ELTROXIN

Main information

  • Trade name:
  • ELTROXIN levothyroxine sodium 175 microgram tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ELTROXIN levothyroxine sodium 175 microgram tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 206958
  • Last update:
  • 10-10-2017

Patient Information leaflet

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.

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

31-8-2018

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles

FDA - U.S. Food and Drug Administration

29-8-2018

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

FDA - U.S. Food and Drug Administration

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

25-5-2018

Orphan designation:  Treprostinil sodium,  for the: Treatment of chronic thromboembolic pulmonary hypertension

Orphan designation: Treprostinil sodium, for the: Treatment of chronic thromboembolic pulmonary hypertension

On 8 February 2013, orphan designation (EU/3/13/1103) was granted by the European Commission to SciPharm S.a.r.L, Luxembourg, for treprostinil sodium for the treatment of chronic thromboembolic pulmonary hypertension.

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

10-7-2018

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Swedish Orphan Biovitrum International AB)

Ammonaps (Active substance: Sodium phenylbutyrate) - Centralised - Yearly update - Commission Decision (2018)4483 of Tue, 10 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency

19-6-2018

Xyrem (UCB Pharma S.A.)

Xyrem (UCB Pharma S.A.)

Xyrem (Active substance: Sodium oxybate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3912 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/593/T/74

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety