Accupril

Main information

  • Trade name:
  • Accupril 10 mg Tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, 1x7 starter pack, 7 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Hovione Limited

Documents

Localization

  • Available in:
  • Accupril 10 mg Tablet
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 4881
  • Authorization date:
  • 18-10-1990
  • Last update:
  • 27-09-2017

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

ACCUPRIL

ACCUPRIL

®

Quinapril hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Accupril.

It does not contain all the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Accupril

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with your

Accupril tablets.

You may need to read it again.

What Accupril is used

for

Accupril is used to lower high blood

pressure (hypertension). It is also

used to treat heart failure.

Hypertension

Accupril is used to lower high blood

pressure (hypertension). Everyone

has blood pressure. This pressure

helps get your blood all around your

body. Your blood pressure may be

different at different times of the day,

depending on how busy or worried

you are. You have hypertension

(high blood pressure) when your

blood pressure stays higher than is

needed, even when you are calm and

relaxed.

There are usually no symptoms of

hypertension. The only way of

knowing that you have hypertension

is to have your blood pressure

checked on a regular basis. If high

blood pressure is not treated it can

lead to serious health problems,

including stroke, heart disease and

kidney failure.

Heart Failure

Heart failure means that the heart

muscle is weak and cannot pump

blood strongly enough to supply all

the blood needed throughout the

body. Heart failure is not the same

as heart attack and does not mean

that the heart stops. Heart failure

may start off with no symptoms, but

as the condition progresses, patients

may feel short of breath or may get

tired easily after light physical

activity such as walking. Some

patients may wake up short of breath

at night. Fluid may collect in

different parts of the body, often first

noticed as swollen ankles and feet.

How Accupril works

Accupril works by widening your

blood vessels, which reduces

pressure in the vessels, making it

easier for your heart to pump blood

around your body. This helps

increase the supply of oxygen to your

heart, so that when you place extra

demands on your heart, such as

during exercise, your heart may cope

better and you may not get short of

breath as easily.

Accupril belongs to a group of

medicines called angiotensin

converting enzyme (ACE) inhibitors.

Your doctor may have prescribed

Accupril for another reason.

Ask your doctor if you have any

questions about why Accupril has

been prescribed for you.

Accupril is not addictive.

This medicine is available only with

a doctor's prescription.

Use in Children

The safety and effectiveness of

Accupril in children have not been

established.

Before you take

Accupril

When you must not take it

Do not take Accupril if:

you have an allergy to Accupril

or any other medicine containing

quinapril, or any of the

ingredients listed at the end of

this leaflet

you have taken any other 'ACE

inhibitor' medicine before, which

caused your face, lips, tongue,

throat, hands or feet to swell up,

or made it hard for you to breathe

you or your family have a history

of swelling of the face, lips,

tongue, throat, hands or feet for

no apparent reason.

Symptoms of an allergic reaction

may include skin rash, itchiness,

shortness of breath, swelling of the

face, lips or tongue, muscle pain or

tenderness or joint pain.

ACCUPRIL

If you have had an allergic reaction

to an ACE inhibitor before, you may

be allergic to Accupril.

Do not take Accupril if:

you have kidney problems or a

condition called 'renal artery

stenosis'

you have regular dialysis for

blood filtration.

You may experience an allergic

reaction.

Do not take Accupril if you are

currently taking a blood pressure

lowering medicine containing

aliskiren or with medicines known

as angiotensin receptor blockers

(ARB) or other ACE inhibitors

and you have the following

conditions:

diabetes

kidney problems

high levels of potassium in your

blood

congestive heart failure.

You may experience severe side

effects.

Do not take Accupril if you are

pregnant or breastfeeding.

Accupril may enter your womb or it

may pass into the breast milk and

there is the possibility that your baby

may be affected.

Do not take Accupril after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If you are not sure whether you

should start taking Accupril, talk

to your doctor.

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.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

kidney problems, or are having

dialysis

liver problems

heart problems

low blood pressure, which you

may notice as dizziness or light-

headedness

diabetes

high levels of potassium in your

blood.

You must also tell your doctor if

you:

are following a very low salt diet

are about to receive

desensitisation therapy for an

allergy

are about to undergo dialysis or

lipoprotein apheresis

are about to have surgery or a

general anaesthetic

plan to become pregnant or

breastfeed.

If you have not told your doctor

about any of the above, tell them

before you start taking Accupril.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including:

all prescription medicines

all medicines, vitamins, herbal

supplements or natural therapies

you buy without a prescription

from a pharmacy, supermarket,

naturopath or health food shop.

Some medicines may be affected by

Accupril 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 will advise you.

Tell your doctor or pharmacist if

you are taking any of the

following:

other medicines used to treat high

blood pressure

other medicines that work in a

similar fashion to ACE Inhibitors,

such as Angiotensin Receptor

Blockers (these are used to treat

high blood pressure and/or heart

failure).

diuretics, also known as fluid or

water tablets

non-steroidal anti-inflammatory

drugs (NSAIDs) or Cox 2

inhibiting medicines used to

relieve pain, swelling and other

symptoms of inflammation,

including arthritis

potassium supplements or

potassium-containing salt

substitutes

lithium, a medicine used to treat

mood swings and some types of

depression

tetracycline antibiotics

trimethoprim or

trimethoprim/sulfamethoxazole,

medicines used to treat bacterial

infections.

Tell your doctor if you are taking

any of the following blood pressure

lowering medicines:

angiotensin II receptor blocker

(ARB)

aliskiren.

For some patients, Accupril should

not be taken in combination with

these medicines.

Your doctor may check your kidney

function, blood pressure and the

amount of electrolytes (e.g.

potassium) in your blood at regular

intervals.

Tell your doctor if you are taking

any of the following medicines:

mTOR inhibitors (e.g.

temsirolimus), used in the

treatment of kidney cancer

DPP-IV inhibitors (e.g.

vildagliptin), used in the

treatment of diabetes.

Taking Accupril in combination with

these medicines may increase your

risk of having an allergic reaction.

If you are not sure if you are taking

any of the medicines mentioned in

this leaflet, check with your doctor or

pharmacist.

ACCUPRIL

Your doctor and pharmacist may

have more information on medicines

to be careful with or avoid while

taking Accupril.

How to take Accupril

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

Your doctor or pharmacist will tell

you how many tablets you will need

to take each day. This depends on

your condition and whether or not

you are taking any other medicines.

For high blood pressure

For most patients, not on diuretics,

the usual starting dose is 5 mg to 10

mg taken once a day. The dose may

need to be increased depending on

your blood pressure at an interval of

4 weeks. Most patients take between

10 mg and 40 mg each day.

This dose may be taken once a day or

divided into two equal doses per day

(one in the morning and one at

night).

For heart failure

The usual starting dose is 5 mg taken

once a day. In most patients,

effective doses are between 10 mg

and 20 mg a day. Your doctor will

advise whether the dose is to be

taken as a single dose or as two

separate doses (one in the morning

and one at night).

How to take it

Swallow Accupril whole with a full

glass of water.

Do not chew the tablets.

When to take it

Take Accupril at about the same

time each day.

Taking your tablets at the same time

each day will have the best effect. It

will also help you remember when to

take the tablets.

Take Accupril before meals.

Food with a high fat content may

interfere with the absorption of

Accupril.

How long to take it

Continue taking your medicine for

as long as your doctor tells you.

Accupril helps control your

condition, but does not cure it. It is

important to keep taking your

medicine every day even if you feel

well.

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 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.

If you take too much

(overdose)

Immediately telephone your doctor

or the Australian Poisons

Information Centre (telephone 13

11 26), or the New Zealand

National Poisons Information

Centre (telephone 0800 POISON

or 0800 764 766), or go to Accident

and Emergency at the nearest

hospital, if you think that you or

anyone else may have taken too

much Accupril.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

If you take too much Accupril, you

may feel light-headed, dizzy or you

may faint.

While you are taking

Accupril

Things you must do

If you are about to be started on

any new medicine, remind your

doctor, dentist or pharmacist that

you are taking Accupril.

Make sure you drink enough water

during exercise and hot weather

when you are taking Accupril,

especially if you sweat a lot.

If you do not drink enough water

while taking Accupril, you may feel

faint, light-headed or sick. This is

because your blood pressure is

dropping suddenly. If you continue

to feel unwell, tell your doctor.

Tell your doctor if you have excess

vomiting or diarrhoea while taking

Accupril.

You may lose too much water and

salt and your blood pressure may

drop too much.

Tell your doctor immediately if

you feel light-headed or dizzy after

taking your first dose of Accupril,

or when your dose is increased.

This is especially important if you

are taking Accupril for heart failure.

If you are going to have surgery

that needs a general anaesthetic,

tell your doctor or dentist that you

are taking Accupril.

Your blood pressure may drop

suddenly.

If you become pregnant while

taking Accupril, tell your doctor

immediately.

ACCUPRIL

If you are about to have any blood

tests, tell your doctor that you are

taking Accupril.

Accupril may interfere with the

results of some tests.

Have your blood pressure checked

when your doctor says, to make

sure Accupril is working.

Go to your doctor regularly for a

check-up.

Your doctor may occasionally do a

blood test to check your potassium

levels and see how your kidneys are

working.

Things you must not do

Do not give Accupril to anyone

else, even if they have the same

condition as you.

Do not take Accupril to treat any

other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking Accupril, or

change the dosage, without

checking with your doctor.

Things to be careful of

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the

change in position and blood

pressure. If this problem continues

or gets worse, talk to your doctor.

Be careful driving or operating

machinery until you know how

Accupril affects you.

As with other ACE inhibitor

medicines, Accupril may cause

dizziness, light-headedness or

tiredness in some people. Make sure

you know how you react to Accupril

before you drive a car, operate

machinery, or do anything else that

could be dangerous if you are dizzy

or light-headed. If this occurs do not

drive. If you drink alcohol, dizziness

or light-headedness may be worse.

Things that would be helpful

for your blood pressure or

heart failure

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.

Weight

Your doctor may suggest losing

some weight to help lower your

blood pressure and help lessen the

amount of work your heart has to do.

Some people may need a dietician's

help to lose weight.

Diet

Eat a healthy diet which includes

plenty of fresh vegetables, fruit,

bread (preferably wholegrain),

cereals and fish. Also eat less sugar

and fat (especially saturated fat)

which includes sausages, fatty meats,

full cream dairy products, biscuits,

cakes, pastries, chocolates, chips and

coconut. Monounsaturated and

polyunsaturated fats from olive oil,

canola oil, avocado and nuts are

beneficial in small quantities.

Salt

Your doctor may advise you to watch

the amount of salt in your diet. To

reduce your salt intake you should

avoid using salt in cooking or at the

table and avoid cooked or processed

foods containing high sodium (salt)

levels.

Exercise

Regular exercise, maintained over

the long term, helps to reduce blood

pressure and helps get the heart fitter.

Regular exercise also improves your

blood cholesterol levels, helps reduce

your weight and stress levels, and

improves your sleep, mood and

ability to concentrate. However, it is

important not to overdo it. Before

starting any exercise, ask your doctor

about the best kind of programme for

you.

Smoking

Your doctor may advise you to stop

smoking or at least cut down. Ask

your doctor or pharmacist for further

information and advice.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Accupril.

Accupril helps most people with high

blood pressure and heart failure, but

it may have unwanted side effects in

a few people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

It can be difficult to tell whether side

effects are the result of taking

Accupril, effects of your condition or

side effects of other medicines you

may be taking. For this reason it is

important to tell your doctor of any

change in your condition.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the list of

side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if...

Ask your doctor or pharmacist for

advice if you notice any of the

following and they worry you:

feeling light-headed, dizzy or

faint

dry cough

headache

feeling sick (nausea) or vomiting

stomach pain

diarrhoea

constipation

ACCUPRIL

unusual tiredness or weakness,

fatigue

feeling drowsy or sleepy during

the day

hair loss or thinning

dry mouth or throat

taste disturbances or loss of taste

confusion or nervousness

back pain

rash

difficulty in getting or

maintaining an erection.

