Aclin

Main information

  • Trade name:
  • Aclin 100 mg Tablet
  • Dosage:
  • 100 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Bottle, plastic, White HDPE bottle with white PP double wadded CRC, 50 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • ZaCh System S.p.A

Documents

Localization

  • Available in:
  • Aclin 100 mg Tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ACLIN is indicated for acute or long-term use in the treatment of the following:· Osteoarthritis · Rheumatoid arthritis · Ankylosing spondylitis · Periarticular diseases such as acute painful shoulder (acute subacromial bursitis/supraspinatus tendonitis) and tenosynovitis · Acute gouty arthritis · Painful low back syndrome (low back pain, commonly referred to as lumbago).

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 4945
  • Authorization date:
  • 24-09-1987
  • Last update:
  • 27-09-2017

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

Page 1 of 4

NEW ZEALAND CONSUMER MEDICINE INFORMATION

ACLIN

Sulindac Tablets 100mg and 200mg

What is in this leaflet

This leaflet answers some common

questions about ACLIN.

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 taking ACLIN

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the

medicine. You may need to read it

again.

What ACLIN is used

for

ACLIN is used to treat:

Osteoarthritis

Rheumatoid arthritis

Ankylosing spondylitis

Joint problems such as acute

painful shoulder

Acute gouty arthritis

Painful low back syndrome (low

back pain, also referred to as

lumbago).

ACLIN contains the active

ingredient sulindac. It belongs to a

group of medicines called non-

steroidal anti-inflammatory drugs

(NSAIDs).

It works by relieving pain,

inflammation and tenderness, and

promotes joint mobility.

Ask your doctor if you have any

questions about why this

medicine has been prescribed for

you.

Your doctor may have prescribed it

for another reason.

This medicine is available only with

a doctor’s prescription.

This medicine is not known to be

addictive.

Before you take

ACLIN

When you must not take

it

You must not take ACLIN:

If you have an active peptic

(stomach) ulcer or

gastrointestinal (stomach or

bowel) bleeding

If you have a history of

repeated gastrointestinal ulcer

or bleeding

If you are vomiting blood or

material that looks like coffee

grounds

If you have bleeding from the

rectum (back passage), have

sticky black stools (bowel

motions), or bloody diarrhoea

If you have had an asthma

attack, hives or itchy rash, or

runny or blocked nose caused

by aspirin or other NSAIDs

If you recently had coronary

artery bypass graft (CABG)

surgery

If you have severe liver

problems

If you have severe heart failure.

Do not take ACLIN if you have an

allergy to:

Any medicine containing

sulindac

Any of the ingredients listed at

the end of this leaflet

Aspirin or any other NSAID

medicines.

Some of the symptoms of an

allergic reaction may include:

shortness of breath; wheezing or

difficulty breathing; swelling of the

face, lips, tongue or other parts of

the body; rash, itching or hives on

the skin.

Do not give this medicine to a

child under the age of 18 years.

Safety and effectiveness in children

younger than 18 years have not

been established.

Do not take this medicine after

the expiry date printed on the

pack or if the packaging is torn or

shows signs of tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take

it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you have or

have had any of the following

medical conditions:

Heart problems such as

cardiovascular (heart) disease,

atherosclerotic (narrowing of

the blood vessels)

cardiovascular disease,

previous heart attack, CABG

surgery, high blood pressure,

angina or chest pain

Stroke

Diabetes

Heartburn, indigestion, stomach

ulcer or other stomach

problems

Asthma

Kidney or liver problems

Swelling of the feet or ankles

(fluid retention or oedema)

A tendency to bleed

Any current infection

Page 2 of 4

Tell your doctor if:

You are or have ever been

dependent on alcohol

You are or have been a

smoker.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Aclin may increase the risk of

complications or miscarriage.

Your doctor can discuss with you

the risks and benefits involved.

Caution is advised in elderly

people.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

ACLIN.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop.

Some medicines and ACLIN may

interfere with each other. These

include:

Aspirin, salicylates and other

NSAIDs

Medicines used to prevent

blood clots such as warfarin

Some medicines used to treat

high blood pressure

Some medicines used to treat

diabetes

Methotrexate, a medicine used

to treat arthritis and some

cancers

DMSO (dimethyl sulfoxide),

another medicine used to treat

arthritis

Ciclosporin, a medicine used to

suppress the immune system.

These medicines may be affected

by ACLIN or may affect how well

ACLIN works. You may need

different amounts of your

medicines, or you may need to take

different medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while taking

this medicine.

How to take ACLIN

Follow all directions given to you

by your doctor or pharmacist

carefully. They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the bottle, ask

your doctor or pharmacist for

help.

Elderly patients may be more

susceptible to the risk of adverse

reactions (side effects) and

therefore lower dosages are

generally recommended.

ACLIN is not recommended for

children.

How much to take

The usual dose of ACLIN is 400mg

daily, taken in divided doses. Your

doctor may lower the dose

depending on how you respond.

Ask your doctor or pharmacist if you

have any questions.

How to take it

Take the tablets during, or

immediately after a meal with a

glass of water. This will help reduce

the chance of any unwanted

stomach or bowel effects.

When to take it

Take your medicine at about the

same times each day. If used

once daily, the medicine should

be taken in the evening.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

It does not matter if you take this

medicine before or after food.

How long to take it

Continue taking your medicine

for as long as your doctor tells

you.

The duration for which you need to

take this medicine will depend on

what medical problem you are

taking it for. Ask your doctor if you

have any questions.

If you forget to take it

If you forget a dose, just take the

next dose when it is due.

