COSDOR

Main information

  • Trade name:
  • COSDOR dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COSDOR dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217250
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217250

COSDOR dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop bottle

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharma Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

25/09/2014

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. COSDOR dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop bottle

Product Type

Single Medicine Product

Effective date

25/09/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

COSDOR is indicated in the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when

concomitant therapy is appropriate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

2 Years

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Discard 4 weeks after

opening

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. COSDOR dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drop bottle

Dosage Form

Eye Drops

Route of Administration

Ophthalmic

Visual Identification

Clear, slightly viscous, colorless aqueous solution

Active Ingredients

Dorzolamide hydrochloride

22.26 mg/mL

Timolol maleate

6.83 mg/mL

© 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 06:26:01 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

COSDOR

®

Dorzolamide hydrochloride/Timolol maleate

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about COSDOR. 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 using

COSDOR against the benefits

they expect it will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What COSDOR is used

for

COSDOR is used to lower raised

pressure in the eye and to treat

glaucoma. Glaucoma is a condition

in which the pressure of fluid in the

eye may be high. However, some

people with glaucoma may have

normal eye pressure. Also, some

people with raised eye pressure may

not have glaucoma.

Glaucoma is usually caused by a

build-up of the fluid which flows

through the eye. This build up

occurs because the fluid drains out

of your eye more slowly than it is

being pumped in. Since new fluid

continues to enter the eye, joining

the fluid already there, the pressure

continues to rise. This raised

pressure may damage the back of

the eye resulting in gradual loss of

sight. Damage can progress so

slowly that the person is not aware

of this gradual loss of sight.

Sometimes even normal eye

pressure is associated with damage

to the back of the eye.

There are usually no symptoms

of glaucoma. The only way of

knowing that you have glaucoma

is to have your eye pressure,

optic nerve and visual field

checked by an eye specialist or

optometrist. If glaucoma is not

treated it can lead to serious

problems. You may have no

symptoms but eventually

glaucoma can lead to total

blindness. In fact, untreated

glaucoma is one of the most

common causes of blindness.

Although COSDOR helps control

your glaucoma it does not cure it.

For more information about

glaucoma, contact Glaucoma

Australia Inc., PO Box 420, Crows

Nest 1585, telephone 02 9906 6640.

COSDOR contains two active

ingredients, dorzolamide

hydrochloride and timolol maleate.

Both of these active ingredients

lower pressure in the eye by

reducing the production of fluid,

but they do this in different ways.

Dorzolamide hydrochloride belongs

to a family of medicines called

carbonic anhydrase inhibitors.

Timolol maleate belongs to a family

of medicines called beta-blockers.

COSDOR is not addictive.

Before you use

COSDOR

When you must not use it

Do not use COSDOR if you have an

allergy to COSDOR or any of the

ingredients listed at the end of this

leaflet.

Do not use COSDOR if:

you have now or have had

in the past certain serious

breathing problem such as

asthma, chronic obstructive

lung disease (emphysema),

or other breathing problems

you have certain heart

conditions, such as slow heart

rate, an irregular heartbeat,

or heart failure.

Do not use COSDOR if you are

breast-feeding or intend to

breast- feed.

Your

baby

absorb

this

medicine

from

breast

milk

therefore there is a possibility of

harm to the baby.

Do not put the eye drops into

your eye(s) while you are

wearing contact lenses.

The preservative in COSDOR

(benzalkonium chloride) may be

deposited in soft contact lenses.

You can put your contact lenses

back into your eyes 15 minutes

after you have used COSDOR.

Do not use COSDOR if:

the seal around the cap

is broken

the bottle shows signs

of tampering

the expiry date on the pack

has passed.

If you use this medicine after

the expiry date has passed, it

may not work.

If you are not sure whether you

should start using COSDOR,

talk to your doctor.

There is limited experience with

COSDOR in children.

Before you start to

use it

Tell your doctor if:

1.

you are pregnant or intend

to become pregnant

Your doctor will discuss the

possible risks and benefits of

using COSDOR during

pregnancy and a decision can be

made if you should or should not

use it.

2.

you have any medical

conditions, especially the

following:

heart problems (such as

coronary heart disease, heart

failure or low blood

pressure)

heart rate disturbances (such

as slow or irregular

heartbeats)

poor blood circulation

problems (such as Raynaud's

syndrome)

lung or breathing problems

(such as asthma or chronic

obstructive lung disease)

diabetes or other blood sugar

problems

thyroid disease

kidney disease

liver disease

3.

if you have an allergy to

sulfonamide medicines

One of the active ingredients of

COSDOR, dorzolamide

hydrochloride, is a

sulfonamide- related compound.

Therefore, if you are allergic to

sulfonamide medicines you may

be allergic to COSDOR. Check

with your doctor or pharmacist

if you are not sure whether you

are allergic to sulfonamides.

4.

you are already using

another beta-blocker eye

drop

It is not recommended to use

two beta-blocker eye drops at

the same time.

5.

you have a history of allergic

problems, including eczema,

hives or hay fever

6.

you have had an allergy to

any other medicines or any

other substances, such as

foods, preservatives or dyes.

If you have not told your doctor

about any of the above, tell them

before you use COSDOR.

Tell your doctor before you have

an operation that you are using

COSDOR, as it may change the

effects of some medicines during

anesthesia.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines and COSDOR

may interfere with each other.

These include:

medicines for high blood pressure

or heart conditions, including a

group of medicines called beta-

blockers

quinidine, a medicine used to

treat irregular heart beats

medicines to treat diabetes

tablets used to treat glaucoma

large amounts of aspirin or

salicylates

medicines to treat depression

These medicines may be affected by

COSDOR, 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 or pharmacist has more

information on medicines to be

careful with or avoid while using

COSDOR.

How to use COSDOR

How much to use

Your doctor will tell you how

many drops you need to use each

day.

Use COSDOR only when

prescribed by your

doctor.

The usual dose for adults is one

drop of COSDOR twice a day, in

either one or both eyes.

Follow all directions given to

you by your doctor carefully.

They may differ from the

information contained in this

leaflet.

Use COSDOR every day, at

about the same time each day,

unless your doctor tells you

otherwise.

Using your eye drops at the same

time each day will have the best

effect on your eye pressure. It will

also help you remember when to

use the eye drops.

After using COSDOR, wait at least

10 minutes before putting any

other eye drops in your eye(s).

How to use it

You may find it easier to put drops

in your eye while you are sitting or

lying down.

Before opening the bottle for

the first time, make sure the

Safety Strip on the front of the

bottle is not broken. If it is, do

not use the bottle and return it

to your pharmacist.

You will notice a small space

between the cap and the bottle- this is

normal.

If you are wearing soft contact

lenses, remove them before

putting the drops in your eye.

Wash your hands well with

soap and water.

To open the bottle for the first

time, tear off the Safety Strip

to break the seal. Then hold

the bottle upright, and turn the

cap in the direction of the

arrows until you can lift it off.

Place the cap upside down

(arrows face down) on a flat

surface. Do not touch the

inside of the cap. This will

help keep the inside of the cap

clean and keep germs out of

the eye drops.

Hold the bottle upside down

in one hand, with your thumb

or index finger over the

"finger push" area.

Using your other hand, gently

pull down your lower eyelid

to form a pouch.

Tilt your head back and look

Put the tip of the bottle close

to your lower eyelid. Do not

let it touch your eye.

Release one drop into the

pouch formed between your

eye and eyelid by gently

squeezing the bottle. Close

your eye and keep it closed.

Do not blink or rub your eye.

While your eye is still closed,

place your index finger

against the inside corner of

your eye and press against

your nose for about two

minutes. This will help to

stop the medicine from

draining through the tear duct

to the nose and throat, from

where it can be absorbed into

other parts of your body. Ask

your doctor for more specific

instructions on this technique.

Replace the cap, sealing it

tightly. Do not overtighten

the cap.

Wash your hands again with

soap and water to remove any

residue.

Wait at least 15 minutes before

replacing your contact lenses.

Be careful not to touch the dropper

tip against your eye, eyelid or

anything else to avoid

contaminating the eye drops.

Contaminated eye drops may give

you an eye infection.

You may feel a slight burning

sensation in the eye after using the

eye drops.

If this persists, or is very

uncomfortable, contact your

doctor or pharmacist.

How long to use it

COSDOR helps control your

condition but does not cure it.

Therefore COSDOR must be used

every day. Continue using COSDOR

for as long as your doctor prescribes.

If you forget to use it

If it is almost time for your next

dose, skip the dose you missed and

have your next dose when you are

meant to. Otherwise, use the drops

as soon as you remember, and then

go back to using them as you

would normally.

If you are not sure whether to skip

the dose, talk to your doctor or

pharmacist.

Do not use double the amount to

make up for the dose that you

missed.

If you have trouble remembering

to use your eye drops, ask your

pharmacist for some hints.

If you use too much

(overdose)

If you think that you or anyone

else may have swallowed any or all

of the contents of a bottle of

COSDOR, or used too many drops,

immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26) for advice, or

go to accident or emergency at

your nearest hospital. Do this even

if there are no signs of discomfort

or poisoning.

If COSDOR is accidentally

swallowed, or if you use too many

drops, you may feel light-headed or

dizzy, you may faint, have a very

slow pulse rate, or have wheezing or

difficulty breathing.

While you are using

it

Things you must do

Have your eye pressure

checked when your eye

specialist says, to make sure

COSDOR is working.

If you develop an eye

infection, receive an eye

injury, or have eye surgery

tell your doctor.

Your doctor may tell you to use a

new bottle of COSDOR because

of possible contamination of the

old one, or may advise you to stop

your treatment with COSDOR.

If you become pregnant while

using COSDOR, tell your

doctor.

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are using COSDOR.

Things you must not do

Do not give COSDOR to

anyone else, even if they have

the same condition as you.

Do not stop using COSDOR

without first talking to your

doctor.

If you stop using your eye drops,

your eye pressure may rise again

and damage to your eye may occur.

Things to be careful of

Be careful driving or

operating machinery until

you know how COSDOR

affects you.

COSDOR generally does not cause

any problems with your ability to

drive a car or operate machinery.

However, COSDOR may cause

blurred vision or dizziness in some

people. Make sure you know how

you react to COSDOR or that your

vision is clear before driving a car

or operating machinery.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using COSDOR.

COSDOR helps most people with

high eye pressure and glaucoma, 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 treatment if

you get some of the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

problems with your eye/s such

as:

- blurred vision, double vision

or other visual problems

- allergic reactions including

redness, swelling and/or

itching of the eye

- burning and stinging of the

eyes, eye pain

- watering of the eyes or

discharge

- conjunctivitis

- irritation or feeling of having

something in the eye, dry

eyes

- swelling of the eyelids,

drooping of the eyelids

difficulty thinking or working

because of:

- headache

- tiredness, weakness

- ringing or buzzing in the ears

- difficulty sleeping, nightmares

- changes in mood such as

depression, memory loss

mouth or stomach problems

- feeling sick (nausea), upset

stomach, stomach pain

- diarrhoea

- bitter or abnormal taste, dry

mouth

respiratory problems

- cough

- sore throat and discomfort

when swallowing

- cold or flu-like symptoms

such as sneezing, runny nose,

cough, red or infected throat

- feeling of tension or fullness

in the nose, cheeks and

behind your eyes, sometimes

with a throbbing ache, also

called sinusitis

changes in the way your

hands and feet feel such as:

- cold hands or feet

- numbness, tingling and

colour change (white, blue

then red) in fingers when

exposed to the cold

(Raynaud's Phenomenon)

- numbness or tingling in the

fingers or toes

symptoms of a urinary tract

infection including an urge to

urinate frequently and in

small amounts, or painful

burning when passing urine

back pain

nose bleeds

hair loss or thinning

less desire for sex

These are usually mild side effects.

Tell your doctor immediately if

you notice any of the following:

fast or irregular heartbeats, also

called palpitations

slow or irregular heart beats

dizziness and light-headedness,

which may be due to low blood

pressure

skin rash, itching

swelling of the hands, feet or

ankles

These may be serious side effects.

You may need urgent medical

attention.

Serious side effects are rare.

If any of the following happen, stop

using COSDOR and tell your

doctor immediately or go to

accident and emergency at your

nearest hospital:

wheezing, difficulty in

breathing, shortness of breath

very slow pulse, chest pain

fainting

swelling of the face, lips, mouth,

tongue or throat which may

cause difficulty in breathing or

swallowing

severe and sudden onset of

pinkish, itchy swellings on

the skin, also called hives or

nettle rash

These

serious

side

effects.

need

urgent

medical

attention. These side effects are

rare.

Other side effects not listed

above may also occur in some

patients. Tell your doctor if you

notice any other effects.

Do not be alarmed by this list of

possible side effects. You may

not experience any of them.

After using it

Storage

Keep your eye drops in a cool

place where the temperature stays

below 25°C.

Do not store it or any other

medicine in the bathroom or near

a sink.

Do not leave it in the car or

on window sills.

Do not carry the eye drops

in pockets of your clothes.

Heat and dampness can destroy

some medicines.

Keep the eye drops away

from light.

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.

Do not leave the cap off the

bottle for any length of time to

avoid contaminating the eye

drops.

Disposal

Write the date on the bottle when

you open the eye drops and throw

out any remaining solution after

four weeks.

Eye drops contain a preservative

which helps prevent germs growing

in the solution for the first four weeks

after opening the bottle. After this

time there is a greater risk that the

drops may become contaminated and

cause an eye infection. A new bottle

should be opened.

If your doctor tells you to stop

using the eye drops or they have

passed their expiry date, ask your

pharmacist what to do with any

remaining solution.

Product description

This leaflet was prepared in March

2015.

Australian Register Number:

AUST R 217250.

How does it come?

COSDOR comes as eye drops in a

5mL bottle.

Ingredients

Active ingredients:

dorzolamide hydrochloride,

equivalent to dorzolamide

2% w/v

timolol maleate, equivalent to

timolol 0.5% w/v

Inactive ingredients:

sodium citrate

hydroxyethylcellulose

sodium hydroxide

mannitol

water for injection

benzalkonium chloride as

preservative

Supplier

COSDOR is supplied in Australia by:

Aspen Pharma Pty Ltd

34-36 Chandos Street

St Leonards NSW 2065

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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

5-6-2018

DuoTrav (Novartis Europharm Limited)

DuoTrav (Novartis Europharm Limited)

DuoTrav (Active substance: Travoprost / Timolol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3622 of Tue, 05 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/665/T/53

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Active substance: emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3453 of Wed, 30 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2312/T/91

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Active substance: canagliflozin / metformin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)3463 of Wed, 30 May 2018

Europe -DG Health and Food Safety

29-5-2018

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Spedding Research Solutions SAS)

EU/3/18/2017 (Active substance: Ambroxol hydrochloride) - Orphan designation - Commission Decision (2018)3384 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/236/17

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3261 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3262 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3260 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - PSUSA - Modification - Commission Decision (2018)3276 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/2003/201708

Europe -DG Health and Food Safety