EPIRUBICIN

Main information

  • Trade name:
  • EPIRUBICIN ACCORD epirubicin hydrochloride 20mg/10mL concentrated injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EPIRUBICIN ACCORD epirubicin hydrochloride 20mg/10mL concentrated injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210085
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210085

EPIRUBICIN ACCORD epirubicin hydrochloride 20mg/10mL concentrated injection vial

ARTG entry for

Medicine Registered

Sponsor

Accord Healthcare Pty Ltd

Postal Address

Level 24 570 Bourke Street,Melbourne, VIC, 3000

Australia

ARTG Start Date

9/10/2014

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. EPIRUBICIN ACCORD epirubicin hydrochloride 20mg/10mL concentrated injection vial

Product Type

Single Medicine Product

Effective date

23/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Epirubicin has produced responses in a wide spectrum of neoplastic diseases, and is indicated for the treatment of breast cancer, gastric cancer, ovarian

cancer, small cell lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma, superficial bladder cancer (Tis; Ta). In

bladder cancer, Epirubicin is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage Ta

multifocal papillary cancers (grades 2 and 3).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

2 Years

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Do not Freeze

Refrigerate

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. EPIRUBICIN ACCORD epirubicin hydrochloride 20mg/10mL concentrated injection vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Intravesical

Visual Identification

Clear red solution in a clear glass vial with white flip off seal

Active Ingredients

epirubicin hydrochloride

20 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 27.11.2017 at 10:02:38 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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Version 2.0

Page 1 of 4

EPIRUBICIN ACCORD

Epirubicin Hydrochloride Concentrated Injection

10 mg/5 mL, 20 mg/10 mL, 50 mg/ 25 mL and 200 mg/100 mL

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Epirubicin Accord.

It does not contain all of 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

using Epirubicin Accord against the

benefits it is expected to have for you.

If you have any concerns about using

Epirubicin Accord, ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

What Epirubicin Accord

is used for

This medicine is used to treat the

following types of cancer:

breast cancer

gastric (stomach) cancer

ovarian cancer

small cell lung cancer

lymphoma (non-Hodgkin's

lymphoma), a cancer of the lymph

glands

sarcoma

bladder cancer

This medicine belongs to a group of

medicines called antineoplastic or

cytotoxic medicines.

You may also hear of these being called

chemotherapy medicines. Epirubicin

Accord is an anthracycline-type of

chemotherapy.

This medicine works by killing cancer

cells and stopping cancer cells from

growing and multiplying.

Ask your doctor if you have any

questions about why this medicine has

been prescribed for you.

Your doctor may have prescribed it for

another reason.

Epirubicin Accord may be used alone or

in combination with other medicines to

treat cancer.

This medicine is not addictive. This

medicine is available only with a doctor's

prescription.

Before you are given

Epirubicin Accord

When you must not be given

it

Do not use Epirubicin Accord if you

have ever had an allergic reaction to

epirubicin (the active ingredient in

Epirubicin Accord), other medicines to

treat cancer or any of the ingredients

listed at the end of this leaflet.

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 use the medicine for injection

into a vein if you have:

a low number of red blood cells, white

blood cells or platelets in your blood

sore, red mouth from previous treatment

or radiation therapy

an infection

severe liver problems

heart problems or have ever had heart

problems

already received the highest dose

allowed for medicines such as

mitozantrone, mitomycin C,

doxorubicin or daunorubicin

Do not use the medicine for injection

into the bladder if you have:

cancer that has gone into the bladder

wall

kidney or urinary tract infection

swollen or inflamed bladder

problems with a catheter (a tube in

your bladder)

blood in the urine

Do not use Epirubicin Accord if you

are pregnant.

Epirubicin Accord may harm the unborn

child.

Do not use Epirubicin Accord if you

are breastfeeding.

You should not breastfeed while taking

Epirubicin Accord.

Do not use this medicine after the

expiry date printed on the pack or if

the packaging is torn or shows signs of

tampering.

Before you are given it

Version 2.0

Page 2 of 4

You must tell your doctor if you:

have heart problems or have ever had

heart problems

have liver problems

have kidney problems

have had radiation therapy previously or

are having radiation therapy

have been treated previously with

medicines to treat cancer

you are going to be vaccinated (have an

injection to prevent a certain disease)

are planning to have children Epirubicin

Accord may decrease the fertility of

men and women.

