TRUSAMIDE

Main information

  • Trade name:
  • TRUSAMIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRUSAMIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217251
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217251

TRUSAMIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops 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. TRUSAMIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops 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

TRUSAMIDE Eye Drops are indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

2 Years

Store below 30

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Discard 4 weeks after

opening

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 5 mL

(S4) Prescription Only Medicine

Components

1. TRUSAMIDE dorzolamide (as hydrochloride) 20 mg/mL eye drops 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

© 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 06:25:30 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

TRUSAMIDE

®

Dorzolamide hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about TRUSAMIDE. 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

TRUSAMIDE 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 it is used for

TRUSAMIDE 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 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 TRUSAMIDE 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.

TRUSAMIDE is used, either alone

or in combination with other eye

drops or medicines, to lower raised

pressure within your eye(s).

TRUSAMIDE lowers pressure in the

eye by reducing the production of

fluid.

TRUSAMIDE belongs to a family of

medicines called carbonic anhydrase

inhibitors.

TRUSAMIDE is not addictive.

Before you use it

When you must not use it

Do not use TRUSAMIDE if:

you have an allergy to

TRUSAMIDE or any of

the ingredients listed at the

end of this leaflet

you are breast-feeding

or intend to breast-feed

It is not known whether

TRUSAMIDE passes into

breast milk.

Do not put the eye drops into

your eye(s) while you are

wearing soft contact lenses.

The preservative in TRUSAMIDE

(benzalkonium chloride) may be

deposited in soft contact lenses.

You can put your soft contact

lenses back into your eyes at least

15 minutes after you have used

TRUSAMIDE.

Do not use TRUSAMIDE 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 TRUSAMIDE,

talk to your doctor.

Do not give TRUSAMIDE to a

child.

The safety and effectiveness of

TRUSAMIDE in children have not

been established.

Before you start to use it

Tell your doctor if:

1.

you are pregnant or

intend to become pregnant

Your doctor will discuss the risks

and benefits of using

TRUSAMIDE during pregnancy

and a decision can be made if you

should or should not use it.

2.

you have now or have had

in the past any medical

conditions, especially the

following:

kidney disease

liver disease

3.

you have an allergy to

sulfonamide medicines

The active ingredient of

TRUSAMIDE, dorzolamide

hydrochloride, is a sulfonamide-

related compound. Therefore, if you

are allergic to sulfonamide

medicines you may be allergic to

TRUSAMIDE. Check with your

doctor or pharmacist if you are not

sure whether you are allergic to

sulfonamides.

4.

you have any allergies 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

TRUSAMIDE.

Taking other medicines

Tell your doctor if you are using

any other medicines or eye drops,

including medicines that you buy

without a prescription from your

pharmacy, supermarket or health

food shop.

Some medicines and TRUSAMIDE

may interfere with each other. These

include:

tablets used to treat glaucoma

large amounts of aspirin

or salicylates

These medicines may be affected by

TRUSAMIDE, or may affect how

well it works. You may need

different amounts of your medicine,

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

TRUSAMIDE.

How to use it

How much to use

Your doctor will tell you how many

drops you need to use each day.

Use TRUSAMIDE only

when prescribed by your

doctor.

When TRUSAMIDE is used alone,

the usual dose for adults is one drop

three times a day, in either one or

both eyes.

If your doctor has recommended that

you use TRUSAMIDE with a beta-

blocker eye drop, then the usual dose

for adults is one drop of

TRUSAMIDE 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.

After using TRUSAMIDE, wait at

least 10 minutes before putting any

other eye drops in your eye(s).

When to use it

If you are using TRUSAMIDE three

times a day, use the drops first thing

in the morning, in the early afternoon

and at bedtime (i.e. approximately 8

hours apart). If you are using

TRUSAMIDE twice a day, use the

drops in the morning and in the

evening (i.e. approximately 12 hours

apart).

Use TRUSAMIDE 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.

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 two safety

seals joining the cap to the bottle

are not broken. If they are, 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, hold the bottle upright

and turn the cap in the direction of

the arrows until you can lift it off.

This will break the two safety

seals.

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 shortly after

using the eye drops.

If this persists, or is very

uncomfortable, contact your

doctor or pharmacist.

How long to use it

TRUSAMIDE helps control your

condition but does not cure it.

Therefore TRUSAMIDE must be

used every day. Continue using

TRUSAMIDE 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

use 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

TRUSAMIDE, or used too many

drops, immediately telephone your

doctor or Poisons Information

Centre (telephone 13 11 26) for

advice, or go to accident and

emergency at your nearest

hospital. Do this even if there are

no signs of discomfort or

poisoning.

While you are using

it

Things you must do

Have your eye pressure checked

when your eye specialist says, to

make sure TRUSAMIDE 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 container of TRUSAMIDE

because of possible contamination of

the old one, or may advise you to stop

your treatment with TRUSAMIDE.

If you become pregnant while

using TRUSAMIDE tell your

doctor.

If you are about to be started on

any new medicine tell your doctor

and pharmacist that you are using

TRUSAMIDE.

Things you must not do

Do not give TRUSAMIDE to

anyone else, even if they have the

same condition as you.

Do not stop using

TRUSAMIDE without first

talking to your doctor.

If you stop using your eye drops,

your eye pressures 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

TRUSAMIDE affects you.

TRUSAMIDE generally does not

cause any problems with your ability

to drive a car or operate machinery.

However, it may cause certain side

effects in some people, including

blurred vision and dizziness. Make

sure you know how you react to

TRUSAMIDE before you drive a car

or operate machinery.

Side effects

Tell your doctor or pharmacist

as soon as possible if you do not

feel well while you are using

TRUSAMIDE.

TRUSAMIDE 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:

eye problems such as burning,

stinging, itching, conjunctivitis,

watering of the eye(s), redness of

the eye(s), swelling or crusting of

the eyelids(s), eye pain, blurred

vision

feeling sick

bitter taste, dry mouth

nose bleeds

throat irritation

headache, dizziness

tiredness, weakness

numbness or tingling in fingers

or toes

These are usually mild side effects of

TRUSAMIDE.

If any of the following happen,

stop using TRUSAMIDE and tell

your doctor immediately or go to

accident and emergency at your

nearest hospital:

wheezing, difficulty in

breathing, shortness of breath

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

nettlerash

skin rash, itchiness

These may be serious side effects.

You may have an allergic reaction to

TRUSAMIDE. You may need

urgent medical attention. Serious

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 dry

place where the temperature stays

below 30°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.

TRUSAMIDE contains 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

What does it look like

TRUSAMIDE comes as eye drops

in a 5 mL bottle.

Ingredients

Active ingredient:

dorzolamide hydrochloride,

equivalent to dorzolamide 2%

Inactive ingredients:

hydroxyethylcellulose

mannitol

sodium citrate

sodium hydroxide

benzalkonium chloride as

preservative

Supplier

TRUSAMIDE is supplied in

Australia by:

Aspen Pharma Pty Ltd

34-36 Chandos Street

St Leonards NSW 2065

Australia.

This leaflet was prepared in March

2015.

Australian Register Numbers:

TRUSAMIDE - AUST R 217251

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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

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

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

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

10-8-2018

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