OVARID TABLETS

Main information

  • Trade name:
  • OVARID TABLETS 20MG MEGESTROL ACETATE B.P.
  • Pharmaceutical form:
  • ORAL TABLET
  • Units in package:
  • 200Tab
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • OVARID TABLETS 20MG MEGESTROL ACETATE B.P.
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CAT | DOG | DOG - FEMALE (BITCH) | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
  • Therapeutic area:
  • hormone
  • Therapeutic indications:
  • EOSINOPHILIC GRANULOMAS | IMPROVING BEHAVIOUR | MAMMARY TUMOURS | MILIARY ECZEMA | MODIFY HYPERSEXUALITY | POSTPONE OESTRUS | PREVENT OESTRUS | PSEUDO-PREGNANCY | URINE SPRAY | ELIMINATE URINE SPRAYING | EXCESS LIBIDO - REDUCE | PSEUDO-CYESIS | PSEUDO-PREGNANCY LACTATION
  • Product summary:
  • For postponement or prevention of oestrus & treatment of false pregnancy and oestrogen-dependent mammary tumors in bitches. For oestrus control and treatment of miliary eczema and oesinophilic granuloma in cats. For the treatment of behavioural abnormalitNot recommended in diabetic animals. See DIRECTIONS FOR USE on leaflet also.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 36150/1298
  • Authorization date:
  • 15-12-1998
  • Last update:
  • 15-06-2017

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

____________________________________________________________________________________________________

i:\wp\labels\ovarid5.doc:03/09/99

Page 1 of

INFOPEST – Company Supplied Label

OVARID 20MG

CARTON FRONT & REAR

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Ovarid® tablets 20 mg

MEGESTROL ACETATE B.P.

For the postponement or prevention of oestrus and the

treatment of false pregnancy and oestrogen-dependent

mammary tumours in bitches. For oestrus control and for the

treatment of miliary eczema and oesinophilic granuloma

(rodent ulcer) in cats. For the treatment of behavioural

abnormalities, such as hypersexuality in male dogs and urine

spraying in cats.

200 tablets

JUROX

____________________________________________________________________________________________________

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Page 2 of

OVARID 20MG

CARTON SIDE (1)

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

Made in Australia by

JUROX LOGO

Jurox Pty. Ltd.

Unit 22, Slough Estate, Holker St.,

Silverwater, NSW, 2128, Australia

Under licence from:

Schering-Plough Animal Health

® Schering-Plough Animal Health Limited Registered Trade Mark

____________________________________________________________________________________________________

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Page 3 of

OVARID 20MG

CARTON SIDE (2)

DISPOSE of container by wrapping in paper and putting in garbage.

STORE below 30

C (Room Temperature) in a dry place.

EXP.

NRA 36150/1298

____________________________________________________________________________________________________

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Page 4 of

OVARID 20MG

CARTON FLAPS (BOTTOM AND TOP)

Ovarid® tablets 20 mg

200 tablets

____________________________________________________________________________________________________

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Page 5 of

OVARID 20MG

FOIL

FOR ANIMAL TREATMENT ONLY

OVARID®

20 mg MEGESTROL ACETATE

JUROX

[B]

[E]

NRA 36150/1298

____________________________________________________________________________________________________

i:\wp\labels\ovarid5.doc:03/09/99

Page 6 of

OVARID 20MG

LEAFLET

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Ovarid

® Tablets 5mg Megestrol Acetate B.P.

Ovarid

® Tablets 20mg Megestrol Acetate B.P.

Description

Each tablet contains megestrol acetate (6 methyl-

–17 acetoxy progesterone) in a dried yeast

base. Two strengths are available:-

20 mg tablets, packed in silver foil.

5 mg tablets, packed in gold foil.

Indications

Megestrol

acetate

potent

progestagen

with

marked

anti-oestrogenic

properties.

recommended for administration by the oral route in bitches for the postponement or prevention of

oestrus and the treatment of false pregnancy and oestrogen-dependent mammary tumours. In cats it

is recommended for oestrus control and for the treatment of miliary dermatitis and oesinophilic

granuloma (rodent ulcer). It can also be used in dogs and cats for the treatment of behavioural

abnormalities such as hypersexuality in male dogs and urine spraying in cats.

Postponement of oestrus (Bitches)

Ovarid tablets may be used to postpone an anticipated oestrus. Following the recommended course

it is not possible to state, with any degree of accuracy, when the next oestrus period will occur as this

will depend on the stage of anoestrus when the tablets were administered. It is most likely,

however, that it will appear some three months later. It is unlikely that oestrus will be delayed by

more than six months.

