Afinitor

Main information

  • Trade name:
  • Afinitor 10 mg Tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, PA/AL/PVC, 30 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Lek Pharmaceuticals d.d.

Documents

Localization

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

Therapeutic information

  • Therapeutic indications:
  • The treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. The evidence is based on change in SEGA volume. Further clinical benefit, such as improvement of disease-related symptoms, has not been demonstrated.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 13654
  • Authorization date:
  • 31-07-2008
  • Last update:
  • 27-09-2017

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

Afinitor®

Page 1 of 5

Afinitor

2.5mg, 5mg and 10mg tablets

Everolimus

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Afinitor.

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 final

page. More recent information on the

medicine may be available.

You should ensure that you speak to

your pharmacist or doctor to obtain

the most up to date information on

the medicine.

You can also download

the most up to date leaflet from

www.medsafe.govt.nz

Those updates may contain important

information about the medicine and its

use of which you should be aware.

All medicines have risks and benefits

Your doctor has weighed the risks of

you taking Afinitor 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 the medicine.

You may need to read it again.

What Afinitor is used

for

Afinitor is used in the treatment of

renal cell carcinoma, a type of kidney

cancer; pancreatic neuroendocrine

tumours (pNET), a type of cancer

located in the pancreas; or

subependymal giant cell astrocytoma

(sometimes called ‘SEGA’), a specific

type of brain tumor) associated with a

disease called tuberous sclerosis.

Everolimus is the active substance in

Afinitor.

Treatment of kidney cancer

Afinitor stops the cancer from making

new cells and cuts off the blood

supply. This slows the growth and

spread of the cancer.

Treatment of pNET

Afinitor is used to control the growth

of these tumours located in the

pancreas.

Treatment of SEGA

Afinitor reduces the size of brain s

(SEGA) that are caused by a genetic

disorder called tuberous sclerosis. This

may stop the tumors from causing

problems as they grow, such as

hydrocephalus (excessive

accumulation of fluid within the brain).

The medicine is started by a

specialist doctor experienced in

tumour treatments. Ask your doctor

if you have any questions about why

this medicine has been prescribed

for you.

Your doctor may have prescribed it for

another reason.

Afinitor is available only with a

doctor’s prescription and is not

addictive.

Afinitor is not to be used in children

and adolescents (below 18 years of

age) who have liver problems.

Before you take Afinitor

When you must not take it

Do not take Afinitor if you have an

allergy to:

everolimus, the active ingredient in

Afinitor

a medicine called Rapamune which

contains the active ingredient

sirolimus

any of the ingredients listed at the

end of this leaflet

Some of the symptoms of an allergic

reaction may include shortness of

breath, wheezing or difficulty

breathing; swelling of the face, lips,

tongue or other parts of the body; rash,

itching or hives on the skin.

Do not take this medicine after the

expiry date printed on the pack or if

the packaging is torn or shows signs

of tampering.

If it has expired or is damaged, return it

to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have or have

had any of the following medical

conditions:

problems with your liver

diabetes or high levels of blood

sugar

Tell your doctor if you have any

infections.

It may be necessary to treat your

infections before starting Afinitor.

Tell your doctor if you are pregnant

or plan to become pregnant.

Afinitor is not recommended for use

during pregnancy. Your doctor can

discuss with you the risks and benefits

involved.

Tell your doctor if you are breast-

feeding.

Breastfeeding is not recommended

while you are taking Afinitor and for

two weeks after the last dose of

Afinitor. It is not known whether

Afinitor passes into breast milk and

could affect your baby.

Women of child-bearing potential

should use a highly effective

contraceptive method

(like condoms

or the Pill) during treatment with

Afinitor and for 8 weeks after

treatment has stopped. If you think you

may have become pregnant, ask your

doctor for advice before taking any

more Afinitor.

Afinitor may have an impact on male

fertility. Absence of periods

(amenorrhea) has been observed in

some female patients receiving

Afinitor.

Afinitor®

Page 2 of 5

Tell your doctor if you have lactose

intolerance.

Afinitor tablets contain lactose.

Tell your doctor if you are about to

have surgery or if you have had

recent surgery or if you still have an

unhealed wound following surgery.

Afinitor may increase the risk of

problems with wound healing.

Tell your doctor if you have allergies

to any other medicines, foods,

preservatives or dyes.

Your doctor will want to know if you

are prone to allergies.

Tell your doctor if you have

previously had hepatitis B, because it

may be reactivated during treatment

with Afinitor.

