Adalat Oros

Main information

  • Trade name:
  • Adalat Oros 60 mg Modified release tablet
  • Dosage:
  • 60 mg
  • Pharmaceutical form:
  • Modified release tablet
  • Units in package:
  • Blister pack, PA/Al/PVC (Alu/Alu), 30 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Bayer AG

Documents

Localization

  • Available in:
  • Adalat Oros 60 mg Modified release tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • -Treatment of coronary heart disease -Chronic stable angina pectoris (angina of effort) - Treatment of hypertension

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 2891
  • Authorization date:
  • 23-07-1992
  • Last update:
  • 27-09-2017

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

New Zealand Consumer Medicine Information

131112AdalatOrosNZCMI

ADALAT

®

OROS

(Add·a·lat Or·us)

nifedipine

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

This leaflet answers some common

questions about Adalat Oros. It

does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

This leaflet is for Adalat Oros. It is

different from the leaflet for other

forms of Adalat products.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Adalat Oros

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 with the

medicine.

You may need to read it again.

WHAT ADALAT OROS

IS USED FOR

Adalat Oros is used either to treat

high blood pressure or to prevent a

type of angina (chest pain), known

as chronic stable angina.

Adalat Oros is not used for the

relief of a sudden attack of

angina or to manage unstable

angina

Adalat Oros contains the active

substance nifedipine which

belongs to a group of medicines

called calcium channel blockers.

They work by opening up blood

vessels in the body to lower blood

pressure and improve the supply of

blood and oxygen to the heart.

Adalat Oros is specially designed

to allow the slow release of the

active substance from the tablet

after it is taken. It is composed of a

strong outer shell which does not

dissolve in the body and is

excreted in the faeces. It is normal

to find these “ghost-tablets” in the

faeces. The active substance

contained in them has been

absorbed by the body before

excretion.

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.

BEFORE YOU TAKE

ADALAT OROS

When you must not take it

Do not take Adalat Oros if you

have an allergy to:

nifedipine, the active

ingredient in Adalat Oros

any of the 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 Adalat Oros if you

are in cardiogenic shock (very

low blood pressure due to a

failing heart).

Do not take Adalat Oros if you

have a Kock Pouch or ileostomy

(a surgically created reservoir in

the small intestine).

Do not take Adalat Oros if you

are taking another medicine

containing the active substance

rifampicin, an antibiotic used to

treat tuberculosis and other

serious infections.

Do not take this medicine in the

first 20 weeks of your

pregnancy.

It may affect your developing baby

if you take it during pregnancy.

Do not breast-feed if you are

taking this medicine.

The active ingredient in Adalat

Oros passes into breast milk and

there is a possibility that your baby

may be affected.

Do not take this medicine after

the expiry date printed on the

pack and blister.

The expiry date is printed on the

carton and on each blister after

“EXP” (e.g. 11 18 refers to

November 2018). The expiry date

refers to the last day of that month.

If it has expired return it to your

pharmacist for disposal.

Do not take this medicine if the

packaging is torn or shows signs

of tampering.

If the packaging is damaged, return

it to your pharmacist for disposal.

131112AdalatOrosNZCMI

Do not take tablets that show

visible signs of deterioration (e.g.

are broken or discoloured).

If you are not sure whether you

should start taking this

medicine, talk to your doctor.

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 you have or

have had any of the following

medical conditions:

heart failure

other heart or blood vessel

disorders

low blood pressure

stroke

mini-stroke (also known as

TIA or transient ischaemic

attack)

liver disease

narrowing of your oesophagus

or intestine, e.g. due to

previous injury, infection or

surgery

If you have not told your doctor

or pharmacist about any of the

above, tell them before you start

taking Adalat Oros.

Tell your doctor if you eat

grapefruit or drink grapefruit

juice regularly, including in the

last 3 days before starting Adalat

Oros.

You should not have

grapefruit while you are taking

Adalat Oros because this can cause

unwanted changes in the blood

pressure lowering effect of the

tablets.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including those that

you buy without a prescription

from a pharmacy, supermarket

or health food shop.

Some medicines and Adalat Oros

may interfere with each other.

Examples are given below but this

is not a complete list. Talk to your

doctor or pharmacist if you have

any questions.

