Abilify

Main information

  • Trade name:
  • Abilify 10 mg Tablet
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, Al/AL - 5 tablets, 5 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Otsuka Pharmaceutical Co Ltd

Documents

Localization

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

Therapeutic information

  • Therapeutic indications:
  • ABILIFY is indicated of the treatment of schizophrenia including maintenance of clinical improvement during continuation therapy.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12918
  • Authorization date:
  • 18-08-2006
  • Last update:
  • 27-09-2017

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

ABILIFY™

ABILIFY™

5mg, 10mg, 15mg, 20mg & 30mg tablet

Aripiprazole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ABILIFY. It does

not contain all the available

information. Some of the information

contained in this leaflet may not

apply to you.

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 ABILIFY

against the benefits it is expected to

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 ABILIFY is used

for

ABILIFY is a trade name

(manufacturer's name) for the

medicine aripiprazole (Ari-pip-rah-

zol).

ABILIFY belongs to a group of

medicines called antipsychotic agents

which improve the symptoms of

certain types of mental illness.

ABILIFY is used to treat symptoms

of schizophrenia.

ABILIFY may be given to treat acute

episodes of sustained upward mood

swings (mania) in adult patients with

Bipolar 1 Disorder. During mania,

patients experience episodes of

overactivity, elation or irritability.

Schizophrenia is a mental illness

with disturbances in thinking,

feelings and behaviour.

Bipolar disorder is a condition with

symptoms such as feeling "high",

having excessive amounts of energy,

needing much less sleep than usual,

talking very quickly with racing

ideas and sometimes severe

irritability.

Your doctor may have prescribed

ABILIFY for another reason. Ask

your doctor if you have any questions

about why ABILIFY has been

prescribed for you.

There is no evidence that ABILIFY

is addictive.

This medicine is available only with

a doctor's prescription.

ABILIFY is not recommended for

use in children under the age of 18,

as safety and efficacy have not been

established in this age group.

Before you take

ABILIFY

When you must not take it

Do not take ABILIFY if you have

an allergy to:

aripiprazole

any of the ingredients listed at the

end of this leaflet

Symptoms of an allergic reaction

include:

rash, itching or hives on the skin

shortness of breath, wheezing or

difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

Do not take ABILIFY after the

expiry or use by date printed on

the pack.

If you take this medicine after this

date has passed, it may not work as

well.

Do not take ABILIFY if the

packaging is torn or shows signs of

tampering.

If this is the case, return it to your

pharmacist.

If you are not sure whether you

should start taking ABILIFY, talk

to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines

any other substances such as

foods, preservatives or dyes

Tell your doctor if you are

pregnant or intend to become

pregnant.

ABILIFY is not recommended for

use during pregnancy. If you need to

take ABILIFY during your

pregnancy, your doctor will discuss

with you the benefits and risks of

taking it. Babies exposed to

antipsychotics (including ABILIFY)

during the third trimester of

pregnancy are at risk of experiencing

shaking, muscle stiffness, difficulty

in feeding and/or withdrawal

symptoms. These symptoms may

ABILIFY™

resolve spontaneously or require

additional medical treatment.

Tell your doctor or pharmacist if

you are breast-feeding or plan to

breast-feed.

It is recommended that you do not

breast-feed while taking ABILIFY,

as it may pass into breast milk and

therefore there is a possibility that the

breast-fed baby may be affected.

Tell your doctor if you have, or

have had any medical conditions,

especially the following:

a reaction to some medicines with

a sudden increase in body

temperature, sweating, fast heart

beat, muscle stiffness and

fluctuating blood pressure, which

may lead to coma. This reaction

is called neuroleptic malignant

syndrome.

a reaction to some medicines with

abnormal movements of the

tongue, or other uncontrolled

movements of the mouth, tongue,

cheeks or jaw which may

progress to the arms and legs.

This reaction is called tardive

dyskinesia.

low blood pressure

problems with your heart or blood

vessels

epilepsy, seizures or fits

problems with your oesophagus

(food pipe) such as difficulty in

swallowing.

high blood sugar or diabetes

mellitus

Alzheimer's disease or dementia

alcohol or drug abuse or

dependence or a history of one of

these

venous thromboembolism or are

at risk of venous

thromboembolism

lactose intolerance

Tell your doctor if you have past

experience of excessive gambling.

Tell your doctor if you drink

alcohol.

Your doctor may advise you to avoid

alcohol as it can magnify the side-

effects of this medicine.

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start taking

ABILIFY.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and ABILIFY may

interfere with each other. These

include:

medicines used to treat brain

disorders such as, anxiety,

depression, mood swings,

epilepsy or seizures, Parkinson's

disease or insomnia.

medicines used to treat high

blood pressure

medicines used to treat fungal

infections

medicines used to treat heart

rhythm disturbances

medicines used to treat bacterial

or viral infections

a medicine called cyclosporin (

Neoral

; Sandimmun

a medicine called cimetidine

(Tagamet

; Magicul

These medicines may be affected by

ABILIFY, or may affect how well it

works. Your doctor may need to

adjust your dose of Abilify or of the

other medicine.

Eating grapefruit or drinking

grapefruit juice may affect how

ABILIFY works.

Your doctor or pharmacist may have

more information on medicines to be

careful with or avoid while taking

ABILIFY.

How to take ABILIFY

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

Your doctor or pharmacist will tell

you how much you will need to take

each day. This will depend on your

condition and whether you are taking

any other medicines.

The label put on the carton by the

pharmacist will tell you how much

you should take.

If you do not understand the

instructions on the carton, ask

your doctor or pharmacist for

help.

How to take it

ABILIFY tablets should be

swallowed whole and washed down

with a glass of water.

Take ABILIFY at about the same

time each day.

Unless your doctor gives you other

directions, you should take ABILIFY

only once a day.

Taking the medicine at the same time

each day will have the best effect. It

will also help you remember when to

take it.

It does not matter whether you take

ABILIFY with or without food.

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.

ABILIFY™

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

How long to take it

Continue taking ABILIFY for as

long as your doctor tells you.

ABILIFY helps to control your

condition but does not cure it.

Therefore you must take ABILIFY

every day. Improvement in

symptoms may take several days to

some weeks to occur. Even if you

feel better do not stop taking

ABILIFY unless your doctor tells

you to.

If you take too much

(overdose)

Immediately telephone your doctor

or pharmacist or the Poisons

Information Centre (telephone

131126), or go to the Accident

Emergency Centre at your nearest

hospital, if you or anyone else may

have taken too much ABILIFY. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are taking

ABILIFY

Things you must do

Tell any doctors, dentists or

pharmacists who are treating you

that you are taking ABILIFY.

If you are about to be started on

any new medicine, tell your doctor,

dentist and pharmacist that you

are taking ABILIFY.

If you plan to have any kind of

surgery that needs a general

anaesthetic, tell your doctor or

dentist that you are taking

ABILIFY.

If you become pregnant while

taking ABILIFY, tell your doctor

immediately.

Be sure to keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not give ABILIFY to anyone

else, even if their symptoms seem

similar or they have the same

condition as you.

Do not take ABILIFY to treat any

other complaints unless your

doctor or pharmacist tells you to.

Do not stop taking ABILIFY or

lower the dosage, even if you are

feeling better, without checking

with your doctor.

If you stop taking ABILIFY

suddenly your condition may worsen.

Do not take more of this medicine

and do not take it more often than

your doctor has ordered.

Things to be careful of

Make sure that you know how you

react to ABILIFY before you drive

a car, operate machinery or do

anything else that could be

dangerous if you are dizzy or light

headed or not alert.

ABILIFY may cause some people to

become drowsy or less alert than they

are normally or cause light-

headedness, dizziness or tiredness. If

this occurs do not undertake the

activity.

If ABILIFY makes you feel light-

headed, dizzy or faint, be careful

when getting up from a sitting or

lying position.

Getting up slowly may help.

Be careful when drinking alcohol

while taking ABILIFY.

Your doctor may suggest you avoid

alcohol while you are being treated

with ABILIFY.

Make sure you keep cool in hot

weather and keep warm in cool

weather.

ABILIFY may affect the way your

body reacts to temperature changes.

It may prevent sweating, even during

heatwaves. You may feel dizzy or

faint if you are too hot. To stay cool

in hot weather, try to do the

following:

wear light clothing

spend time in air-conditioned

environments (or keep windows

open and use electric fans)

drink plenty of water

take cool baths or showers and

avoid hot baths and saunas

try to restrict exercise or heavy

work to cool parts of the day

Side-Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

ABILIFY.

Like other medicines ABILIFY may

cause some unwanted side effects.

These are likely to vary from patient

to patient. ABILIFY is generally

well-tolerated and the side effects are

often hard to distinguish from disease

symptoms. It is important that you

tell your doctor as soon as possible

about any unwanted effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following side effects and

they worry you:

headache

indigestion

nausea

vomiting

insomnia

constipation

light-headedness

drowsiness

agitation

anxiety

inability to sit or stand still;

restless movement of the arms

and legs such as tapping,

ABILIFY™

marching in places, rocking,

crossing and uncrossing the legs.

These are the more common side

effects of ABILIFY

Tell your doctor if you notice the

following side effects:

feeling dizzy especially when

getting up from a lying or sitting

position

altered or increased sexual

interest

These side effects are uncommon.

high blood sugar (excessive thirst,

hunger and weakness) or the

onset or worsening of diabetes

This side effect is rare.

weight gain

weight loss

loss of appetite

excessive sweating

drowsiness

high blood pressure

chest pain

frequent infections such as fever,

severe chills, sore throat or mouth

ulcers

bleeding or bruising more easily

than normal

speech disorder

urinary incontinence

difficulty swallowing

hiccups

These side effects are very rare.

Tell your doctor if you have

obsessive (recurring) thoughts or

behaviours or trouble controlling

impulsive urges or while taking

ABILIFY.

Obsessive compulsive behaviours

(feeling the need to check things

repeatedly or having certain thoughts

repeatedly), gambling urges, sexual

urges, compulsive spending, binge or

compulsive eating and other urges

have occurred in some patients.

Tell your doctor immediately or go

to Accident and Emergency at

your nearest hospital if you notice

any of the following:

seizure, fits or convulsions.

fainting.

abnormal movements of the

tongue, or other uncontrolled

movements of the tongue, mouth,

cheeks, or jaw which may

progress to the arms and legs.

sudden increase in body

temperature, sweating, fast heart

beat, muscle stiffness, high blood

pressure and convulsions.

rash.

allergic reaction (rash, itching or

hives on the skin; shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body).

muscle pain, muscle weakness or

muscle stiffness.

inflammation of the pancreas,

severe upper stomach pain often

with nausea and vomiting.

disorder of body temperature

regulation resulting in low body

temperature or high body

temperature.

painful irreversible erection.

difficulty in passing urine.

yellowing of the skin and/or eyes,

also called jaundice with or

without nausea, vomiting, loss of

appetite, feeling generally unwell,

fever, itching and dark coloured

urine.

serious lung infection with fever,

chills, shortness of breath, cough,

chest pain and blood streaked

phlegm.

thoughts or talk about death or

suicide; thoughts or talk about

self-harm or doing harm to

others; any recent attempts at

self-harm; an increase in

aggressive behaviour, irritability

or agitation. If you or someone

you know is showing these signs

contact your doctor or a mental

health advisor right away or go to

the nearest hospital for treatment.

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

All of these side effects are very rare.

Other side effects not listed above

may occur in some patients.

Also, while taking ABILIFY, some

elderly patients with dementia have

suffered serious side effects such as a

"mini" stroke, stroke, pneumonia or

heart problems. These serious side

effects can be life threatening.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Do not be alarmed by this list of

possible side effects.

You may not experience any or only

some of them.

After using ABILIFY

Storage

Store ABILIFY in a cool place

where the temperature stays below

30°C.

Do not store it or any other

medicine in the bathroom. Do not

leave it in the car or on window

sills.

Heat and dampness can destroy some

medicines.

Keep it 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. Do

not keep outdated medicine or

medicine no longer needed.

Disposal

If your doctor tells you to stop

taking ABILIFY or the medicine

has passed its expiry date, ask your

pharmacist what to do with any

leftover medicine.

Be sure that any discarded

medicine is out of the reach of

children.

ABILIFY™

Product Description

What it looks like

5mg ABILIFY tablets are blue,

rectangular with a bevel edge and are

marked on one side with "A-007"

and "5" (Not available in New

Zealand)

10mg ABILIFY tablets are pink,

rectangular with a bevel edge and are

marked on one side with "A-008"

and "10".

15mg ABILIFY tablets are yellow,

round with a bevel edge and are

marked on one side with "A-009"

and "15".

20mg ABILIFY tablets are white to

pale yellowish white, round with a

bevel edge and are marked on one

side with "A-010" and "20".

30mg ABILIFY tablets are pink,

round with a bevel edge and are

marked on one side with "A-011"

and "30".

ABILIFY tablets are packed in

aluminium blisters in a carton. Each

carton contains 30 tablets.

Ingredients

Active ingredients:

aripiprazole

Other ingredients:

lactose, starch - maize, cellulose -

microcrystalline,

hydroxypropylcellulose and

magnesium stearate. The following

colorants are also present in the

tablets:

5mg tablets - indigo carmine

CI73015 aluminium lake (not

available in New Zealand)

10mg tablets - iron oxide red

CI77491

15mg tablets - iron oxide yellow

CI77492

20mg tablets - no colourants

30mg tablets - iron oxide red

CI77491

ABILIFY does not contain sucrose,

gluten, tartrazine or any other azo

dyes.

Sponsored by

In Australia:

Otsuka Australia Pharmaceutical Pty

Level 20, Tower A, The Zenith

821 Pacific Highway

Chatswood NSW 2067

Tel: Toll Free 1800 059 606

In New Zealand:

Pharmacy Retailing (NZ) Ltd trading

as Healthcare Logistics

58 Richard Pearse Drive

Airport Oaks

Mangere

Auckland 2022

Tel: Toll free 0800 602 200

Registration Numbers -

Australia

AUST R 90925 - 5mg tablets

AUST R 90997 - 10mg tablets

AUST R 90998 - 15mg tablets

AUST R 90999 - 20mg tablets

AUST R 91000 - 30mg tablets

Date of Preparation September 2016

ABILIFY is a trademark of Otsuka

Pharmaceutical Co., Ltd.

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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

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety