ADVATE

Main information

  • Trade name:
  • ADVATE octocog alfa (rch) 4000 IU powder for injection vial with diluent vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVATE octocog alfa (rch) 4000 IU powder for injection vial with diluent vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214709
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214709

ADVATE octocog alfa (rch) 4000 IU powder for injection vial with diluent vial

ARTG entry for

Medicine Registered

Sponsor

Baxalta Australia Pty Ltd

Postal Address

1 Baxter Drive,OLD TOONGABBIE, NSW, 2146

Australia

ARTG Start Date

16/07/2014

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. ADVATE octocog alfa (rch) 4000 IU powder for injection vial with diluent vial

Product Type

Composite Pack

Effective date

31/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ADVATE is indicated for use in haemophilia A for prevention and control of haemorrhagic episodes. Patients with haemophilia A may be treated with

ADVATE as perioperative management. ADVATE is not indicated in Von Willebrand's disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Not recorded

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial with advate (octocog alfa (rch)) 4000 IU powder and 1 vial of diluent

(WFI) with a drug delivery system (Baxject II or Baxject III)

exempt from scheduling - Appendix A; prescription medicine

Components

1.

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

white to off-white lyophilised powder

Active Ingredients

Octocog alfa

4000 IU

2. water for injection diluent vial

Dosage Form

Diluent, not applicable

Route of Administration

Intravenous

Visual Identification

© 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 07:31:44 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

ADVATE

ADVATE

Octocog alfa (rch) [Recombinant Antihaemophilic FVIII, Plasma / Albumin Free Method (rAHF-PFM)]

injection

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common

questions about ADVATE.

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 you using ADVATE

against the benefits they expect it

will have for you.

If you have any concerns about

having this medicine ask your

doctor or pharmacist.

Please read this leaflet carefully

and keep it for future reference.

Please also note that this leaflet is

subjected to change, therefore, ask

your doctor whether this is the latest

information regarding this medicine.

What is ADVATE

ADVATE belongs to the group of

medicines called blood coagulation

factor VIII.

What ADVATE is used for

It is used for the treatment and

prophylaxis of bleeding in patients

with haemophilia A (congenital

factor VIII deficiency).

This preparation does not contain

von Willebrand factor and is

therefore not suitable for use in von

Willebrand's disease.

ADVATE is a recombinant factor

VIII, which has been shown

successfully to correct factor VIII

deficiency.

How does ADVATE work

Under normal physiological

condition, factor VIII is essential for

blood clotting and maintenance of a

bleeding episode.

Individuals with haemophilia A

disease, which is a hereditary

disorder of blood coagulation have a

low level of factor VIII in their blood

circulation. As a result of factor VIII

deficiency, the individual with this

disease may have a heavy bleeding

into joints, muscles or internal organs

either spontaneously or as a result of

accidental or surgical trauma.

ADVATE is similar to plasma-

derived factor VIII. As it works in

the same way, it can be used as a

replacement therapy in patients with

haemophilia A.

Before you are given

the ADVATE

ADVATE should not be given to

you if:

you are allergic (hypersensitive)

to mouse, hamster proteins or any

other ingredients in this product.

you have tendency of allergic

reaction or hypersensitivity to any

human derived injection. Some of

the symptoms of allergic reaction

may include skin rash, swelling

of the face, lips or tongue, which

may cause difficulty swallowing

or shortness of breath, tightness

of the chest.

it has expired.

You must tell your doctor if you:

have any other illness

are taking any prescription

medicine or any other medicines

purchased from a pharmacy,

health food store or supermarket.

Some medicines and ADVATE

may interfere with each other.

You must tell your doctor if you

are pregnant, planning to become

pregnant or breast-feeding.

How ADVATE is given

How much is given

Your doctor will decide how much

ADVATE will be given to you,

which depends on your need and

condition. Each individual will

receive a different dosage, which in

itself may vary between doctor visits.

The dose you receive will be based

A. body weight;

B. the amount of antihaemophilic

factor (AHF) your body is able to

make;

C. how much and how often and

which sites (knees, muscles etc)

of your body are bleeding;

D. whether your body may build up

antibodies to this medicine. After

a while your body may build up

these antibodies, leading to a less

effective treatment than the usual.

ADVATE

Method of Administration

(use aseptic technique):

ADVATE is usually administered in

a hospital. However, some

individuals may be trained to use this

product at home. It is administered

by intravenous injection.

If you have been trained to inject at

home, take the dry medicine vial and

the small vial of water out of the

refrigerator and let them come to

room temperature (15°C to 30°C).

Visually examine the dry medicine

vial and contents, and do not use if

there is any sign of damage or

discolouration. The dry medicine

should appear clear, colourless.

After preparation, the medicine

should be used immediately or at

least within 3 hours after it is

reconstituted. Do not refrigerate

after reconstitution. Please refer to

the directions on the package or talk

to your doctor.

Do not reuse syringes and needles.

Place them in a puncture resistant

disposable container, or otherwise

dispose of them as directed by your

doctor. Likewise, discard any

unused solution as directed by your

doctor.

How often is it given

Your doctor will tell you how often

and what intervals ADVATE is to be

administered. Usually, a substitution

therapy, such as ADVATE is a

lifetime treatment. Although no

overdose adverse effect has been

reported with ADVATE, if you have

used this product more often than

you should you must tell your doctor.

If you miss/forget your

injection

Proceed with the next administration

immediately, and continue at regular

intervals as advised by your doctor.

Do not take a double dose to make up

the forgotten dose.

How it is given

ADVATE is intended for intravenous

injection only and must be

administered within 3 hours after

reconstitution. Aseptic conditions

(meaning clean and germ free) are

required during the reconstitution and

administration. Use only the medical

devices for reconstitution and

administration provided with each

package of 250 International Units

(IU), 500 IU, 1000 IU, 1500 IU,

2000IU, 3000 IU and 4000 IU (see,

INSTRUCTION FOR USE).

ADVATE must not be mixed with

other infusion solutions. It is to be

used in one patient on one occasion

only.

Overdose

No symptoms of overdose with

ADVATE have been reported.

While you are being

treated with ADVATE

Discuss with your doctor the

progress you have experienced after

the treatment, especially during the

first few days. As ADVATE is given

in a hospital, your healthcare

professional will take records of the

progress and unexpected reactions.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are under ADVATE

treatment.

Like all medicines, ADVATE can

cause side effects, although not

everybody gets them.

A rare adverse reaction known as

"anaphylactic shock", which was not

experienced during clinical studies

with ADVATE, may nevertheless

occur as the active ingredient is a

protein. If any of the following

symptoms happen, for example, rash,

swelling of the face, lips, mouth or

difficulty in breathing, tell your

health professional on duty

immediately. These symptoms can

constitute an early warning for a

serious allergic reaction. Then your

healthcare professional will take an

appropriate action promptly to

reverse the symptoms.

Due to the decrease in injection

volume for ADVATE reconstituted

in 2 mL, the time to react to

hypersensitivity reactions during an

injection is further reduced.

Therefore, caution is advised during

injection of ADVATE reconstituted

in 2 mL.

You must contact your doctor

immediately if you have any of the

following early symptoms of allergic

(hypersensitivity) reactions:

rash, hives, wheals, generalised

itching,

swelling of lips and tongue,

difficulty in breathing, wheezing,

tightness in the chest,

general feeling of being unwell,

dizziness and loss of

consciousness.

Severe symptoms, including

difficulty in breathing and (nearly)

fainting, require prompt emergency

treatment.

Side effects may occur with certain

frequencies, which are defined as

follows:

very common: affects more than

1 user in 10

common: affects 1 to 10 users in

uncommon: affects 1 to 10 users

in 1,000

rare: affects 1 to 10 users in

10,000

very rare: affects less than 1 user

in 10,000

not known: frequency cannot be

estimated from the available data.

Common side effects

Factor VIII inhibitors development,

headache and fever.

