APO-PANTOPRAZOLE

Main information

  • Trade name:
  • APO-PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack.
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack.
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 213716
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

213716

APO-PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack.

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

15/10/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. APO-PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40 mg enteric-coated tablet blister pack.

Product Type

Single Medicine Product

Effective date

15/12/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

1. For symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: i) Duodenal ulcer; ii) Gastric ulcer;

iii) Gastro-oesophageal reflux disease (GORD): Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD; Reflux

oesophagitis; iv) Gastrointestinal lesions refractory H2 blockers; v) Zollinger-Ellison Syndrome. Patients whose gastric or duodenal ulceration is not

associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs

whether on first presentation or on recurrence. 2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux

oesophagitis. 3. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs

(NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Yellow, oval, biconvex enteric-coated tablets, plain on both sides.

Active Ingredients

Pantoprazole sodium sesquihydrate

45.4 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 10:58:18 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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

APO-Pantoprazole

Tablets

Contains the active ingredient, pantoprazole (as sodium sesquihydrate)

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine

This leaflet answers some common

questions about pantoprazole. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your

medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Pantoprazole It contains the active

ingredient, pantoprazole (as sodium

sesquihydrate).

This medicine belongs to a group of

medicines called proton pump

inhibitors (PPIs). PPIs work by

decreasing the amount of acid the

stomach makes, to give relief from

the symptoms and allow healing to

take place.

Ulcers

It is used to treat and help heal

duodenal and gastric ulcers.

Depending on the position of the

ulcer it is called a gastric or duodenal

ulcer. A gastric ulcer occurs in the

stomach. A duodenal ulcer occurs in

the duodenum which is the tube

leading out of the stomach. These

can be caused in part by too much

acid being made in the stomach.

Pantoprazole may also be used to

prevent ulcers associated with the use

of non-steroidal anti-inflammatory

drugs (NSAIDs). These are

medicines used to relieve pain,

swelling and other symptoms of

inflammation, including arthritis

(inflammation of the joints).

Reflux disease

Pantoprazole is also used to treat

reflux oesophagitis or reflux disease.

This can be caused by "washing

back" (reflux) of food and acid from

the stomach into the food pipe, also

known as the oesophagus.

Reflux can cause a burning sensation

in the chest rising up to the throat,

also known as heartburn.

Pantoprazole is also used to prevent

reflux oesophagitis from coming

back.

Zollinger-Ellison syndrome

Pantoprazole is used to treat a rare

condition called Zollinger-Ellison

syndrome, where the stomach

produces very large amounts of acid,

much more than in ulcers and reflux

disease.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed it

for another reason.

This medicine is available only with

a doctor's prescription.

There is no evidence that this

medicine is addictive.

Use in children

There is not enough information to

recommend the use of this medicine

in children.

Before you take this

medicine

When you must not take it

Do not take APO-Pantoprazole if

you:

APO-PANTOPRAZOLE TABLETS

have had an allergic reaction to

pantoprazole or any of the

ingredients listed at the end of

this leaflet.

Some of the symptoms of an

allergic reaction may include:

shortness of breath, wheezing or

difficulty breathing; swelling of

the face, lips, tongue, throat or

other parts of the body; muscle

pain or tenderness or joint pain;

or rash, itching or hives on the

skin.

Do not take pantoprazole if you

have severe liver disease or

cirrhosis.

Do not take pantoprazole in

combination with antibiotics or

any other medicine if:

you are allergic to any of the

antibiotics or medicines your

doctor may prescribe with

pantoprazole

you have moderate to severe liver

or kidney disease.

Do not take pantoprazole in

combination with atazanavir (anti-

viral medications).

Do not take this medicine after the

expiry date (EXP) printed on the

pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do not take this medicine if the

packaging is torn, shows signs of

tampering or if it does not look

quite right.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if:

1.

You have allergies to:

pantoprazole

any other ingredients listed at the

end of this leaflet

any other substances, such as

foods, preservatives or dyes.

2.

You have or have had any

medical conditions especially

the following:

a bone fracture of the hip, wrist or

spine (mainly a risk in people

who take high doses of PPIs or

use them long term (a year or

longer))

kidney disease.

3.

You plan to become pregnant

or breast-feed.

Your doctor will discuss the risks

and benefits of taking

pantoprazole during pregnancy or

while breast-feeding.

4.

Tell your doctor if you have any

of the following symptoms:

unintentional weight loss

repeated vomiting

vomiting blood

difficulty or pain when

swallowing

you look pale and feel weak

you notice blood in your stools

Your doctor may need to perform

some additional tests before you

take this medicine.

If you have not told your doctor

about any of the above, tell them

before you start taking this

medicine.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and pantoprazole

may interfere with each other. These

include:

warfarin and phenprocoumon -

medicines used to prevent blood

clots (anticoagulants)

atazanavir, - medicines used to

treat viral infections such as HIV

ketoconazole, itraconazole,

posaconazole - medicines used to

treat fungal infection

methotrexate - a medicine used to

treat arthritis and some types of

cancer

erlotinib or related medicines

used to treat cancer

tacrolimus, mycophenolate

mofetil - medicines used to

suppress the immune system

fluvoxamine - a medicine used to

treat anxiety and depression.