Medicines to be careful with or

avoid while taking Adalat Oros

include:

beta blockers, e.g. metoprolol,

atenolol

other medicines used to treat

high blood pressure or angina,

e.g. diltiazem

medicines used to treat

arrhythmia (fast or irregular

heartbeats), e.g. quinidine

other medicines used to treat

heart disease, e.g. digoxin

some medicines used to treat

stomach ulcers and heartburn,

e.g. cimetidine, cisapride

rifampicin, used to treat

tuberculosis and other serious

infections

other medicines used to treat

bacterial infections, e.g.

erythromycin, quinupristin,

dalfopristin

medicines used to treat fungal

infections, e.g. ketoconazole

medicines used to treat HIV,

e.g. ritonavir

medicines used to treat

epilepsy, e.g. phenytoin,

carbamazepine, valproic acid,

phenobarbitone

anti-depressants, e.g.

fluoxetine, nefazodone

tacrolimus, used to prevent

rejection after organ transplant

These medicines may be affected

by Adalat Oros or may affect

how well it works. You may need

to take different amounts of your

medicine or you may need to

take different medicines.

Your doctor or pharmacist has a

more complete list of medicines to

avoid while taking Adalat Oros.

HOW TO TAKE

ADALAT OROS

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this

leaflet.

Do not remove tablets from the

blister pack until you are ready

to take them.

If you do not understand the

instructions on the pharmacist

label, ask your doctor or

pharmacist for help.

How much to take

The correct dose of Adalat Oros to

take has been decided by your

doctor. Make sure you follow the

instructions given to you by your

doctor.

The usual dose is 30 mg or 60 mg

once daily. Your doctor may

increase the dose if required.

How to take it

Immediately after removing a

tablet from the blister pack,

swallow it whole with some liquid.

Do not break or chew the tablets.

When to take it

Take Adalat Oros once a day, at

about the same time each day.

Adalat Oros can be taken either

with or without a meal.

How long to take it

Your doctor will determine how

long you should take Adalat Oros

tablets. Do not stop taking the

tablets unless you are told to do so

by your doctor.

If you forget to take it

If you forget to take your daily

dose of Adalat Oros at the right

time and remember in less than 12

131112AdalatOrosNZCMI

hours, take it straight away, then

continue as normal the next day.

Otherwise, skip that day’s dose but

be sure to take the next day’s dose

when it is due.

Do NOT take a double dose to

make up for the dose you missed.

If you have missed several doses,

consult your doctor.

If you take too much

(overdose)

Immediately telephone your

doctor or Poisons Information

Centre for advice (New Zealand:

0800 POISON or 0800 764 766),

or go to Accident and

Emergency at your nearest

hospital, if you think that you or

anyone else may have taken too

many Adalat Oros tablets. Do

this even if there are no signs of

discomfort or poisoning.

may need urgent medical attention.

Signs of an overdose include

feeling dizzy and fainting due to

drop in blood pressure, irregular or

rapid heart beats, shortness of

breath, shock and loss of

consciousness.

WHILE YOU ARE

TAKING ADALAT

OROS

Things you must do

Take Adalat Oros exactly as told

by your doctor.

If you do not

follow your doctor’s instruction,

you may not get control of your

blood pressure or relief from your

angina.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Adalat Oros.

Tell your doctor if you continue to

have angina attacks or if they

become more frequent while you

are taking Adalat Oros.

Tell all doctors, dentists and

pharmacists who are treating

you that you are taking Adalat

Oros.

The use of Adalat Oros may

affect the results of certain

laboratory tests or x-rays.

If you are about to have any tests

or x-rays, tell your doctor that you

are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Things you must not do

Do not give this medicine to

anyone else, even if their

symptoms seem similar to yours.

Do not use it to treat any other

medical conditions unless your

doctor says so.

Do not eat grapefruit or drink

grapefruit juice while you are

taking this medicine.

Grapefruit can cause unwanted

changes in the blood pressure

lowering effect of Adalat Oros.

Do not stop taking your

medicine or lower the dosage

without checking with your

doctor.

If you stop taking it suddenly, your

condition may worsen or you may

have unwanted side effects.

Things to be careful of

Be careful driving or operating

machinery until you know how

Adalat Oros affects you.

It may cause dizziness or fainting

in some patients, especially when

they first start taking the medicine,

change dose, or drink alcohol.

If you have angina, be careful not

to overdo physical activities when

you first start taking Adalat Oros.

You may feel better when you start

taking it, but you will need time to

improve your physical fitness.

SIDE EFFECTS

Tell your doctor or pharmacist

as soon as possible if you do not

feel well while you are taking

Adalat Oros.

