ELTROXIN

Main information

  • Trade name:
  • ELTROXIN levothyroxine sodium 112 microgram tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELTROXIN levothyroxine sodium 112 microgram tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 206967
  • Last update:
  • 10-10-2017

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

ELTROXIN- Consumer Medicine Information

Page 1 of 4

ELTROXIN

®

thyroxine sodium

Consumer Medicine Information (CMI)

What is in this

leaflet

This leaflet answers some

common questions about

Eltroxin tablets.

It does not contain all the

available information about the

medicine.

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 taking

Eltroxin against the benefits he

or she expects it will have.

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.

The name of your medicine is

Eltroxin. It is available in

tablets of six different

strengths: 25 micrograms

(scored), 50 micrograms, 75

micrograms, 100 micrograms,

125 micrograms and 200

micrograms.

The active ingredient is called

thyroxine sodium.

What is it used for

Thyroxine sodium is a thyroid

hormone. It is used as

replacement therapy in the

treatment of thyroid hormone

deficiency.

Eltroxin is used to treat:

1. Thyroid hormone deficiency

also known as Hypothyroidism.

Hypothyroidism is a disease in

which the thyroid gland is

underactive and does not

produce enough thyroxine, a

hormone, which is important

for controlling your

metabolism. Symptoms of

hypothyroidism include

tiredness, muscle weakness,

and cramps, feeling the cold, a

slow heart rate, dry and flaky

skin, hair loss, a deep husky

voice and weight gain.

2. TSH-responsive tumours

(certain tumours of the thyroid

gland) of the thyroid

For these conditions to be

treated, patients need a supply

of thyroid hormones in their

body. Eltroxin replaces the

shortage of thyroid hormones.

Use Eltroxin only as

directed.

Your doctor may have

prescribed Eltroxin for another

condition.

Ask your doctor if you have

any questions about why the

medicine has been

prescribed for you.

Ask your doctor if you have

any concerns about taking it.

Eltroxin tablets are only

available with a doctor’s

prescription.

Before you take it

When you must not take it

Do not take Eltroxin if you

are allergic to:

Thyroxine sodium or any

other thyroid hormone (eg.

Tertroxin)

Any of the inactive

ingredients listed at the end of

this leaflet.

Some of the symptoms of an

allergic reaction to Eltroxin

may include red, itchy skin

rashes, difficulty in breathing,

swelling of the face or throat or

faintness.

Do not use Eltroxin after the

expiry date (EXP.) printed on

the pack.

If you take the medicine after

the expiry date has passed, it

may not work as well.

Do not take the medicine if

the packaging shows signs

of tampering.

Before you start to take it

Tell your doctor if:

1. You are allergic to any

other medicines or any

foods, dyes or preservatives.

2. You are pregnant or

intend to become pregnant.

Thyroxine levels will need to

be watched carefully during

pregnancy. Your dosage of

Eltroxin may need to be

increased while you are

pregnant.

Ask your doctor about the

risks and benefits of taking

Eltroxin during pregnancy.

3. You are breastfeeding or

intend to breastfeed.

ELTROXIN- Consumer Medicine Information

Page 2 of 4

Although small amounts of

Eltroxin are found in breast

milk, women who are

breastfeeding should continue

treatment with Eltroxin.

4. You have or have had any

other medical conditions/

health problems, including:

Overactive thyroid gland

Adrenal gland problem

Hyperthyroidism

Heart problems such as

cardiovascular disorder

High blood pressure

Diabetes

Long-standing

hypothyroidism, an

underactive thyroid gland.

If you have not told your

doctor about any of the

above, tell them before you

start to take any Eltroxin.

Taking other medicines

Tell your doctor if you are

taking any other medicines,

including medicines that you

buy without a prescription

from a pharmacy,

supermarket or health food

shop.

Some of these medicines may

interfere with Eltroxin. These

include:

Anticoagulants, medicines

used to thin your blood (eg.

Warfarin)

Antidepressants, medicines

used to treat depression (e.g.

Lithium, SSRIs, Tricyclic

antidepressants)

Antivirals, medicines used

to treat HIV/AIDS infection

(e.g. ritonavir)

Antimalarials, medicines

used to treat and prevent

malaria (e.g. chloroquine and

proguanil)

Medicines used to treat

diabetes (e.g. insulin)

Beta-blockers, medicines

used to treat high blood

pressure and heart conditions

(e.g. propranolol)

Ion-exchange resins,

medicines used to decrease

cholesterol in the blood (e.g.

cholestyramine)

Corticosteroids,

antiinflammatory medicines

(e.g. prednisolone and

dexamethasone)

Oral contraceptives and

hormone replacement

medicines such as oestrogens

and androgens

Medicines used for epilepsy

(e.g. phenytoin and

carbamazepine)

Medicines used to treat

heart failure (e.g. digoxin)

Iron supplements

Calcium supplements

Rifampicin, an antibiotic

used to treat tuberculosis and

other serious infections

Ciprofloxacin, an antibiotic

used to treat various infections

Soyabean flour (e.g. some

infant formula and other

products)

Antacids (e.g. aluminium

hydroxide, magnesium

hydroxide and calcium

carbonate)

Amiodarone, a medicine

used to treat irregular heart

beat

Non-steroidal anti-

inflammatory drugs (NSAIDs),

medicines used to relieve pain

and/or inflammatory conditions

including arthritis.

These medicines may affect

how well Eltroxin works, or

react with it resulting in

unwanted or sometimes

serious side effects.

This list is not exhaustive.

Your doctor or pharmacist has

more information on medicines

to be careful with or avoid

while taking it.

Before you start to take any

other medicine, tell your

doctor or pharmacist that

you are taking Eltroxin.

How to take it

Your doctor will decide on the

right dose for you.

It may take a few weeks for

Eltroxin to begin working. Until

it begins working you may not

notice any change in your

symptoms.

Follow your doctor's

instructions carefully, as

they may differ from the

information contained in this

leaflet.

How much to take

The usual starting dose for

adults is 50 to 100 micrograms

daily. The dose may be

increased over time. The

average adult maintenance

dose is 100 to 200

micrograms. Lower doses are

used in the elderly and

children. Your doctor will

calculate the dose required for

you.

Your doctor will monitor your

blood tests to make sure

Eltroxin is working for you.

Carefully follow the dosage

instructions, as given by

your doctor.

Do not change your dose

unless your doctor tells you

to do so.

Talk to your doctor if you

have any further questions.

ELTROXIN- Consumer Medicine Information

Page 3 of 4

How to take it

Swallow Eltroxin tablets with

a glass of water.

When to take it

Eltroxin tablets should be

taken first thing in the morning

on an empty stomach, at least

30 minutes and preferably 60

minutes before any food or

other medications .

How long to take it

Continue taking it as long as

your doctor recommends it.

If you forget to take it

If it is almost time for your

next dose, skip the dose you

missed and take your next

dose when you are meant to.

Otherwise, take your dose as

soon as you remember, and

then go back to taking it as

you would normally.

Do not take a double dose to

make up for the dose that

you missed.

If you are unsure about

whether to take your next

dose, speak to your doctor

or pharmacist.

If you have trouble

remembering when to take

your medicine, ask your

pharmacist for some hints.

If you take too much

(Overdose)

Immediately telephone your

doctor or Poisons

Information Centre

(telephone 13 11 26) for

advice, or go to Accident

and Emergency at your

nearest hospital, if you think

that you or anyone else may

have taken too much

Eltroxin. Do this even if there

are no signs of discomfort or

poisoning.

If you take too much you may

have the following symptoms:

restlessness; vomiting;

flushing; breathing difficulties;

chest pain; convulsions or

paralysis.

Keep your doctor,

pharmacist, Accident and

Emergency phone numbers

handy.

While you are taking

it

Things you must do

Do not switch or interchange

with other brands unless

advised by your doctor.

Immediately stop taking

Eltroxin if a skin rash or

other allergic reaction

occurs.

Use it exactly as directed or

as your doctor has

prescribed.

Tell your doctor if you feel

Eltroxin is not helping your

condition.

Visit your doctor regularly.

Your doctor needs to check

your progress.

Tell any other doctors,

dentists and pharmacists

who are treating you that

you are using Eltroxin.

Always discuss with your

doctor any problems or

difficulties during or after

taking it.

If you plan to have surgery, tell

your doctor or dentist that you

are taking Eltroxin.

If you are about to start taking

any new medicines, remind

your doctor and pharmacist

that you are taking Eltroxin.

Ensure you do not run out of

medicine over the weekend or

on holidays.

Things you must not do

Do not drive or operate

machinery where alertness is

required, until you know how

the medicine affects you.

Do not give this medicine to

anyone else, even if his or her

symptoms seem similar to

yours.

Side effects

Do not be alarmed by this

list of possible side effects.

You may not experience any of

them.

Tell your doctor or

pharmacist as soon as

possible if you do not feel

well while you are taking it.

Tell your doctor or

pharmacist if you notice any

of the following and they

worry you:

nervousness

anxiousness

excitation

restlessness

muscle weakness & cramps

inability to sleep

sleep disturbances

unusual movements,

including tremor

headache

lack of concentration

diarrhoea

vomiting

heat intolerance

excessive sweating

flushing

weight loss

menstrual irregularities

decreased libido

fever

shortness of breath

rapid breathing

irregular heart beats

chest pain

hair loss

irritability.

ELTROXIN- Consumer Medicine Information

Page 4 of 4

Some people may get other

side effects with Eltroxin.

Check with your doctor as

soon as possible if you have

any problems while taking it

even if you do not think the

problems are connected with

this medicine or are not

listed in this leaflet.

After using it

Storage

Store below 25°C.

Store in the original

package. Keep the bottle

tightly closed. Protect from

light.

If you do not keep the tablets

in the bottle they may not keep

well.

Do not store Eltroxin, or any

other medicines in a

bathroom or near a sink.

Do not leave it in the car or

on windowsills.

Heat and dampness can

destroy some medicines.

Do not take ELTROXIN

tablets if the tablet’s colour

has changed.

Keep the medicine out of

reach of children.

Disposal

If your doctor tells you to

stop taking this medicine or

it has passed its expiry date,

ask your pharmacist what to

do with any left over.

Product description

What it looks like

Eltroxin 25 microgram tablets

are round, white, flat tablets

marked with ‘25’ on one side

and bisected on the other side.

Eltroxin 50 microgram tablets

are round, white, flat tablets

marked with ‘50’ on one side

and ‘L01’ on the other side.

Eltroxin 75 microgram tablets

are round, white, flat tablets

marked with ‘75’ on one side

and ‘L02’ on the other side.

Eltroxin 100 microgram tablets

are round, white, flat tablets

marked with ‘100’ on one side

and ‘L10’ on the other side.

Eltroxin 125 microgram tablets

are round, white, flat tablets

marked with ‘125’ on one side

and ‘L12’ on the other side.

Eltroxin 200 microgram tablets

are round, white, flat tablets

marked with ‘200’ on one side

and ‘L21’ on the other side.

Eltroxin is available in bottles

of 200 tablets.

Ingredients

Each Eltroxin tablet contains

thyroxine sodium as the active

ingredient.

Each Eltroxin tablet contains

the following excipients:

microcrystalline cellulose

maize starch

purified talc

colloidal anhydrous silica

magnesium stearate

They are free from gluten,

sucrose, lactose and azo dyes.

Sponsor

Aspen Pharma Pty Ltd

34-36 Chandos St

St Leonards NSW 2065

The Australian Registration

Numbers are:

Eltroxin 25 microgram:

AUST R 206944

Eltroxin 50 microgram:

AUST R 206960

Eltroxin 75 microgram:

AUST R 206961

Eltroxin 100 microgram:

AUST R 206963

Eltroxin 125 microgram:

AUST R 206974

Eltroxin 200 microgram:

AUST R 206954

This leaflet was revised in

December 2015.

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Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Orphan designation: Sodium 2-hydroxylinoleate, Treatment of biliary tract cancer, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

28-2-2019

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Unither Therapeutik GmbH)

EU/3/04/197 (Active substance: Treprostinil sodium (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)1741 of Thu, 28 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004330

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Orphan designation: Trans-4-[4-[5-[[6-(trifluoromethyl)-3-pyridinyl]amino]-2-pyridinyl]phenyl] cyclohexane acetic acid sodium salt, Treatment of familial chylomicronaemia syndrome (type-I hyperlipoproteinaemia), 14/09/2012, Withdrawn

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Opinion/decision on a Paediatric investigation plan (PIP): Zeftera (previously Zevtera),Ceftobiprole medocaril (sodium), decision type: , therapeutic area: , PIP number: P/0406/2018

Europe - EMA - European Medicines Agency

15-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Opinion/decision on a Paediatric investigation plan (PIP): Rabeprazole (sodium), decision type: , therapeutic area: , PIP number: P/0401/2018

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (IDEA Innovative Drug European Associates (Ireland) Limited)

EU/3/08/554 (Active substance: Beraprost sodium (modified release tablet)) - Transfer of orphan designation - Commission Decision (2019)1354 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003232

Europe -DG Health and Food Safety

4-2-2019

Elmiron (bene-Arzneimittel GmbH)

Elmiron (bene-Arzneimittel GmbH)

Elmiron (Active substance: pentosan polysulfate sodium) - Centralised - Yearly update - Commission Decision (2019)848 of Mon, 04 Feb 2019

Europe -DG Health and Food Safety

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sodium thiosulfate, decision type: , therapeutic area: , PIP number: P/0312/2018

Europe - EMA - European Medicines Agency

24-1-2019


Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Patent blue V sodium: List of nationally authorised medicinal products - PSUSA/00002320/201804

Europe - EMA - European Medicines Agency

21-1-2019

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names

Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names (Active substance: Diclofenac sodium) - Community Referrals - Art 29 - Commission Decision (2019)589 of Mon, 21 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1467

Europe -DG Health and Food Safety

17-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Opinion/decision on a Paediatric investigation plan (PIP): Inclisiran sodium, decision type: , therapeutic area: , PIP number: P/0321/2018

Europe - EMA - European Medicines Agency

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Ability Pharmaceuticals SL)

EU/3/18/2121 (Active substance: Sodium 2-hydroxylinoleate) - Orphan designation - Commission Decision (2018)9036 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/142/18

Europe -DG Health and Food Safety

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: CMDh scientific conclusions and grounds for variation, amendments to the product information and timetable for the implementation - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

12-12-2018


Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate: List of nationally authorised medicinal products - EMEA/H/N/PSR/S/0016

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

3-12-2018


Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Withdrawn application: Zydax, glucuronoxylan sulfate sodium, Date of withdrawal: 03/12/2018, Initial authorisation

Europe - EMA - European Medicines Agency

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Opinion/decision on a Paediatric investigation plan (PIP): Exviera,Dasabuvir (sodium monohydrate), decision type: , therapeutic area: , PIP number: P/0174/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Pfizer Europe MA EEIG)

EU/3/13/1184 (Active substance: (1R,3R,4R,5S)-3-O-[2-O-benzoyl-3-O-(sodium(2S)-3-cyclohexyl-propanoate-2-yl)-beta-D-galactopyranosyl]-4-O-(a-L-fucopyranosyl)-5-orothylamido-cyclohexane-1-carboxylic acid ethyl-2-amidyl-ethyloxy-2-acetyl-(8-amino-1,3,6-naphthalene-tris sodium sulfonate) amide) - Transfer of orphan designation - Commission Decision (2018)7836 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/13/T/01

Europe -DG Health and Food Safety

19-11-2018


Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use

Europe - EMA - European Medicines Agency

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

27-8-2018

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Aspen Pharma Trading Limited)

Arixtra (Active substance: Fondaparinux sodium) - PSUSA - Modification - Commission Decision (2018)5708 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/403/PSUSA/1467-201712

Europe -DG Health and Food Safety

3-8-2018

Sodium oxybate

Sodium oxybate

Sodium oxybate (Active substance: Sodium oxybate) - Centralised - Art 28 - (PSUR - Commission Decision (2018)5381 of Fri, 03 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10612/201710

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Dr Ulrich Granzer)

EU/3/18/2043 (Active substance: Combination of carboplatin and sodium valproate) - Orphan designation - Commission Decision (2018)5275 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/036/18

Europe -DG Health and Food Safety

11-7-2018

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Merck Sharp and Dohme B.V.)

Fosavance (Active substance: Alendronate Sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4518 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/619/T/42

Europe -DG Health and Food Safety

10-7-2018

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Merck Sharp and Dohme B.V.)

Adrovance (Active substance: Alendronate sodium / Colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4477 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/759/T/39

Europe -DG Health and Food Safety