THIAMINE

Main information

  • Trade name:
  • THIAMINE HYDROCHLORIDE thiamine hydrochloride 100 mg in 1 mL injection, vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • THIAMINE HYDROCHLORIDE thiamine hydrochloride 100 mg in 1 mL injection, vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218622
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218622

THIAMINE HYDROCHLORIDE thiamine hydrochloride 100 mg in 1 mL injection, vial

ARTG entry for

Medicine Registered

Sponsor

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

Postal Address

PO Box 702,BRAESIDE, VIC, 3195

Australia

ARTG Start Date

25/09/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. THIAMINE HYDROCHLORIDE thiamine hydrochloride 100 mg in 1 mL injection, vial

Product Type

Single Medicine Product

Effective date

25/09/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Thiamine Hydrochloride Injection is used for the prevention and treatment of vitamin B1 deficiency.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Coloured 12 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

Pack of 1 vial

Not scheduled. Not considered by committee

Pack of 5 vials

Not scheduled. Not considered by committee

Pack of 10 vials

Not scheduled. Not considered by committee

Pack of 6 vials

Not scheduled. Not considered by committee

Components

1. THIAMINE HYDROCHLORIDE thiamine hydrochloride 100 mg in 1 mL injection, vial

Dosage Form

Injection

Route of Administration

Intravenous

Intramuscular

Visual Identification

A clear and colourless solution contained in an amber glass vial, sealed

with a grey chlorobutyl rubber stopper and aluminium seal with red

polypropylene flip-off insert

Active Ingredients

Thiamine hydrochloride

100 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 04:39:03 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

Thiamine Hydrochloride 100mg in 1mL Injection

for Intravenous or Intramuscular Use

Thiamine hydrochloride (thy-a-min hy-dro-clor-ride)

Consumer Medicine Information

Biological Therapies Thiamine Hydrochloride 100mg in 1mL Injection

Version ID: cmi119s1410

page 1 of 3

Biological

Therapies

Consumer name and address:

Date of Dispensing:

Pharmacist Name:

Pharmacist Address:

What is in this leaflet

This leaflet answers some common

questions about Thiamine Hydrochloride

Injection.

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 giving you

Thiamine Hydrochloride Injection against the

benefits they expect it will have for you.

If you have any concerns about having

this medicine, ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

What Thiamine Hydrochloride

Injection is used for

Thiamine is used for the prevention and

treatment of vitamin B1 deficiency.

Thiamine hydrochloride is a form of

Vitamin B1.

This medicine works by increasing the

amount of thiamine in your body.

Vitamin B1 deficiencies:

Thiamine deficiencies may occur as a result

of a diet deficient in B vitamins, malnutrition,

or changes to the gastrointestinal tract which

slow or prevent the absorption of B vitamins

(e.g. abdominal surgery or some diseases of

the gastro-intestinal tract).

A specific deficiency of vitamin B1 (thiamine)

may cause the disease beriberi and cause

the condition Wernicke’s encephalopathy.

Extra vitamin B1 may be needed during

pregnancy, with increased carbohydrate

intake, increased physical activity, infection

and with some diseases relating to the liver.

Your doctor may prescribe this medicine to

treat vitamin B1 deficiency, to supplement

vitamin B1 missing in your diet or to raise the

level of Thiamine in your body.

Your doctor may decide that Thiamine

Hydrochloride Injection is the best way for

you to take Vitamin B1.

Malnutrition resulting from alcoholism:

Alcoholism can lead to a diet deficient in B

vitamins.

The normal metabolism of alcohol

in your liver also requires B vitamins,

especially thiamine.

Your doctor may have prescribed this

medicine for another reason.

Ask your doctor if you have any

questions about why this medicine has

been prescribed for you.

This medicine is not addictive.

This medicine is only available from a

medical practitioner or from a pharmacy with

a prescription from a medical practitioner.

This medicine is not expected to affect your

ability to drive a car or operate machinery.

Before you are given Thiamine

Hydrochloride Injection

When you must not be given it:

You must not be given this medicine if

you have an allergy to:

any medicine containing thiamine

any of the ingredients listed at the end

of this leaflet

latex

Some of the symptoms of an allergic reaction

may include:

Coughing or 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

You must not be given this medicine if

you are taking high dose B vitamins

This medicine should not be given to you if

you have high levels of B vitamins in your

body from other sources, such as high dose

vitamin supplements.

This medicine must not be given to a

child under 2 years.

This medicine should not be given to

Children under the age of 2 years because it

contains benzyl alcohol which may be

harmful.

You must not be given this medicine if the

solution in the vial is not clear or contains

particles.

You must not be given this medicine after

the expiry date printed on the pack or if

the packaging is torn or shows signs of

tampering

If you are given this medicine after the expiry

date has passed, it may not work and it may

be harmful to you.

If it is expired or damaged, return it to your

pharmacist for disposal.

If you are not sure whether you should be

given this medicine, talk to your doctor.

Before you are given this

medicine:

Tell your doctor or pharmacist if you have

had an allergy to any of the ingredients

listed at the end of this leaflet

Your doctor may test if you have an allergy to

this medicine by injecting a small amount

under your skin

Tell your doctor if you have any of the

following medical conditions:

Memory problems

Tell your doctor if you have allergies to

any other medicines or any other

substances, such as foods, preservatives

or dyes

Tell your doctor if you are pregnant or

plan to become pregnant.

There is an increased need for some B

vitamins during pregnancy.

It is

recommended that you and your doctor

discuss your requirements during pregnancy

and the possible risks and benefits of having

this medicine during pregnancy.

Tell your doctor if you are breastfeeding

or are intending to breastfeed

There is an increased need for some B

vitamins during breastfeeding.

It is

recommended that you and your doctor

discuss your requirements during

breastfeeding and the possible risks and

benefits of having this medicine during

breastfeeding.

If you have not told your doctor about any

of the above, tell them before you are

given Thiamine Hydrochloride Injection.

Biological Therapies Thiamine Hydrochloride 100mg in 1mL Injection

Version ID: cmi119s1410

page 2 of 3

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 Thiamine

Hydrochloride Injection may interfere with

each other.

These include:

Vitamin and Mineral Supplements

Medicines used to relax muscles,

Some antibiotic drugs such as kanamycin

sulfate and streptomycin sulfate

These medicines may be affected by

Thiamine Hydrochloride Injection, or affect

how well it works.

You may need different

amounts of your medicines, or you may need

to take different medicines.

Your doctor and pharmacist have more

information about medicines to be careful

with, or avoid while you are being treated

with this medicine.

How Thiamine Hydrochloride

Injection is given

Thiamine Hydrochloride Injection is given as

an injection, usually into a large muscle, or it

may be given by infusion (slow injection) into

a vein in your arm.

This medicine must only be given by a doctor

or nurse.

How much is given:

Your doctor will decide how much Thiamine

Hydrochloride Injection will need to be given

and for how long it will need to be given.

This is determined by many factors including

your body weight and your medical condition.

The usual dose of thiamine hydrochloride is

5mg to 100 mg under normal circumstances

or much higher amounts in critically ill

patients.

Follow all directions given to you by your

doctor carefully.

They may differ from the

information contained in this leaflet.

How long to be treated with it:

Each person will respond differently to

Thiamine Hydrochloride Injection.

Treatment times will differ depending on the

reason for prescribing this medicine.

Your doctor will tell you know how long you

will need to be treated with this medicine.

If you miss an appointment:

If you miss an appointment, talk to your

doctor and arrange another appointment as

soon as possible.

If you are not sure what to do, contact

your doctor or pharmacist as soon as

possible.

If too much is given (overdose):

Your doctor or nurse should be the only

person to inject Thiamine Hydrochloride

Injection, so an overdose is not likely to

occur.

Immediately telephone your doctor or

Poisons Information Centre (telephone

13 11 26) or go to Accident and

Emergency at your nearest hospital if you

think that you or anyone else may have been

given too much Thiamine Hydrochloride

Injection.

Do this even if there are no

signs of discomfort or poisoning.

may need urgent medical attention.

While you are being given

Thiamine Hydrochloride Injection

Things you must do:

If you are about to be started on any new

medicine, remind your doctor and

pharmacist that you are being treated

with Thiamine Hydrochloride Injection.

Tell any other doctors, dentists and

pharmacists who treat you that you are

being given this medicine

If you are going to have surgery, tell the

surgeon and anaesthetist that you are

being treated with this medicine.

It may affect other medicines used during

surgery.

If you are about to have any urine or

blood tests tell your doctor that you are

being treated with this medicine.

It may

interfere with the results of some tests.

If you become pregnant while being

treated with Thiamine Hydrochloride

Injection, tell your doctor immediately.

Tell your doctor if you feel that giving

Thiamine Hydrochloride Injection is not

helping your condition.

Keep all of your doctor’s appointments so

that your progress can be checked.

Your doctor may do some tests from time to

time to make sure the medicine is working

and to prevent unwanted side effects.

Things you must not do:

Do not attempt to inject this medicine

yourself.

Do not take any other medicines, whether

they require a prescription or not, without

first telling your doctor or consulting a

pharmacist.

Do not give your medicine to anyone else,

even if they have the same condition as

you

Side effects

Tell your doctor or pharmacist as soon as

possible if you do not feel well while you

are being given or treated with Thiamine

Hydrochloride Injection.

This medicine helps most people with

Vitamin B1 deficiency conditions, but it may

have unwanted side effects in a few people.

All medicines can have side effects.

Sometimes they are serious, most of the time

they are not.

You may need medical

attention if you get some of the 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, nurse or pharmacist as

soon as possible if you notice any of the

following and they worry you:

Tenderness or a hard lump around the

injection site

The above list includes the more common

side effects of this medicine.

They are

usually mild and short-lived.

Tell your doctor as soon as possible if

you notice any of the following:

Allergic reaction such as nausea,

sweating, a feeling of warmth, tingling,

weakness, tightness of the throat, pain in

the chest, fast heart beat, difficulty

breathing, faintness

The above list includes serious side effects

that may require medical attention.

Serious

side effects are rare.

If any of the following happen, tell your

doctor immediately, or go to Accident and

Emergency Department at your nearest

hospital:

severe allergic reaction which may

include sudden signs of allergy such as

rash, itching or hives on the skin, or

swelling of the face, lips, tongue, throat or

other parts of the body.

sneezing

severe rash

temporary itchiness

blue discolouration of the skin

bleeding

prolonged stomach pain

severe dizziness or drowsiness

muscular paralysis

low blood pressure

prolonged nausea or vomiting

Restlessness

Scaling of the facial skin

Inability to focus eyes

The above list includes very serious side

effects.

You may need urgent medical

attention or hospitalisation.

These side effects are rare.

Tell your doctor or pharmacist if you

notice anything that is making you feel

unwell, even if it is not on this list.

This is not a complete list of all possible side

effects.

Others may occur in some people

and there may be some side effects not yet

known.

Ask your doctor or pharmacist if you

don’t understand anything in this list.

Biological Therapies Thiamine Hydrochloride 100mg in 1mL Injection

Version ID: cmi119s1410

page 3 of 3

Do not be alarmed by this list of possible side

effects.

You should not experience any of them.

After being given Thiamine

Hydrochloride Injection

Storage

Thiamine Hydrochloride Injection is usually

stored in the doctor’s surgery or clinic, or at

the pharmacy.

If you need to store Thiamine

Hydrochloride Injection keep it in the

original pack until it is time for it to be

given.

If you take the vials out of the pack they may

not keep well.

Keep this medicine in a cool dry place,

where the temperature stays below 25°C.

Do not store Thiamine Hydrochloride

Injection 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 it where children cannot reach it.

A locked cupboard at least one-and-a-half

metres above the ground is a good place to

store medicines.

This product is for SINGLE USE in one

patient on one occasion only.

It will be

used once only and then it will be

discarded.

It must never be stored after it

is opened or used for more than one

person.

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 vials

that are left over.

Product Description

What it looks like:

Biological Therapies Thiamine Hydrochloride

100mg in 1mL Injection is a clear and

colourless solution contained in an amber

glass vial sealed with a rubber stopper and

aluminium seal with red polypropylene flip-off

insert.

It is packed in a white and orange

outer carton.

This medicine may be available in

4 pack sizes:

1 x 1mL vials

5 x 1mL vials.

6 x 1mL vials.

10 x 1mL vials.

Ingredients per vial:

Biological Therapies Thiamine Hydrochloride

100mg in 1mL Injection contains the

following ingredients:

Active Ingredient:

Thiamine Hydrochloride 100mg

It also contains:

Benzyl alcohol

Disodium edetate

Water for injections

This medicine does not contain lactose,

sucrose, gluten, tartrazine or any other azo

dyes.

Manufacturer/Supplier

This medicine is made, distributed and

supplied in Australia by:

Biological Therapies

A Division of Orthomolecular Medisearch

Laboratories Pty Ltd.

Suite 5, 20-30 Malcolm Road

Braeside VIC 3195

AUSTRALIA

Biological

Therapies

Australian Registration Number:

AUST R: 218622

This leaflet was prepared in

October 2014

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

15-5-2018

Votrient (Novartis Europharm Limited)

Votrient (Novartis Europharm Limited)

Votrient (Active substance: Pazopanib hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3062 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1141/T/46

Europe -DG Health and Food Safety