ADVATE

Uncommon side effects

itching, increased sweating, unusual

taste in the mouth, hot flushes,

migraines, dizziness, memory

impairment, fainting, tremors,

palpitations, chills, diarrhoea,

stomach pain, nausea, vomiting,

shortness of breath, sore throat,

infection of the lymphatic vessels,

whitening of skin, eye inflammation,

rashes, excessive sweating, foot and

leg swelling, increase in enzymes

that track liver function, reduced

percentage of red blood cells and

pain in the upper abdomen or lower

chest.

Related to surgery

catheter-related infection, decreased

red cell blood count, swelling of

limbs and joints, prolonged bleeding

after drain removal, decreased Factor

VIII level and post-operative bruise.

Related to central venous access

devices (CVAD)

catheter-related infection, systemic

infection and local blood clot at the

catheter site.

Side effects with unknown

frequency

Potentially life-threatening reactions

(anaphylaxis) and other allergic

reactions (hypersensitivity), general

disorders (tiredness, lack of energy).

If any of these side effects gets

serious, or if you notice any side

effects not listed in this leaflet, please

tell your doctor.

Other adverse effects that may occur

include irregular heartbeats, chest

pain, chest discomfort, tremors,

fainting, abdominal pain, chills and

eye inflammation.

Product descriptions

What ADVATE looks like?

It is a white to cream colour powder

in a single dose glass vial

accompanied by Sterile Water for

Injection in glass vial for

reconstitution. ADVATE 250, 500,

1000, 1500 IU strengths may be

supplied with either a 5 mL Sterile

Water for Injection vial (grey cap) or

a 2mL Sterile Water for Injection vial

(clear colourless cap). ADVATE

2000, 3000 and 4000 IU strengths are

only supplied with either a 5 mL

Sterile Water for Injection vial (grey

cap).

ADVATE must always be

reconstituted with the Sterile Water

for Injection vial supplied in the

same carton.

Below is summarised what strengths

of ADVATE are available, which

strengths can be reconstituted with

the 2 mL vial of sterile water for

injection, and how to differentiate the

packaging of the 2 mL and 5 mL

Sterile Water for Injection

configurations.

ADVATE with 5 mL Sterile Water

for Injection vial is available in the

following strengths (IU) 250, 500,

1000, 1500, 2000, 3000, 4000 with a

grey WFI vial cap:

It is supplied in a yellow background

carton.

ADVATE with 2 mL Sterile Water

for Injection vial is available in the

following strengths (IU), 250, 500,

100, 1500 with a clear, colourless

WFI vial cap:

It is supplied in a purple background

carton.

The package also contains a needle

less transfer device.

What is in ADVATE?

The active ingredient in ADVATE is

Octocog alfa [antihaemophilic factor

VIII Recombinant Coagulation

Factor VIII (rhc)] produced by

recombinant technology, which does

not use any animal protein in cells

culture media during the

manufacturing process. Seven

strengths of ADVATE are

commercially available, from the

lowest strength (250 IU) to the

highest strength (4000 IU). The

amounts of each component of the

excipients in all strengths are the

same.

The amounts in 2 mL or 5 mL of the

reconstituted solution are as follows:

trehalose (40 mg), histidine (8 mg),

trometamol (6 mg), sodium chloride

(26.5 mg), calcium chloride (1.3 mg),

glutathione in reduced form (0.4 mg),

polysorbate 80 (0.5 mg), mannitol

(160 mg).

How to store ADVATE

ADVATE is a protein preparation,

therefore it should be stored at 2°C -

8°C in a refrigerator for the duration

of its shelf life: do not freeze as it

may damage the water for injection

vial. In case it is needed for

ambulatory use, ADVATE may be

stored at below 25°C (room

temperature) for a single period of up

to 6 months and then discarded. After

ADVATE has been stored at room

temperature it should not be

refrigerated. Store in the original

package in order to protect from

light.

ADVATE does not contain

antimicrobial preservation.

