Alustal European Dust Mite Extract

Main information

  • Trade name:
  • Alustal European Dust Mite Extract 10 IR/mL Solution for injection
  • Dosage:
  • 10 IR/mL
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Vial, glass, multi-dose, 11mL vial (5mL fill volume), 5 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Stallergenes

Documents

Localization

  • Available in:
  • Alustal European Dust Mite Extract 10 IR/mL Solution for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 10799
  • Authorization date:
  • 28-05-2002
  • Last update:
  • 27-09-2017

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

CONSUMER MEDICINE INFORMATION

ALUSTAL

Page 1 of 7

ALUSTAL

®

Pronounced (al-u-stal)

Contains

active

ingredients

different

allergens

Table of contents

What is in the leaflet.......p.1

What Alustal is used for p.1

Before you are given Alustal

........................................p.1

How Alustal is given.......p.2

While

receiving

Alustal............................ p.3

Side effects..................... p.3

After using Alustal.........p.4

Product description.......p.4

Presentation..................p.4

____________________

What is in this leaflet

____________________

This

leaflet

answers

some

common

questions

about

Alustal allergen extracts.

It does not contain all of the

available information.

It does not take the place of

talking

your

doctor

pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed

risks

giving you Alustal

allergen

extracts against the expected

benefits it will have for you.

If

you have any concerns

about

being

given

this

medicine, ask your

doctor or pharmacist.

____________________

What Alustal is used for

____________________

Alustal

belongs to a group

medicines

called

anti-

allergy preparations and is

used

treatment

seasonal

perennial

rhinitis,

conjunctivitis

rhino-conjunctivitis

with or

without associated asthma.

Alustal

given

subcutaneous treatment

this

often referred to as

(Subcutaneous

Immunotherapy Treatment)

How it works:

A list

allergen available

Australia

Zeeland is

provided at

this

leaflet.

exact

type will

depend on

your allergy and what

your

doctor

identifies

cause of

your

allergy.

treatment

with

allergen

extracts

prevent

more

severe

allergic

reactions

experience.

Alustal

works

slowly

increasing your tolerance to

specific

allergens

decreases

severity

your allergic reactions.

The injection is specifically

designed

according

individual patient needs.

Alustal

helps

increase

your

tolerance to allergens

decrease

severity

your

allergic

reactions.

Ask

your

doctor

if

you

have

any

questions

why

Alustal

has

been

prescribed for you.

Alustal is not addictive. This

medicine

available

only

with a doctor’s prescription

administered

under

doctor’s supervision.

____________________

Before

you

are

given

Alustal

____________________

When

you

must

not

be

given Alustal

Do

not

start

Alustal

treatment if:

You have unstable asthma,

severe

immunodeficiency,

malignant

disease,

autoimmune

disease.

Injection

should

avoided

have

bleeding tendency.

currently

receiving

treatment

with

beta-blockers

(often

medicines

blood

pressure

heart

conditions), as you may be

unresponsive to the usual

doses of adrenaline used to

treat

anaphylactic

reactions.

You have

problems

with

your

kidneys

renal

insufficiency - as this may

increase

risk

accumulation

aluminium

from

aluminium

hydroxide

preparations

aluminium

hydroxide

vaccine)

into

tissues

(central

nervous

system,

bones)

The package shows signs

of tampering.

expiry

date

(EXP)

printed on the

pack has

passed.

you receive injections of

this

medicine

after

expiry date

passed,

may not work as well.

It is not advisable to use SIT

during

pregnancy:

pregnancy is not

considered

CONSUMER MEDICINE INFORMATION

ALUSTAL

Page 2 of 7

as a contraindication to the

continuation

immunotherapy

treatment

should

started during pregnancy.

a patient

becomes pregnant

during initial treatment, stop

injections;

patient

becomes

pregnant

during

maintenance

therapy,

treatment

continue

well tolerated.

There is no data available on

excretion

allergen

extracts

in human milk or

effect

breast-fed

infants.

If you are not sure if you

should be taking Alustal,

talk to your doctor

Before

you

start

your

treatment with Alustal:

Tell your doctor if:

You have any other health

problems,

especially

following:

Asthma

other

respiratory problems.

have,

have

previously had,

a serious

immunological disease.

have

bleeding

tendency.

You have an autoimmune

disease.

Your

doctor

will

decide

risk

from

allergen

exposure

greater

than

risk

exacerbating

autoimmune disease.

have

acute

fever,

uncontrolled

allergic

symptoms

recent

exacerbation

asthma.

Your doctor can decide to

delay treatment.

