Adefin XL

Main information

  • Trade name:
  • Adefin XL 60 mg Modified release tablet
  • Dosage:
  • 60 mg
  • Pharmaceutical form:
  • Modified release tablet
  • Units in package:
  • Blister pack, PA/Al/PVC (Alu/Alu), 30 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Bayer AG

Documents

Localization

  • Available in:
  • Adefin XL 60 mg Modified release tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • For the treatment of coronary heart disease.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12272
  • Authorization date:
  • 11-11-2005
  • Last update:
  • 27-09-2017

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

Page 1 of 4

NEW ZEALAND CONSUMER MEDICINE INFORMATION

ADEFIN XL

Nifedipine 30 mg & 60 mg modified release tablets

What is in this leaflet

This leaflet answers some common

questions about Adefin XL.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Adefin XL

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 Adefin XL is

used for

Adefin XL is used either to treat

high blood pressure or to prevent

chronic stable angina, one of a

number of types of angina.

Adefin XL is not used for the

relief of a sudden attack of

angina.

Adefin XL contains the active

substance nifedipine which belongs

to a group of medicines called

calcium channel blockers. They

work by opening up blood vessels in

the body to lower blood pressure

and improve the supply of blood

and oxygen to the heart.

Your doctor, however, may

prescribe Adefin XL for another

purpose.

Ask your doctor if you have any

questions about why Adefin XL

has been prescribed for you.

Before you take

Adefin XL

When you must not take

it

Do not take Adefin XL if you have

an allergy to:

nifedipine, the active

ingredient in Adefin XL

any of the ingredients listed

at the end of this leaflet

active substances similar to

nifedipine such as:

amlodipine, felodipine,

lercanidipine, nimodipine

and isradipine

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, and rash, itching or hives

on the skin.

Do not take Adefin XL if you are

pregnant or plan to become

pregnant.

It may affect your developing baby if

you take it during pregnancy.

Do not take Adefin XL if you are

breast-feeding or plan to breast-

feed.

The active ingredient in Adefin XL

passes into breast milk and there is

a possibility that your baby may be

affected.

Do not take Adefin XL if you have

had a heart attack in the last 8

days.

Do not take Adefin XL if you are

in cardiogenic shock (very low

blood pressure due to a failing

heart).

Symptoms of cardiogenic shock

include rapid, shallow breathing,

cold, clammy skin, a rapid, weak

pulse, dizziness, weakness and

fainting.

Do not take Adefin XL if you have

Kock Pouch or ileostomy (a

surgically created reservoir in the

small intestine).

Do not take Adefin XL if you are

taking another medicine

containing rifampicin, an

antibiotic used to treat

tuberculosis and other serious

infections.

Do not take this medicine after

the expiry date printed on the

pack and blister.

The expiry date is printed on the

carton and on each blister. If it has

expired return it to your pharmacist

for disposal.

Do not take this medicine if the

packaging shows signs of

tampering or the tablets are

broken, discoloured or show any

other sign of deterioration.

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 allergies

to any other medicines, foods,

preservatives or dyes.

Tell your doctor if you have or have

had any of the following medical

conditions:

heart failure

other heart or blood vessel

disorders

low blood pressure

stroke

mini-stroke (also known as

TIA or transient ischaemic

attack)

narrowing of the aorta

liver disease

diabetes

kidney disease

blockage of your

oesophagus or intestines

Page 2 of 4

prolonged diarrhoea (eg.

Crohn’s disease or

ulcerative colitis)

any surgical operations

carried out on your bowel.

You should discuss these medical

conditions with your doctor to check

whether Adefin XL is suitable for

you.

If you have not told your doctor

or pharmacist about any of the

above, tell them before you start

taking Adefin XL.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

can buy without a prescription

from a pharmacy, supermarket or

health food shop.

Some medicines may be affected

by Adefin XL or may affect how it

works. These include:

beta blockers, e.g.

metoprolol, atenolol

medicines used to treat

high blood pressure or

angina (chest pain), e.g.

diltiazem

medicines used to treat

heart disease, e.g. digoxin

medicines used to treat

arrhythmia (fast or irregular

heartbeats), e.g. quinidine

medicines used to treat

stomach ulcers, e.g.

cimetidine, cisapride

medicines used to treat

bacterial infections, e.g.

erythromycin, quinupristin

and dalfopristin

medicines used to treat

fungal infections, e.g.

ketoconazole

medicines used to treat

HIV, e.g. ritonavir

medicines used to treat

epilepsy, e.g. phenytoin,

carbamazepine, valproic

acid, phenobarbitone

medicines used to treat

depression, e.g. fluoxetine,

nefazodone

tacrolimus, a medicine used

to prevent rejection after

organ transplant.

You should not eat grapefruit or

drink grapefruit juice while you are

taking Adefin XL because this can

cause unwanted changes in the

blood pressure lowering effect of

the tablets.

If you are not sure whether you

are taking any of these

medicines, check with your

doctor or pharmacist.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while taking

Adefin XL.

How to take Adefin

XL

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 pharmacist

label, ask your doctor or

pharmacist for help.

How much to take

The dose varies from person to

person.

Your doctor will tell you how much

you need to take each day and

when to take it.

This may depend on your condition,

age, other medicines you may be

taking and how you respond to

Adefin XL.

The usual starting dosage is 30 mg

once daily. Your doctor may

increase the dose slowly over a

period of time, depending on how

you respond to this medicine.

How to take it

Swallow Adefin XL tablets whole

with some water. The tablets

must not be chewed, halved or

broken up.

Your chances of getting unwanted

side effects are increased if you

chew or break the tablets. Adefin XL

tablets are specially designed with a

strong outer shell, which allows the

medicine to be released slowly into

the body.

When to take it

The tablets should generally be

taken in the morning.

Adefin XL tablets can be taken

either with or without a meal.

How long to take it

Keep taking Adefin XL for as long

as your doctor recommends.

This medicine helps to control your

condition, but it does not cure it. It is

important to keep taking your

medicine even if you feel well.

If you forget to take it

If you forget to take your daily

dose of Adefin XL at the right

time and remember in less than

12 hours, take it straightaway,

then continue as normal the next

day.

Otherwise, skip that day’s dose

but be sure to take the next day’s

dose when it is due.

Do NOT take a double dose to

make up for the dose you

missed.

This may increase the chance of

you getting an unwanted side effect.

If you have missed several

doses, consult your doctor.

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 Poisons Information

Centre for advice (0800 POISON

or 0800 764 766), or go to

Accident and Emergency at your

nearest hospital, if you think that

you or anyone else may have

taken too many Adefin XL tablets.

Do this even if there are no signs

of discomfort or poisoning. You

may need urgent medical attention.

Signs of an overdose include feeling

dizzy and fainting due to drop in

blood pressure, irregular or rapid

Page 3 of 4

heartbeats, shortness of breath and

even loss of consciousness.

While you are taking

Adefin XL

Things you must do

Take Adefin XL exactly as

prescribed by your doctor.

If you do not follow your doctor's

instructions, you may not get control

of your blood pressure or relief from

your angina.

If you become pregnant while

taking Adefin XL, tell your doctor

immediately.

It may affect your developing baby if

you take it during pregnancy.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Adefin XL.

Tell your doctor if you continue

to have angina attacks or if they

become more frequent while you

are taking Adefin XL.

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking Adefin XL.

If you are about to have any

blood tests or x-rays, tell your

doctor that you are taking this

Adefin XL.

It may affect the results of some

tests.

Adefin XL tablets are specially

designed with a strong outer shell.

This outer shell allows the medicine

to be released slowly into the body

over a longer period of time after it

is taken. The outer shell is excreted

or passed out in the faeces (or

bowel motions), as it does not

dissolve in the body. Therefore, it is

normal to find these "ghost-tablets"

in the faeces.

Things you must not do

Do not take Adefin XL to treat any

other complaints unless your

doctor tells you to.

Do not give this medicine to

anyone else, even if they have

the same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

If you stop taking it suddenly, your

condition may worsen or you may

have unwanted side effects.

Things to be careful of

Be careful driving or operating

machinery until you know how

Adefin XL affects you.

It may cause dizziness or fainting in

some patients, especially when they

first start taking the medicine,

change dose, or drink alcohol.

If you have angina, be careful not

to overdo physical activities

when you first start taking Adefin

XL.

You may feel better when you start

taking it, but you will need time to

improve your physical fitness.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

Adefin XL.

This medicine helps most people,

but it may have unwanted effects in

a few people. All medicines can

have side effects. Sometimes they

are serious, most of the time they

are not. You may need medical

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.

headache

constipation

feeling dizzy

flushing

unusual tiredness or

weakness

generally feeling unwell

general swelling and/or

swelling of the arms, ankles

or legs.

Your doctor may need to monitor

your liver function, as Adefin XL can

increase your liver enzymes.

You may not experience any

specific symptoms.

Swelling at the back of the throat

can occur, which may cause

difficulty in talking or breathing.

Tell your doctor if this occurs; you

may need urgent medical attention.

If any of the following happen,

stop taking Adefin XL and tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

chest pain

signs of allergy such as

rash, itching or hives on the

skin, swelling of the face,

lips, tongue, or other parts

of the body, shortness of

breath, wheezing, or trouble

breathing

signs of liver problems such

as yellowing of the skin

and/or eyes (jaundice)

signs of frequent infections

such as fever, severe chills,

sore throat or mouth ulcers

These are very serious side effects.

If you have these side effects, you

may need urgent medical attention

or hospitalisation.

Very rarely, some people

experience a purple/brown

discolouration of the skin or

redness, flaking and itching of the

skin. Also, it has been reported that

some people develop a rash or

blistering of the skin when they are

exposed to sunlight. Tell your doctor

if you experience any of these

symptoms.

Very rarely, the undissolved tablet

shell may not pass out in the faeces

and may collect in the stomach.

Surgical intervention may be

necessary to remove these shells.

Tell your doctor if you experience

symptoms of bowel blockage.

In a small number of cases of in

vitro fertilisation, medicines like

nifedipine appeared to have

interfered with the normal function

of sperm. This effect went away

after the medicine was stopped. In

those men who are taking Adefin XL

Page 4 of 4

and are repeatedly unsuccessful in

fathering a child by in vitro

fertilisation, the medicine should be

considered as one of the possible

causes if no other explanation can

be found.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

After taking Adefin

XL

Storage

Keep your tablets in the pack

until it is time to take them.

If you take the tablets out of the

pack they may not keep well.

Keep your tablets in a cool dry

place where the temperature

stays below 25°C (for Adefin XL

30 mg), or below 30°C (for Adefin

XL 60 mg).

Do not store Adefin XL or any other

medicine in the bathroom, near a

sink. Do not leave it on a window-sill

or in the car. Heat and damp can

destroy some medicines.

Keep the tablets where children

cannot reach them.

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

Adefin XL 30 mg tablets are round,

biconvex film-coated tablets, pink in

colour marked with "30" on one

side. The tablets are supplied in

blister packs of 30 tablets, with each

tablet containing 30 mg of

nifedipine.

Adefin XL 60 mg tablets are round,

biconvex film-coated tablets, pink in

colour marked with "60" on one

side. The tablets are supplied in

blister packs of 30 tablets, with each

tablet containing 60 mg of

nifedipine.

Ingredients

The active ingredient in Adefin XL is

nifedipine.

Each Adefin XL 30 tablet

contains 30 mg of

nifedipine.

Each Adefin XL 60 tablet

contains 60 mg of

nifedipine.

Adefin XL also contains the

following inactive ingredients:

hypromellose

polyethylene oxide

magnesium stearate

sodium chloride

iron oxide red (E172/CI

77491)

cellulose acetate

macrogol 3350

hydroxpropyl cellulose

propylene glycol

titanium dioxide (E171/CI

77491)

Black printing ink

Adefin XL is lactose, gluten and

sugar free.

If you want to know

more

Should you have any questions

regarding this product, please

contact your pharmacist or doctor.

Who supplies this

medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd,

PO Box 11183,

Ellerslie,

Auckland.

Telephone: (09) 579 2792

Date of Information

11 October 2016

(Based on the Adefin XL datasheet

dated 10 October 2016)

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-11-2018

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

FDA - U.S. Food and Drug Administration

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

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

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

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

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

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

24-10-2018

Vita Health Products Recall (2018-10-24)

Vita Health Products Recall (2018-10-24)

Health Canada

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

20-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more:  https://go.usa.gov/xP

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xP

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Beckman Coulter Life Sciences Beckman Coulter Life Sciences recalls the FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers. Find out more: https://go.usa.gov/xPAtn  #MedicalDevice #FDA pic.twitter.com/6e064UQ2wg

FDA - U.S. Food and Drug Administration

16-11-2018

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (GlaxoSmithKline (Ireland) Limited)

Benlysta (Active substance: belimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7679 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2015/T/60

Europe -DG Health and Food Safety

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