Therefore:

use within 3 hours after

reconstitution

do not refrigerate preparation

after reconstitution

discard any unused solution

appropriately

do not use the product with a torn

packaging or any sign of

deterioration such as

discolouration.

Where can you get more

information?

You can get more information from

your doctor or pharmacist.

ADVATE

INSTRUCTIONS FOR USE

(For intravenous use only)

IMPORTANT:

Contact your doctor or local

Haemophilia Treatment Centre if you

experience any problems with this

procedure. These instructions are

intended only as a visual aid for

those patients who have been

instructed by their doctor or

haemophilia centre on the proper

way to self-infuse the product.

Do not attempt to self-infuse unless

you have been taught how by your

doctor or haemophilia centre.

In a quiet place, prepare a clean

surface and gather all the materials

you will need for the infusion. Check

the expiration date on the ADVATE

concentrate vial or package and let

the vial with the ADVATE

concentrate and the Sterile Water for

Injection EP (diluent) warm up to

room temperature. Wash your hands

and put on clean exam gloves. If self-

infusing at home the use of gloves is

optional.

ADVATE is supplied either with a

BaxJect II or a BaxJect III (pre-

assembled) reconstitution device.

Please refer to the instructions

corresponding to the device supplied

with your ADVATE, as illustrated

below:

Reconstitution using

BAXJECT II device:

ADVATE with 5 mL Diluent

ADVATE with 2 mL Diluent

1. After washing your hands and

putting on gloves, remove caps

from the factor concentrate and

diluent to expose the centres of

the rubber stoppers.

2. Disinfect the stoppers with an

alcohol swab (or other suitable

solution suggested by your doctor

of haemophilia centre) by rubbing

the stoppers firmly for several

seconds and allow to dry prior to

use. Place the vials on a flat

surface.

3. Open the BAXJECT II device

package by peeling away the lid

without touching the inside of the

package. The BAXJECT II

device remains in the package at

this time. Do not remove the

device from the package.

4. Turn the package with the device

upside down and place it over the

top of the diluent vial. Fully insert

the clear plastic spike of the

BAXJECT II device into the

centre of the diluent vial's stopper

by pushing straight down. Grip

the package at its edge and pull it

off the device. After removing the

packaging be careful not to touch

the white plastic exposed spike.

Do not remove the blue cap from

BAXJECT II device.

Please note that the connection

of the two vials should be done

expeditiously to close the open

fluid pathway created by the

first insertion of the spike to the

diluent vial.

5. Quickly turn over the diluent vial

with the BAXJECT II device,

place on top of the vial containing

the factor concentrate and fully

insert the white plastic spike into

the factor concentrate vial's

stopper by pushing straight down.

The vacuum will draw the diluent

into the factor concentrate vial.

ADVATE

6. Swirl the factor concentrate

gently and continuously with the

BAXJECT II attached until it is

completely dissolved.

Do not shake.

Check to make sure the factor

concentrate is completely

dissolved. The solution should be

clear and colourless in

appearance.

7. Remove the blue cap from the

BAXJECT II device. Connect the

syringe to the BAXJECT II

device. DO NOT INJECT AIR.

8. Turn the system over so that the

factor concentrate solution vial is

on top. Withdraw the factor

concentrate solution into the

syringe by pulling back the

plunger slowly. Disconnect the

syringe, leaving the BAXJECT II

device connected. Attach the

infusion needle to the syringe

using at winged infusion set, if

available. Point the needle up and

remove any air bubbles by gently

tapping the syringe with your

finger and slowly and carefully

pushing the air out of the syringe.

Dispose of the used BAXJECT II

system in your hard-walled

Sharps container without taking it

apart.

Reconstitution using

BAXJECT III device:

1. Open the ADVATE package by

peeling away the lid. Remove the

ADVATE in the BAXJECT III

system from the package and

verify that the expiration date on

the label has not passed and the

potency unit number is same as

expected.

2. Place the ADVATE on a flat

surface with the diluent vial on

top. The diluent vial has a blue

stripe.

Do not remove the blue cap

until instructed in a later step.