These medicines may be affected by

pantoprazole, or may affect how well

it works. You may need to use

different amounts of your medicine,

or take different medicines.

Your doctor and pharmacist can tell

you if you are taking any of these

medicines. They may also have more

information on medicines to be

careful with or avoid while taking

pantoprazole.

Other interactions not listed above

may also occur.

How to take this

medicine

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may be different to the

information in this leaflet.

If you do not understand any written

instructions, ask your doctor or

pharmacist for help.

How much to take

The usual dose is one tablet per day.

Your doctor will prescribe the dose

that is right for you.

The dose and frequency of

pantoprazole that your doctor

prescribes for you depends on your

medical condition. Your doctor may

change the dose as your condition

changes.

How to take it

Swallow your tablets whole with a

little water with or without food.

APO-PANTOPRAZOLE TABLETS

Do not crush or chew the tablets.

APO-Pantoprazole tablets have a

special coating to protect them

from the acidic contents of your

stomach. For the tablets to work

effectively, this coating must not be

broken.

When to take it

Take it at about the same time

each day.

Taking your medicine at the same

time each day will have the best

effect. It will also help you remember

when to take it.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take your next dose when you are

meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make up

for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(Tel: 13 11 26 for Australia) for

advice, or go to the Accident and

Emergency Department at the

nearest hospital, if you think that

you or anyone else may have taken

too much pantoprazole.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

this medicine

Things you must do

Use pantoprazole exactly as your

doctor has prescribed.

Tell your doctor immediately if

you become pregnant while you

are taking pantoprazole.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking pantoprazole.

If you take pantoprazole for a long

period of time, e.g. over 1 year, you

will need to see your doctor regularly

so that he/she can monitor your

condition.

Tell your doctor if you do not feel

better while taking pantoprazole.

Your doctor may recommend further

examination.

Things you must not do

Do not give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Do not take your medicine to treat

any other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking your medicine,

or change the dosage, without

checking with your doctor.

Things to be careful of

Be careful while driving or

operating machinery until you

know how pantoprazole affects

you.

Things that may help your

condition

Some self-help measures suggested

below may help your condition. Talk

to your doctor or pharmacist about

these measures and for more

information.

Alcohol - your doctor may advise

you to limit your alcohol intake.

Aspirin and many other

medicines used to treat arthritis,

period pain, headaches - these

medicines may irritate the

stomach and may make your

condition worse. Your doctor or

pharmacist may suggest other

medicines you can take.

Caffeine - your doctor may advise

you to limit the number of drinks

which contain caffeine, such as

coffee, tea, cocoa and cola drinks,

because they contain ingredients

that may irritate your stomach.

Eating habits - eat smaller, more

frequent meals. Eat slowly and

chew your food carefully. Try not

to rush at meal times.

Smoking - your doctor may

advise you to stop smoking or at

least cut down.

Weight - your doctor may suggest

losing some weight to help your

condition.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

pantoprazole.

Like other medicines, pantoprazole

can cause some side effects. If they

occur, most are likely to be minor

and temporary. However, some may

be serious and need medical

attention. Your doctor has weighed

the risks of using this medicine

against the benefits they expect it

will have for you.

Ask your doctor or pharmacist to

answer any questions you may

have.

Following is a list of possible side

effects. Do not be alarmed by this

list. You may not experience any of

them.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

APO-PANTOPRAZOLE TABLETS

headache

dizziness

diarrhoea

nausea or vomiting

stomach pain

excessive gas in the stomach or

bowel

indigestion

constipation

dry mouth

metallic taste

weakness or tiredness

increased sweating or body

temperature

blurred vision

skin problems, such as itchiness

and rash

These are the more common side

effects of pantoprazole. Some of

these side effects may be due to the

combination of other medicines you

are taking with pantoprazole.

Tell your doctor as soon as possible

if you notice any of the following:

unusual tiredness or weakness

nausea, vomiting, loss of appetite,

feeling generally unwell, fever,

itching, yellowing of the skin and

eyes, and dark coloured urine

blood in the urine

increased or decreased need to

urinate

skin problems such as itchiness

and rash, or swelling, blistering or

peeling of the skin

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

chest pain

shortness of breath

high blood pressure

swelling of the legs

bleeding or bruising more easily

than normal

depression, confusion or anxiety

These may be serious side effects and

you may need urgent medical

attention. Serious side effects are

rare.

Other side effects not listed above

may occur in some people. Tell your

doctor if you notice anything that is

making you feel unwell when you are

taking, or soon after you have

finished taking pantoprazole.

Ask your doctor or pharmacist if

you do not understand some of the

information in this list.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take

them.

If you take the tablets out of their

original packaging they may not keep

well.

New Formulation

Keep your medicine in a cool dry

place where the temperature will

stay below 30°C.

Old Formulation

Keep your medicine in a cool dry

place where the temperature will

stay below 25°C. Protect from light

and moisture.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor or pharmacist tells

you to stop taking this medicine or

it has passed its expiry date, ask

your pharmacist what to do with

any medicine that is left over.

Product description

What APO-Pantoprazole

looks like

The tablets are available as 20 mg

and 40 mg strengths. The tablets

have an acid-resistant coating called

an enteric coating.

New Formulation

20 mg tablets

Yellow, oval, biconvex enteric-

coated tablets, plain on both sides.

Blister pack of 5 and 30 tablets.

40 mg tablets

Yellow, oval, biconvex enteric-

coated tablets, plain on both sides.

Blister pack of 5 and 30 tablets.

*Not all strengths and/or pack sizes

may be available.

Old Formulation

20 mg tablets

Yellow, oval, biconvex, enteric-

coated tablets engraved "APO" on

one side, "20" on the other side.

Blister pack of 30 tablets.

Bottle of 30, 100 and 500 tablets.

40 mg tablets

Yellow, oval, biconvex, enteric-

coated tablets engraved "APO" on

one side, "40" on the other side.

Blister pack of 5 and 30 tablets.

Bottle of 30, 100 and 500 tablets.

*Not all strengths and/or pack sizes

may be available.

*Not all strengths, pack types and/or

pack sizes may be available.

Ingredients

New Formulation

The active ingredient in the tablets is

pantoprazole (as sodium

sesquihydrate).

APO-PANTOPRAZOLE TABLETS

The tablets also contain the following

as inactive ingredients:

mannitol

anhydrous sodium carbonate

sodium starch glycollate

crospovidone

anhydrous colloidal silica

calcium stearate

hypromellose

macrogol 6000

sodium hydroxide

Eudragit L30-D55

Opadry AMB Aqueous Moisture

Barrier Coating System

80W52172 Yellow.

This medicine is lactose free, gluten-

free, sucrose-free, tartrazine-free and

other azo dyes-free.

Old Formulation

The active ingredient in the tablets is

pantoprazole (as sodium

sesquihydrate).

The tablets also contain the following

as inactive ingredients:

anhydrous lactose

crospovidone

microcrystalline cellulose

magnesium stearate

hypromellose

macrogol 8000

anhydrous sodium carbonate

methacrylic acid copolymer

triethyl citrate

purified talc

titanium dioxide

iron oxide yellow.

This medicine is gluten-free, sucrose-

free, tartrazine-free and other azo

dyes-free.

Australian Registration

Numbers

New Formulation

APO-Pantoprazole 20 mg tablets

(blister): AUST R 213715.

APO-Pantoprazole 40 mg tablets

(blister): AUST R 213716.

Old Formulation

APO-Pantoprazole 20 mg tablets

(blister): AUST R 156338.

APO-Pantoprazole 40 mg tablets

(blister): AUST R 156334.

APO-Pantoprazole 20 mg tablets

(bottle): AUST R 156339.

APO-Pantoprazole 40 mg tablets

(bottle): AUST R 156341.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are the registered

trade marks of Apotex Inc.

This leaflet was last updated in:

December 2015

APO-PANTOPRAZOLE TABLETS

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Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-2-2019

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Published on: Mon, 25 Feb 2019 No abstract available. © European Food Safety Authority, 2015 Safety and efficacy of a molybdenum compound (E7) sodium molybdate dihydrate as feed additive for sheep based on a dossier submitted by Trouw Nutrition International B.V.

Europe - EFSA - European Food Safety Authority EFSA Journal

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of El Guapo Chile Habanero and Chile Pasilla-Ancho pouches due to an unlabeled peanut allergen.

FDA - U.S. Food and Drug Administration

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

Apo-Prednisone 5 mg Tablet (2018-12-18)

Health Canada

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

11-12-2018

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

The recalled product does not have proper consumer chemical hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

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

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

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

15-3-2019


Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Orphan designation: Dantrolene sodium, Treatment of Wolfram syndrome, 12/12/2016, Positive

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

EU/3/15/1597 (Active substance: Sodium (2R,3S,5R)-5-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-2-(hydroxymethyl)tetrahydrofuran-3-yl ((2R,3S,5R)-5-(2-amino-6-oxo-1H-purin-9(6H)-yl)-3-hydroxytetrahydrofuran-2-yl)methyl phosphate) - Transfer of orphan designation - Commission Decision (2019)2107 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004914

Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Boyd Consultants Limited)

EU/3/16/1800 (Active substance: Dantrolene sodium) - Transfer of orphan designation - Commission Decision (2019)2111 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005192

Europe -DG Health and Food Safety

14-3-2019


Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Orphan designation: Treprostinil sodium (inhalation use), Treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension, 14/04/2004, Positive

Europe - EMA - European Medicines Agency

8-3-2019


Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Active substance: Treprostinil sodium (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)1741 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004330

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (Active substance: Beraprost sodium (modified release tablet)) - Transfer of orphan designation - Commission Decision (2019)1354 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003232

Europe -DG Health and Food Safety

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

Elmiron (Active substance: pentosan polysulfate sodium) - Centralised - Yearly update - Commission Decision (2019)848 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

24-1-2019


Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Europe - EMA - European Medicines Agency

21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467

Europe -DG Health and Food Safety

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

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

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

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

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

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

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

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety