile Injection

For luteolysis of functional corpora lutea in cows, mares and sows.

ACTIVE CONSTITUENT

Each mL contains 250 µg cloprostenol (sodium).

Read package insert prior to use.

WITHHOLDING PERIODS

Milk and meat: Nil

STORAGE

Store below 25 °C. Protect from light. Store locked up.

Use within 28 days of withdrawing the first dose.

Do not use as a diluent for PREGNECOL.

ACVM No. A011733

See www.foodsafety.govt.nz for registration conditions.

BAYER NEW ZEALAND LTD

3 Argus Place, Hillcrest, Auckland 0627, New Zealand.

Customer Info Line: 0800 927 733

Manufactured at: Corner of Wiri Station Road and Hobill Avenue, Manukau City, Auckland,

New Zealand

Batch

Unit carton label – 20 mL packs

(main panel)

Issue date: 18 Jul 2019

The information above this line is not included in the label

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE

Ovuprost Beta

20 mL

Cloprostenol Sterile Injection

For luteolysis of functional corpora lutea in cows, mares and sows.

For use with Prosynch and Oestrus synchrony programmes.

Unit carton label – 20 mL packs

(side panels)

Issue date: 18 Jul 2019

The information above this line is not included in the label

ACTIVE CONSTITUENT

Each mL contains 250 µg cloprostenol (as cloprostenol sodium).

CONTRAINDICATIONS

Do not administer by the intravenous route.

Do not use in pregnant animals when abortion or induced parturition is not the objective. Do

not use in mares suffering from acute or subacute disorders of the gastrointestinal or

respiratory system.

DIRECTIONS FOR USE

Read package insert prior to use.

By IM injection into the anterior half of the neck.

DOSE RATE

Cows

Single or repeat doses of 2 mL

Mares

< 400 kg bodyweight 0.5 – 1 mL

> 400 kg bodyweight 1 – 2 mL

Sows

0.7 mL within 3 days of expected farrowing date

ADDITIONAL SAFETY INFORMATION

Women of child-bearing age, asthmatics or other people with bronchial disease should use

extreme caution when handling cloprostenol as the drug may induce abortion or acute

bronchoconstriction. Gloves should be worn when handling or administering the drug. As

cloprostenol is readily absorbed through the skin, any cloprostenol contacting skin must be

washed off immediately using soap and water.

Unit carton label – 20 mL packs

(side panels cont’d)

Issue date: 18 Jul 2019

The information above this line is not included in the label

WITHHOLDING PERIODS

Milk and meat: Nil

STORAGE

Store below 25 °C (room temperature). Protect from light. Store locked up.

Use within 28 days of withdrawing the first dose.

Do not use as a diluent for PREGNECOL.

Registered pursuant to the ACVM Act 1997, No. A011733

See www.foodsafety.govt.nz for registration conditions.

BAYER NEW ZEALAND LTD

3 Argus Place, Hillcrest, Auckland 0627, New Zealand.

Customer Info Line: 0800 927 733

Manufactured at: Corner of Wiri Station Road and Hobill Avenue, Manukau City, Auckland,

New Zealand

Batch

Package insert

Issue date: 18 Jul 2019

The information above this line is not included in the label

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

RESTRICTED VETERINARY MEDICINE

Ovuprost Beta

Prostaglandin (PGF2α) Injection

DESCRIPTION

A clear, sterile, aqueous solution for injection. Each mL contains 250 µg Cloprostenol (as

sodium salt). Cloprostenol is a functional synthetic analogue of the naturally occurring

PGF2α. In the reproductive system, prostaglandins (PGs) play a role in ovulation, luteolysis,

gamete transport, uterine motility, expulsion of foetal membranes and sperm transport in

both the male and female tracts. PGs are employed in reproductive therapeutics primarily for

their potent luteolytic effects.

MODE OF ACTION

PGF2α causes rapid regression of functional corpora lutea, with resultant rapid decline in

progesterone production. Luteolysis is usually followed by ovarian follicular development and

a return to oestrus with normal ovulation.

The precise mechanism of PG-induced luteolysis is uncertain but may relate to blood flow

changes in the utero-ovarian vessels, inhibition of the normal ovarian response to circulating

Gonadotrophin, or stimulation of catalytic enzymes. PGF2α also has a direct stimulatory

effect on uterine smooth muscle, causing contraction and a relaxant effect on the cervix.

Cloprostenol is rapidly distributed in the body following intramuscular administration. In

cattle, maximum tissue levels are reached within 30 minutes of dosing. Cloprostenol is

eliminated in approximately equal amounts via the kidney and in bile. Excretion in urine is

partly as unchanged Cloprostenol and partly as its tetranor acid, both in conjugated and

unconjugated form.

cattle,

Cloprostenol

biological

half-life

hours.

Within

hours,

concentration

Cloprostenol

injection

site

falls

below

limits

detection.

Cloprostenol does not accumulate in the mammary gland.

INDICATIONS

For luteolysis of functional corpora lutea in cows, mares and sows.

COWS

Cloprostenol induces luteolysis of functional corpora lutea, with return to oestrus in most

cows in 2 - 4 days. The corpus luteum is refractory to the effects of PG in the first 4 - 5 days

post ovulation. Conception rates at the induced and subsequent oestrus periods are normal,

and there are no detrimental effects on calves conceived following PG treatment.

Ovuprost Beta can be used in the following clinical situations:

1. Synchronisation of the oestrus cycle for controlled breeding

Ovuprost Beta alone can be used in a number of treatment regimens to synchronise the

oestrus cycle of groups of cows. Some of these are described below:

Double Prostaglandin Programme - Two injections of Ovuprost Beta 14 days apart. Artificial

insemination or natural mating at the induced oestrus, which should be detected 2 - 4 days

after the second injection.

Why Wait Programme - Heat detection during the first 5 - 7 days of the mating period and

artificial insemination or natural joining of cows observed in oestrus. Injection of cows not

observed in oestrus with Ovuprost Beta at the end of the 5 - 7 day period and artificial or

natural mating at the induced oestrus, which should be detected 2 - 4 days after injection.

Modified Why Wait Programmes - Heat detection during the 6 days prior to the start of

mating. Cows not observed in oestrus are given a single injection of Ovuprost Beta on

mating start date. Cows observed in oestrus are given a single injection of Ovuprost Beta on

day 5 of the mating period. In both groups artificial or natural mating at the induced oestrus

which would be detected 2 - 4 days after the injection.

PGF2α

+

GnRH

Programmes-

Injection

Prostaglandin

PGF2α

(Ovuprost

Beta)

combination with Gonadotrophin Releasing Hormone (Ovurelin) followed by fixed time

artificial insemination (FTAI).

One such programme may be summarised as follows:

Day 0

GnRH administration

Day 7

PGF2α administration

Day 9

GnRH administration (48 hours after PGF2α)

Day 10

Insemination 8-24 hours after second GnRH

Insemination is performed at a fixed time 8 - 24 hours after the second GnRH dose,

regardless of the presence or absence of visible oestrus. Synchronisation of ovulation,

achieved

protocol

above,

degree

precision

that

allows

fixed

time

insemination, which provides numerous management and economic benefits, particularly in

situations where the level of oestrus detection is low. Large groups of cows may be

inseminated together, the need for oestrus detection in the first round is eliminated, the

calving to conception interval is reduced and a tighter calving pattern is achieved. This

protocol has compared favourably against standard prostaglandin programmes in terms of

reproductive parameters such as pregnancy rate and calving to conception interval. GnRH /

PGF2α oestrus synchronisation protocols are intended for lactating dairy cattle. Variable

results are reported in the literature for the application of GnRH / PGF2α in heifers.

2. Treatment of anoestrus

One such programme is Prosynch, which can be summarised as follows:

Day 0

Insertion of Progesterone (P4) device and injection of

GnRH (Ovurelin).

Day 7

Removal

device

injection

of

PGF2α

(Ovuprost Beta )

Then either:

A. With Prosynch (Hybrid) mate to detected oestrus over the next 72 hours and on Day 10

inject all remaining cows with no visible oestrus (so not mated) with GnRH (Ovurelin). Then

employ Fixed Time AI within 24 hours. Or:

B. With Prosynch (FTAI) inject with GnRH (Ovurelin) on day 9 and Fixed Time AI between

16-20 hours after 2

Ovurelin injection.

3. In combination with PREGNECOL (ACVM No A5279) in reproduction programmes

for cattle.

In a number of published reproduction programmes for cattle, equine chorionic

gonadotrophin (PREGNECOL) is given as an injection of at the same time as PGF2α

(OVUPROST Beta). In such protocols where PREGNECOL (20000 i.u. eCG per vial) is

planned to be used at the same time as OVUPROST Beta, OVUPROST Beta (100mL

flexipack only) may be used as a diluent for PREGNECOL, so that both products may be

administered to the cow via a single injection.

4. Unobserved oestrus in cows with normal corpora lutea

Cows may be cycling normally, but either fail to display behavioural oestrus or display only

very subtle signs. This condition occurs most commonly in high yielding dairy cows at peak

lactation. Normal ovarian cyclical activity should be determined by rectal palpation of a

corpus luteum prior to Ovuprost Beta administration. Oestrus should commence 2 - 4 days

following treatment, with artificial insemination or joining at the detected heat. Failure of

oestrus induction may result if the treatment is given during the refractory period of the

corpus luteum and will necessitate a further injection 14 days after the first.

5. Termination of unwanted normal pregnancies (e.g. following misalliance)

Pregnancy can be terminated by treatment with Ovuprost Beta from 7 - 150 days following

conception. Between days 7 - 100, abortion is rapidly and reliably induced within 3 - 5 days

of treatment. Between days 100 - 150, results may be less reliable due to the decreasing

role of luteal progesterone and increasing role of placental progesterone in the maintenance

of pregnancy. If abortion has not occurred by the eighth day following treatment, a repeat

injection should be given. Treated animals should be closely observed until expulsion of the

foetus and placental membranes is complete. Abortion should not be induced with Ovuprost

Beta alone after day 150 of gestation.

6. Termination of abnormal pregnancy (e.g. expulsion of mummified foetuses)

Foetal death may result in the mummification of the foetus in utero. Treatment with Ovuprost

Beta at any stage of gestation will result in luteolysis and expulsion of the mummified foetus

from the uterus. Occasionally manual removal of the foetus from the vagina is necessary.

Pathological accumulation of placental fluids (hydramniosis or hydroallantois) can be a life

threatening condition, and is rarely resolved by surgical drainage. Termination of pregnancy

by Ovuprost Beta is often the preferred treatment option.

7. Induction of parturition (not for routine induction – see Code)

Parturition may be induced using Ovuprost Beta but to optimise calf viability should be

carried out as close to the predicted calving date as possible and should not be attempted

prior to day 270 of gestation. Parturition usually occurs between 36 - 48 hours following

treatment with Ovuprost Beta. All cows so induced should be closely supervised. As with all

other methods used to induce parturition there may be a higher than usual incidence of

retained foetal membranes. Any reduction in survival rates of calves born as a result of

parturition induction is considered to be a result of prematurity rather than an effect

attributable to PG treatment.

8. Retained foetal membranes, pyometra or chronic endometritis

Cloprostenol has a stimulatory effect on the myometrium, causing uterine contraction. This

action can aid in the expulsion of retained foetal membranes. In the absence of septicaemia,

Ovuprost Beta may aid in the treatment of post-partum uterine infections via regression of

the corpus luteum and stimulation of the myometrial contractions. The rapid decline in

progesterone and increase in oestrogen, which occur as a result of luteolysis, stimulate

uterine defence mechanisms and further aid in resolution of infection.

9. Luteal cysts

Cystic ovaries may be associated with persistent luteal tissue, and treatment with

Cloprostenol may effectively resolve such conditions and allow a return to normal cyclical

activity.

MARES

Cloprostenol causes regression of the corpus luteum in mares. Oestrus commences 2 - 5

days following Cloprostenol administration, with normal ovulation occurring 8 -12 days after

treatment. Conception rates at the induced oestrus are normal, and there are no deleterious

effects on foals born as a result of cycle manipulation. Ovuprost Beta may be of clinical

value in the following situations:

1. Unobserved or undetected oestrus (“silent heat”) in mares cycling normally

Mares cycling normally may not display full behavioural oestrus or other physiological

changes commonly associated with oestrus (e.g. oedema and relaxation of the cervix),

resulting in failure to observe optimal covering times. This condition has a higher incidence

in maiden mares early in the breeding season. Rectal palpation or ultrasound aids in the

diagnosis of normal cyclical activity. Treatment with Ovuprost Beta enables prediction of the

time of onset of oestrus, allowing optimum utilisation of teasing and stallion resources.

2. Prolonged dioestrus

Prolonged dioestrus due to the presence of persistent corpora luteum occurs in up to 20% of

mares, and responds to a single injection of Ovuprost Beta.

3. Early foetal death followed by resorption

Early foetal death (in the first 100 days) occurs in up to 8 -10% of mares, and may be

followed by foetal resorption and a failure to return to cyclical activity due to the presence of

persistent corpora lutea. Ovuprost Beta administration may be useful in the treatment of this

condition.

4. Pseudopregnancy

Mares with a persistent corpus luteum may display signs of pregnancy but be found to be

non-pregnant on examination. Treatment with Ovuprost Beta should induce luteolysis and a

return to normal cyclical activity.

5. Lactation-related anoestrus

Lactational anoestrus occurs relatively commonly, particularly in mares which foal early in

the breeding season. Affected mares may or may not ovulate at the “foal heat” but thereafter

fail to return to oestrus, often for several months. Ovuprost Beta may be effective in inducing

a return to normal cyclical activity, although results are variable.

6. Induction of abortion prior to day 45 (e.g. following misalliance)

Abortion may be induced by treatment with a single injection of Cloprostenol prior to day 35

following conception. Following the formation of the endometrial cups at day 35 treatment

with a single injection of PG may fail to induce abortion, and Ovuprost Beta must be

administered at daily intervals for 4 days to induce abortion in such mares. Mares in which

abortion is induced after day 35 do not return to oestrus until the endometrial cups cease

functioning.

7. Nomination of time of service

Ovuprost Beta may be employed to bring mares into oestrus at nominated times, for the

optimal management of high demand stallions during the breeding season.

8. Synchronisation of oestrus cycles

Ovuprost Beta may be employed to synchronise the cycles of a group of mares, for example

donor and recipient mares used in embryo transfer Programmes.

SOWS

In pigs the corpus luteum is refractory to the effects of PGF2α in the first 11 - 12 days post

ovulation. The period during which Cloprostenol can be employed for oestrus manipulation in

cyclic sows is too short to be clinically useful for oestrus synchronisation.

In the sow the production of progesterone by the corpus luteum is responsible for the

maintenance of gestation; parturition commences when blood PGF2α levels rise and cause

luteolysis. A single injection of Cloprostenol administered to sows between days 111 - 117 of

gestation will induce parturition within 48 hours. Most sows farrow within 36 hours following

treatment with Ovuprost Beta. Induced parturitions proceed normally and piglet survival is

unaffected by the use of Cloprostenol, provided parturition is not induced too prematurely,

i.e. more than 3 days prior to expected due date. Fertility of Cloprostenol treated sows at

post-weaning oestrus is normal.

DIRECTIONS FOR USE

Do not use in pregnant animals when abortion or induced parturition is not the objective. Do

not administer intravenously. Do not use in mares suffering from acute or subacute disorders

of the gastrointestinal or respiratory system.

Cows:

Single or repeat

doses

2mL (500

µg Cloprostenol)

intramuscular

injection in the anterior half of the neck.

In combination with PREGNECOL (ACVM No A5279):

Where OVUPROST BETA (100mL flexipack) is to be given at the same time as Pregnecol

(20,000 iu eCG per vial) in a reproduction programme, Ovuprost Beta may be used as a

diluent for the Pregnecol so the two products can be administered via a single injection.

Instructions for using OVUPROST BETA (100mL flexipack) as a diluent for PREGNECOL

(20,000 iu eCG per vial):

Use a sterile syringe to withdraw 3 to 5mL of OVUPROST BETA from the 100mL

OVUPROST BETA flexipack. Add the contents of the syringe to the vial of freeze-dried

PREGNECOL (20,000 iu eCG per vial). Rock the contents of the PREGNECOL vial gently

then withdraw the total contents and add back to the OVUPROST BETA 100mL flexipack.

Repeat the procedure to ensure complete recovery of the PREGNECOL vial contents. After

reconstitution of a full vial (20,000iu) of PREGNECOL into a full 100mL flexipack of

OVUPROST BETA, each ml of the solution will contain 250 ug Cloprostenol and 200i.u. of

eCG.

Immediately after mixing, mark the flexipack clearly to indicate the date and that the contents

include PREGNECOL. For most programmes, a dose of 2mL (500 ug Cloprostenol and

400iu eCG) will be indicated. The dose should be given by intramuscular injection in the

anterior half of the neck.