3. With one hand holding the

ADVATE in a BAXJECT III

system, press down firmly on the

diluent vial with the other hand

until the system is fully collapsed

and the diluent flows down into

the ADVATE vial. Both vials

will move into the housing when

pressed.

Do not remove the blue cap

until instructed in a later step.

4. Swirl the ADVATE in the

BAXJECT III system gently and

continuously until the ADVATE

is completely dissolved.

Do not shake. Do not

refrigerate after reconstitution.

Inspect the ADVATE solution for

particulate matter and

discoloration prior to

administration. The solution

should be clear and colorless in

appearance. If not, do not use the

solution and notify your

healthcare provider immediately.

5. Take off the blue cap from the

BAXJECT III system and

connect the syringe.

Be careful to not inject air into

the ADVATE in the BAXJECT

III system.

ADVATE

6. Turn over the ADVATE in the

BAXJECT III system so that the

vial containing the ADVATE

solution is on top. Draw the

ADVATE solution into the

syringe by pulling back the

plunger slowly. If the solution

does not draw into the syringe, be

sure that both vials are pressed

firmly together. The contents of

more than one vial may be drawn

into a single, appropriately sized

syringe if you are using more

than one vial of ADVATE.

7. Disconnect the syringe from the

system. Attach the infusion

needle to the syringe using a

winged (butterfly) infusion set, if

available. Point the needle up and

remove any air bubbles by gently

tapping the syringe with your

finger and slowly and carefully

pushing air out of the syringe and

needle.

Administration of

reconstituted Advate

1. If receiving more than one vial of

ADVATE the contents of

multiple vials may be drawn into

the same syringe.

Please note that the BAXJECT

II or III reconstitution device is

intended for use with a single

vial of ADVATE and Sterile

Water for Injection only,

therefore reconstituting and

withdrawing a second vial into

the syringe requires a second

BAXJECT II or III

reconstitution device.

2. Apply a tourniquet and prepare

the injection site by wiping the

skin well with an alcohol swab

(or other suitable solution

suggested by your doctor or

haemophilia centre).

3. Insert the needle into the vein and

remove the tourniquet. Infuse the

factor concentrate.

Do not infuse any faster than

10mL per minute.

Remove the needle from the vein

and apply pressure with sterile

gauze to the infusion site for

several minutes.

Do not recap the needle after

the infusion, and do not dispose

in ordinary household trash.

Place it with the used syringe in a

hard-walled Sharps container for

proper disposal.

4. After the infusion remove the

peel-off label from the factor

concentrate vial (for BAXJECT

II) or from the blister label (for

BAXJECT III) and place in your

factor log book. Clean up any

spilled blood with a freshly

prepared mixture of 1 part bleach

and 9 parts water, soap and water,

or any household disinfecting

solution.

5. Do not reuse syringes and

needles. Place them in a puncture

resistant disposable container, or

otherwise dispose of them as

directed by your doctor.

Likewise, discard any unused

solution as directed by your

doctor.

Name and address of the

Sponsor

Baxalta Australia Pty Ltd

1 Baxter Drive,

Old Toongabbie, NSW 2146,

Sydney.

AUST R 100384 (ADVATE 250

IU)

AUST R 100385 (ADVATE 500

IU)

AUST R 100386 (ADVATE 1000

IU)

AUST R 100387 (ADVATE 1500

IU)

AUST R 136204 (ADVATE 2000

IU)

AUST R 150366 (ADVATE 3000

IU)

AUST R 214709 (ADVATE 4000

IU)

This leaflet was prepared in April

2016.

Advate and Baxalta are trademarks

of Baxalta Incorporated.

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ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Merck Sharp and Dohme B.V.)

ViraferonPeg (Active substance: Peginterferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6477 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/329/T/128

Europe -DG Health and Food Safety

2-10-2018

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Merck Sharp and Dohme B.V.)

IntronA (Active substance: Interferon alfa-2b) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6487 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/281/T/116

Europe -DG Health and Food Safety

24-9-2018

Kanuma (Alexion Europe SAS)

Kanuma (Alexion Europe SAS)

Kanuma (Active substance: sebelipase alfa) - Centralised - Yearly update - Commission Decision (2018)6245 of Mon, 24 Sep 2018

Europe -DG Health and Food Safety

24-9-2018

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Merck Europe B.V.)

Ovitrelle (Active substance: Choriogonadotrophin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6220 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/320/T/75

Europe -DG Health and Food Safety

4-9-2018

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Hexal AG)

Epoetin alfa Hexal (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5857 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/726/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Binocrit (Sandoz GmbH)

Binocrit (Sandoz GmbH)

Binocrit (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5856 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/725/II/WS/1406

Europe -DG Health and Food Safety

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety

4-9-2018

VEYVONDI (Baxalta Innovations GmbH)

VEYVONDI (Baxalta Innovations GmbH)

VEYVONDI (Active substance: vonicog alfa) - Centralised - Authorisation - Commission Decision (2018)5866 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4454

Europe -DG Health and Food Safety

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

27-8-2018

Beromun (BELPHARMA s.a.)

Beromun (BELPHARMA s.a.)

Beromun (Active substance: Tasonermin (Tumor Necrosis Factor alfa-1a)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5699 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/206/T/40

Europe -DG Health and Food Safety

27-8-2018

Aranesp (Amgen Europe B.V.)

Aranesp (Amgen Europe B.V.)

Aranesp (Active substance: darbepoetin alfa) - Centralised - Yearly update - Commission Decision (2018)5707 of Mon, 27 Aug 2018

Europe -DG Health and Food Safety

22-8-2018

Luveris (Merck Europe B.V.)

Luveris (Merck Europe B.V.)

Luveris (Active substance: Lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5631 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000292/T/0077

Europe -DG Health and Food Safety

22-8-2018

Pergoveris (Merck Europe B.V.)

Pergoveris (Merck Europe B.V.)

Pergoveris (Active substance: follitropin alfa / lutropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5629 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000714/T/0059

Europe -DG Health and Food Safety

8-8-2018

GONAL-f (Merck Europe B.V.)

GONAL-f (Merck Europe B.V.)

GONAL-f (Active substance: Follitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5445 of Wed, 08 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/71/T/140

Europe -DG Health and Food Safety

6-8-2018

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Pfizer Europe MA EEIG)

ReFacto AF (Active substance: Moroctocog alfa ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5374 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/232/T/146

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Italfarmaco S.p.A.)

EU/3/18/2046 (Active substance: Givinostat) - Orphan designation - Commission Decision (2018)5278 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/062/18

Europe -DG Health and Food Safety

30-7-2018

NovoEight (Novo Nordisk A/S)

NovoEight (Novo Nordisk A/S)

NovoEight (Active substance: turoctocog alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5093 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2719/II/23

Europe -DG Health and Food Safety

25-7-2018

Bemfola (Gedeon Richter Plc.)

Bemfola (Gedeon Richter Plc.)

Bemfola (Active substance: follitropin alfa) - Centralised - Yearly update - Commission Decision (2018)4989 of Wed, 25 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

BeneFIX (Pfizer Limited)

BeneFIX (Pfizer Limited)

BeneFIX (Active substance: Nonacog alfa) - Centralised - Yearly update - Commission Decision (2018)3778 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

11-6-2018

ALPROLIX (Swedish Orphan Biovitrum AB (publ))

ALPROLIX (Swedish Orphan Biovitrum AB (publ))

ALPROLIX (Active substance: eftrenonacog alfa) - Centralised - Yearly update - Commission Decision (2018)3776 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety

18-5-2018

Ovaleap (Teva B.V.)

Ovaleap (Teva B.V.)

Ovaleap (Active substance: Follitropin alfa) - Centralised - Renewal - Commission Decision (2018)3154 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2608/R/23

Europe -DG Health and Food Safety

16-5-2018

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Merck Sharp and Dohme B.V.)

Elonva (Active substance: corifollitropin alfa) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3049 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1106/T/40

Europe -DG Health and Food Safety