Skinoren

Hauptinformation

  • Handelsname:
  • Skinoren 15% - Gel
  • Einheiten im Paket:
  • 5 g (Tube), Laufzeit: 36 Monate,30 g (Tube), Laufzeit: 36 Monate,50 g (Tube), Laufzeit: 36 Monate,2 x 50 g (Tube), Laufzeit: 36
  • Verschreibungstyp:
  • Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Skinoren 15% - Gel
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiebereich:
  • Azelainsäure
  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 1-24583
  • Berechtigungsdatum:
  • 03-07-2002
  • Letzte Änderung:
  • 08-03-2018

Öffentlichen Beurteilungsberichts

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

1/11

Public Assessment Report

Scientific discussion

Skinoren 15% Gel

Azelaic acid

AT/H/0124/001/MR

This module reflects the scientific discussion for the approval of Skinoren. The procedure was

finalised on 15-11-2002. For information on changes after this date please refer to the module

‘Update’.

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

2/11

I.

INTRODUCTION

Skinoren 15% Gel is a new pharmaceutical form of the trade mark Skinoren, containing 15 % of the

active ingredient azelaic acid in micronized form in a hydrogel base for the treatment of acne vulgaris.

The second indication, i.e. topical treatment of papolopustular rosacea, was approved in the variation

AT/H/124/01/W04.

Azelaic acid is also the active ingredient of Skinoren Cream, which contains 20 % azelaic acid.

Skinoren Gel has been developed especially to meet the needs in acne patients with greasy skin and

contains a moisturizer complex of lecithin, medium chain triglycerides and Polysorbate 80.

Skinoren Gel is the subject of a Mutual Recognition Procedure with Austria as RMS.

Skinoren Cream has been authorized in national procedures both in the RMS and in all CMS.

Therefore the active ingredient azelaic acid is not a new active substance in any CMS.

Azelainsäure “Schering” Gel is a Co-Marketing of Skinoren Gel. Whenever the term “Skinoren Gel”

is used, the same text can also be applied to Azelainsäure “Schering” Gel.

II.

QUALITY ASPECTS

II.1

Introduction

Skinoren 15% Gel is a gel, which is presented in an aluminium tube with internal epoxide coating and

polyethylene screw cap.

II.2

Drug Substance

The active substance in Skinoren is azelaic acid. The specification of the active substance meets the

current scientific requirements. The adequate quality of the active substance has been shown by

submitting the appropriate control data. The stability of the active substance has been tested under ICH

conditions. The results of the stability studies support the established retest-period.

II.3

Medicinal Product

Skinoren contains the following excipients:

1 mg benzoic acid /g Gel, 0.12 g propylene glycol /g Gel, lecithin, triglycerides (medium chain),

polysorbate 80, carbomer 980, sodium hydroxide, disodium edetate and purified water.

The manufacturer responsible for batch release is Intendis Manufacturing S.p.A., Via E. Schering 21,

20090 Segrate, Italy.

The development of the product has been sufficiently made and deemed appropriate. The usage of all

the excipients has been described.

The release specification includes the check of all parameters relevant to this pharmaceutical form.

Appropriate data concerning the control of the finished product support the compliance with the

release specifications.

The packaging of the medicinal product complies with the current legal requirements.

Stability studies under ICH conditions have been performed and data presented support the shelf life

claimed in the SmPC, with a shelf life of 3 years without special storage conditions.

The pharmaceutical quality of Skinoren has been adequately shown.

II.4

Discussion on chemical, pharmaceutical and biological aspects

Information on development, manufacture and control of active substance and medicinal product has

been presented in a satisfactory manner. The results of tests carried out indicate satisfactory

consistency and uniformity of important product quality characteristics.

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

3/11

III.

NON-CLINICAL ASPECTS

III.1

Introduction

Azelaic acid (AzA) is a saturated, straight-chained, nine carbon atom dicarboxylic acid. AzA has been

found as a constituent in animals, humans and plants.