If you have not told your doctor about

any of the above, tell your doctor

before you start using Epirubicin

Accord.

Taking other medicines

Tell your doctor if you are taking any

other medicines, including medicines

that you buy without a prescription

from a pharmacy, supermarket or

health food shop.

Some medicines and Epirubicin Accord

may interfere with each other. Some

of these medicines include:

5-fluorouracil

cyclophosphamide

cisplatin

paclitaxel

docetaxel

trastuzumab

other medicines to treat cancer

nifedipine

verapamil

diltiazem

felodipine

amlodipine

lercanidipine

propranolol

cimetidine

You may need to take different amounts

of your medicines or you may need to use

different medicines. Your doctor will

advise you.

How Epirubicin Accord

is given

How much is given

Treatment will normally take place in a

hospital. Epirubicin Accord is usually

given as a slow injection or a drip

(infusion) into a vein. It might also be

injected into the bladder.

Do not drink fluids for 12 hours before

treatment if Epirubicin Accord is to be

used in the bladder.

Epirubicin Accord may be given alone or

in combination with other medicines.

Your doctor will decide the dose of

Epirubicin Accord to be given. Treatment

is usually given every 3 to 4 weeks, in

cycles of therapy.

However, your doctor may give

Epirubicin Accord more or less

frequently.

Treatment will not be repeated until your

blood counts have returned to acceptable

levels and any unwanted effects have

been controlled.

Your doctor may change your dose

during treatment.

Your doctor will let you know how many

cycles of treatment you will need.

Ask your doctor if you have any

questions about the dose of Epirubicin

Accord and how it is given.

If you take too much

(Overdose)

As epirubicin is given to you under the

supervision of your doctor, it is very

unlikely that you will receive too much.

However, if you experience any severe

side effects after being given

epirubicin, tell your doctor

immediately or go to Accident and

Emergency at the nearest hospital.

You may need urgent medical attention.

Symptoms of overdose with Epirubicin

Accord include the side effects below in

the 'Side Effects' section, but they are

usually of a more severe nature.

While you are being

given Epirubicin Accord

Things you must do

Tell your doctor or nurse immediately

if the injection stings or hurts while it

is being given.

The injection may need to be stopped and

injected into a different vein.

Make sure you follow your doctor's

instructions and keep all appointments.

Your doctor will regularly check the

function of your heart, liver and kidneys.

You will also need to have blood tests.

Use contraception to prevent

pregnancy while you or your partner

are being treated with Epirubicin

Accord.

Epirubicin Accord may cause birth

defects if either the male or female is

being treated with Epirubicin Accord.

Both men and women being treated with

Epirubicin Accord and their partners

must use a reliable method of

contraception (birth control) during

treatment with Epirubicin Accord.

Tell your doctor immediately if you

become pregnant while taking

Epirubicin Accord

Tell your doctor if you have an

infection or fever.

Version 2.0

Page 3 of 4

Epirubicin Accord lowers your ability to

fight infection.

Tell your doctor if you would like to

take medicine to prevent or treat

nausea (feeling sick) or vomiting.

Epirubicin Accord may cause nausea and

vomiting.

Tell any doctor, dentist or pharmacist

who treats you that you are being

treated with Epirubicin Accord.

If you are about to be started on any

new medicine, tell your doctor and

pharmacist that you are being treated

with Epirubicin Accord.

Things to be careful of

Be careful driving or operating

machinery until you know how

epirubicin affects you.

This medicine may cause dizziness or

light-headedness in some people. If you

have any of these symptoms, do not

drive, operate machinery, or do anything

else that could be dangerous.

Be careful when drinking, alcohol

while you are taking this medicine.

you drink alcohol, dizziness or light-

headedness may be worse.

Try to stay out of direct sunlight after

treatment with epirubicin.

Epirubicin

can increase your sensitivity to the sun.

Side Effects

Tell your doctor or nurse as soon as

possible if you do not feel well while

you are being treated with epirubicin.

All medicines can have unwanted side

effects. Sometimes they are serious, most

of the time they are not.

You may need medical treatment if you

get some of the side effects.

Medicines can affect people in different

ways.

Ask your doctor or pharmacist to answer

any questions you may have.

Tell your doctor or pharmacist if you

notice any of the following and they

worry you:

nausea (feeling sick) or vomiting

diarrhoea

sore mouth or tongue, mouthulcers,

redness of mouth, sore vagina or rectum

redness of the skin or vein at the site of

the injection

hair loss, beard stops growing

dehydration (thirsty, dry mouth, dry

skin, loss of body fluid)

sore oesophagus (food pipe)

stomach pain or burning feeling in

stomach

skin rash, itchy skin, hives, sensitive

skin, blisters

change in colour of skin or nails

increased sensitivity to the sun

itchy eye, crusty eyelid, sore red eye,

blurred vision, conjunctivitis

loss of appetite

absence of menstrual bleeding

(temporary loss of periods)

hot flushes

weakness, tiredness, dizziness,

confusion, depression

tingling or numbness of hands or feet;

pins and needles

gout

red coloured urine

Epirubicin Accord is red and may cause

the urine to be a red colour for one or two

days after treatment. There is no cause

for alarm.

Tell your doctor immediately if you get

any of the following side effects:

stinging, swelling or pain at the site of

injection

flushing of face while the injection is

being given

an infection or chills, fever, sore throat,

swollen glands, shock

heart problems, fast or irregular

heartbeat, shortness of breath

swelling of ankles, feet, legs or hands,

bleeding or bruising under the skin

cough, difficulty breathing, chest pain,

coughing up blood

swelling, pain, tenderness and redness

of the leg

The above side effects may be serious.

You may need urgent medical attention.

Tell your doctor if you notice anything

else that is making you feel unwell.

Other side effects not listed above, such

as leukaemia, may also occur in some

patients.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After using Epirubicin Accord tell

your doctor immediately if you notice

any of the following side effects, even if

they occur several months or years

after stopping treatment with

Epirubicin Accord:

heart problems, fast or irregular

heartbeat, shortness of breath

swelling of ankles, feet, legs or hands,

swelling in the stomach

fever or other signs of infection

Leukaemia may occur after treatment

with Epirubicin Accord and other

medicines to treat cancer. It is rare.

Storage

Epirubicin Accord will be stored in the

pharmacy or on the ward. The injection is

kept in the refrigerator where the

Version 2.0

Page 4 of 4

temperature stays between 2-8°C and is

protected from light.

Product Description

What it looks like

Epirubicin Accord is a clear red solution

in a glass vial. It is supplied in vials as

single packs. It comes in four sizes (5mL,

10mL, 25mL and 100mL)

Ingredients

The active ingredient in Epirubicin

Accord is epirubicin hydrochloride.

It also contains as inactive ingredients:

sodium chloride, water for injections and

hydrochloric acid. It does not contain

lactose, sucrose, gluten, tartrazine or any

other azo dyes.

Name and Address of the

Sponsor

Accord Healthcare Pty Ltd

Level 24, 570 Bourke Street

Melbourne, VIC, 3000

Australia

Australian Registration Numbers

10 mg/5 mL: AUST R 210084

20 mg/10 mL: AUST R 210085

50 mg/25 mL: AUST R 210086

200 mg/100 mL: AUST R 227997

Date of Preparation

This leaflet was prepared on 23 January

2017.

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Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Doxolipad,doxorubicin hydrochloride,  31/01/2019,  Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Europe - EMA - European Medicines Agency

29-1-2019


Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

28-1-2019

Clomicalm (Elanco GmbH)

Clomicalm (Elanco GmbH)

Clomicalm (Active substance: Clomipramine hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)720 of Mon, 28 Jan 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/000039/T/0030

Europe -DG Health and Food Safety

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

16-1-2019

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Isabelle Ramirez)

EU/3/18/2125 (Active substance: Benserazide hydrochloride) - Orphan designation - Commission Decision (2019)221 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000001719

Europe -DG Health and Food Safety

16-1-2019

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (FGK Representative Service GmbH)

EU/3/10/833 (Active substance: Doxorubicin hydrochloride (in heat-sensitive liposomes)) - Transfer of orphan designation - Commission Decision (2019)237 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003113

Europe -DG Health and Food Safety

16-1-2019

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Celgene Europe B.V.)

EU/3/16/1672 (Active substance: 3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride) - Transfer of orphan designation - Commission Decision (2019)236 of Wed, 16 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003283

Europe -DG Health and Food Safety

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

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