If

you have not

told your

doctor

about

any of

the

above,

tell

him/her before

you start

treatment

with

Alustal.

Taking other medicines

Tell

your

doctor

taking

other

medicines,

including

that you have bought from

pharmacy,

supermarket

or health food shop.

Some

medicines

interfere

with

Alustal.

These medicines include:

Beta-blockers

(blood

pressure

heart

medications),

including

topically administered beta-

blockers,

known

interfere

with treatment

anaphylactic

reactions.

They

make

less

responsive

usual

doses

epinephrine

(adrenaline)

used

treat

anaphylactic reactions.

Your

doctor

will

advise

you.

Your

doctor

pharmacist

more

information

medicines to be careful with

or avoid while taking any of

the Alustal.

your

doctor

pharmacist

you are

sure if your medicine is one

of the ones listed above.

______________________

How Alustal is given

______________________

How much is given

Your

treatment

schedule

will include:

Initial

treatment

maintenance treatment:

Your

doctor

will

tell

how much medicine will be

given during each treatment.

Normally

initial

treatment

will be weekly

injections

lasting

approximately 14 weeks.

This

will

allergen

that

allergic to in increasing

concentrations up to the

highest

dose

tolerate.

Maintenance

treatment

will

monthly

injections of

the highest

concentration

that

can tolerate comfortably.

Where

two

different

courses are being given

concurrently,

the

two

extracts

must

never be

mixed within the same

syringe.

Injections

extracts may be given at

same

visit,

separate

arms.

However

mixtures of allergens may

have been prescribed for

you by your Doctor, these

will already be mixed and

given

single

injection.

the doctor

may need to give

more

than one injection if

are being treated for more

than one allergy.

How Alustal is given

Alustal

given

injection

under

skin

(subcutaneously)

injected into a blood vessel

or intramuscularly.

How long to have Alustal

for

Treatment

maintenance

should continue for

3 to 5

years

depending

CONSUMER MEDICINE INFORMATION

ALUSTAL

Page 3 of 7

severity of

the allergy and

response to treatment.

If you miss a dose:

you miss a dose,

talk to

your

doctor

arrange

another

visit

soon

possible.

If you are given too much

(overdose)

Overdose

unlikely

because

your

doctor

will

give you this

medicine by

injection.

you think that

you may have

been given

much

Alustal,

immediately tell your doctor

Accident

Emergency at

your

nearest

hospital.

Symptoms

such

generalized rash,

itching,

swelling

lips,

face,

tongue or other parts of

the body,

shortness

breath,

respiratory

cardiac

distress

(including

asthma),

seizures,

may occur.

If you have any

concerns, ask your doctor.

______________________

While you are

receiving

Alustal

______________________

Things you must do

Tell

all

doctors,

dentists

and pharmacists who are

treating you,

that you are

receiving Alustal.

Tell your doctor if you feel

the

treatment

is

not

helping your condition.

Keep

your

appointments

with

your

doctor so that your progress

checked.

important

have

your

follow-up doses

Alustal

the appropriate times

make

sure

immunotherapy has the best

chance of working.

Things you must not do

is recommended to avoid

activity

that

increase blood flow through

injection

site

such

strenuous

exercise,

baths,

sauna,

application of

local heat or rubbing, for the

remainder of the day.

Things to be careful of

must

avoid

strenuous

activity

remainder

You must

wait

in the

doctor’s

waiting room

for at

least

30 minutes

following your

Alustal

injection.

The majority

of serious reactions will

begin

within

minutes

after

injection.

Patients

should be instructed to

seek

medical

advice

immediately

symptoms

develop

after leaving the clinic.

more

rapidly

symptoms

begin,

more

severe

they

likely

more rapidly treatment

measures should begin.

Alustal

is presumed to

be unlikely to produce

an effect

on the ability

drive

machinery.

______________________

Side effects

______________________

Alustal

allergen

extracts

helps

most

people

with

allergies but they may have

unwanted side effects

in a

few people.

All medicines can have side

effects.

Sometimes they are

serious,

most

time

they are not.

You may need

medical treatment if you get

some of these side effects.

Contact

your

doctor

or

nurse

immediately

if

symptoms

of

an allergic

reaction occur.

Tell

your

doctor

or

pharmacist

as

soon

as

possible if you do not feel

well

while

you

are

receiving Alustal.

Tell

your

doctor

immediately if

you notice

any of

the following and

they worry you:

Common Side Effects

Itching

redness

the injection site.

