APO-CLOPIDOGREL

Main information

  • Trade name:
  • APO-CLOPIDOGREL clopidogrel 75mg (as hydrogen sulfate) tablets bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-CLOPIDOGREL clopidogrel 75mg (as hydrogen sulfate) tablets bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221806
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221806

APO-CLOPIDOGREL clopidogrel 75mg (as hydrogen sulfate) tablets bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

20/06/2014

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-CLOPIDOGREL clopidogrel 75mg (as hydrogen sulfate) tablets bottle

Product Type

Single Medicine Product

Effective date

11/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with history of

symptomatic atherosclerotic disease.

Acute Coronary Syndrome

Clopidogrel is indicated in combination with aspirin for patients with: - Unstable angina or non-ST-elevation myocardial infarction in order to prevent early

and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Clopidogrel is indicated for the treatment

of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent). - ST-segment elevation

acute myocardial infarction in order to prevent atherothrombotic events. In this population, Clopidogrel has been shown to reduce the rate of death from

any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

28 tablets

(S4) Prescription Only Medicine

1000 (for dispensing only)

(S4) Prescription Only Medicine

500 (for dispensing only)

(S4) Prescription Only Medicine

100 (for dispensing only)

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Reddish brown, round, biconvex film-coated tablets, imprinted "APO" on

one side and "CL" over "75" on the other side.

Active Ingredients

clopidogrel hydrogen sulfate

98 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 12:33:38 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-Clopidogrel

Tablets

Contains the active ingredient clopidogrel

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 clopidogrel. 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-

Clopidogrel. It contains the active

ingredient clopidogrel.

It is used to prevent blood clots

forming in hardened blood vessels (a

process known as atherothrombosis)

which can lead to events such as

stroke, heart attack or death.

You may have been prescribed

clopidogrel because you have

previously suffered a heart attack

or stroke, or have a condition

known as peripheral arterial

disease (leg pain on walking or at

rest).

suffered acute coronary syndrome

(either a severe type of chest pain

called unstable angina, or a heart

attack). In this case you may also

be prescribed aspirin.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Clopidogrel belongs to a group of

medicines called anti-platelet

medicines.

Platelets are very small blood cells

which clump together during blood

clotting. By preventing this

clumping, anti-platelet medicines

reduce the chances of blood clots

forming (a process called

thrombosis).

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children.

Before you take this

medicine

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

a medical condition that is

causing bleeding such as a

stomach ulcer or bleeding within

your head

severe liver disease

You are breast-feeding or

intend to breast-feed.

Clopidogrel may pass into

human breast milk.

You are hypersensitive to, or

have had an allergic reaction to,

clopidogrel or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

APO-CLOPIDOGREL TABLETS

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

bleeding disorders or blood

clotting problems

any illness or disability that was

caused by bleeding, for example

impaired sight or vision because

of bleeding within the eye

recent serious injury

recent surgery (including dental

surgery)

any form of liver disease

a genetic condition which means

that a certain enzyme (CYP2C19)

in your liver works differently

and can negatively effect the

amount of clopidogrel converting

into its active form, resulting in

reduced effects. Your doctor may

perform a test for this condition

and depending on results may

change your dose or consider an

alternative treatment option.

allergy to other antiplatelet

medicines (such as ticlopidine,

prasugrel).

You are currently pregnant or you

plan to become pregnant. It is

recommended that clopidogrel is

not taken during pregnancy. Do

not take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breast-feed. Do not

take this medicine whilst

breastfeeding, clopidogrel may

pass into human breast milk.

You have recently been

vaccinated or plan to get a

vaccination.

You are planning to have surgery

(including dental surgery) or an

anaesthetic. Your doctor will

decide whether or not you need to

stop clopidogrel prior to surgery.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

clopidogrel. These include:

medicines used to treat or prevent

blood clots, for example: aspirin,

heparins, warfarin, ticlopidine

and prasugrel. There may also be

others.

non-steroidal anti-inflammatory

drugs (NSAIDs), used to treat

arthritis, period pain,

inflammation, aches and pain

medicines used to treat stomach

ulcers or reflux disease (also

called heartburn)

phenytoin, a medicine used to

treat epilepsy

tolbutamide and repaglinide, a

medicine used to treat diabetes

tamoxifen or paclitaxel, a

medicine used to treat breast

cancer

fluvastatin, a medicine used to

lower cholesterol

proton pump inhibitors,

medicines used to prevent gastric

reflux such as omeprazole

medicines which may affect the

liver enzyme in your body which

makes clopidogrel work,

including: fluvoxamine,

fluoxetine, moclobemide,

voriconazole, fluconazole,

ticlopidine, ciprofloxacin,

cimetidine, carbamazepine,

oxcarbazepine and

chloramphenicol.

These medicines may be affected by

clopidogrel or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to 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

clopidogrel.

Other interactions not listed above

may also occur.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions 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

Your doctor will tell you how much

of this medicine you will need to

take. This will depend on your

condition and whether or not you are

taking any other medicines.

The usual dose of clopidogrel is one

75 mg tablet daily.

If you have acute coronary

syndrome, you may receive a single

starting dose of 300 mg (four 75 mg

tablets) and then continue at one 75

mg tablet daily.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

APO-CLOPIDOGREL TABLETS

How to take it

Swallow the tablet with a glass of

water. Do not crush or chew the

tablets.

When to take it

Your clopidogrel tablets are provided

in a calendar pack which is designed

to remind you when to take this

medication.

To do this, take your first dose from

the position marked "First Day ". On

the following day, take the first tablet

which is labelled with the appropriate

day of the week. When you have

taken all doses in this pack, take your

next prescription in the same way.

Take this medicine at the same time

each day. Taking it at the same time

each day will have the best effect and

will also help you remember when to

take it.

It does not matter if you take it

before, with or after food.

How long to take it for

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 to take your next

dose, skip the missed dose and take

your next dose at the usual time.

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 missed doses.

This may increase the chance of you

experiencing side effects.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

If you take too much clopidogrel,

you may experience excessive

bleeding (see 'Possible side effects'

section).

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you plan to have any vaccinations

or immunisations

you are pregnant or are planning

to become pregnant, it is

recommended you do not take

clopidogrel whilst pregnant

you are breastfeeding or are

planning to breast-feed, you must

not take clopidogrel whilst

breastfeeding

you are about to have any blood

tests

you are going to have surgery

(including dental work) or an

anaesthetic or are going into

hospital. Clopidogrel may

increase the risk of bleeding

during an operation or some

dental work.

Take clopidogrel exactly as your

doctor prescribed. Your doctor may

occasionally do tests to make sure the

medicine is working and to prevent

side effects. Go to your doctor

regularly for a check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Ask your doctor whether there are

any activities you should avoid

while taking clopidogrel, for

example certain sports.

Sometimes after an injury, bleeding

may occur inside your body without

you knowing about it.

Tell your doctor immediately if

you are injured while taking

clopidogrel.

Tell your doctor immediately if

you notice any of the following:

abnormal bruising or bleeding

abnormal nose bleeds

bloody or black bowel motions

red or purple blotches on your

skin

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty swallowing or breathing

(see also 'Side effects' section)

It may take longer than usual to stop

bleeding while you are taking it.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful while driving or

operating machinery until you

know how clopidogrel affects you.

As with other medicines, clopidogrel

may cause faintness or dizziness in

some people. Make sure you know

how you react to the medicine before

you drive a car or operate machinery,

or do anything else that could be

APO-CLOPIDOGREL TABLETS

dangerous if you are faint or dizzy. If

this occurs, do not drive. If you drink

alcohol, faintness or dizziness may

be worse.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking clopidogrel or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

diarrhoea

itching

pain or stiffness in the joints

things taste different.

Tell your doctor immediately if

you notice any of the following:

(Note: if you take both clopidogrel

and aspirin, the risk of side effects

related to bleeding may be increased)

bloody or black bowel motions

diarrhoea with blood, mucus,

stomach pain and fever

abdominal or stomach pain

vomiting of blood or vomit that

looks like coffee grounds

coughing up blood

blood in the eyes

blood in the urine

unusually heavy bleeding or

oozing from cuts or wounds

bleeding (including nose bleeds)

or bruising more easily than

normal

unusually heavy or unexpected

menstrual bleeding

numbness (paralysis) or problems

with co-ordination

nausea or vomiting

headache (severe and continuing)

faintness or dizziness

light-headedness or blurred vision

slurred speech or other difficulty

in speaking

confusion or hallucinations

fever or other signs of infection,

such as a sore throat

rash or hives

chills, sweating or clammy skin

fever, muscle weakness, loss of

appetite and fatigue

muscle pain

weight loss

anaemia (being tired and looking

pale)

red or purple spots visible

through your skin

itching, inflamed, cracking or red

skin

tightness of the chest, wheezing,

coughing or difficulty breathing

yellowing of the skin or the

whites of the eyes, pale stools and

dark urine with vomiting and

stomach pain.

These may be serious side effects and

you may need urgent medical

attention

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to clopidogrel, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and Disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C.

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 this medicine 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 tells you to stop taking

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What APO-Clopidogrel looks

like

APO-Clopidogrel 75 mg is a reddish

brown, round biconvex film-coated

tablets, engraved "APO" on one side

and "CL" over "75" on the other side.

Blister packs of 28 tablets.

Bottles of 28, 100, 500 & 1000

tablets.

Not all pack types and/or pack sizes

may be available.

Ingredients

Each tablet contains 75 mg of

clopidogrel.

APO-CLOPIDOGREL TABLETS

It also contains the following inactive

ingredients:

lactose

methylcellulose

crospovidone

colloidal anhydrous silica

zinc stearate

hydroxypropylcellulose

hypromellose

macrogol 8000

titanium dioxide

iron oxide red.

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

APO-Clopidogrel 75 mg tablets

(blister pack): AUST R 198523.

APO-Clopidogrel 75 mg tablets

(bottle): AUST R 221806.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was prepared in:

May 2017

APO-CLOPIDOGREL TABLETS

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Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-1-2019

Succinate dehydrogenase inhibitor (SDHI) fungicides: ANSES presents the results of its expert appraisal

Succinate dehydrogenase inhibitor (SDHI) fungicides: ANSES presents the results of its expert appraisal

A group of scientists recently warned of the potential health risks of using succinate dehydrogenase inhibitor (SDHI) fungicides in agriculture. In this context, ANSES asked a group of independent experts to examine the hypotheses put forward by these scientists. The experts considered all the available scientific data in order to determine, in particular, whether this evidence constituted a health alert.

France - Agence Nationale du Médicament Vétérinaire

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

21-12-2018

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabel...

Health Canada

18-12-2018

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

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

Health Canada

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

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

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

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

7-8-2018

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Voluntary Recall Notice of El Guapo Jamaica Hibiscus Flower Pouches Due to Unlabeled Peanut Allergen

Mojave Foods Corporation is initiating a voluntary recall of four sizes of El Guapo Jamaica Hibiscus Flower packages in flexible packaging due to an unlabeled peanut allergen

FDA - U.S. Food and Drug Administration

26-7-2018

Trek Bicycle Corporation recalls Bontrager Line Pro Flat Bicycle Pedals

Trek Bicycle Corporation recalls Bontrager Line Pro Flat Bicycle Pedals

The pedals may have been manufactured with hydrogen embrittlement in the spindle of the pedals, causing one or both of the pedals to fail. When it fails, the pedal body separates from the spindle. If this happens while the bicycle is being operated, the rider could potentially lose control of the bicycle and fall.

Health Canada

19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Dicerna Ireland Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Transfer of orphan designation - Commission Decision (2019)2156 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004770

Europe -DG Health and Food Safety

18-3-2019


Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Orphan designation: Amikacin sulfate (liposomal), Treatment of Pseudomonas aeruginosa lung infection in cystic fibrosis, 25/07/2006, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Amikacin sulfate, Treatment of nontuberculous mycobacterial lung disease, 08/04/2014, Positive

Orphan designation: Amikacin sulfate, Treatment of nontuberculous mycobacterial lung disease, 08/04/2014, Positive

Orphan designation: Amikacin sulfate, Treatment of nontuberculous mycobacterial lung disease, 08/04/2014, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues, Treatment of primary hyperoxalu

Orphan designation: synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues, Treatment of primary hyperoxalu

Orphan designation: synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues, Treatment of primary hyperoxaluria, 31/07/2018, Positive

Europe - EMA - European Medicines Agency

11-3-2019


Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

25-2-2019

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Insmed Netherlands B.V.)

EU/3/14/1259 (Active substance: Amikacin sulfate) - Transfer of orphan designation - Commission Decision (2019)1625 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003885

Europe -DG Health and Food Safety

25-2-2019

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Insmed Netherlands B.V.)

EU/3/06/387 (Active substance: Amikacin sulfate (liposomal)) - Transfer of orphan designation - Commission Decision (2019)1624 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003770

Europe -DG Health and Food Safety

22-2-2019


Orphan designation: Triheptanoin, Treatment of long-chain 3-hydroxyacyl-coA dehydrogenase deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of long-chain 3-hydroxyacyl-coA dehydrogenase deficiency, 28/07/2015, Positive

Orphan designation: Triheptanoin, Treatment of long-chain 3-hydroxyacyl-coA dehydrogenase deficiency, 28/07/2015, Positive

Europe - EMA - European Medicines Agency

22-2-2019


Orphan designation: Triheptanoin, Treatment of very long-chain acyl-CoA dehydrogenase deficiency, 19/06/2015, Positive

Orphan designation: Triheptanoin, Treatment of very long-chain acyl-CoA dehydrogenase deficiency, 19/06/2015, Positive

Orphan designation: Triheptanoin, Treatment of very long-chain acyl-CoA dehydrogenase deficiency, 19/06/2015, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,Potassium hydrogen carbonate, decision type: , therapeutic area: , PIP number: P/0355/2018

Europe - EMA - European Medicines Agency

4-2-2019

Clopidogrel Teva (Teva B.V.)

Clopidogrel Teva (Teva B.V.)

Clopidogrel Teva (Active substance: Clopidogrel) - Centralised - Yearly update - Commission Decision (2019)851 of Mon, 04 Feb 2019

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

4-2-2019

Stalevo (Orion Corporation)

Stalevo (Orion Corporation)

Stalevo (Active substance: Levodopa,carbidopa,entacapone) - Centralised - Yearly update - Commission Decision (2019)847 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

29-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,Isavuconazonium (sulfate), decision type: , therapeutic area: , PIP number: P/0314/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,Isavuconazonium (sulfate), decision type: , therapeutic area: , PIP number: P/0314/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cresemba,Isavuconazonium (sulfate), decision type: , therapeutic area: , PIP number: P/0314/2018

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

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), decision type: , therapeutic area: , PIP number: P/0346/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), decision type: , therapeutic area: , PIP number: P/0346/2018

Opinion/decision on a Paediatric investigation plan (PIP): Amikacin (sulfate), decision type: , therapeutic area: , PIP number: P/0346/2018

Europe - EMA - European Medicines Agency

11-1-2019


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

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

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

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Active substance: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1))) - Orphan designation - Commission Decision (2018)9019 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/157/18

Europe -DG Health and Food Safety

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

Ziagen (Active substance: abacavir sulfate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8685 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/252/T/104

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

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

Opinion/decision on a Paediatric investigation plan (PIP): Potassium citrate monohydrated,potassium hydrogen carbonate (ADV7103), decision type: , therapeutic area: , PIP number: P/0214/2018

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

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

14-11-2018

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Teva B.V.)

Clopidogrel ratiopharm (Active substance: clopidogrel) - Centralised - Yearly update - Commission Decision (2018)7602 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Dicerna EU Limited)

EU/3/18/2052 (Active substance: Synthetic double-stranded siRNA oligonucleotide directed against lactate dehydrogenase A mRNA and containing four modified nucleosides which form a ligand cluster of four N-acetylgalactosamine residues) - Orphan designation - Commission Decision (2018)5284 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/052/18

Europe -DG Health and Food Safety