Actilyse

Main information

  • Trade name:
  • Actilyse 10 mg Injection with diluent
  • Dosage:
  • 10 mg
  • Pharmaceutical form:
  • Injection with diluent
  • Units in package:
  • Ampoule, 10 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Boehringer Ingelheim Pharma GmbH & Co KG

Documents

Localization

  • Available in:
  • Actilyse 10 mg Injection with diluent
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ACTILYSE is indicated for fibrinolytic therapy in acute thrombotic artery occlusion to restore coronary artery patency, reduce infarct size, preserve ventricular function, prevent cardiac insufficiency and reduce mortality · 90 minutes (accelerated) dose regimen: for patients in whom treatment can be started within 6 h of symptom onset; · 3 hour dose regimen: for patients in whom treatment can be started between 6 - 12 hrs after symptom onset.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 4765
  • Authorization date:
  • 19-03-1987
  • Last update:
  • 27-09-2017

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

ACTILYSE NZ CMI v01

Actilyse

®

Injection with diluent

alteplase, rch

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Actilyse.

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 being treated with Actilyse

against the benefits they expect it will

have for you.

If you have any concerns about

being treated with this medicine,

ask your doctor or pharmacist.

This leaflet was last updated on the

date at the end of this leaflet. More

recent information may be available.

The latest Consumer Medicine

Information is available from your

pharmacist, doctor, or from

www.medsafe.govt.nz/

Consumers/cmi/CMIForm.asp and

may contain important information

about the medicine and its use of

which you should be aware.

Keep this leaflet.

You may need to read it again.

What Actilyse is used

for

Actilyse is used to treat a number of

conditions caused by blood clots

forming within blood vessels,

including:

heart attacks caused by blood clots

in the arteries of the heart

(myocardial infarction)

blood clots in the arteries of the

lung (pulmonary embolism)

stroke caused by a blood clot in an

artery of the brain (acute ischaemic

stroke).

Actilyse contains the active ingredient

alteplase. It belongs to a group of

medicines called thrombolytic agents.

Actilyse works by dissolving clots in

the blood vessels. These clots cause

disease by interfering with normal

blood flow.

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.

Before you are given

Actilyse

When you must not be given

it

You should not be given Actilyse if

you have an allergy to:

any medicine containing alteplase

(the active ingredient in Actilyse)

gentamycin (an antibiotic)

natural rubber (also called latex

which is part of the packaging

material)

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.

Because of the risk of bleeding,

Actilyse should not be given to you if

you have, or have had:

current bleeding or severe bleeding

in the past 6 months

a family history of bleeding

disorders or a tendency to bleed

a previous condition resulting in

bleeding or suspected bleeding in

the brain

heart and lung resuscitation,

childbirth, organ biopsy or an

invasive medical procedure in the

past 10 days

major surgery, including heart,

head or spinal surgery, or

significant trauma (including

trauma to the head) in the past 10

days

severe and uncontrolled high blood

pressure

tumours in which the risk of

bleeding is increased

any blood clotting defect

ACTILYSE NZ CMI v01

current treatment with other

thrombolytic agents (medicines

used for dissolving blood clots) or

an anti-clotting agent

(anticoagulant), such as warfarin

certain diseases of the blood

vessels, heart, brain, oesophagus,

stomach/

intestine, liver, kidney or pancreas

in which the risk of bleeding is

increased.

In addition to the above medical

conditions, Actilyse should not be

used for the treatment of heart attack

or pulmonary embolism if you have,

or have had:

a stroke caused by bleeding in the

brain (condition known as

haemorrhagic stroke) or a stroke of

unknown origin at any time

a stroke caused by a blood clot in

the artery of the brain (condition

known as ischaemic stroke) or a

transient ischaemic attack (TIA) in

the past 6 months, unless the

symptoms of your stroke occurred

within the past 4.5 hours and you

are about to be treated for it.

Actilyse should not be used for the

treatment of acute ischaemic stroke if

you have, or have had:

experienced the symptoms of your

stroke for more than 4.5 hours or if

you do not know when they began

only very mild symptoms or the

symptoms are rapidly improving

before receiving Actilyse

a very severe stroke

fits or seizures at the onset of

stroke

treatment with heparin in the past

48 hours (and abnormal bleeding

time)

previous stroke or serious head

injury/trauma within the last 3

months

previous stroke and you are

diabetic

a low platelet count (platelets are

blood cells involved in blood

clotting)

severe high blood pressure (over

185/110 mmHg)

abnormal blood glucose levels.

Do not give this medicine to a child

or adolescent under the age of 18

years.

Safety and effectiveness in children

and adolescents younger than 18 years

have not been established.

Actilyse should not be used after the

expiry date printed on the pack or if

the packaging is torn or shows signs of

tampering.

If you are not sure whether you

should be given this medicine, talk

to your doctor.

Before you are given it

It is important that your doctor knows

your medical history before

administering Actilyse.

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 conditions:

a previous heart attack or any other

heart condition

a previous stroke caused by a

blood clot or a transient ischaemic

attack (TIA) more than 6 months

previously (this only applies for

treatment of heart attack or

pulmonary embolism)

diabetes mellitus

bleeding from inside or around

your eyes or visual disturbances

high blood pressure

severe liver disease

any recent medical procedure such

as a biopsy or injection.

If you are uncertain as to whether

you have, or have had, any of these

conditions you should raise those

concerns with your doctor.

Tell your doctor if you are pregnant

or plan to become pregnant or are

breastfeeding.

Your doctor can discuss with you the

risks and benefits involved.

Tell your doctor if you are over the

age of 80 years.

The risks of treatment with Actilyse

may be increased in any patient over

80 years of age.

Before starting treatment with

Actilyse your doctor will assess other

factors which may increase the risks

of using Actilyse. Your doctor will

take special care with Actilyse if you

have or have had:

any infected veins and cannula

sites

any condition in which bleeding is

a significant risk or would be

particularly difficult to manage

because of its location

ever received Actilyse before.

If you have not told your doctor

about any of the above, tell him/her

before you are given Actilyse.

Taking other medicines

Tell your doctor 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 Actilyse may

interfere with each other. These

include:

aspirin, heparin, warfarin or any

other medicines used to “thin” the

blood and prevent blood clots

ACE inhibitors, a group of

medicines used to treat high blood

pressure.

These medicines may be affected by

Actilyse or may affect how well it

works. You may need different

ACTILYSE NZ CMI v01

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while using this

medicine.

How Actilyse is given

Actilyse will be prepared and

administered to you by your doctor or

by a healthcare professional. It is not

for self-administration.

Treatment with Actilyse should be

initiated as soon as possible after the

start of your symptoms.

Actilyse is supplied as a powder and

sterilised water for injections. Before

use, the water for injections is added

to the powder to form a solution ready

for administration. This solution is

given into a vein through a drip line.

How much is given

The recommended dose is 100 mg

given over 90 or 180 minutes for a

heart attack, or over 120 minutes for

acute massive pulmonary embolism. A

lower dose (1.5 mg/kg) is

recommended for patients weighing

less than 65 kg. No more than 100 mg

should be given because it is

associated with a higher risk of

bleeding (especially in the brain).

For treatment of acute ischaemic

stroke a dose equivalent to 0.9 mg/kg

body weight is given over 60 minutes.

The maximum dosage should not

exceed 90 mg.

Your doctor might prescribe a

different dose or duration of treatment

to that described here.

If you want more information, ask

your doctor.

If you are given too much

(overdose)

Overdose is unlikely because Actilyse

is administered under medical

supervision.

Symptoms of an overdose may include

bleeding.

In the case of serious bleeding, your

doctor will immediately stop treatment

with Actilyse and heparin. Your

doctor will start appropriate treatment

to control the bleeding and, if

necessary, replace the lost blood.

While you are using

Actilyse

Things you must not do

You should not take aspirin for the

first 24 hours after treatment with

Actilyse.

Your doctor may give you an injection

with heparin if this is necessary.

Things to be careful of

Actilyse increases the risk of bleeding

and bruising. After treatment with

Actilyse medical staff will avoid

giving you injections or moving you

unless absolutely necessary.