All medicines can have side

effects. Sometimes they are

serious, most of the time they are

not. You may need medical

attention if you get some of the

side effects.

Do not be alarmed by the

following lists of side effects.

You may not experience any of

them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you.

The following list includes the

common side effects of your

medicine. They are usually mild

and short-lived.

headache

flushing

constipation

generally feeling unwell

general swelling and/or

swelling of the arms, ankles or

legs

Your doctor may need to monitor

your liver function, as Adalat Oros

can increase your liver enzymes.

You may not experience any

specific symptoms.

If any of the following happen,

stop taking Adalat Oros and tell

your doctor immediately or go to

131112AdalatOrosNZCMI

Accident and Emergency at your

nearest hospital:

chest pain

rash, itching or hives on the

skin

swelling of the face, lips,

tongue, or other parts of the

body

shortness of breath, wheezing,

or trouble breathing

signs of liver problems such as

yellowing of the skin and/or

eyes (jaundice)

signs of frequent infections

such as fever, severe chills,

sore throat or mouth ulcers.

These serious side effects are not

common. If you have these side

effects, you may need urgent

medical attention.

There have been reports of

purple/brown discolouration of the

skin or redness, flaking and itching

of the skin. Also, it has been

reported that some people develop

a rash or blistering of the skin

when they are exposed to sunlight.

In very rare cases, the undissolved

shell of the Adalat Oros tablet or

“ghost-tablets” may not be

excreted in the faeces and may

collect in the stomach. Tell your

doctor if you experience symptoms

of bowel blockage. Surgery may be

necessary to remove these shells.

In a small number of cases of

in

vitro

fertilisation, medicines like

nifedipine appeared to have

interfered with the normal function

of sperm. This effect went away

after the medicine was stopped. In

those men who are taking Adalat

Oros and are repeatedly

unsuccessful in fathering a child

in vitro

fertilisation, the

medicine should be considered as

one of the possible causes if no

other explanation can be found.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

AFTER TAKING

ADALAT OROS

Storage

Keep the 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 the medicine in a cool dry

place and follow the storage

instructions stated on the carton.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a window-sill.

Do not leave it in the car.

Heat and damp can destroy some

medicines.

Keep the tablets where children

cannot reach them.

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 this medicine 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

Adalat Oros 30 mg tablets are

round, biconvex film-coated

tablets in rose-pink colour marked

with “30” on one side and a pin-

prick hole on the other side to aid

in delivery of your medicine. The

tablets are supplied in blister packs

of 30 tablets, with each tablet

containing 30 mg of nifedipine.

Adalat Oros 60 mg tablets are

round, biconvex film-coated

tablets in rose-pink colour marked

with “60” on one side and a pin-

prick hole on the other side to aid

in delivery of your medicine. The

tablets are supplied in blister packs

of 30 tablets, with each tablet

containing 60 mg of nifedipine.

Ingredients

Active Ingredient per tablet:

Adalat Oros 30 - nifedipine

30 mg

Adalat Oros 60 - nifedipine

60 mg

Inactive ingredients:

polyethylene oxide

magnesium stearate

sodium chloride

hypromellose

iron oxide red (CI 77491)

hydroxypropylcellulose

cellulose acetate

macrogol 3350

titanium dioxide

propylene glycol

Supplier

Made in Germany for:

Bayer New Zealand Limited

3 Argus Place

Hillcrest, North Shore

Auckland 0627

Date of preparation

November 2013

See MEDSAFE website

(www.medsafe.govt.nz) for latest

New Zealand Consumer Medicine

Information.

® Registered Trademark of Bayer

AG, Germany

© Bayer Australia Ltd

All rights reserved

131112AdalatOrosNZCMI

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Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

17-12-2018

 Occupational health: aiming to take better account of multiple exposure

Occupational health: aiming to take better account of multiple exposure

Workers can potentially be exposed to numerous health risk factors through their occupations. The question of multiple exposure is a major challenge for all those active in the field of occupational health, safety and prevention. As part of the 2016-2020 National Occupational Health Plan, a review of the measures taken by the main players to address the question of multiple exposure in France and abroad is being published today. This work has helped determine the state of knowledge and the issues surroun...

France - Agence Nationale du Médicament Vétérinaire

14-12-2018

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Published on: Thu, 13 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State France for the pesticide active substance bromoxynil are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to bromoxynil can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions w...