Do not take a double dose to

make up for the dose that you

missed.

This may increase the chance of

you getting an unwanted side effect.

If you are not sure what to do,

ask your doctor or pharmacist.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints.

If you take too much

(overdose)

Immediately telephone your

doctor or the National Poisons

Information Centre (0800 POISON

or 0800 764 766) for advice, or go

to Accident and Emergency at

the nearest hospital, if you think

that you or anyone else may have

taken too much ACLIN. Do this

even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

Symptoms of an overdose may

include:

Inability to think straight

Coma

Decreased urine production

Low blood pressure

While you are taking

ACLIN

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking ACLIN.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist

that you are taking this medicine.

It may affect other medicines used

during surgery.

Page 3 of 4

If you become pregnant while

taking this medicine, tell your

doctor immediately.

If you are about to have any

blood tests, tell your doctor that

you are taking this medicine.

It may interfere with the results of

some tests.

Keep all of your doctor’s

appointments so that your

progress can be checked.

Your doctor may do some tests

from time to time (like blood tests to

check liver and kidney function) to

make sure the medicine is working

and to prevent unwanted side

effects.

Tell your doctor if you get an

infection while you are taking

ACLIN.

ACLIN can hide some of the signs

of an infection and therefore, you

may mistakenly think that you are

better, or that the infection is less

serious than it might be. Symptoms

of an infection include fever, pain,

swelling or redness.

Things you must not do

Do not take ACLIN to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone else, even if they have

the same condition as you.

Do not stop taking your medicine

or change the dosage without

checking with your doctor.

Things to be careful of

Be careful driving or operating

machinery until you know how

ACLIN affects you.

This medicine may cause dizziness,

tiredness, blurred vision, fainting or

seizures in some people. If you

have any of these symptoms, do not

drive, operate machinery or do

anything else that could be

dangerous.

Be careful when drinking alcohol

while you are taking this

medicine.

If you drink alcohol while you are

taking this medicine, you may be at

higher risk of side effects.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

ACLIN.

This medicine may have unwanted

side effects in some people. All

medicines can have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical attention if you get

some of the side effects.

If you are over 65 years of age you

may have an increased chance of

getting side effects.

Do not be alarmed by the

following lists of side effects.

You may not experience any of

them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

Stomach upset, including

nausea (feeling sick), vomiting,

indigestion

Constipation, diarrhoea,

stomach pain, wind

Loss of appetite

Dizziness, sleepiness,

drowsiness

Headache

Feeling anxious

Buzzing or ringing in the ears

Swelling of the legs, ankles or

feet.

The above list includes the more

common side effects of your

medicine.

They are usually mild and short-

lived.

Tell your doctor as soon as

possible if you notice any of the

following:

Severe pain or tenderness in

the stomach

Eye problems including blurred

vision

Severe dizziness or spinning

sensation

Changes in mood

Fast and/or irregular heartbeat

Unusual bruising or bleeding,

reddish or purple blotches

under the skin

Signs of frequent infections

such as fever, chills, sore throat

or mouth ulcers

Signs of anaemia such as

tiredness, being short of breath

and looking pale

A change in the colour of urine,

or blood in the urine

An increase or decrease in the

amount of urine passed,

burning feeling when passing

urine

Yellowing of eyes or skin

(jaundice)

Symptoms of sunburn (such as

redness, itching, swelling,

blistering) which may occur

more quickly than normal

‘Flu-like’ symptoms

Skin hypersensitivity.

The above list includes less

common but serious side effects

that may require medical attention.

If any of the following happen,

tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital:

Swelling of the face, lips or

tongue which may cause

difficulty in swallowing or

breathing

Sudden or severe itching, skin

rash, hives

Fainting, seizures or fits

Breathing problems including

asthma, wheezing, shortness of

breath

Tightness in the chest or chest

pain.

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

This list of side effects is not

complete. Other side effects not

listed above may also occur in

some people.

Some of the side effects (for

example blood pressure) can only

be found when your doctor does

tests from time to time to check your

progress.

Page 4 of 4

After using ACLIN

Storage

Keep your tablets in the bottle

until it is time to take them.

If you take the tablets out of the

bottle they may not keep well.

Keep your tablets in a cool dry

place where the temperature

stays below 30°C.

Do not store ACLIN or any other

medicine in the bathroom or near a

sink. Do not leave it on a window sill

or in the car. Heat and dampness

can destroy some medicines.

Keep medicines where children

cannot reach them.

A locked cupboard at least one-and-

a half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it looks like

ACLIN 100mg tablets are 8 mm

flat bevelled edge orange-yellow

tablets marked with “SD” over

breakline “100” on one side and “α”

on the other side.

ACLIN 200 mg tablets are 10 mm

flat bevelled edge orange-yellow

tablets marked with “SD” over

breakline “200” on one side and “α”

on the other side.

Ingredients

Each ACLIN 100 mg and ACLIN

200 mg tablet contains sulindac 100

mg and 200 mg as the active

ingredient, respectively.

Each ACLIN tablet also contains:

Lactose

Microcrystalline cellulose

Povidone

Sodium starch glycollate

Quinoline yellow

Talc

Magnesium stearate.

This medicine does not contain

sucrose, gluten or tartrazine.

If you want to know

more

Should you have any questions

regarding this product, please

contact your pharmacist or doctor.

Who supplies this

medicine

Distributed in New Zealand by:

Mylan New Zealand Ltd

PO Box 11183

Ellerslie

Auckland.

Telephone: (09) 579 2792

Date of Information

01 August 2017

(Based on datasheet dated 01

August 2017)

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Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety