APO-Metformin

Main information

  • Trade name:
  • APO-Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218270
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218270

APO-Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

9/09/2014

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. APO-Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack

Product Type

Single Medicine Product

Effective date

9/12/2016

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. Metformin may be used as monotherapy or in combination with other oral hypoglycaemic agents, or with insulin.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PCTFE (Aclar)/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

60 Tablets

(S4) Prescription Only Medicine

Components

1. APO-Metformin XR 1000 metformin hydrochloride 1000 mg modified release tablet blister pack

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

White to off-white capsule-shaped biconvex tablet engraved MXR 1000 on

one side and plain on the other side.

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 26.11.2017 at 05:14:09 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

APO-Metformin XR

Contains the active ingredient metformin hydrochloride

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about metformin. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking this medicine

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 this medicine is

used for

APO-Metformin XR Tablets is 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.

Metformin XR can be used alone, or

in combination with other medicines

for treating diabetes.

Metformin 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.

This medicine is available only with

a doctor's prescription.

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.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have prescribed this

medicine for another reason.

Use in children

There is not enough information to

recommend the use of this medicine

for children.

Before you take this

medicine

When you must not take it

Do not take this medicine if you

have an allergy to:

any medicine containing

metformin.

APO-METFORMIN XR

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

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

Do not take this medicine if you

have or have had any of the

following:

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 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 this medicine 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 metformin 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.

Insulin is more suitable for

controlling blood glucose during

pregnancy. Your doctor will replace

metformin with insulin while you are

pregnant.

Do not breastfeed if you are taking

this medicine.

Your doctor will discuss with you the

options of either breast-feeding or

using metformin.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

kidney problems

liver problems

alcohol dependence

current dehydration

current infection

pancreatitis (inflammation of the

pancreas)

thyroid problems

heart or blood vessel problems,

including heart failure.

Before starting metformin, your

doctor will ask you to have a

blood test to check your kidney

function.

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 metformin may also lead

to serious side effects.

Your doctor may suggest you stop

drinking or reduce the amount of

alcohol you drink. You should also

avoid taking other medicines that

contain alcohol.

Tell your doctor if you are

planning to have any operations or

radiographic procedures.

If you have not told your doctor

about any of the above, tell him/

her before you start taking this

medicine.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and metformin may

interfere with each other. These

include:

other medicines used to treat

diabetes such as insulin, glitinides

(repaglinide) and sulfonylureas

(e.g. gliclazide, glibenclamide,)

iodinated contrast agents (dyes)

medicines that contain alcohol,

such as cough and cold syrups

corticosteroids such as

prednisolone, prednisone and

cortisone

tetracosactrin, a medicine used in

people with multiple sclerosis,

APO-METFORMIN XR

and also 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

(metoprolol), calcium channel

blockers (nifedipine, amlodipine)

and ACE inhibitors (captopril,

enalapril, fosinopril, lisinopril,

perindopril, ramipril, quinapril

and trandolapril).

some medicines used to treat

asthma such as salbutamol and

terbutaline

diuretics, also called fluid, or

water tablets, such as amiloride ,

bumetanide, frusemide,

hydrochlorothiazide and

spironolactone

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,

including arthritis such as aspirin,

diclofenac, meloxicam, naproxen

and piroxicam

medicines used to treat ulcers and

reflux, such as cimetidine

medicines used to prevent blood

clots such as warfarin

thyroid hormones, such as

thyroxine.

These medicines may be affected by

metformin or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different medicines.

Other medicines not listed above

may also interact with metformin.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How to take this

medicine

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 pack, ask your

doctor or pharmacist for help.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

The usual starting dose is 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

2 grams once per day.

The elderly and people with kidney

problems may need smaller doses.

How to take it

Swallow the tablets whole with a

full glass of water.

Do not break, crush or chew the

tablets.

If you break, crush or chew the

tablets, they will not work as well.

Metformin XR are modified 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 at about the

same time each day.

Taking the tablets 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

Continue taking your medicine for

as long as your doctor tells you.

Metformin will help control diabetes

but will not cure it. Most people will

need to take metformin for long

periods of time.

When you start treatment with

metformin, it can take up to some

weeks for your blood glucose levels

to be properly controlled.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your

next dose, skip the dose you missed

and take your next dose when you

are meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking your medicine as you would

normally.

Do not take a double dose to make

up for the dose that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, 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.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

APO-METFORMIN XR

If you take too much metformin, 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 metformin

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 a non-diet

soft drink or taking glucose tablets.

While you are taking

this medicine

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking this one.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

Tell your doctor that you are

taking this medicine if you

experience any of the following

signs which may indicate a life-

threatening condition called lactic

acidosis:

muscle cramps

stomach pain

feeling weak

problems breathing.

Tell your doctor if you plan to have

any radiographic procedures

requiring an injection of an

iodinated contrast agent (dye).

Your doctor will advise you when to

stop taking metformin before you

have these procedures and when to

start again.

If you become pregnant or plan to

breastfeed while taking this

medicine, tell your doctor

immediately.

Visit your doctor regularly for

check-ups.

Your doctor may want to check your

kidneys, liver, heart and blood levels

while you are taking metformin.

Make sure you 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.

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 going to have surgery

you are having an examination

such as an X-ray or a scan

requiring an injection of an

iodinated contrast agent (dye).

you become pregnant.

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 metformin with

insulin.

Hypoglycaemia

Metformin does not normally cause

hypoglycaemia (low blood sugar),

although you may experience it while

taking other medicines for diabetes

such as insulin, sulfonylureas or

glitinides. 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 Metformin XR than

prescribed

APO-METFORMIN XR

taking certain other medicines

too little exercise

eating more carbohydrates than

normal.

Things you must not do

Do not take this medicine 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 stop taking your medicine

or lower the dosage without

checking with your doctor.

Do not skip any meals while taking

metformin.

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, metformin by itself

is unlikely to affect how you drive or

operate machinery.

Things to be aware of

After 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 metformin works.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking this

medicine.

Metformin helps most people with

(indication), but it 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.

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:

feeling sick (nausea), being sick

(vomiting)

diarrhoea

stomach pain

taste disturbance, loss of appetite

skin reactions such as redness of

the skin, itching or an itchy rash

(urticaria).

The above list includes the more

common side effects of your

medicine, which disappear after the

first few weeks. Taking metformin

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 (jaundice) and dark coloured

urine.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

The below list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

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 IS A VERY

RARE BUT SERIOUS SIDE

EFFECT REQUIRING URGENT

MEDICAL ATTENTION OR

HOSPITALISATION.

ALTHOUGH RARE, IF IT DOES

OCCUR, LACTIC ACIDOSIS

CAN BE FATAL. THE RISK OF

LACTIC ACIDOSIS IS HIGHER

IN THE ELDERLY, OR PEOPLE

WITH POORLY CONTROLLED

DIABETES, PROLONGED

FASTING, CERTAIN HEART

CONDITIONS, SEVERE LIVER

OR KIDNEY PROBLEMS OR

PEOPLE WHO DRINK

ALCOHOL.

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell. It is very

important that you speak to your

doctor immediately if a side effect

is severe, occurred suddenly or gets

worse rapidly.

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.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store any medicine in the

bathroom or near a sink. Do not

leave it on a window sill or in the

car.

APO-METFORMIN XR

Heat and dampness can destroy some

medicines.

Keep it 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, your pharmacist can dispose

of the remaining medicine safely.

Product description

What APO-Metformin XR

tablets looks like

New formulation

Metformin XR 500 contains 500 mg

metformin hydrochloride as modified

release tablets: White, capsule

shaped uncoated tablet with XR 500

on one side and a plain on the other

side.

It is available in blister packs of 120

tablets.

Metformin XR 1000 contains 1000

mg metformin hydrochloride as

modified release tablets: White

capsule shaped uncoated tablet with

XR 1000 one side and a plain on the

other side.

It is available in blister packs of 60

tablets.

Old formulation

Metformin XR 500 contains 500 mg

metformin hydrochloride as modified

release tablets: white to off-white

capsule-shaped, unscored tablet;

engraved "APO" on one side and

"XR500" on the other side.

It is also available in blister of 120

tablets.

Metformin XR 1000 contains 1000

mg metformin hydrochloride as

modified release tablets: white to off-

white capsule-shaped biconvex

tablet; engraved "MXR 1000" on one

side and plain on the other side.

It is also available in blister of 60

tablets.

* Not all strengths, pack types and/or

pack sizes may be

Ingredients

New formulation

Each modified release tablet contains

either 500 mg or 1000 mg metformin

hydrochloride as the active

ingredient. It also contains the

following inactive ingredients:

hypromellose

Povidone

colloidal anhydrous silica

magnesium stearate

Old formulation

Each modified release tablet contains

either 500 mg or 1000 mg metformin

hydrochloride as the active

ingredient.

It also contains the following inactive

ingredients:

hypromellose

methylcellulose

colloidal anhydrous silica

magnesium stearate.

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Australian Registration

Numbers

APO-Metformin XR 500 (blister):

AUST R 281211.

APO-Metformin XR 1000 (blister):

AUST R 281210.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

April 2017.

APO-METFORMIN XR

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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

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 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

30-7-2018

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Merck Sharp and Dohme B.V.)

Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2

Europe -DG Health and Food Safety

30-7-2018

Ceplene (Noventia Pharma Srl)

Ceplene (Noventia Pharma Srl)

Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36

Europe -DG Health and Food Safety

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

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 (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

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 (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

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 (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety