Actemra

Main information

  • Trade name:
  • Actemra 20 mg/mL Concentrate for infusion
  • Dosage:
  • 20 mg/mL
  • Pharmaceutical form:
  • Concentrate for infusion
  • Units in package:
  • Vial, glass, 400mg/20mL, 1 dose unit
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Genentech Inc

Documents

Localization

  • Available in:
  • Actemra 20 mg/mL Concentrate for infusion
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ACTEMRA is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients:· in combination with methotrexate (MTX) in those not previously treated with MTX. · in combination with methotrexate (MTX) or other non-biological disease-modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs; or · as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Actemra has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 13435
  • Authorization date:
  • 05-02-2008
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Actemra 170613

Consumer Medicine Information

Actemra

®

concentrate for intravenous infusion

Tocilizumab

80 mg in 4 mL, 200 mg in 10 mL and 400 mg in 20 mL concentrate for solution for

infusion

What is in this leaflet

This leaflet answers some common questions about Actemra infusion.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Actemra against

the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet.

You may need to read it again.

What Actemra is used for

Actemra contains the active ingredient tocilizumab.

Actemra belongs to a group of medicines called anti-rheumatic agents. There are many different

classes of anti-rheumatic agents. Actemra belongs to a class called monoclonal antibodies.

Monoclonal antibodies are proteins which specifically recognise and bind to other unique proteins in

the body.

Actemra is used to treat moderate to severe rheumatoid arthritis (RA) in adults. Actemra is also used

to treat active systemic juvenile idiopathic arthritis (sJIA) and active polyarticular juvenile idiopathic

arthritis (pJIA) in children over 2 years of age.

For RA, Actemra can also prevent damage occurring to your joints and improve your ability to do your

normal daily activities.

Some of the signs and symptoms of RA, pJIA and sJIA are caused by the actions of a protein called

interleukin-6 receptor (IL-6R).Actemra works by binding and blocking IL-6R thereby helping to relieve

some of the signs and symptoms of RA, pJIA and sJIA.

Actemra is approved to treate RA, pJIA and sJIA, however your doctor may have prescribed Actemra

for another purpose.

Ask your doctor if you have any questions about why Actemra has been prescribed for you.

Actemra is not addictive.

This medicine is available only with a doctor’s prescription.

Before you are given Actemra

When you must not be given Actemra

Do not use Actemra if:

1.

you have had an allergic reaction to Actemra 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

Actemra 170613

difficulty breathing, swelling of the face, lips, tongue or other parts of the body, and rash, itching or

hives on the skin.

2.

you have had an allergic reaction to any other recombinant human or humanised

antibodies or proteins that are of hamster origin

3.

you have an active, severe infection

4.

the package is torn or shows signs of tampering

5.

the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.

If you are not sure if you should be given Actemra, talk to your doctor.

Before you are given Actemra

Tell your doctor if:

1.

you have an infection, or a history of a recurring or long-term infection

Actemra can reduce your body’s ability to respond to infections and may make an existing infection

worse or increase the chance of getting a new infection. This is particularly important if you have

diabetes or diverticulitis as you may have an increased risk of infection.

2.

you have any other health problems, especially the following:

liver disease such as viral hepatitis

tuberculosis

diverticulitis or intestinal ulcers

a low white blood cell count or a low platelet count

diabetes

raised blood pressure

high cholesterol or triglycerides

kidney disease

cancer

3.

you have a history of macrophage activation syndrome (MAS)

MAS is a complication of sJIA. If you have a history of MAS your doctor will decide if you can still

be given Actemra.

4.

you are pregnant or plan to become pregnant

It is not known whether Actemra is harmful to an unborn baby when taken by a pregnant

woman. If there is a need to take Actemra when you are pregnant your doctor will discuss the risks

and benefits to you and the unborn baby.

5.

you are breast-feeding or plan to breast-feed

It is not known whether Actemra passes into breast milk. It is recommended that you stop

breast-feeding while you are treated with Actemra.

6.

you are planning to have a vaccination or have recently had a vaccination

Certain types of vaccines should not be given while receiving Actemra. It is particularly

recommended that sJIA patients receive all necessary vaccinations prior to receiving Actemra.

7.

you are on a controlled sodium diet

Actemra contains a small amount of sodium.

8.

you are allergic to any other medicines, foods, dyes or preservatives

If you have not told your doctor about any of the above, tell them before you start taking

Actemra.

Actemra 170613

Use in Children

The safety and efficacy of Actemra in patients below 18 years of age with conditions other than pJIA or

sJIA have not been established. The use of Actemra in children under the age of 2 has not been

studied.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you have bought from

a pharmacy, supermarket or health food shop.

Do not use Actemra with other biological medicines used to treat RA, pJIA or sJIA, including infliximab,

adalimumab, etanercept, anakinra, abatacept, rituximab, certolizumab pegol and golimumab. It is

unknown how Actemra interacts with these medicines.

Actemra may interfere with some medicines. These include:

warfarin, a medicine used to prevent blood clots

cyclosporin, a medicine used after organ transplants

atorvastatin and simvastatin, medicines used to reduce cholesterol levels

calcium channel blockers, such as amlodipine, which treat raised blood pressure

theophylline, a medicine used to treat bronchitis

phenytoin, a medicine used to treat epilepsy

benzodiazepines, such as diazepam, which treat anxiety

omeprazole, a medicine used to treat reflux disease and peptic ulcers

dextromethorphan, a cough medicine

These medicines may be affected by Actemra, or may affect how well the medicine works. You may

need to use different amounts of your medicine, or you may need to take different medicines. Your

doctor will advise you.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking

Actemra.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

How Actemra is given

How Actemra is given

Actemra is given by infusion into a vein (intravenous ‘drip’) by a health care professional.

The infusion usually takes one hour.

For RA, Actemra is usually given in combination with methotrexate (MTX) or other arthritis

medications. However you may receive Actemra on its own if your doctor decides that MTX is

inappropriate for you.

For pJIA or sJIA, Actemra may be given on its own or in combination with MTX.

How much is given

Your doctor will prescribe an amount of Actemra that is right for you.

For RA the normal dose of Actemra is 8 mg per kilogram (kg) of your body weight.

For pJIA the normal dose of Actemra is 8 mg per kg of your body weight if you weigh 30 kg or more, or

10 mg per kg of your body weight if you weigh less than 30 kg.

For sJIA the normal dose of Actemra is 8 mg per kg of your body weight if you weigh 30 kg or more, or

12 mg per kg of your body weight if you weigh less than 30 kg.

How long Actemra is given

For RA and pJIA you will be treated with Actemra once every 4 weeks. For sJIA you will be treated with

Actemra once every 2 weeks. The number of infusions you will receive depends on how you are

responding to treatment. Your doctor will discuss this with you.

Continue receiving Actemra until your doctor tells you to stop.

Actemra 170613

If you miss a dose

As Actemra is given to you under the supervision of your doctor, you are unlikely to miss a dose.

However, if you do then your doctor will decide when you should be given your next dose of Actemra.

In case of an overdose

As Actemra is given to you under the supervision of your doctor it is unlikely that you will be given too

much. However, if you experience any side effects after being given Actemra, tell your doctor

immediately.

While you are receiving Actemra

Things you must do

Tell your doctor immediately if you experience allergic reactions such as chest tightness,

wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after

receiving Actemra.

Tell your doctor immediately if you develop an infection while you are being treated with

Actemra.

Tell your doctor immediately if you develop severe blisters and bleeding in the lips, eyes,

mouth, nose and genitals while you are being treated with Actemra.

Tell all doctors, dentists and pharmacists who are treating you that you are receiving Actemra.

Tell your doctor if you become pregnant while taking Actemra.

Tell your doctor if you are breast-feeding while being treated with Actemra.

Tell your doctor if you feel Actemra is not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be

checked.

Your doctor may test your blood to help guide your treatment.

Things you must not do

You should not breast-feed your infant during treatment with Actemra.

It is not known whether Actemra crosses into human milk.

Do not take any other medicines whether they require a prescription or not without first telling

your doctor or consulting a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how Actemra affects you.

Actemra has not been shown to impair the ability to drive or operate machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are

receiving Actemra.

Actemra helps many patients with RA, pJIA or sJIA but it may have unwanted side effects. All

medicines can have 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.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

mild fever and chills

high blood pressure (symptoms may include headache, dizziness, ringing in the ears)

rashes or itching

headache

cough

Actemra 170613

blocked or runny nose

sore throat

dizziness

nausea or indigestion

stomach pain

constipation

diarrhoea

cold sores

mouth or skin blisters

mouth ulcers

skin infection (redness, pain and/or swelling)

pain in the joints

These are the more common side effects of Actemra. Mostly these are mild.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you

notice any of the following:

difficulty breathing, chest tightness or wheezing

severe light-headedness

severe skin rash, itching, hives

swelling of the face, lips, mouth

signs of serious infection such as severe fever and chills, stomach ache or persistent

headaches

bleeding from the stomach or intestines. Signs and symptoms may include severe

stomach pain, vomiting blood or material that looks like coffee grounds, bleeding from your

rectum, black sticky bowel motions, bloody diarrhoea

severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

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 if you notice anything else that is making you feel unwell, even if it is not on

this list.

Ask your doctor or pharmacist if you don’t understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After receiving Actemra

Storage

Actemra should be stored in the pharmacy or on the hospital ward. The concentrated solution for

infusion should be kept in a refrigerator at 2°C to 8°C. It should not be frozen.

Actemra should be stored away from light.

Product description

Availability

Actemra is available as 80 mg/4 mL, 200 mg/10 mL and 400 mg/20 mL single dose vials.

Actemra comes in packs of 1 vial for each of the 80 mg, 200 mg and 400 mg strengths.

Actemra is also available in a pre-filled syringe for subcutaneous injection.

What Actemra looks like

Actemra is a clear to opalescent, colourless to pale yellow liquid for intravenous infusion.

Ingredients

Actemra 170613

Active ingredient

tocilizumab (rch)

Inactive ingredients

polysorbate 80, sucrose, dibasic sodium phosphate dodecahydrate, monobasic sodium

phosphate dihydrate, water for injections

Distributor

Actemra is distributed in New Zealand by:

Roche Products (New Zealand) Limited

PO Box 109113 Newmarket

Auckland 1149

NEW ZEALAND

Medical Enquiries: 0800 656 464

This leaflet was prepared on 13 June 2017.

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24-10-2018

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, LLC is Expanding Recall to Include All Product Lots Manufactured from February 27, 2018 Through July 20, 2018, Because of Possible Listeria Monocytogenes Health Risk

G & C Raw, of Versailles, OH is recalling all products lots manufactured from February 27, 2018 through July 20, 2018, as a precaution because they have the potential to be contaminated with Listeria monocytogenes

FDA - U.S. Food and Drug Administration

4-10-2018

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Nederland organiseert wereldwijde conferentie tegen antibioticaresistentie

Samen met de Wereldgezondheidorganisatie (WHO) zal Nederland in april 2019 een wereldwijde ministeriële conferentie organiseren over de strijd tegen antibioticaresistentie. Dat heeft minister Bruno Bruins (Medische Zorg) bekend gemaakt tijdens de G20-bijeenkomst in Argentinië. Bij deze bijeenkomst maakte Bruins afspraken met zijn collega’s uit de grootste 20 economieën van de wereld over een gezamenlijke aanpak van gezondheidsvraagstukken. Mede door jarenlange inzet van Nederland, staat antibioticaresist...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-9-2018

Pending EC decision:  Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Pending EC decision: Buvidal, buprenorphine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Emgality, galcanezumab, Opinion date: 20-Sep-2018

Pending EC decision: Emgality, galcanezumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Pending EC decision: RoActemra, tocilizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Pending EC decision: Venclyxto, venetoclax, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Pending EC decision: Jivi, damoctocog alfa pegol, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Gilenya, fingolimod, Opinion date: 20-Sep-2018

Pending EC decision: Gilenya, fingolimod, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Apealea, paclitaxel, Opinion date: 20-Sep-2018

Pending EC decision: Apealea, paclitaxel, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Pending EC decision: Alunbrig, brigatinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Pending EC decision: Cabometyx , cabozantinib, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Pending EC decision: Luxturna, voretigene neparvovec, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Fulphila, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Pelmeg, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Pending EC decision: Ziextenzo, pegfilgrastim, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Pending EC decision: Poteligeo, mogamulizumab, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Pending EC decision:  Pifeltro, doravirine, Opinion date: 20-Sep-2018

Pending EC decision: Pifeltro, doravirine, Opinion date: 20-Sep-2018

Europe - EMA - European Medicines Agency

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Pending EC decision:  Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Pending EC decision: Xtandi, enzalutamide, Opinion date: 20-Sep-2019

Europe - EMA - European Medicines Agency

24-12-2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement, Meeting 20, 16 November 2018

ACCM meeting statement for 16 November 2018 published

Therapeutic Goods Administration - Australia

21-12-2018

Consultation: Fees and charges proposal 2019-20

Consultation: Fees and charges proposal 2019-20

The TGA is seeking comments from interested parties on the proposed changes in fees and charges for 2019-2020. Closing date: 8 February 2018

Therapeutic Goods Administration - Australia

20-12-2018

Namuscla (Lupin Europe GmbH)

Namuscla (Lupin Europe GmbH)

Namuscla (Active substance: Mexiletine) - New authorisation - Commission Decision (2018)9133 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4584

Europe -DG Health and Food Safety

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

18-12-2018


Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/20

Human medicines European public assessment report (EPAR): Vabomere, meropenem / vaborbactam, Urinary Tract Infections,Bacteremia,Bacterial Infections,Respiratory Tract Infections,Pneumonia,Pneumonia, Ventilator-Associated, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

18-12-2018


Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Human medicines European public assessment report (EPAR): Buvidal, buprenorphine, Opioid-Related Disorders, Date of authorisation: 20/11/2018, Status: Authorised

Europe - EMA - European Medicines Agency

12-12-2018


Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Human medicines European public assessment report (EPAR): Exondys, eteplirsen, Muscular Dystrophy, Duchenne, Date of refusal: 20/09/2018, Status: Refused

Europe - EMA - European Medicines Agency

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

28-11-2018

PHEBURANE (Eurocept International BV)

PHEBURANE (Eurocept International BV)

PHEBURANE (Active substance: Sodium Phenylbutyrate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8043 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2500/T/20

Europe -DG Health and Food Safety

26-11-2018

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health te

Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.

FDA - U.S. Food and Drug Administration

16-11-2018

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A.)

Latuda (Active substance: lurasidone) - Centralised - Renewal - Commission Decision (2018)7674 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2713/R/20

Europe -DG Health and Food Safety

14-11-2018

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Otsuka Pharmaceutical Netherlands B.V.)

Jinarc (Active substance: tolvaptan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7604 of Wed, 14 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2788/T/20

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

17-9-2018

Agenda:  Agenda - CHMP agenda of the 17-20 September 2018 meeting

Agenda: Agenda - CHMP agenda of the 17-20 September 2018 meeting

Europe - EMA - European Medicines Agency