These side effects are usually mild.

All side effects should be reported to

a health professional.

Tell your doctor as soon as

possible if...

Tell your doctor as soon as possible

if you notice any of the following:

disturbed vision

symptoms of sunburn (such as

redness, itching, swelling,

blistering) which may occur more

quickly than normal

itchy, raised or red skin rash

signs of worrying or frequent

infections such as fever, severe

chills, sore throat or mouth ulcers

aching, tender or weak joints or

muscles not caused by exercise

feelings of deep sadness and

unworthiness (depression)

severe upper stomach pain, often

with nausea and vomiting

passing little or no urine

bleeding or bruising more easily

than normal.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

Go to hospital if...

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital, if you notice

any of the following:

fainting within a few hours of

taking a dose

fast or irregular heart beat

shortness of breath or tightness in

the chest

sudden onset of stomach pains or

cramps with or without nausea or

vomiting

severe flaking or peeling of the

skin

severe blisters and bleeding in the

lips, eyes, mouth, nose and

genitals

chest pain.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation. These

side effects are very rare.

Stop taking Accupril and tell your

doctor immediately or go to

Accident and Emergency at your

nearest hospital if you notice the

following:

swelling of the face, lips, mouth,

tongue or throat which may cause

difficulty in swallowing or

breathing.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking Accupril

Storage

Keep your tablets in the box until

it is time to take them.

If you take the tablets out of the box

they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25 °C.

Do not store Accupril or any other

medicine in the bathroom or near a

sink.

Do not leave it on a windowsill or

in the car on hot days.

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 Accupril or the

tablets have passed their expiry

date, ask your pharmacist what to

do with any that are left over.

Product description

What it looks like

Accupril tablets come in three

strengths and each has a different

appearance:

Accupril 5 mg - Reddish-brown,

oval, biconvex, film-coated tablet

with bisecting score on both sides

and debossing "5" on both sides in

opposite direction.

Accupril 10 mg - Reddish-brown,

triangular, biconvex film-coated

tablet with bisecting score on both

sides and debossing "10" on one side.

Accupril 20 mg - Reddish-brown,

round, biconvex film-coated tablet,

with bisecting score on both sides

and debossing "20" on one side.

A box of Accupril contains 30

tablets.

Ingredients

Active ingredient:

Accupril 5 mg - 5 mg quinapril

(as the hydrochloride)

Accupril 10 mg - 10 mg quinapril

(as the hydrochloride)

Accupril 20 mg - 20 mg quinapril

(as the hydrochloride)

Other ingredients:

magnesium carbonate

lactose

ACCUPRIL

gelatin

crospovidone

magnesium stearate

candelilla wax

iron oxide red

titanium dioxide.

Accupril does not contain sucrose,

gluten, tartrazine or any other azo

dyes.

Supplier

Accupril is supplied in Australia by:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

West Ryde NSW 2114

Australia

Toll Free Number: 1800 675 229

Accupril is supplied in New Zealand

Pfizer New Zealand Limited

PO Box 3998

Auckland

New Zealand

Toll Free Number: 0800 736 363

Australian Registration

Numbers

Accupril 5 mg - AUST R 40926

Accupril 10 mg - AUST R 40928

Accupril 20 mg - AUST R 40930

This leaflet was prepared in August

2015.

©Pfizer Australia Pty Ltd 2015.

®Registered Trademark.