If you have not told your doctor

about any of the above, tell him/her

before you start taking Afinitor.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other medicines,

including any that you get without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and Afinitor may

interfere with each other. These

include:

antibiotics such as rifampicin,

rifabutin, clarithromycin and

erythromycin

antifungal medicines such as

ketoconazole, voriconazole,

fluconazole and itraconazole

medicines for high blood pressure

or heart problems such as diltiazem

and verapamil

medicines used to treat high blood

pressure or other cardiovascular

problems known as ACE inhibitors

drugs used to treat HIV/AIDS such

as ritonavir, amprenavir,

fosamprenavir, efavirenz and

nevirapine

epilepsy medicines such as

carbamazepine, phenobarbitone and

phenytoin

St John’s wort

drugs used to stop the body from

rejecting organ transplants such as

cyclosporin

drugs uses to prevent vomiting such

as aprepitant

corticosteroids such as

dexamethasone, prednisone,

prednisolone

Such medicines may be affected by

Afinitor or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Tell your doctor if you are taking

anti-seizure medications and your

dose changes.

A change in the dose of your

medication (up or down) may require a

change in Afinitor dose.

Tell your doctor if you need to

receive a vaccination.

Some vaccines may be less effective if

given when taking Afinitor.

Your doctor and pharmacist have more

information on medicines to be careful

with or avoid while taking this

medicine.

How to take Afinitor

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 label ask your

doctor or pharmacist for help.

How much to take

Treatment of kidney cancer and

pancreatic neuroendocrine tumours

Your doctor will tell you the dose that

you should take. The usual dose is

10 mg taken once a day

.

A higher or lower dose may be

recommended in some situations (e.g.

if you have liver problems).

Treatment of SEGA

Your doctor will tell you the dose that

you need to take depending on your

body size and other medicines you are

taking.

Blood tests are necessary during

treatment with Afinitor to measure the

amount of Afinitor in your blood and

find the appropriate daily dose for you.

How to take it

Take it on an empty stomach or after

a light fat-free meal. Do not take it

with a meal that is high in fat.

Dietary fats can interfere with the

absorption of the tablet and stop it

working properly.

Swallow the tablet whole with a glass

of water. Do not crush or chew it.

If you cannot swallow Afinitor tablets

whole, you can stir them into a glass of

water:

Put the required tablet(s) into a

glass of water (containing

approximately 30 mL)

Gently stir the contents until the

tablet(s) break apart and drink

immediately

Rinse the glass with the same

amount of water (approximately

30 mL) and drink the contents to

make sure that you get the full

dose of Afinitor

Take the tablet at the same time each

day, preferably in the morning.

Taking it at the same time each day

will help you remember when to take

it. It will also help to keep a steady

amount of the medicine in your

bloodstream.

Do not take it with grapefruit juice.

Grapefruit juice can interfere with the

absorption of the tablet. Grapefruit, star

fruit and Seville oranges should be

avoided during treatment.

How long to take it

Keep taking this medicine for as long

as your doctor tells you.

If you have certain side effects from

Afinitor (e.g. lung or breathing

problems, mouth ulcers), your

doctor might need to reduce your

dose of Afinitor; or to interrupt or

discontinue your treatment with

Afinitor.

If you forget to take it

If it is more than 6 hours after you

normally take it, skip the tablet you

missed and take your next tablet

when you are meant to.

If it is less than 6 hours after you

normally take it, you may still have

the tablet. Then go back to taking

your medicine as you would

normally.

Afinitor®

Page 3 of 5

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 Poisons and Hazardous

Chemicals National Information

Centre, Dunedin (telephone 0800

POISON or 0800 764 766) for advice,

or go to the Accident and Emergency

Department at the nearest hospital,

if you think that you or anyone else

may have taken too much Afinitor.

Do this even if there are no signs of

discomfort or poisoning.

While you are taking

Afinitor

Things you must do

Keep all of your doctor’s

appointments so that your progress

can be checked.

Your doctor will do tests from time to

time to make sure the medicine is

working and to prevent unwanted side

effects.

You will have regular blood tests

during treatment. These will monitor

the amount of blood cells (white blood

cells, red blood cells and platelets) in

your body to see if Afinitor is having

an unwanted effect on these cells.

Blood tests will also be carried out to

monitor your kidney function (levels of

creatinine, blood urea nitrogen or

urinary protein), liver function (level of

transaminases) and your blood sugar

levels, because these can also be

affected by Afinitor.

Kidney failure has been observed in

some patients receiving Afinitor. Your

doctor will monitor your kidney

function during your treatment with

Afinitor.

Tell your doctor if you experience

new or worsening cough, difficulty

breathing or wheezing.

Your doctor may need to change the

amount of Afinitor you have, or add

another medicine to help with this side

effect.

Tell you doctor straight away if you

have a temperature or chills, or

another sign of an infection.

Some infections may be severe and

may have fatal consequences in adults

and children.

You may need medical treatment.

Tell your doctor if you experience

pain or discomfort in the mouth or

have open sores in the mouth.

You might need treatment with a

mouthwash or gel. Some mouthwashes

and gels can make ulcers worse, so

don’t try anything without checking

with your doctor first.

Make sure you use a contraceptive to

prevent pregnancy during treatment

with Afinitor. If you become

pregnant while taking this medicine,

tell your doctor immediately.

If you want to be vaccinated, tell

your doctor you are taking Afinitor

before you have the vaccination.

Afinitor may affect your response to

vaccination. Some vaccines may not be

suitable for you.

If you are about to be started on any

new medicine, remind your doctor

and pharmacist that you are taking

Afinitor.

Tell any other doctors, dentists, and

pharmacists who treat you that you

are taking this medicine.

Things you must not do

Do not take Afinitor to treat any

other complaints unless your doctor

tells you to.

Do not give your medicine to anyone

else, even if they have the same

condition as you.

Things to be careful of

Be careful driving or operating

machinery until you know how

Afinitor affects you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Afinitor.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists 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 or pharmacist if

you notice any of the following and

they worry you:

sore mouth, cold sores or mouth

ulcers

dry mouth

dehydration

fatigue or unusual weakness

trouble sleeping (insomnia)

aggression, irritability, feeling

agitated, fits

nausea, vomiting, diarrhoea,

constipation, abdominal pain

difficulty swallowing, loss of

appetite, disturbance of taste,

weight loss

heartburn

headache, dizziness

nose bleeds

absence of periods (amenorrhea) or

irregular periods in females

swelling of hands, feet or limbs due

to fluid retention

dry or red skin

rash and pain on the palms of your

hands or soles of your feet

infections including inflammation

of the sinuses and nasal passages,

middle or outer ear infection,

gastric infection, sore throat and

runny nose, skin infections,

ringworm (a fungus infection of the

skin), infections of the hair follicle,

urinary tract infection,

conjunctivitis, upper respiratory

tract infection, pneumonia

fever

cough, stuffy or runny nose

poor wound healing

mouth ulcers

nail disorders

Afinitor®

Page 4 of 5

acne

red, itching, oozing cysts which

become scaly, crusted, or hardened

small, solid pink or red bumps on

the skin

painful skin rash with small fluid-

filled blisters in a limited area on

one side of the body (left or right),

often in a stripe (herpes zoster)

headache, pressure in the eyes, nose

or cheek area which is a sign of

swelling of the sinuses and nasal

area

breathlessness

bleeding eg. in the gut wall

cloudy urine

trouble walking (gait disturbance).

If any of the following happen, tell

your doctor immediately:

symptoms of an allergic reaction

such as shortness of breath,

wheezing or difficulty breathing;

swelling of the face, lips, tongue or

other parts of the body; rash,

itching or hives on the skin

constant "flu-like" symptoms such

as fever, chills, sore throat, aching

joints, swollen glands, cough, or

any other signs of infection such as

infection of a cut or scratch

burning sensation on urination or

increased urgency to urinate

coughing or shortness of breath,

which could be signs of a lung

problem

shortness of breath or rapid

breathing which could be a sign of

a lung problem

fever, coughing, difficulty

breathing or wheezing

fever, chills, rapid breathing and

heart rate, rash, and possibly

confusion and disorientation (signs

of serious infection)

shortness of breath, swelling of the

feet or legs which could be a sign

of heart failure

sudden onset of shortness of breath,

chest pain or coughing up blood

which could be a sign of one or

more blocked arteries in your lungs

symptoms of hepatitis B such as

fever, skin rash, joint pain,

inflammation, fatigue, loss of

appetite, nausea, jaundice

(yellowing of the skin), pain in the

upper right abdomen, pale stool or

dark urine

high level of sugar in the blood

(diabetes), worsening of diabetes

swelling and/or pain in one of your

legs, usually your calf, (redness or

warm skin in the affected area)

swelling, feeling of heaviness or

tightness, pain, limited movement

of body parts which could be a sign

of fluid build-up and a problem

with your lymphatic system.

The above list includes serious side

effects. You may need urgent medical

attention or hospitalisation.

Hepatitis B reactivation has been

observed in some patients receiving

Afinitor. Tell your doctor if you

experience any of the following

hepatitis B symptoms:

The first symptoms may be

nonspecific, including fever, skin rash,

joint pain and inflammation. Other

symptoms may include fatigue, loss of

appetite, nausea, jaundice (yellowing

of the skin), and pain in the upper right

abdomen. Pale stool or dark urine may

also be signs of hepatitis.

Tell your doctor straight away

if you

experience new or worsening

lung/breathing symptoms like cough,

chest pain or shortness of breath, as

severe lung or breathing problems

might have life-threatening

consequences. Your doctor might need

to reduce your dose of Afinitor; or to

interrupt or discontinue your treatment

with Afinitor, and add another

medicine to help with this side effect.

Tell your doctor

if you experience

pain or discomfort in the mouth or

have open sores in the mouth. Your

doctor might need to reduce your dose

of Afinitor; or to interrupt or

discontinue your treatment with

Afinitor.

Tell your doctor if you notice

anything else that is making you feel

unwell.

Other side effects not listed here or not

yet known may happen in some people.

Some of these side effects can only be

found by laboratory testing (for

example high levels of cholesterol or

lipids or sugar in the blood).

After taking Afinitor

Storage

Keep the tablets in the original

packet and foils until it is time to

take them.

Store the tablets in a cool, dark and

dry place at room temperature.

Do not store Afinitor or any other

medicine in the bathroom or near a

sink.

Do not leave it in the car or on

window sills.

Keep the medicine where young

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 the expiry date has

passed, ask your pharmacist what to

do with any medicine that is left

over.

Product description

What it looks like

Afinitor tablets are white to yellowish,

round and marbled. Afinitor tablets are

available in three different strengths,

supplied in packs of 30 tablets:

2.5 mg: with “LCL” on one side

and “NVR” on the other

5 mg: with “5” on one side and

“NVR” on the other

10 mg: with “UHE” on one side

and “NVR” on the other

Ingredients

Afinitor tablets contain 2.5, 5 and 10

mg of everolimus

as the active

ingredient. They also contain:

butylated hydroxytoluene

magnesium stearate

lactose

hypromellose

crospovidone

lactose anhydrous

Afinitor®

Page 5 of 5

This medicine does not contain

sucrose, gluten, tartrazine or any other

azo dyes.

Sponsor

Afinitor is supplied in New Zealand

Novartis New Zealand Limited

109 Carlton Gore Road

Newmarket

Auckland 1023

PO Box 99102

Newmarket

Auckland 1149

Telephone 0800 354 335

= Registered Trademark

This leaflet was prepared in June 2017.

(afi090617cNZ.doc) based on DS

(afi090617iNZ.doc)

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Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018


European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

European network of paediatric research at the European Medicines Agency (Enpr-EMA) Coordinating Group and networks meeting, European Medicines Agency via Adobe Connect, from 22/10/2018 to 22/10/2018

Europe - EMA - European Medicines Agency

29-11-2018


Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Committee for Medicinal Products for Human Use (CHMP): 15-18 October 2018, European Medicines Agency, London, UK, from 15/10/2018 to 18/10/2018

Europe - EMA - European Medicines Agency

28-11-2018

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk

Sprout Creek Farm of Poughkeepsie, New York is recalling 4 wheels of “Kinkead” cheese made on 5-10-18, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, L...

FDA - U.S. Food and Drug Administration

24-11-2018

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

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

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

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

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

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

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: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia

Orphan designation: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII, Treatment of haemophilia A, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

10-1-2019


Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment

Orphan designation: glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine, Treatment of maple syrup urine disease, 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

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

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

10-12-2018

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

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

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

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

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

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Krka d. d., Novo mesto)

Emtricitabine/Tenofovir disoproxil Krka (Active substance: emtricitabine / tenofovir disoproxil) - Centralised - 2-Monthly update - Commission Decision (2018)7884 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4215/IB/10G

Europe -DG Health and Food Safety

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

12-11-2018

Spinraza (Biogen Netherlands B.V.)

Spinraza (Biogen Netherlands B.V.)

Spinraza (Active substance: nusinersen) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7550 of Mon, 12 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4312/T/10

Europe -DG Health and Food Safety

23-10-2018

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Eli Lilly Nederland B.V.)

EU/3/16/1804 (Active substance: Pegylated recombinant human interleukin-10) - Transfer of orphan designation - Commission Decision (2018)6994 of Tue, 23 Oct 2018

Europe -DG Health and Food Safety

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

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

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

Europe -DG Health and Food Safety