Mares:

400kg

bodyweight:

(125

Cloprostenol)

intramuscular injection.

Over

400kg

bodyweight:

(250

Cloprostenol)

intramuscular injection.

Sows:

Single dose of 0.7mL (175µg Cloprostenol) by intramuscular injection in the

anterior half of the neck within 3 days of expected farrowing date.

ADVERSE EFFECTS

Occasional side effects have been observed following intramuscular administration of PGs.

Such effects are generally transient and have little detrimental effect on the animal.

In cattle, increased body temperature and salivary secretion has been reported, usually

associated with the administration of 5 - 10 times the recommended dose. Experimental

administration of 50 - 100 times the recommended dose to cattle resulted in signs of

uneasiness, salivation and milk let down, but no other adverse effects.

In mares, sweating, increased respiratory and heart rates, ataxia, watery diarrhoea and

signs of mild abdominal pain have been observed. Such reactions have usually resulted

from doses in excess of that recommended, and are generally mild and transient.

In sows, occasional side effects including increased respiration rate and biting of farrowing

crate bars have been observed. Such reactions are usually transient and of little clinical

significance.

WITHHOLDING PERIODS

Milk and meat: Nil

READ ENTIRE LABEL BEFORE USE.

May damage fertility or the unborn child from repeated oral exposure. Presumed to/may

cause organ damage from repeated oral exposure at high doses.

HANDLING PRECAUTIONS:

Use personal protective equipment as required. Do not eat, drink or smoke when using this

product.

FIRST AID:

For advice contact the National Poisons Centre – 0800 POISON (0800 764 766) – or a

doctor, immediately.

ADDITIONAL SAFETY INFORMATION

Women of child-bearing age, asthmatics or other people with bronchial disease should use

extreme caution when handling cloprostenol as the drug may induce abortion or acute

bronchoconstriction. Gloves should be worn when handling or administering the drug. As

cloprostenol is readily absorbed through the skin, any cloprostenol contacting skin must be

washed off immediately using soap and water.

STORAGE

Store below 25 °C (room temperature). Protect from light. Store locked up.

Use within 28 days of broaching the vial or flexipack when used in a sterile manner, or

discard the unused portion.

If 100mL flexipack is mixed with PREGNECOL (ACVM No A5279), store mixed product

below 25 °C, and use within 21 days of mixing.

DISPOSAL

Preferably dispose of the product by use. Otherwise dispose of product and packaging in an

approved landfill or other approved facility.

PRESENTATION

20 mL glass/PET/HDPE vial and 100 mL flexipack.

Registered pursuant to the ACVM Act 1997, No. A011733.

See www.foodsafety.govt.nz for registration conditions.

BAYER NEW ZEALAND LTD

3 Argus Place, Hillcrest, Auckland 0627, New Zealand.

Customer Info Line: 0800 927 733

Manufactured at: Corner of Wiri Station Road and Hobill Avenue, Manukau City, Auckland,

New Zealand

Ref No A11733-01

Public Record of Delegate Decision

For granting an application for registration under section 21 of the Agricultural Compounds and Veterinary

Medicines Act 1997

Product details

Trade name

Ovuprost Beta

Ref No

A11733-01

Applicant

Bayer New Zealand Limited

Application type

NEW PRODUCT

Date of Delegate

Decision

6 August 2019

Registration

Expiry Period

This registration will expire 5 years from the date of this Delegate’s Decision.

Protected

Confidential

Information

Status

Application not eligible for protection of confidential information

Summary of reasons for the Decision to grant the Application

Except for the trade name, this product is identical in all respects to an already registered product.

Recommendation to Register

On the basis of the above information, the product as approved, and when imported, manufactured, sold or used

in accordance with the conditions listed below, is not likely to cause unacceptable risks to:

public health

trade in primary produce

animal welfare or

agricultural security.

In balance, there are sufficient benefits to warrant this product to be registered.

When used in accordance with this approval, the product is not likely to cause residues in primary produce, food

or food-related products that would breach domestic food residue standards.

The assessed label content is adequate to provide sufficient consumer information to allow the product to be used

appropriately and safely and meets labelling requirements.

Delegate’s decision

Being satisfied of the matters above, and under delegated authority pursuant to the Agricultural Compounds and

Veterinary Medicines Act 1997, this application for registration is granted, under section 21(1)(d) under the

conditions as listed on the Register.

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