Shortness of breath,

Asthma,

Rhinitis,

Laryngeal swelling,

Swelling

lips,

face,

tongue or other parts of

the body,

Itching,

Uncommon Side Effects

Anaphylactic shock

Conjunctivitis

Very Rare Side effects

Pre-existing

atopic

eczema outbreaks

Myalgia

within

serum

sickness like syndrome

Headache,

weakness,

lack of strength

CONSUMER MEDICINE INFORMATION

ALUSTAL

Page 4 of 7

these,

the more serious

effects can include

generalized rash,

itching,

swelling

lips,

face,

tongue or other parts of

the body,

shortness

breath or

tightness

(including

asthma)

seizures

Tell

your

doctor

immediately

or

go

to

Accident

and Emergency

at your nearest hospital

if

you

notice

any

of

the

above:

Serious side effects are rare.

This is not a complete list of

possible

side

effects.

Others

may occur

in some

people

there

some

side

effects

known.

Tell

your

doctor

if

you

notice anything else that is

making

you feel

unwell,

even if it is not on this list.

your

doctor

pharmacist

answer

questions you may have and

to explain anything you do

not understand on this list.

Do not be alarmed by this

list of possible side effects.

You may not experience any

of them.

______________________

After

using

Alustal

______________________

Storage

Alustal

is usually stored in

doctor’s

surgery.

However,

need

store it:

Keep it

where children

cannot reach it

Keep it

in the original

pack

Keep

refrigerator (between 2°

to 8°C). Do not freeze.

Disposal

Your doctor will

dispose of

any unfinished medicine if

the vials have passed their

expiry date.

______________________

Product description

______________________

What Alustal looks like

Each

vial

contains

specific

allergen

extract(s)

suspension

available

various

concentrations

many

different

allergens.

Your

Doctor

will

choose

correct allergen to treat your

allergy.

Other ingredients in

allergen

suspensions

include

aluminium

hydroxide,

sodium chloride,

phenol

manitol

and water

for injections.

ALUSTAL presentation

Initial treatment set: 3 vials,

each vial

containing either

0.1,

1.0 and 10.0 IR/mL or

IC/mL.

Maintenance

set:

single

vial

containing 10.0 IR/mL

or IC/mL.

Available Concentrations:

Vial

containing

mL of

suspension.

Yellow cap:

IR/mL

IC/mL

Green cap:

IR/mL

IC/mL

Blue cap:

10.0 IR/mL

10.0

IC/mL

(IR/mL

Index

Reactivity per mL)

(IC/mL

Index

Concentration per mL)

Ingredients

Alustal

products

contain

either

single

allergen

extract

or a combination of

allergen extracts within the

mite

pollen

group

allergens.

ALUSTAL is prepared from

freeze-dried

allergen

extracts

adsorbed

onto

aluminium hydroxide

gel.

freeze-dried

allergen

extracts

prepared

ammonium

bicarbonate

extraction

allergen

source materials e.g.

pollen,

mites.

Specific allergen(s)

are selected by the physician

for Specific Immunotherapy

Treatment

(SIT)

individual patient

.

____________________

Sponsor

______________________

Distributed

in

Australia

for Helex-A Pty Ltd by:

Link Medical

Products Pty

5 Apollo Street

Warriewood NSW 2102

AUSTRALIA

Ph: 1800 824166

Fax: 1800 824199

Distributed

and

Registered in New Zealand

by:

EBOS Group Ltd

324 Cashel Street

CHRISTCHURCH

NEW ZEALAND

Ph: 64 9 4153 267

Fax: 0800 262 262

CONSUMER MEDICINE INFORMATION

ALUSTAL

Page 5 of 7

ALUSTAL ALLERGEN EXTRACT AVAILABILITY IN AUSTRALIA AND NEW ZEALAND

REGISTRATION

NAME

ACTIVE INGREDIENT

AUSTRALIA

AUST R

NEW

ZEALAND

Mites

ALUSTAL

House

Dust

Mites Extract

Dermatophagoides

pteronyssinus

and Dermatophagoides

farinae body extracts

AUST

132680

AUST R 132725 (I)

ALUSTAL European Dust

Mite Extract

Dermatophagoides pteronyssinus body extract

AUST

132678

AUST R 132723 (I)

TT50-6900a (I)

TT50-6900b (M)

ALUSTAL American Dust

Mite Extract

Dermatophagoides farinae body extract)

AUST

132679

AUST R 132724 (I)

TT50-6900/1a (I)

TT50-6900/1b (M)

Animals

ALUSTAL

Epithelia

Extract

Feline epithelium extract

TT50-6901a (I)

TT50-6901b (M)

ALUSTAL Dog

Epithelia

Extract

Canine epithelium extract

TT50-6901/1a (I)

TT50-6901/1b (M)

ALUSTAL Horse Epithelia

Extract

Equine epithelium extract

TT50-6901/2a (I)

TT50-6901/2b (M)

ALUSTAL Feathers

Extract

Chicken feather/ Duck feather/ Goose feather extract

TT50-6901/3a (I)

TT50-6901/3b (M)

Pollens

ALUSTAL

Birch

Pollen

Extract

Betula alba pollen extract

TT50-6902a (I)

TT50-6902b (M)

ALUSTAL

Oleaceae

Pollen Mix Extract

Fraxinus excelsior/ Olea europaea/

Ligustrum vulgare pollen extracts

TT50-6902/1a (I)

TT50-6902/1b (M)

ALUSTAL Plantain Pollen

Extract

Plantago lanceolata extract

AUST R 132838 (M)

AUST R 132839 (I)

TT50-6902/3a (I)

TT50-6902/3b (M)

ALUSTAL Fat

Hen Pollen

Extract

Chenopodium album extract

TT50-6902/4a (I)

TT50-6902/4b (M)

ALUSTAL

Sorrel

Pollen

Extract

Rumex acetosa pollen extract

TT50-6902/5a (I)

TT50-6902/5b (M)

ALUSTAL Wheat

Pollen

Extract

Triticum aestivum pollen extract

AUST R 132836 (M)

AUST R 132837 (I)

ALUSTAL Bermuda Grass

Extract

Cynodon dactylon pollen extract

AUST R 132834 (M)

AUST R 132835 (I)

ALUSTAL

Grass

Extract

Lolium perenne pollen extract

AUST R 132843 (M)

AUST R 132844 (I)

ALUSTAL

Olive

Tree

Extract

Olea europea pollen extract

AUST R 132840 (M)

AUST R 132841 (I)

ALUSTAL

Extract

Three Grasses

Dactylis

glomerata /

Lolium perenne/

Phleum pratense

pollen extracts

AUST R 132845 (M)

AUST R 132846 (I)

ALUSTAL Extract

of Five

Grasses

Dactylis

glomerata /

Poa pratensis

Lolium perenne /

Anthoxanthum odoratum / Phleum pratense pollen extracts

AUST R 132847 (M)

AUST R 132848 (I)

TT50-6902/6a (I)

TT50-6902/6b (M)

ALUSTAL

Extract

Twelve Grasses

Agrostis

tenuis

Cynodon dactylon /

Bromus

inermis

Dactylis

glomerata /

Festuca elatior

Poa pratensis

Arrhenatherum elatius

Lolium perenne /

Anthoxantum

odoratum / Phleum pratense / Avena fatua / Holcus latanus

pollen extracts

AUST R 132849 (M)

AUST R 132850 (I)

X = Not Available; I = Initial treatment; M = Maintenance treatment

CONSUMER MEDICINE INFORMATION

ALUSTAL

Page 6 of 7

Patient Verification

The following table has been provided to allow the patient

and physician to verify that

vial specifically for the patient is being used at time of treatment.

Injection

Date

Vial

(concentration)

Physician’s

Initial

Patient’s

Initial

Initial Set

1

0.1 IR/mL or

0.1 IC/mL

(Yellow cap)

2

3

4

5

1 IR/mL or

1 IC/mL

(Green cap)

6

7

8

9

10 IR/mL or

10 IC/mL

(Blue cap)

10

11

12

13

14

Maintenance Set

15

10 IR/mL or

10 IC/mL

(Blue cap)

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30

31

32

CONSUMER MEDICINE INFORMATION

ALUSTAL

Page 7 of 7

Injection

Date

Vial

(concentration)

Physician’s

Initial

Patient’s

Initial

33

34

35

36

10 IR/mL or

10 IC/mL

(Blue cap)

37

38

39

40

Maintenance Set

41

42

43

44

45

46

47

48

49

50

51

52

53

CMI Ver. 9.0

Date of Preparation: 10 January 2012

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Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).

Health Canada

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

18-7-2018

Orphan designation:  Recombinant humanised anti-human interleukin-1 beta monoclonal antibody,  for the: Treatment of Behçet’s disease

Orphan designation: Recombinant humanised anti-human interleukin-1 beta monoclonal antibody, for the: Treatment of Behçet’s disease

On 1 October 2010, orphan designation (EU/3/10/796) was granted by the European Commission to XOMA Ireland Ltd, Ireland, for recombinant humanised anti-human interleukin-1 beta monoclonal antibody for the treatment of Behçet’s disease.