Extended postponement of oestrus (Bitches)

Experimentation has shown that oestrus can be postponed safely for longer periods of time by an

extended dosage regimen. In this case a full forty day postponement course of Ovarid should be

given starting in anoestrus, preferably 14 but at least 7 days before the effect is required. At the end

of the period treatment may be continued on a twice weekly basis as long as it is desired to postpone

oestrus, but not exceeding four months. Oestrus will not occur whilst bitches are receiving the tablets,

but as is the case with the shorter dosage regimen, it is not possible to say exactly when oestrus will

occur after withdrawal of the tablets. In the majority of bitches however, this interval is likely to be

about two to three months.

Suppression (prevention) of oestrus (Bitches)

When the tablets are used by the recommended method for the prevention of oestrus, the signs of

pro-oestrus usually disappear in two to three days and the subsequent oestrus normally occurs four to

six weeks earlier than would have been the case had medication not been given.

Treatment of false Pregnancy (Bitches)

Ovarid tablets will in most cases alleviate the physical and nervous signs of false pregnancy within

three days. In a small percentage of treated cases the signs of false pregnancy may recur some

three to six weeks later. This incidence can be minimised by commencing treatment immediately the

signs are seen. Treatment with Ovarid is least effective in cases which have recurred. Ovarid should

not be used in cases which have been recently treated with oestrogens. Experience has shown that

bitches can conceive normally at the subsequent heat following the withdrawal of Ovarid.

____________________________________________________________________________________________________

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Page 7 of

OVARID 20MG

LEAFLET (continued)

Oestrus control in Cats

Oestrus can be prevented or postponed by selecting an appropriate dose regimen. It should be

recognised that the cat is seasonally polyoestrus and that ovulation is induced by coitus, as these

factors may affect the occurrence of oestrus after treatment.

Miliary eczema in Cats

In the past corticosteroids and sex hormones have been used in the treatment of miliary eczema but

the results have been inconsistent. Field experience with Ovarid, however, has shown it to be very

successful. A response being noticed, in most cases, within the first few days of commencing

treatment. It should be recognised that other factors, such as flea infestation and diet may play a role

in the aetiology of miliary eczema.

Eosinophilic granuloma (rodent ulcer) in Cats

Some veterinary surgeons have found that Ovarid can be beneficial in this condition.

Oestrogen-dependent mammary tumours in Bitches

It has been found that Ovarid will reduce the size of these tumours. It has also been noted that the

blood supply to the neoplasm is often reduced. It becomes more circumscribed and thus surgical

removal can be more easily accomplished.

Control of behavioural abnormalities in the Dog and Cat

Ovarid has been used beneficially in the treatment of a number of behavioural abnormalities in the

dog and cat.

DIRECTIONS FOR USE

A slight change of temperament may be noted in a few animals while they are receiving the

tablets. In some cats dosage with Ovarid may cause temporary increase in weight.

A reversible diabetes-like syndrome may develop with prolonged continuous use of Ovarid. This

condition is reversible on cessation of treatment. Ovarid is not recommended in diabetic animals.

Progestagens, like other synthetic hormones, should always be used with care. This is particularly so

in bitches treated at their first oestrus. Owners should be advised that this class of bitch and a small

proportion of others which have abnormal oestrus cycles may show excessive libido or oestrus may

return earlier than expected because of difficulties which may be encountered with the timing of

administration. Apart from these considerations experience has shown that, when used correctly,

Ovarid tablets do not produce undesirable side effects since oral administration allows the duration of

effect to more accurately controlled than is the case with depot injections.

The timing of administration is of great importance if the best results are to be obtained,

. In some

cases it may be necessary to use vaginal cytology to identify the stage of the oestrus cycle so that

correct dosing may be undertaken

. If Ovarid tablets are given once ovulation has occurred

megestrol acetate may aid conception.

1.

DOGS

Postponement of oestrus (Bitches)

(i)

Normal dosage regimen: 0.5mg/kg daily for a maximum period of forty days. The course of

tablets should be commenced preferably 14 days but at least 7 days before the effect is required and

should not be repeated more frequently than once every six months. The following table may be used

to help in dispensing tablets.

____________________________________________________________________________________________________

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Page 8 of

OVARID 20MG

LEAFLET (continued)

Weight of Bitch

5 mg Tablets

20 mg Tablets

In kg

In lbs

No. Daily

No. for

Maximum

Course

No. Daily

No. for

Maximum

Course

<5

5-10

10-15

15-20

20-30

30-40

40-50

50-60

<11

11-22

22-33

33-44

44-66

66-88

88-110

110-142

0.25

0.50

1.50

(ii)

Extended dosage regimen: 0.1 to 0.2 mg/kg twice weekly for a maximum period of four

months, following a forty day course as described above. Bitches should be allowed to have a normal

unmedicated oestrus before this course is repeated.