Europe - EFSA - European Food Safety Authority Publications

9-1-2019


Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Guideline on assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products

Europe - EMA - European Medicines Agency

7-1-2019

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy

The TGA seeks comments on the extent to which a similar approach will be appropriate in the Australian regulatory context. Closing date: 18 February 2019

Therapeutic Goods Administration - Australia

20-12-2018


Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Programme to rationalise international good-manufacturing-practice inspections of active-pharmaceutical-ingredient / active-substance manufacturers: Terms of reference and procedures for participating authorities

Europe - EMA - European Medicines Agency

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

19-12-2018

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (PharmaSwiss CeskA republika s.r.o.)

Macugen (Active substance: pegaptanib sodium) - Withdrawal - Commission Decision (2018)9064 of Wed, 19 Dec 2018

Europe -DG Health and Food Safety

19-12-2018

Perlinring and associated names

Perlinring and associated names

Perlinring and associated names (Active substance: etonogestrel/ethinylestradiol) - Community Referrals - Art 29 - Commission Decision (2018)9141 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1473

Europe -DG Health and Food Safety

17-12-2018

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Intercept Pharma Ltd)

OCALIVA (Active substance: obeticholic acid) - Centralised - Annual renewal - Commission Decision (2018)8909 of Mon, 17 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4093/R/9

Europe -DG Health and Food Safety

14-12-2018


Final Guideline on Active Substance Master File Procedure - Revision 4

Final Guideline on Active Substance Master File Procedure - Revision 4

Final Guideline on Active Substance Master File Procedure - Revision 4

Europe - EMA - European Medicines Agency

14-12-2018

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Teva B.V.)

Desloratadine Teva (Active substance: desloratadine) - Centralised - Yearly update - Commission Decision (2018)8912 of Fri, 14 Dec 2018

Europe -DG Health and Food Safety

14-12-2018

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (GlaxoSmithKline (Ireland) Limited)

Revinty Ellipta (Active substance: fluticasone furoate / vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8927 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2745/T/38

Europe -DG Health and Food Safety

14-12-2018

Valdoxan (Les Laboratoires Servier)

Valdoxan (Les Laboratoires Servier)

Valdoxan (Active substance: agomelatine) - Centralised - Renewal - Commission Decision (2018)8932 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/915/R/42

Europe -DG Health and Food Safety

14-12-2018

Ogivri (Mylan S.A.S.)

Ogivri (Mylan S.A.S.)

Ogivri (Active substance: trastuzumab) - Centralised - Authorisation - Commission Decision (2018)8913 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4916

Europe -DG Health and Food Safety

14-12-2018

LONGRANGE (Merial)

LONGRANGE (Merial)

LONGRANGE (Active substance: eprinomectin) - Refusal of authorisation - Commission Decision (2018)8905 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4291

Europe -DG Health and Food Safety

14-12-2018

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (GlaxoSmithKline (Ireland) Limited)

Relvar Ellipta (Active substance: fluticasone furoate/vilanterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8928 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2673/T/40

Europe -DG Health and Food Safety

14-12-2018

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Sanofi Pasteur)

Dengvaxia (Active substance: dengue tetravalent vaccine (live, attenuated)) - Centralised - Authorisation - Commission Decision (2018)8933 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4171

Europe -DG Health and Food Safety

14-12-2018

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Seqirus Netherlands B.V.)

Flucelvax Tetra (Active substance: influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) - Centralised - Authorisation - Commission Decision (2018)8911 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4814

Europe -DG Health and Food Safety

14-12-2018

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Pfizer Europe MA EEIG)

Pregabalin Pfizer (Active substance: pregabalin) - Centralised - Renewal - Commission Decision (2018)8908 of Fri, 14 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3880/R/25

Europe -DG Health and Food Safety

13-12-2018

voriconazole

voriconazole

voriconazole (Active substance: voriconazole) - Centralised - Art 28 - (PSUR - Commission Decision (2018)8915 of Thu, 13 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/3127/201802

Europe -DG Health and Food Safety

12-12-2018

Oncaspar (Les Laboratoires Servier)

Oncaspar (Les Laboratoires Servier)

Oncaspar (Active substance: pegaspargase) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8757 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3789/T/21

Europe -DG Health and Food Safety

12-12-2018

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Bristol-Myers Squibb Pharma EEIG)

Daklinza (Active substance: daclatasvir) - Centralised - Yearly update - Commission Decision (2018)8758 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Bristol-Myers Squibb Pharma EEIG)

EVOTAZ (Active substance: atazanavir / cobicistat) - Centralised - Yearly update - Commission Decision (2018)8679 of Wed, 12 Dec 2018

Europe -DG Health and Food Safety

12-12-2018

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Swedish Orphan Biovitrum AB (publ))

Elocta (Active substance: efmoroctocog alfa) - Centralised - Variation - Commission Decision (2018)8678 of Wed, 12 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3964/X/21

Europe -DG Health and Food Safety

11-12-2018

Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Tenofovir disoproxil Zentiva (Zentiva, k.s.)