Europe - EMA - European Medicines Agency

13-6-2018

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. Voluntarily Recalls Spicy Edamame Because Of Undeclared Allergens

World Variety Produce, Inc. of Los Angeles, CA is voluntarily recalling Spicy Edamame 7oz, because it contains the undeclared shellfish/crustacean allergen “Oyster Extract” ingredient within the spicy sauce packet. People who have an allergy or severe sensitivity to shellfish run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

30-4-2018

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg

Stonewall Kitchen is voluntarily recalling a limited amount of 10.25oz Basil Pesto Aioli with an Enjoy By date of 28 Sep 2019 which may contain the undeclared allergen egg, as we may have inadvertently placed the label for our Basil Pesto on a small portion of our most recent production run.

FDA - U.S. Food and Drug Administration

4-1-2019


New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

Europe - EMA - European Medicines Agency

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/3/09/628 (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

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

10-9-2018

Alkindi (Diurnal Limited)

Alkindi (Diurnal Limited)

Alkindi (Active substance: hydrocortisone) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5945 of Mon, 10 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4416/T/03

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Omeros London Limited)

EU/3/18/2067 (Active substance: Recombinant human monoclonal antibody against mannan-binding lectin-associated serine protease-2) - Orphan designation - Commission Decision (2018)5737 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/044/18

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

19-7-2018

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Global Regulatory Limited)

EU/3/12/1083 (Active substance: Humanised single chain monoclonal antibody against CD37) - Transfer of orphan designation - Commission Decision (2018)4839 of Thu, 19 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/128/12/T/02

Europe -DG Health and Food Safety

10-7-2018

Tegsedi (IONIS USA Limited)

Tegsedi (IONIS USA Limited)

Tegsedi (Active substance: inotersen) - Centralised - Authorisation - Commission Decision (2018)4458 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4782

Europe -DG Health and Food Safety

10-7-2018

Revolade (Novartis Europharm Limited)

Revolade (Novartis Europharm Limited)

Revolade (Active substance: Eltrombopag) - PSUSA - Modification - Commission Decision (2018)4487 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/1205/201709

Europe -DG Health and Food Safety

10-7-2018

Hirobriz Breezhaler (Novartis Europharm Limited)

Hirobriz Breezhaler (Novartis Europharm Limited)

Hirobriz Breezhaler (Active substance: indacaterol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4486 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1211/T/47

Europe -DG Health and Food Safety

10-7-2018

Visudyne (Novartis Europharm Limited)

Visudyne (Novartis Europharm Limited)

Visudyne (Active substance: verteporfin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4484 of Tue, 10 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/305/T/96

Europe -DG Health and Food Safety

2-6-2018

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Novartis Europharm Limited)

EU/3/14/1350 (Active substance: Recombinant human monoclonal antibody of the IgG1 kappa class against human macrophage colony-stimulating factor) - Transfer of orphan designation - Commission Decision (2018)3630 of Sat, 02 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Novartis Europharm Limited)

EU/3/13/1205 (Active substance: Human monoclonal antibody against human interleukin 13) - Transfer of orphan designation - Commission Decision (2018)3042 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/118/13/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Novartis Europharm Limited)

EU/3/12/1034 (Active substance: Humanised monoclonal antibody against P-selectin) - Transfer of orphan designation - Commission Decision (2018)3040 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/026/12/T/02

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Novartis Europharm Limited)

EU/3/10/765 (Active substance: Midostaurin) - Transfer of orphan designation - Commission Decision (2018)3039 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/016/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Novartis Europharm Limited)

EU/3/10/764 (Active substance: Everolimus) - Transfer of orphan designation - Commission Decision (2018)3038 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/10/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Novartis Europharm Limited)

EU/3/08/605 (Active substance: Recombinant human monoclonal antibody to human Nogo-A protein of the IgG4/kappa class) - Transfer of orphan designation - Commission Decision (2018)3035 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/059/08/T/01

Europe -DG Health and Food Safety

15-5-2018

Izba (Novartis Europharm Limited)

Izba (Novartis Europharm Limited)

Izba (Active substance: travoprost) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3002 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2738/T/10

Europe -DG Health and Food Safety

28-3-2018

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Astellas Pharma Europe B.V.)

EU/3/10/803 (Active substance: Chimeric monoclonal antibody against claudin-18 splice variant 2) - Transfer of orphan designation - Commission Decision (2018)2007 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/083/10/T/01

Europe -DG Health and Food Safety