VALGANCICLOVIR

Main information

  • Trade name:
  • VALGANCICLOVIR MYLAN valganciclovir (as hydrochloride) 450 mg film-coated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VALGANCICLOVIR MYLAN valganciclovir (as hydrochloride) 450 mg film-coated tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218477
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218477

VALGANCICLOVIR MYLAN valganciclovir (as hydrochloride) 450 mg film-coated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462,ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

25/09/2015

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. VALGANCICLOVIR MYLAN valganciclovir (as hydrochloride) 450 mg film-coated tablet bottle

Product Type

Single Medicine Product

Effective date

11/05/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

VALGANCICLOVIR MYLAN is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome

(AIDS).

VALGANCICLOVIR MYLAN is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in patients at risk of CMV

disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. VALGANCICLOVIR MYLAN valganciclovir (as hydrochloride) 450 mg film-coated tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

A pink, film-coated, oval, biconvex, beveled edge tablet debossed with M

on one side of the tablet and V45 on the other side.

Active Ingredients

Valganciclovir hydrochloride

496.3 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 19.10.2017 at 05:58:40 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

VALGANCICLOVIR

MYLAN

contains the active ingredient valganciclovir

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common

questions about

VALGANCICLOVIR MYLAN

tablets.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking

VALGANCICLOVIR MYLAN

against the benefits expected for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What

VALGANCICLOVIR

MYLAN is used for

VALGANCICLOVIR MYLAN

contains the active ingredient

valganciclovir. In the body

valganciclovir rapidly changes to

ganciclovir.

VALGANCICLOVIR MYLAN

belongs to a class of medicines used

to prevent the growth of viruses.

VALGANCICLOVIR MYLAN acts

against a virus called

cytomegalovirus or CMV (a type of

herpes virus). It prevents this virus

from growing and multiplying in the

body. CMV causes infections, mainly

in people with poor immunity. Poor

immunity can be caused by HIV/

AIDS or by medications taken after

an organ transplant.

VALGANCICLOVIR MYLAN is

used to treat CMV eye infections

(known as CMV retinitis) in AIDS

patients, which, if left untreated can

cause blindness. It is not a cure for

CMV eye infections.

VALGANCICLOVIR MYLAN is

not effective against any underlying

HIV infection.

VALGANCICLOVIR MYLAN is

also used to prevent CMV infection

in patients following organ

transplantation.

Your doctor, however, may have

prescribed VALGANCICLOVIR

MYLAN for another purpose.

Ask your doctor if you have any

questions about why

VALGANCICLOVIR MYLAN

has been prescribed for you.

VALGANCICLOVIR MYLAN is

not addictive.

This medicine is available only with

a doctor's prescription.

Before you take

VALGANCICLOVIR

MYLAN

Animal and other laboratory studies

have shown VALGANCICLOVIR

MYLAN causes infertility, birth

defects and cancer. It is possible that

these effects may also occur in

humans.

When you must not take it

Do not take VALGANCICLOVIR

MYLAN if you have an allergy to:

ganciclovir, valaciclovir or

aciclovir or any ingredients listed

at the end of this leaflet

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 take this medicine if you

have very low blood counts for

platelets (which help clotting),

neutrophils (a type of white blood

cell which defends against

infection) or low haemoglobin

(oxygen carrying substance in the

blood).

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

VALGANCICLOVIR MYLAN,

talk to your doctor.

Use in children

There is limited information on the

safety and effectiveness of the use of

VALGANCICLOVIR MYLAN in

children. Your doctor will advise you

whether VALGANCICLOVIR

MYLAN is suitable for your child.

VALGANCICLOVIR MYLAN

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:

1. you are pregnant or intend to

become pregnant.

VALGANCICLOVIR MYLAN is

not recommended for use during

pregnancy. VALGANCICLOVIR

MYLAN may affect your developing

baby if you take it during pregnancy.

Your doctor will discuss the risks and

benefits of using

VALGANCICLOVIR MYLAN if

you are pregnant.

2. you are breastfeeding or intend

to breastfeed.

It is not known whether

VALGANCICLOVIR MYLAN

passes into breast milk. Breast-

feeding is not recommended during

therapy with VALGANCICLOVIR

MYLAN.

3. you are allergic to any other

medicines, foods, dyes or

preservatives.

Especially any medicine which you

have taken previously to treat your

current condition.