Tenofovir disoproxil Zentiva (Active substance: tenofovir disoproxil) - Centralised - Yearly update - Commission Decision (2018)8683 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Ziagen (ViiV Healthcare BV)

Ziagen (ViiV Healthcare BV)

Ziagen (Active substance: abacavir sulfate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8685 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/252/T/104

Europe -DG Health and Food Safety

11-12-2018

Xermelo (Ipsen Pharma)

Xermelo (Ipsen Pharma)

Xermelo (Active substance: telotristat) - Centralised - Yearly update - Commission Decision (2018)8684 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

11-12-2018

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Clovis Oncology Ireland Limited)

Rubraca (Active substance: rucaparib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8686 of Tue, 11 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4272/T/5

Europe -DG Health and Food Safety

11-12-2018

Aivlosin (ECO Animal Health Ltd)

Aivlosin (ECO Animal Health Ltd)

Aivlosin (Active substance: Tylvalosin) - Centralised - Yearly update - Commission Decision (2018)8687 of Tue, 11 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

Exondys (AVI BioPharma International Ltd)

Exondys (AVI BioPharma International Ltd)

Exondys (Active substance: eteplirsen) - Centralised - Refusal of marketing authorisation - Commission Decision (2018)8620 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4355

Europe -DG Health and Food Safety

10-12-2018

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (JensonR+ Limited)

Ivabradine JensonR (Active substance: ivabradine) - Centralised - Withdrawal - Commission Decision (2018)8623 of Mon, 10 Dec 2018

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (QRC Ireland)

EU/3/16/1662 (Active substance: H-Phe-Ser-Arg-Tyr-Ala-Arg-OH acetate) - Transfer of orphan designation - Commission Decision (2018)8626 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/011/16/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (PTC Therapeutics International Limited)

EU/3/17/1906 (Active substance: Recombinant adeno-associated viral vector serotype 5 carrying the gene for the human frataxin protein) - Transfer of orphan designation - Commission Decision (2018)8634 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002509

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (PTC Therapeutics International Limited)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)8630 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002507

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (PTC Therapeutics International Limited)

EU/3/16/1651 (Active substance: Recombinant adeno-associated viral vector serotype 9 carrying the gene for the human E6-AP ubiquitin protein ligase) - Transfer of orphan designation - Commission Decision (2018)8632 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002508

Europe -DG Health and Food Safety

10-12-2018

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (FGK Representative Service GmbH)

EU/3/16/1802 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)8627 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002422

Europe -DG Health and Food Safety

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

10-12-2018

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Nova Laboratories Ireland Limited)

EU/3/09/628 (Active substance: Mercaptopurine (oral suspension)) - Transfer of orphan designation - Commission Decision (2018)8629 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002301

Europe -DG Health and Food Safety

10-12-2018

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Les Laboratoires Servier)

EU/3/11/933 (Active substance: Nanoliposomal irinotecan) - Transfer of orphan designation - Commission Decision (2018)8625 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/11/T/02

Europe -DG Health and Food Safety

7-12-2018

Olanzapine Mylan (Mylan S.A.S.)

Olanzapine Mylan (Mylan S.A.S.)

Olanzapine Mylan (Active substance: Olanzapine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7622 of Fri, 07 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/961/T/45

Europe -DG Health and Food Safety

5-12-2018

Luxturna (Spark Therapeutics Ireland Ltd)

Luxturna (Spark Therapeutics Ireland Ltd)

Luxturna (Active substance: voretigene neparvovec) - Centralised - Authorisation - Commission Decision (2018)7970 of Wed, 05 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4451

Europe -DG Health and Food Safety

30-11-2018

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Zentiva, k.s.)

Pregabalin Zentiva k.s (Active substance: pregabalin) - Centralised - Yearly update - Commission Decision (2018)8149 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety

30-11-2018

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Teva B.V.)

Pioglitazone Teva (Active substance: pioglitazone) - Centralised - Yearly update - Commission Decision (2018)8159 of Fri, 30 Nov 2018

Europe -DG Health and Food Safety