Your doctor will probably continue to

treat you with heparin and aspirin after

treatment with Actilyse. This is to

reduce the risk of more blood clots

forming.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the change

in position and blood pressure.

If this problem continues or gets

worse, talk to your doctor.

Side effects

Tell your doctor as soon as possible

if you do not feel well while you are

being given Actilyse.

This medicine may have unwanted

side effects in a few people. All

medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

If you are over 80 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the following

list of side effects. You may not

experience any of them.

Ask your doctor to answer any

questions you may have.

If any of the following happen, tell

your doctor immediately:

bleeding or blood clot within the

head or brain. Symptoms may

include collapse, sleepiness,

difficulty in speaking or slurred

speech, numbness or weakness of

the arms or legs, headache,

dizziness, visual disturbance,

confusion, loss of memory,

agitation, depression, weakness on

one side of the body, convulsions,

fits or seizures, psychosis, a severe

mental condition in which the

person loses contact with reality

and is unable to think and judge

clearly, difficulty swallowing

bleeding from the skin, mouth,

gums, nose, or eyes

bruising

bleeding or bruising where the

injection is given

nausea, vomiting or vomiting

blood or material that looks like

coffee grounds

bleeding from the back passage,

black sticky bowel motions

(stools) or bloody diarrhoea

ACTILYSE NZ CMI v01

blood in the urine

coughing up blood

changes in heart rate (fast, slow or

irregular), extra heart beats, weak

pulse

chest pain, pain behind the breast

bone, sometimes spreading to the

neck and shoulders

shortness of breath, tiring easily

after light physical activity such as

walking, waking up short of breath

at night

rapid, shallow breathing

cold, clammy or white skin

light-headedness

weakness

fluid retention in different parts of

the body, often first noticed as

swollen ankles and feet

restlessness

any symptoms of an allergic

reaction (e.g. rash, itching, hives

on the skin, swelling of the face,

lips, mouth, tongue, throat or other

parts of the body, shortness of

breath, wheezing or difficulty

swallowing or breathing)

high body temperature.

Due to the life-threatening nature of

the diseases for which Actilyse is

used, some deaths have occurred after

treatment. However, use of Actilyse in

large numbers of patients has shown

that when used as recommended, the

benefits outweigh the risks.

There have also been reports of

blockages of blood vessels following

treatment with Actilyse. This can lead

to organ failure (e.g. kidney failure).

Nausea and vomiting can occur after a

heart attack and may or may not be

increased by Actilyse.

The above list includes very serious

side effects. You may need urgent

medical attention.

Tell your doctor if you notice

anything that is making you feel

unwell.

Other side effects not listed above

may also occur in some people.

After being given

Actilyse

Storage

Actilyse will be stored in the

pharmacy or on the ward below 25ºC

and protected from light.

After mixing with sterile water for

injections, Actilyse should be used

immediately. If not used immediately,

the product may be stored in a

refrigerator (2-8ºC) for up to 24 hours.

Disposal

The reconstituted solution is for single

use only. Any unused solution or

waste material should be disposed in

accordance with the local

requirements.

Product Description

What it looks like

Actilyse is the brand name of your

medicine. It comes as a sterile white to

off-white powder in clear glass vials

containing 10 mg or 50 mg alteplase.

Actilyse powder must be mixed with

sterile water for injections before use.

When mixed, the resulting solution is

colourless to pale yellow.

Actilyse is available as a pack

containing one vial of powder and one

vial of sterile water for injections.

Ingredients

Active ingredient:

Each vial of Actilyse powder contains

10 mg or 50 mg of alteplase.

Inactive ingredients:

Actilyse powder also contains:

arginine

nitrogen

phosphoric acid

polysorbate 80.

Sodium hydroxide or phosphoric acid

may be added to adjust the acidity of

Actilyse.

A 10 mL or 50 mL vial of sterile

Water for Injections is provided for

mixing with the powder.

Supplier

Actilyse is supplied in New Zealand

Boehringer Ingelheim (N.Z.) Limited,

Auckland

This leaflet was prepared in April

2017.

® Actilyse is a registered trademark of

Boehringer Ingelheim

© Boehringer Ingelheim 2017

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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