Suppression (prevention) of oestrus (Bitches)

The course of tablets should be commenced at the onset of pro-oestrus as indicated by the presence

of haemorrhage and vulval swelling. The stage of the oestrus cycle may be confirmed by the

examination of vaginal smears.

Normal dosage regimen: 2 mg/kg daily for eight days.

Extended dosage regimen: 2 mg/kg daily for four days followed by 0.5 mg/kg daily for sixteen

days.

The use of this prolonged prevention course may be beneficial in bitches with a history of false

pregnancy. In some cases where other abnormalities of the oestrus cycle are known to occur, in first-

season bitches and when the animal to be medicated is housed with other bitches.

The following table may be used as a dosage guide and to help in dispensing tablets.

Weight of Bitch

5 mg Tablets

20 mg Tablets

In kg

In lbs

No. Daily

No. for

Complete

Course-8

days

No. Daily

No. for

Complete

Course-8

days

<1

1-2.5

2.5-5

5-7.5

7.5-10

10-15

15-20

20-25

25-30

30-35

35-40

40-50

50-60

<2

6-11

11-17

17-22

22-33

33-44

44-55

55-66

66-77

77-88

88-110

110-142

0.75

Treatment of false pregnancy

2 mg/kg daily for five to eight days commencing when signs of false pregnancy are first seen. In a

small percentage of treated cases the signs of false pregnancy may recur some three to six weeks

later. This incidence can be minimised by commencing the treatment immediately the signs are seen.

____________________________________________________________________________________________________

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Page 9 of

OVARID 20MG

LEAFLET (continued)

Oestrogen-dependent mammary tumours in bitches

The following dosage regimes have been used:

2 mg/kg daily for ten days, or

(ii)

2 mg/kg daily for five days, followed by 0.5 to 1.0 mg/kg daily for a further ten days.

Behavioural abnormalities – Dog and Cat

It will be necessary to vary the dose to suit individual cases.

As a guide the following dosage may be used:

5 days at 2 mg per kg and then

5 days at 1 mg per kg followed by

5 days at 0.5 mg per kg.

2.

CATS

Oestrus control in cats

(i)

Postponement of oestrus – dosage can commence in di-oestrus or anoestrus.

2.5 mg daily for two months (during breeding season).

2.5 mg once weekly for up to 18 months (during non-breeding season).

(ii)

Prevention of oestrus

5 mg daily for 3 days – commencing as soon as the signs of calling are seen. If necessary dosage

can be repeated at 21 day intervals at commencement of further calling.

Treatment of miliary eczema (miliary dermatitis) and oesinophilic granuloma (rodent ulcer) in

cats.

The recommended dosage is 2.5 to 5 mg every two to three days until the lesions begin to regress,

then once weekly until a satisfactory response is obtained. In some cases it may be necessary to

give a maintenance dosage of 2.5 mg weekly or fortnightly to prevent recurrence of the condition.

Administration

The yeast based tablets are readily accepted by most animals and consequently may be given intact

or crushed and mixed in a small quantity of food.

DISPOSE of container by wrapping in paper and putting in garbage.

STORE below 30

C (Room Temperature) in a dry place.

Aspinal, K.W. and Evans J.M. (1971) Vet. Rec. 88,374.

Fowler, N.G. and Foster, S.J. (1971) Vet Rec. 88,374.

Turner, W.T. (1971) Vet Rec., 88, 315.

Evans, J.M., Uvarov, O. and Vallance, D.K. (1969) Vet. Rec., 85 233, 234.

Pemberton, P.L. (1976) The Post-Graduate Committee in Veterinary Science.

The University of Sydney, Proceedings No. 30, Refresher Course in Neurology, pp. 11-27.

“A Glaxovet Guide to Ovarid”, 48pp. 1980.

Made in Australia by:

JUROX LOGO

Jurox Pty. Ltd.

Unit 22, Slough Estate, Holker Street, Silverwater, NSW 2128, AUSTRALIA

Under licence from Schering-Plough Animal Health Limited

® Limited Registered Trade Mark

Ovarid 5mg NRA 36149/1298

Ovarid 20mg NRA 36150/1298

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Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

21-11-2018

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

21-11-2018

Enforcement Report for the Week of November 21, 2018

Enforcement Report for the Week of November 21, 2018

Recently Updated Records for the Week of November 21, 2018 Last Modified Date: Tuesday, November 20, 2018

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

November 20, 2018: Rochester Man Pleads Guilty to Smuggling Counterfeit Cialis and Viagra into the United States

FDA - U.S. Food and Drug Administration

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

20-12-2018


Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

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

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

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

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

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

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

21-11-2018

Osurnia (Elanco GmbH)

Osurnia (Elanco GmbH)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7842 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003753/T/0010

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/18/2086 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate) - Orphan designation - Commission Decision (2018)7795 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/106/18

Europe -DG Health and Food Safety

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety