DIAFORMIN

Main information

  • Trade name:
  • DIAFORMIN XR 1000 metformin hydrochloride 1000mg extended release tablet blister pack.
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIAFORMIN XR 1000 metformin hydrochloride 1000mg extended release tablet blister pack.
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 208441
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

208441

DIAFORMIN XR 1000 metformin hydrochloride 1000mg extended release tablet blister pack.

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

28/07/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. DIAFORMIN XR 1000 metformin hydrochloride 1000mg extended release tablet blister pack.

Product Type

Single Medicine Product

Effective date

19/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in

adequate glycaemic control. DIAFORMIN XR and DIAFORMIN XR 1000 may be used as monotherapy or in combination with other oral antidiabetic

agents, or with insulin.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

10 (Starter Pack)

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. DIAFORMIN XR 1000 metformin hydrochloride 1000mg extended release tablet blister pack.

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

White to off-white, capsule-shaped, biconvex tablet, debossed on one side

with 1000

Active Ingredients

Metformin hydrochloride

1000 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 27.11.2017 at 11:07:19 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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

Diaformin*XR;

Diaformin*XR 1000

contains the active ingredient metformin hydrochloride

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about Diaformin XR and

Diaformin XR 1000.

It does not contain all the available

information. It does not take the

place of talking to your doctor,

pharmacist or diabetes educator.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking Diaformin XR or

Diaformin XR 1000 against the

benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor, pharmacist or diabetes

educator.

Keep this leaflet with your

medicine.

You may need to read it again.

What Diaformin XR

and Diaformin XR

1000 are used for

Diaformin XR and Diaformin XR

1000 are used to control blood

glucose (sugar) in people with Type

2 diabetes mellitus, especially in

those who are overweight. It is used

when diet and exercise are not

enough to control high levels of

blood glucose.

Diaformin XR and Diaformin XR

1000 can be used alone, or in

combination with other medicines for

treating diabetes.

TYPE 2 DIABETES MELLITUS

Type 2 diabetes mellitus is also

called non-insulin dependent diabetes

mellitus (NIDDM) or maturity onset

diabetes.

Insulin is a hormone that enables

body tissues to take up glucose from

the blood and to use it for energy or

fat storage for future use.

People with Type 2 diabetes are

unable to make enough insulin or

their body does not respond properly

to the insulin it does make. This

causes a build up of glucose in the

blood (hyperglycaemia), which can

lead to serious medical problems.

Long-term hyperglycaemia can lead

to heart disease, blindness, kidney

damage, poor blood circulation and

gangrene.

Signs of hyperglycaemia may

include:

tiredness or lack of energy

headache

thirst

passing large amounts of urine

blurred vision.

How Diaformin XR and

Diaformin XR 1000 works

Diaformin XR and Diaformin XR

1000 belongs to a group of medicines

called biguanides. It lowers high

blood glucose levels by:

improving your body's sensitivity

to insulin and restoring the way it

normally uses glucose

reducing the amount of glucose

your liver makes

delaying the amount of glucose

your intestine absorbs

Ask your doctor if you have any

questions about why Diaformin XR

or Diaformin XR 1000 has been

prescribed for you.

Diaformin XR and Diaformin XR

1000 are not recommended in

children as its safety and

effectiveness have not been

established in this age group.

Diaformin XR and Diaformin XR

1000 are available only with a

doctor's prescription.

There is no evidence that Diaformin

XR or Diaformin XR 1000 is

addictive.

After the active ingredient metformin

is absorbed into your body, you may

see the empty tablet shell in your

faeces (bowel motions). This is

normal and does not affect the way

Diaformin XR and Diaformin XR

1000 works.

Before you take

Diaformin XR or

Diaformin XR 1000

When you must not take it

Do not take Diaformin XR and

Diaformin XR 1000 if you are

allergic to:

medicines containing metformin

or any other biguanide

any of the ingredients listed at the

end of this leaflet.

Some of the symptoms of an allergic

reaction may include skin rash,

itching or hives; swelling of the face,

lips or tongue which may cause

DIAFORMIN*XR, DIAFORMIN*XR 1000

difficulty in swallowing or breathing,

wheezing or shortness of breath.

Do not take Diaformin XR and

Diaformin XR 1000 if you have any

of the following medical

conditions:

type 1 diabetes mellitus that is

well controlled by insulin alone

type 2 diabetes that is already

well controlled by diet alone

serious complications with your

diabetes or any type of metabolic

acidosis such as lactic acidosis,

diabetic ketoacidosis (a symptom

of uncontrolled diabetes, in which

substances called ketone bodies

accumulate in the blood - you

may notice this as an unusual

fruity odour on your breath)

kidney failure or severe kidney

disease

dehydration (for instance due to

persistent or severe vomiting or

diarrhoea)

shock from severe injury or blood

loss

severe liver disease

acute alcohol intoxication,

chronic alcohol dependence

certain heart or blood circulation

problems, including a recent heart

attack or heart failure (when the

heart fails to pump blood

effectively)

blood clots in the lungs

(symptoms include coughing,

shortness of breath, chest pain

and a fast heart rate), severe

breathing difficulties

inflammation of the pancreas

(symptoms include severe upper

stomach pain, often with nausea

and vomiting) if associated with

severe infection or hypoxia (lack

of oxygen)

a severe infection or gangrene.

Do not take Diaformin XR and

Diaformin XR 1000 if you need to

have major surgery or an

examination such as an X-ray or a

scan requiring an injection of

iodinated contrast (dye).

You must stop taking Diaformin XR

and Diaformin XR 1000 for a certain

period of time before and after the

examination or the surgery. Your

doctor will decide whether you need

any other treatment for this time. It is

important that you follow your

doctor's instructions precisely.

Do not take this medicine if you

are pregnant or plan to become

pregnant.

Insulin is more suitable for

controlling blood glucose during

pregnancy. Your doctor will replace

Diaformin XR or Diaformin XR

1000 with insulin while you are

pregnant.

Do not take Diaformin XR and

Diaformin XR 1000 if you are

breastfeeding.

Your doctor will discuss the options

available to you.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking Diaformin XR

or Diaformin XR 1000 , ask your

doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, dyes or preservatives.

Before starting Diaformin XR or

Diaformin XR 1000 your doctor will

ask you to have a blood test to check

your kidney function.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney problems

liver problems

heart or blood vessel problems

including heart failure.

Tell your doctor if you drink

alcohol.

Alcohol can affect the control of your

diabetes. Drinking excessive amounts

of alcohol while you are being

treated with Diaformin XR or

Diaformin XR 1000 may also lead to

serious side effects. Your doctor may

suggest you stop drinking or reduce

the amount of alcohol you drink.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

Diaformin XR or Diaformin XR

1000.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines and Diaformin XR

or Diaformin XR 1000 may interfere

with each other. These include:

other medicines used to treat

diabetes

iodinated contrast agents (dyes)

medicines that contain alcohol,

such as cough and cold syrups

corticosteroids such as prednisone

or cortisone

tetracosactrin, a medicine used in

people with multiple sclerosis,

and in young children to treat

some types of seizures (fits)

danazol, a medicine used to treat

endometriosis

medicines used to treat high

blood pressure and some heart

conditions, such as beta-blockers,

calcium channel blockers or ACE

inhibitors

some medicines used to treat

asthma such as salbutamol or

terbutaline

diuretics, also called fluid tablets

chlorpromazine, a medicine used

to treat schizophrenia and other

mental illnesses

NSAIDs (non-steroidal anti-

inflammatory drugs), medicines

used to relieve pain, swelling and

other symptoms of inflammation,

such as aspirin, diclofenac,

DIAFORMIN*XR, DIAFORMIN*XR 1000

ibuprofen, meloxicam, naproxen

or piroxicam

cimetidine, used to treat ulcers

and reflux

medicines used to prevent blood

clots such as warfarin.

medicines that are substrates/

inhibitors of organic cation

transporters - OCT 1 such as

verapamil; OCT 2 such as

dolutegravir, crizotinib, olaparib,

daclatasvir or vandetanib

medicines that are inducers of

OCT 1 such as rifampicin

These medicines may be affected by

Diaformin XR or Diaformin XR

1000 or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Your doctor and pharmacist also

have more information on medicines

to be careful with or avoid while

taking Diaformin XR or Diaformin

XR 1000.

How to take Diaformin

XR and Diaformin XR

1000

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the pack, ask your

doctor or pharmacist.

How much to take

Diaformin XR comes in two

strengths:

Diaformin XR metformin 500 mg

and Diaformin XR 1000 metformin

1000 mg tablets.

The dose varies from patient to

patient. Your doctor will decide the

right dose for you.

The usual starting dose is 1 tablet

(500 mg) once daily with the evening

meal. Your doctor may increase the

dose slowly, depending on your

blood glucose levels.

The maximum recommended dose is

4 tablets (2 grams) once per day.

Elderly patients and people with

kidney problems may need smaller

doses.

How to take it

Swallow the tablets whole with a

glass of water.

Do not break, crush or chew the

tablets.

If you break, crush or chew

Diaformin XR or Diaformin XR

1000, they will not work as well.

Diaformin XR and Diaformin XR

1000 are extended release tablets.

This means they have a special

coating which allows the active

ingredient, metformin, to be released

slowly over time.

When to take it

Take your medicine everyday with

the evening meal.

Taking Diaformin XR or Diaformin

XR 1000 during or with your evening

meal will reduce the chance of a

stomach upset.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

How long to take it for

Keep taking Diaformin XR and

Diaformin XR 1000 for as long as

your doctor recommends.

Diaformin XR and Diaformin XR

1000 will help control diabetes but

will not cure it. Most people will

need to take Diaformin XR or

Diaformin XR 1000 for long periods

of time.

When you start treatment with

Diaformin XR or Diaformin XR

1000, it can take up to some weeks

for your blood glucose levels to be

properly controlled.

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 you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice, or

go to Accident and Emergency at

the nearest hospital, if you think

you or anyone else may have taken

too much Diaformin XR or

Diaformin XR 1000. Do this even if

there are no signs of discomfort or

poisoning.

If you take too much Diaformin XR

or Diaformin XR 1000, you may feel

very tired, sick, vomit, have trouble

breathing and have unusual muscle

pain, stomach pain or diarrhoea.

These may be early signs of a serious

condition called lactic acidosis (build

up of lactic acid in the blood).

You may also experience symptoms

of hypoglycaemia (low blood

glucose). This usually only happens

if you take too much Diaformin XR

or Diaformin XR 1000 together with

other medicines for diabetes or with

alcohol.

If you do experience any signs of

hypoglycaemia, raise your blood

glucose quickly by eating jelly

beans, sugar or honey, drinking

non-diet soft drink or taking

glucose tablets.

DIAFORMIN*XR, DIAFORMIN*XR 1000

While you are taking

Diaformin XR or

Diaformin XR 1000

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Diaformin XR or

Diaformin XR 1000.

Tell all the other doctors, dentists

and pharmacists who treat you

that you are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

HYPOGLYCAEMIA

Diaformin XR or Diaformin XR

1000 does not normally cause

hypoglycaemia (low blood sugar),

although you may experience it while

taking other medicines for diabetes

such as insulin or sulfonylureas.

Make sure that you, your friends,

family and work colleagues can

recognise the symptoms of

hypoglycaemia (low blood sugar)

and know how to treat them.

Hypoglycaemia can occur suddenly.

Initial signs may include:

weakness, trembling or shaking

sweating

lightheadedness, dizziness,

headache or lack of concentration

irritability, tearfulness or crying

hunger

numbness around the lips and

tongue.

If not treated promptly, these may

progress to:

loss of co-ordination

slurred speech

confusion

fits or loss of consciousness.

If you experience any of the

symptoms of hypoglycaemia, you

need to raise your blood glucose

immediately.

You can do this by doing one of the

following:

eating 5 to 7 jelly beans

eating 3 teaspoons of sugar or

honey

drinking half a can of non-diet

soft drink

taking 2 to 3 concentrated glucose

tablets.

Unless you are within 10 to 15

minutes of your next meal or

snack, follow up with extra

carbohydrates such as plain

biscuits, fruit or milk.

Taking this extra carbohydrate will

prevent a second drop in your blood

glucose level.

HYPERGLYCAEMIA

If you experience any of the signs

of hyperglycaemia (high blood

sugar), contact your doctor

immediately.

The risk of hyperglycaemia is

increased in the following situations:

uncontrolled diabetes

illness, infection or stress

taking less Diaformin XR or

Diaformin XR 1000 than

prescribed

taking certain other medicines

too little exercise

eating more carbohydrates than

normal.

Tell your doctor if any of the

following happen:

you become ill

you become dehydrated (for

instance due to persistent or

severe diarrhoea or recurrent

vomiting)

you are injured

you have a fever

you have a serious infection such

an influenza, respiratory tract

infection or urinary tract infection

you are having major surgery

you are having an examination

such as an X-ray or a scan

requiring an injection of an

iodinated contrast agent (dye).

Your blood glucose may become

difficult to control at these times.

You may also be more at risk of

developing a serious condition called

lactic acidosis. At these times, your

doctor may replace Diaformin XR or

Diaformin XR 1000 with insulin.

Visit your doctor regularly for

check ups.

Your doctor may want to check your

kidneys, liver, heart and vitamin B12

levels while you are taking

Diaformin XR or Diaformin XR

1000.

Check your blood glucose levels

regularly.

This is the best way to tell if your

diabetes is being controlled properly.

Your doctor or diabetes educator will

show you how and when to do this.

Carefully follow the advice of your

doctor and dietician on diet,

drinking alcohol and exercise.

Things you must not do

Do not use Diaformin XR or

Diaformin XR 1000 to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not skip meals while taking

Diaformin XR or Diaformin XR

1000.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

Things to be careful of

If you have to be alert, for example

when driving, be especially careful

not to let your blood glucose levels

fall too low.

Low blood glucose levels may slow

your reaction time and affect your

ability to drive or operate machinery.

Drinking alcohol can make this

worse. However, Diaformin XR and

Diaformin XR 1000 by itself is

unlikely to affect how you drive or

operate machinery.

DIAFORMIN*XR, DIAFORMIN*XR 1000

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Diaformin XR and Diaformin XR

1000.

Diaformin XR and Diaformin XR

1000 helps most people with diabetes

but it may have unwanted side effects

in some people.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Do not be alarmed by the following

lists of side effects.

You may not experience any of them.

Tell your doctor if you notice any

of the following and they worry

you:

feeling sick (nausea)

vomiting

diarrhoea

stomach pain

taste disturbance

loss of appetite

skin reactions such as redness of

the skin, itching or an itchy rash

(urticaria).

These are generally mild side effects

which disappear after the first few

weeks. Taking Diaformin XR or

Diaformin XR 1000 with meals can

help reduce nausea and diarrhoea.

Tell your doctor as soon as possible

if you notice any of the following:

symptoms of liver disease such as

nausea, vomiting, loss of appetite,

feeling generally unwell, fever,

yellowing of the skin and eyes

and dark coloured urine

TELL YOUR DOCTOR

IMMEDIATELY OR GO TO

ACCIDENT AND EMERGENCY

AT THE NEAREST HOSPITAL

IF YOU NOTICE ANY OF THE

FOLLOWING SYMPTOMS OF

LACTIC ACIDOSIS (BUILD UP

OF LACTIC ACID IN THE

BLOOD):

nausea, vomiting, stomach pain

trouble breathing

feeling weak, tired or generally

unwell

unusual muscle pain

sleepiness

dizziness or lightheadedness

shivering, feeling extremely

cold

slow heart beat.

LACTIC ACIDOSIS A VERY

RARE BUT SERIOUS SIDE

EFFECT REQUIRING URGENT

MEDICAL ATTENTION OR

HOSPITALISATION.

ALTHOUGH RARE, IF LACTIC

ACIDOSIS DOES OCCUR, IT

CAN BE FATAL. THE RISK OF

LACTIC ACIDOSIS IS HIGHER

IN THE ELDERLY, THOSE

WHOSE DIABETES IS POORLY

CONTROLLED, THOSE WITH

PROLONGED FASTING, THOSE

WITH CERTAIN HEART

CONDITIONS, THOSE WHO

DRINK ALCOHOL AND THOSE

WITH KIDNEY OR LIVER

PROBLEMS.

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.

Some side effects (e.g. reduced

vitamin B12 level) can only be found

when your doctor does tests from

time to time to check your progress.

After using Diaformin

XR and Diaformin XR

1000

Storage

Keep your tablets in the blister

pack until it is time to take them.

If you take the tablets out of the

blister pack they may not keep well.

Keep your tablets in a cool, dry

place where the temperature stays

below 25°C.

Do not store Diaformin XR or

Diaformin XR 1000 or any other

medicine in the bathroom or near a

sink. Do not leave it in the car or

on a window sill.

Heat and dampness can destroy some

medicines.

Keep Diaformin XR or Diaformin

XR 1000 where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor 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

Diaformin XR comes in two

strengths:

Diaformin XR and Diaformin XR

1000 tablets.

Diaformin XR is a white to off-

white, capsule-shaped, biconvex

tablet, debossed "500" on one

side. It is available in blister

packs of 120 tablets.

Diaformin XR 1000 is a white to

off-white, capsule-shaped,

biconvex tablet, debossed on one

side with "1000". It is available in

blister packs of 60 tablets.

Ingredients

The active ingredient in Diaformin

XR and Diaformin XR 1000 is

metformin hydrochloride.

Each extended release tablet contains

500 mg or 1000 mg of metformin

hydrochloride.

The tablets also contain the following

inactive ingredients:

croscarmellose sodium

hypromellose

DIAFORMIN*XR, DIAFORMIN*XR 1000

microcrystalline cellulose (500

mg only)

magnesium stearate.

The tablets do not contain sucrose,

lactose, gluten, tartrazine or any

other azo dyes.

Supplier

Diaformin XR and Diaformin XR

1000 are supplied in Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers:

Diaformin XR -

AUST R 120868

Diaformin XR 1000 -

208441

This leaflet was prepared on

19 September 2016

* Registered trade mark of

Alphapharm Pty Limited.

DiaforminXR_cmi\ sep16/00

DIAFORMIN*XR, DIAFORMIN*XR 1000

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18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety

6-3-2019

Fortekor and associated names

Fortekor and associated names

Fortekor and associated names (Active substance: Benazepril hydrochloride) - Corrigendum - Commission Decision (2012)772 of Wed, 06 Mar 2019

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (DLRC Pharma Services Ltd)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1623 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003766

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (DLRC Pharma Services Ltd)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1622 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003764

Europe -DG Health and Food Safety

26-2-2019

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (DLRC Pharma Services Ltd)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2019)1621 of Tue, 26 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003767

Europe -DG Health and Food Safety

20-2-2019


Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Europe - EMA - European Medicines Agency

20-2-2019


Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Doxolipad,doxorubicin hydrochloride,  31/01/2019,  Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Europe - EMA - European Medicines Agency

29-1-2019


Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

12-12-2018


Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201804

Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201804

Metformin: List of nationally authorised medicinal products - PSUSA/00002001/201804

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

14-11-2018

Ebymect (AstraZeneca AB)

Ebymect (AstraZeneca AB)

Ebymect (Active substance: dapagliflozin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)7605 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4162/WS/1380

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Xigduo (AstraZeneca AB)

Xigduo (AstraZeneca AB)

Xigduo (Active substance: dapagliflozin/metformin) - Centralised - Renewal - Commission Decision (2018)6462 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2672/R/44

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

15-8-2018

Komboglyze (AstraZeneca AB)

Komboglyze (AstraZeneca AB)

Komboglyze (Active substance: saxagliptin / metformin) - Centralised - 2-Monthly update - Commission Decision (2018)5559 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2059/WS/1289

Europe -DG Health and Food Safety

10-8-2018

Brinavess (Correvio)

Brinavess (Correvio)

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

Europe -DG Health and Food Safety