TRAMADOL

Main information

  • Trade name:
  • TRAMADOL AMNEAL tramadol hydrochloride 50mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRAMADOL AMNEAL tramadol hydrochloride 50mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218122
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218122

TRAMADOL AMNEAL tramadol hydrochloride 50mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Amneal Pharma Australia Pty Ltd

Postal Address

12 River Street,SOUTH YARRA, VIC, 3141

Australia

ARTG Start Date

4/02/2014

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. TRAMADOL AMNEAL tramadol hydrochloride 50mg capsule blister pack

Product Type

Single Medicine Product

Effective date

13/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Relief of moderate to severe pain

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

20 capsules

(S4) Prescription Only Medicine

Components

1. TRAMADOL AMNEAL tramadol hydrochloride 50mg capsule blister pack

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

Hard gelatin capsules, size 3, having green cap and yellow body filled with

a homogeneous white to off-white powder

Active Ingredients

Tramadol hydrochloride

50 mg

© 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 05:26:23 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

Page 1 of 3

Tramadol Amneal v2

Tramadol Amneal Capsules

Tramadol hydrochloride

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Tramadol Amneal.

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 Tramadol

Amneal against the benefits this

medicine is expected to have for

you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Tramadol Amneal

is used for

Tramadol Amneal is used to relieve

moderate to severe pain and

belongs to a group of medicines

called analgesics (pain relievers).

Your doctor may have prescribed

Tramadol Amneal for another

reason. Ask your doctor why

Tramadol Amneal has been

prescribed for you.

This medicine is available only with

a doctor's prescription.

Tramadol Amneal is not normally

addictive although some cases

have been reported.

Before you use

Tramadol Amneal

When you must not use it

Do not use Tramadol Amneal if:

you have a known allergy

to Tramadol Amneal or

any of the ingredients

listed at the end of this

leaflet.

Some of the symptoms of

an allergic reaction may

include skin rash, itching,

difficulty breathing and

swelling of the face

(including lips, tongue,

throat etc)

you are taking medicine

for depression

containing a "monoamine

oxidase inhibitor" (such

as Nardil, Parnate), or

have taken one within the

past two weeks.

Do not use Tramadol Amneal

after the expiry date printed on

the pack.

If you take this medicine after the

expiry date has passed, it may not

work as well.

Do not use Tramadol Amneal if

the packaging is torn or shows

signs of tampering.

Do not give Tramadol Amneal to

children.

There is no experience with the use

of Tramadol Amneal in children.

If you are not sure whether you

should be using Tramadol Amneal,

talk to your doctor.

Before you use it

You must tell your doctor if:

you have a known allergy to

Tramadol Amneal or any of the

ingredients listed at the end of

this leaflet.

you are known to be sensitive

to opioids.

you drink alcohol every day.

you have or ever had any other

health problems, including:

any lung or breathing

problems

any diseases of the kidney,

liver or pancreas

severe stomach problems

a serious head injury

any fits or

convulsions/epilepsy.

you have or have had any

problems with drug or alcohol

dependence.

you are pregnant or intend to

become pregnant.

Tramadol Amneal is not

recommended for use during

pregnancy. Talk to your doctor

about the risks and benefits of

using Tramadol Amneal during

pregnancy.

you are breast-feeding or plan

to breast-feed.

Tramadol Amneal is not

recommended for use during

breast-feeding. Talk to your

doctor about the risks and

benefits of using Tramadol

Amneal when breast- feeding.

If you have not told your doctor

about any of the above, tell them

before you use Tramadol

Amneal.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without a

prescription from your

pharmacy, supermarket or health

food shop. Some medicines may

interfere with Tramadol Amneal.

These include:

carbamazepine (eg. Tegretol)

coumarin derivatives (eg.

Warfarin: Some Brand names

are Coumadin, or Marevan)

ondansetron

medicine for irregular or rapid

heart beat

medicines for depression,

sleeplessness or mental

conditions such as selective

Page 2 of 3

Tramadol Amneal v2

serotonin reuptake inhibitors

(SSRI's), tricyclic

anti-depressants, quinidine,

phenothiazines or anti-

psychotics

some antibiotics.

These medicines may be affected

by Tramadol Amneal, or may affect

how well it works. You may need

different amounts of your medicine,

or you may need to take different

medicines. Other interactions not

listed above may also occur.

Your doctor or pharmacist has

more information on medicines to

be careful with or avoid while taking

Tramadol Amneal.

How Tramadol Amneal

is used

Tramadol Amneal is available as

capsules (to swallow).

Your doctor will decide:

what dose of Tramadol Amneal

you will receive, and

for how long.

How much to take

For moderate pain, one Tramadol

Amneal capsule may be enough for

the first dose, followed by one or

two capsules two or three times a

day as required.

For moderate to severe pain, two

Tramadol Amneal capsules are

usually required for the first dose,

followed by one or two capsules

every four to six hours as required.

Patients over 75 years of age may

require a lower daily dose.

Do not take more than eight

Tramadol Amneal capsules per

day.

Follow carefully all directions given

to you by your doctor and

pharmacist.

These directions may differ from

the information in this leaflet.

If you do not understand the

instructions on the pack, ask your

doctor or pharmacist for help.

How to take it

Tramadol Amneal capsules should

be swallowed whole, with water.

When to take it

You can take Tramadol Amneal

before, with, or after food.

How long to take it

Depending on the medical

condition for which you require

Tramadol Amneal, your doctor may

tell you to take it for only a day or

two or longer, up to a few months

or more.

If you forget to take it

If you forget to take a dose, you

can take it as soon as you

remember. The next dose should

be taken after four or six hours, or

as prescribed by your doctor.

Do not take a double dose to make

up for the dose that you missed.

If you take too much (overdose)

Immediately telephone your

doctor or the Poisons

Information Centre (tel: 131 126)

or go to accident and emergency

at your nearest hospital, if you

think that you or anyone else

may have taken too much

Tramadol Amneal. Do this even if

there are no signs of discomfort

or poisoning.

You may need urgent medical

attention.

If you take too many capsules, this

may result in breathing difficulty

and fits or convulsion.

While you are using

Tramadol Amneal

Things you must do:

If you become pregnant while

you are taking Tramadol Amneal,

tell your doctor immediately.

If you are about to be started on

any new medicine, tell your

doctor and pharmacist that you

are taking Tramadol Amneal.

If your pain is not severe and

you feel that you do not need as

much Tramadol Amneal as your

doctor ordered, consult your

doctor.

Tell your doctor if your pain gets

worse. Do not take extra doses

without checking with your

doctor.

If you have to have any tests tell

your doctor you are taking

Tramadol Amneal. Tramadol

Amneal may affect the results of

some tests.

Things you must not do

Do not give Tramadol Amneal to

anyone else, even if they have

the same condition as you.

Do not use Tramadol Amneal to

treat any other complaints

unless your doctor tells you to.

Things to be careful of

Be careful driving or operating

machinery until you know how

Tramadol Amneal affects you.

Tramadol Amneal may make you

drowsy or dizzy.

Side effects

Check with your doctor as soon as

possible if you have any problems

while taking Tramadol Amneal,

even if you do not think the

problems are connected with the

medicine or are not listed in this

leaflet.

Like other medicines, Tramadol

Amneal can cause side effects. If

they occur, most are likely to be

minor and temporary. However,

some may be serious and need

medical attention.

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.

Common side effects:

Page 3 of 3

Tramadol Amneal v2

dizziness

sedation, fatigue

headache

constipation

nausea or vomiting

sweating

dry mouth

Less common side effects:

indigestion

changes in appetite

skin reactions

sudden onset of low blood

pressure, collapse

muscle weakness

tremor

seizures

respiratory depression

improvement in mood

confusion

sleep disturbance

blurred vision

difficulty in passing urine

Serotonin Syndrome: signs of this

vary and are not specific: they may

include fever, sweating, confusion,

agitation, diarrhoea, muscle

twitching, difficulty with walking and

balance. Serotonin Syndrome may

result from interaction of tramadol

with other medicines which

increase serotonin effects, for

example, the SSRI

antidepressants.

Tell your doctor immediately if

you experience any of the

following side-effects, as urgent

medical treatment may be

required:

skin rash (red spots or

patches), itching, hives, skin

lumps

swelling or puffiness of the

eyelids, face or lips

chest tightness, wheezing or

pain in the chest

heart palpitations, faintness or

collapse

hallucinations

convulsions.

Other side effects not listed above

may also occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Can Tramadol Amneal be

addictive?

When used as prescribed by your

doctor, addiction to Tramadol

Amneal is unlikely.

If you are taking Tramadol Amneal

for a prolonged period of time, your

body may become used to the

medicine and mild withdrawal

symptoms may occur if you

suddenly stop taking the medicine.

It is important therefore to take

Tramadol Amneal only as directed

by your doctor, and do not

suddenly stop taking it. Your

dosage may need to be gradually

reduced.

After using Tramadol

Amneal

Storage

Keep your Tramadol Amneal in

the pack until it is time to take

them.

If you take Tramadol Amneal out of

the pack it may not keep well.

Keep it in a cool dry place where

the temperature stays below

25

o

C.

If ambient temperatures above

30

o

C and/or high humidity are

likely to be experienced during

ongoing storage, a cool, dry

place should be sought to keep

this medicine.

Do not store it in the bathroom

or near a sink.

Do not leave it in the car or on

window sills.

Heat and dampness can destroy

some medicines.

Keep it where children cannot

reach it.

A locked cupboard at least 1½

metres above the ground is a good

place to store medicines.

Disposal

If your doctor tells you to stop

taking Tramadol Amneal or it

passes its expiry date, ask your

pharmacist what to do with any

Tramadol Amneal that is left over.

Tramadol Amneal

description

What it looks like

Tramadol Amneal 50 mg capsules

are hard gelatin capsules, size 3,

having green cap and yellow body

filled with a homogeneous white to

off-white powder, containing

tramadol hydrochloride 50 mg.

They are available in a blister pack

within a carton.

Ingredients

Active ingredient:

Tramadol hydrochloride

Inactive ingredients:

Microcrystalline cellulose

Gelatin

Indigo carmine aluminium lake

Magnesium stearate

Methyl hydroxybenzoate

Propyl hydroxybenzoate

Colloidal anhydrous silica

Sodium lauryl sulphate

Sodium starch glycollate

Titanium dioxide

Distributor

Amneal Pharma Australia Pty Ltd

12 River Street

South Yarra VIC 3141

Australia

Date of preparation:

October 2016

AUST R Number

218122

31-7-2018

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

July 30, 2018: Two People Guilty of Distributing Tramadol Pills

FDA - U.S. Food and Drug Administration

5-6-2018

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA takes action against 53 websites marketing unapproved opioids as part of a comprehensive effort to target illegal online sales

FDA announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing potentially dangerous, unapproved and misbranded versions of opioid medications, including tramadol and oxycodone.

FDA - U.S. Food and Drug Administration

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

16-5-2018

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults

FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults.

FDA - U.S. Food and Drug Administration

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

23-7-2018

Optruma (Eli Lilly Nederland B.V.)

Optruma (Eli Lilly Nederland B.V.)

Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

12-7-2018

Econor (Elanco Europe Ltd)

Econor (Elanco Europe Ltd)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Eli Lilly Nederland B.V.)

Ariclaim (Active substance: duloxetine hydrochloride) - Centralised - Withdrawal - Commission Decision (2018)4515 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

5-7-2018

Scientific guideline:  Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

Scientific guideline: Draft pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance, draft: consultation open

This document provides product-specific guidance on the demonstration of the bioequivalence of pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml.

Europe - EMA - European Medicines Agency

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

Europe -DG Health and Food Safety

3-7-2018

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Merck Sharp and Dohme B.V.)

Ristfor (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4249 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1235/T/77

Europe -DG Health and Food Safety

3-7-2018

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Merck Sharp and Dohme B.V.)

Velmetia (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4252 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/862/T/93

Europe -DG Health and Food Safety

3-7-2018

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Merck Sharp and Dohme B.V.)

Janumet (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4251 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/861/T/90

Europe -DG Health and Food Safety

29-6-2018

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (BioCryst UK Ltd)

EU/3/18/2028 (Active substance: (R)-1-(3-(aminomethyl) phenyl)-N-(5-((3-cyanophenyl)(cyclopropylmethylamino)methyl)-2-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazole-5-carboxamide dihydrochloride) - Orphan designation - Commission Decision (2018)4173 of Fri, 29 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/003/18

Europe -DG Health and Food Safety

14-6-2018

Kuvan (BioMarin International Limited)

Kuvan (BioMarin International Limited)

Kuvan (Active substance: sapropterin dihydrochloride) - Centralised - Yearly update - Commission Decision (2018)3859 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Celgene Europe B.V.)

EU/3/10/811 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3809 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/092/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

30-5-2018

Eviplera (Gilead Sciences Ireland UC)

Eviplera (Gilead Sciences Ireland UC)

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

Europe -DG Health and Food Safety

30-5-2018

Vokanamet (Janssen-Cilag International NV)

Vokanamet (Janssen-Cilag International NV)

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

Europe -DG Health and Food Safety

29-5-2018

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

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

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

Europe -DG Health and Food Safety

24-5-2018

Velmetia (Merck Sharp and Dohme Limited)

Velmetia (Merck Sharp and Dohme Limited)

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

Europe -DG Health and Food Safety

24-5-2018

Ristfor (Merck Sharp and Dohme Limited)

Ristfor (Merck Sharp and Dohme Limited)

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

Europe -DG Health and Food Safety

24-5-2018

Janumet (Merck Sharp and Dohme Limited)

Janumet (Merck Sharp and Dohme Limited)

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

Europe -DG Health and Food Safety

24-5-2018

Efficib (Merck Sharp and Dohme Limited)

Efficib (Merck Sharp and Dohme Limited)

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

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Lupin Europe GmbH)

EU/3/14/1353 (Active substance: Mexiletine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3134 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/074/14/T/03

Europe -DG Health and Food Safety

21-5-2018

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Incyte Biosciences Distribution B.V.)

EU/3/14/1421 (Active substance: Ponatinib hydrochloride) - Transfer of orphan designation - Commission Decision (2018)3141 of Mon, 21 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/212/14/T/02

Europe -DG Health and Food Safety