4. you have, or have had any other

health problems, especially the

following:

you have a history of low blood

counts for platelets

(thrombocytopenia), neutrophils

(neutropenia) or anaemia

you have, or previously have had,

poor kidney function.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

VALGANCICLOVIR MYLAN.

Taking other medicines

Tell your doctor and pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from a

pharmacy, supermarket or health

food shop.

Some medicines may interfere with

VALGANCICLOVIR MYLAN.

These medicines include:

probenecid, a medicine used to

treat gout

zidovudine (AZT) a medicine

used to treat HIV infection

didanosine (ddI), a medicine used

to treat HIV infection

imipenem/cilastatin, a

combination of medicines used to

treat some infections

mycophenolate mofetil, a

medicine used to prevent organ

rejection after a transplant

medicines for the treatment of

cancer such as vincristine,

adriamycin, hydroxyurea

anti-infective agents such as

dapsone, pentamidine, flucytosine

and amphotericin B

other medicines for the treatment

of HIV or HIV-related infections

such as nucleoside analogues

(lamivudine, also known as 3TC;

stavudine, also known as D4T;

zalcitabine also known as ddc;

abacavir; lamivudine / zidovudine

or; abacavir / lamivudine /

zidovudine combinations).

These medicines may be affected by

VALGANCICLOVIR MYLAN, may

affect how well it works or may

increase the risk of side effects with

VALGANCICLOVIR MYLAN. You

may need different amounts of your

medicines, or you may need to take

different medicines. Your doctor will

advise you.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

VALGANCICLOVIR MYLAN.

You should tell any doctor who is

prescribing a new medication for you

that you are taking

VALGANCICLOVIR MYLAN.

Ask your doctor or pharmacist if

you are not sure about this list of

medicines.

How to take

VALGANCICLOVIR

MYLAN

Follow all directions given to you

by your doctor and pharmacist

carefully.

They may differ from the

information contained in this leaflet.

If you do not understand the

instructions on the box, ask your

doctor or pharmacist for help.

How much to take

Take VALGANCICLOVIR

MYLAN exactly as your doctor

has prescribed.

Your doctor will tell you how many

VALGANCICLOVIR MYLAN

tablets to take each day.

Treatment of CMV Retinitis in

AIDS

1. Induction Treatment (for active

CMV retinitis)

The usual dose is 900 mg (two 450

mg tablets) twice daily with food for

21 days.

2. Maintenance Treatment (after

induction treatment or for inactive

CMV retinitis)

The usual dose is 900 mg (two 450

mg tablets) once daily with food.

Prevention of CMV Disease in

Transplantation

The usual dose is 900 mg (two 450

mg tablets) once daily with food,

starting within 10 days of your organ

transplant until 100 days after the

transplant.

If you have received a kidney

transplant, the same daily dose is

required until 200 days after the

transplant.

Your dose may have to be reduced or

stopped if you have or develop low

blood counts, have kidney disease, or

if you are older than 65 years.

How to take it

Swallow tablets whole with a glass

of water. VALGANCICLOVIR

MYLAN must be taken with food.

VALGANCICLOVIR MYLAN

When to take it

Take VALGANCICLOVIR

MYLAN during or immediately

after a meal.

If you take VALGANCICLOVIR

MYLAN on an empty stomach, it

may not work as well.

Take your medicine at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take

your dose.

How long to take it for

Continue taking

VALGANCICLOVIR MYLAN

until your doctor tells you to stop.

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 it as

soon as you remember, and then go

back to taking your tablets as you

would normally.

Do not take a double dose to make

up for the dose you missed.

If you have trouble remembering

to take your medicine, ask your

pharmacist for some hints.

If you are not sure what to do or

whether to skip the dose, ask your

doctor or pharmacist.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) 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

VALGANCICLOVIR MYLAN.

Do this even if there are no signs of

discomfort or poisoning.

While you are taking

VALGANCICLOVIR

MYLAN

Things you must do

Tell all doctors, dentists and

pharmacists who are treating you

that you are taking

VALGANCICLOVIR MYLAN.

A barrier contraceptive should be

used while taking

VALGANCICLOVIR MYLAN

and for 90 days after stopping

treatment.

Tell your doctor if you become

pregnant while taking

VALGANCICLOVIR MYLAN.

See your doctor regularly so that

your CMV disease, blood cell

counts and any other potential side

effects may be monitored carefully.

If blood cell counts are low then this

may reduce your ability to fight

infection, or for your blood to clot

efficiently. If left undetected these

effects on blood cells may contribute

to death or serious illness.

If you have a CMV eye infection,

you must also see your doctor

regularly to monitor the condition

of your retina (part of the eye).

Tell your doctor if, for any reason,

you have not taken your medicine

exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Be sure to keep all of your

appointments with your doctor so

that your progress can be checked.

Things you must not do

Do not stop taking

VALGANCICLOVIR MYLAN or

change the dose without first

checking with your doctor.

Do not let yourself run out of

medicine over the weekend or on

holidays.

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 VALGANCICLOVIR

MYLAN to anyone else even if they

have the same condition as you.

Be careful when handling

VALGANCICLOVIR MYLAN

tablets. Do not break or crush

them. If you accidentally touch

broken or crushed tablets, wash

your hands thoroughly with soap

and water. If any powder from the

tablet gets in your eyes, rinse your

eyes thoroughly with water.

Things to be careful of

Be careful driving or operating

machinery until you know how

VALGANCICLOVIR MYLAN

affects you.

VALGANCICLOVIR MYLAN may

cause drowsiness, dizziness,

confusion or seizures (fits) in some

people and therefore may affect

alertness. Make sure you know how

you react to VALGANCICLOVIR

MYLAN before you drive a car or

operate machinery or do anything

else that could be dangerous if you

are drowsy, dizzy or not alert.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

VALGANCICLOVIR MYLAN.

VALGANCICLOVIR MYLAN

helps most people with CMV

infections 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. Your doctor

has weighed the risks of using this

medicine against the benefits they

expect it will have for you.

Tell your doctor immediately or go

to accident and emergency at your

nearest hospital if you notice any of

the following.

VALGANCICLOVIR MYLAN

swelling of the face, lips, mouth,

throat or tongue which may cause

difficulty in swallowing or

breathing

any sign of infection such as

fever, chills, sore throat or mouth

ulcers

unexplained bruising or bleeding

thinking, hearing or seeing things

that are not real

confusion

agitation

fits

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.

Tell your doctor immediately if

you notice any of the following:

skin rash

abdominal pain

cough

fatigue (tiredness)

oral thrush (sore, creamy yellow

raised patches in the mouth)

insomnia (inability to sleep)

worsening of your eyesight

These may be serious side effects.

You may require urgent medical

attention. Serious side effects are

rare.

Tell your doctor if you notice any

of the following:

headache

nausea

dizziness

looking pale

fever

diarrhoea

vomiting

These are the more common side

effects of VALGANCICLOVIR

MYLAN and are usually short lived.

Do not be alarmed by these lists of

side effects. You may not experience

any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

After taking

VALGANCICLOVIR

MYLAN

Storage

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the pack

they may not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store VALGANCICLOVIR

MYLAN 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.

Disposal

If your doctor tells you to stop

taking VALGANCICLOVIR

MYLAN 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

VALGANCICLOVIR MYLAN

comes in one strength:

VALGANCICLOVIR MYLAN -

valganciclovir 450 mg: A pink,

biconvex, oval, beveled edge

film-coated tablet with "M" on

one side and "V45" on the other

side. Bottles of 60 tablets.

Ingredients

Active Ingredients:

VALGANCICLOVIR MYLAN

contains valganciclovir as the active

ingredient.

VALGANCICLOVIR MYLAN -

450 mg valganciclovir.

Inactive Ingredients:

VALGANCICLOVIR MYLAN also

contains the following inactive

ingredients:

Crospovidone

Stearic acid

Microcrystalline cellulose

The film-coat applied to the tablets

contains Opadry Brown 15B565009,

which consists of the following

inactive ingredients:

Hypromellose

Titanium dioxide

Macrogol 400

Polysorbate 80

Iron oxide red

VALGANCICLOVIR MYLAN does

not contain, sucrose, gluten,

tartrazine or any other azo dyes.

Supplier

VALGANCICLOVIR MYLAN is

supplied in Australia by:

Alphapharm Pty Limited

(ABN 93 002 359 739)

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

Phone: (02) 9298 3999

www.alphapharm.com.au

Australian registration numbers:

VALGANCICLOVIR MYLAN:

AUST R 218477

This leaflet was prepared on

October 2015.

VALGANCICLOVIR

MYLAN_cmi\Oct15/00

VALGANCICLOVIR MYLAN

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