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The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018


Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Paediatric Committee (PDCO): 16-19 October 2018, European Medicines Agency, London, UK, from 16/10/2018 to 19/10/2018

Europe - EMA - European Medicines Agency

21-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

21-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

21-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Enforcement Report for the Week of October 10, 2018

Enforcement Report for the Week of October 10, 2018

Recently Updated Records for the Week of October 10, 2018 Last Modified Date: Tuesday, October 09, 2018

FDA - U.S. Food and Drug Administration

13-9-2018

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee

October 10, 2018: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement

FDA - U.S. Food and Drug Administration

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

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

12-7-2018

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

July 10, 2018: Pawtucket Woman Sentenced for Participation in Opioid Prescription Conspiracy

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

July 10, 2018: VA Medical Center Nurse Indicted, Arraigned for Allegedly Tampering with and Stealing Prescription Opioids

FDA - U.S. Food and Drug Administration

11-7-2018

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

July 10, 2018: Former Des Moines Pharmacy Technician Sentenced for Illegally Tampering with Fentanyl

FDA - U.S. Food and Drug Administration

11-7-2018

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

July 10: 2018: Former Pharmacy Technician Indicted for Stealing Fentanyl, Morphine

FDA - U.S. Food and Drug Administration

6-6-2018

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

January 10, 2018: Six Charged in Complex Fraud Involving Fraudulent Processing of Credit Card Payments

FDA - U.S. Food and Drug Administration

11-5-2018

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

May 10, 2018: South Carolina Couple Sentenced to a Total of 138 Months in Prison for Trafficking Counterfeit Goods, Including Misbranded Pet Medicine

FDA - U.S. Food and Drug Administration

10-5-2018

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

May 10, 2018: Former New Hampshire Pharmacist Sentenced to Two Years in Prison for Drug-Related Offenses

FDA - U.S. Food and Drug Administration

19-4-2018

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

March 30, 2018: Lynn Man Sentenced to Over 10 Years in Prison for Role in Counterfeit Steroid Conspiracy

FDA - U.S. Food and Drug Administration

17-4-2018

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

March 27, 2018: Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud

FDA - U.S. Food and Drug Administration

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

11-1-2019


Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Orphan designation: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant, Treatment of haemophilia B, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Orphan designation: autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA, Treatment of mucopolysaccharidosis type I, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Orphan designation: gefinitib, Treatment of Fanconi anaemia type A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Orphan designation: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG, Treatment of multiple myeloma, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

4-1-2019


Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Orphan designation: avapritinib, Treatment of mastocytosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Orphan designation: melatonin, Treatment of acute radiation syndrome, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

14-12-2018


Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Orphan designation: tiratricol, Treatment of Allan-Herndon-Dudley syndrome, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

26-11-2018

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware o

In the next few months CDRH will make public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. We’re considering focusing on predicates that are >10 years old as a starting point, so the public is aware of those technologies.

FDA - U.S. Food and Drug Administration

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

22-11-2018


Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Symkevi, tezacaftor / ivacaftor, Cystic Fibrosis, Date of authorisation: 31/10/2018, Status: Authorised

Europe - EMA - European Medicines Agency

22-10-2018

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Pfizer Europe MA EEIG)

EU/3/10/815 (Active substance: Sildenafil citrate) - Transfer of orphan designation - Commission Decision (2018)6993 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/068/10/T/01

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

By Aug. 10, all packages and advertisements for “covered” tobacco products (except for cigars and pipe tobacco) and roll-your-own/cigarette tobacco products must have the required nicotine warning statement. https://cards.twitter.com/cards/2m2m96/5xn98 …

FDA - U.S. Food and Drug Administration

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/WAPabvM811

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: WEAR HATS, SUNGLASSES, AND VISORS. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/WAPabvM811

FDA - U.S. Food and Drug Administration

21-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/YRV0lVSRkh

Pls RT: 10 Ways to Keep Athletes Safe While In the Sun: APPLY SUNSCREEN. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/YRV0lVSRkh

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

18-5-2018

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Chiesi Farmaceutici S.p.A.)

EU/3/10/778 (Active substance: Cysteamine bitartrate (gastroresistant)) - Transfer of orphan designation - Commission Decision (2018)3137 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/034/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (AbbVie Deutschland GmbH and Co. KG)

EU/3/10/830 (Active substance: Veliparib) - Transfer of orphan designation - Commission Decision (2018)3021 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/110/10/T/02

Europe -DG Health and Food Safety