The pharmacological and toxicological documentation for Skinoren Gel is an update of the

documentation, which has been created for the authorization of Skinoren Cream about 15 to 20 years

ago. The documentation is supplemented by several pharmacokinetic and toxicological studies, which

had not yet been included in the Skinoren Cream dossiers.

III.2

Pharmacology

Pharmacodynamic studies with azelaic acid (AzA) have shown that AzA exerts its therapeutic efficacy

in acne both by an antimicrobial effect on acne-relevant microorganisms and by a strong comedolytic

effect.

Even extremely high doses of AzA (up to 1000 mg/kg intravenously) did not give evidence of any risk

with respect to safety pharmacology when AzA is applied topically in the treatment of acne.

No interaction studies of AzA with systemically administered drugs have been performed.

III.3

Pharmacokinetics

The only experiment which has been performed with AzA containing hydrogels was a test on an in

vitro skin penetration, using hairless mouse skin. AzA containing hydrogels delivered a higher dose

fraction into the viable skin layers than Skinoren cream. Since the number of experiments was low (n

= 3 - 6) and since the variation between the single experiments was high, these differences should not

be overestimated.

The main results from pharmacokinetic studies which had been performed previously with

systemically applied AzA were as follows:

AzA is almost completely absorbed after intragastric application.

AzA is metabolically degraded by ß- oxidation in the mitochondria, leading to dicarboxylic

acids which are by C2 - units shorter (pimelic acid and glutaric acid).

Both AzA and its metabolites are rapidly excreted with the urine.

III.4

Toxicology

Single dose studies with systemic AzA have shown that the acute toxicity of AzA is very low.

Repeated dose studies with AzA after systemic administration have resulted in a NOEL of about 500

mg/kg. Dermally applied AzA (as Skinoren Cream 20 %) over 6 months in rats and dogs did not show

any local or systemic toxicity.

Reproduction toxicology studies with AzA in rats, rabbits and cynomolgus monkeys have shown some

embryotoxic effects at maternotoxic doses (500 mg/kg and above), but no teratogenic effects have

been observed.

Mutagenicity studies in vitro (Ames test, Chinese hamster V79 cells, human lymphocytes) and in vivo

(dominant lethal test) did not give evidence of any mutagenic potential for AzA.

No life-time carcinogenicity tests have been performed with AzA.

With the present hydrogel formulation, the applicant has performed two local tolerance studies in

rabbits after both single and repeated dose administrations. In the repeated dose tolerance study the gel

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

4/11

and the gel base were compared to the approved cream formulation, and it has been found that the gel

and the gel base formulations were slightly more irritant than the cream formulation. This may be

explained with the dehydrating effect of the gel on the rabbit skin; on the other hand the dehydrating

effect of the gel can be regarded as an advantage in patients with a greasy skin.

AzA has an eye irritating potential.

No sensitising potential has been found for AzA in the maximization test in guinea - pigs.

Phototoxicity and photogenicity of AzA have not been tested in animals.

The excipients carbomer (Carbopol 980), capryl/capric triglyceride (Miglyol 812) , EDTA,

phosphatidylcholine (Lipoid 100), polysorbate 80, propylene glycol, sodium hydroxide and benzoic

acid are frequently used both in pharmaceutics and in cosmetics and can be regarded as safe in the

concentrations which are used in the present medicinal product.

III.5

Ecotoxicity/environmental risk assessment

III.6

Discussion on the non-clinical aspects

No investigations on the systemic toxicity have been performed with the claimed hydrogel

formulation. The applicant is arguing that the systemic resorption of topically applied AzA is low and

that very high systemic doses of AzA are necessary in order to induce toxic effects. The assessor can

follow the arguments of the applicant.

IV.

CLINICAL ASPECTS

IV.1

Introduction

Skinoren Gel has been developed especially to meet the needs in acne patients with greasy skin and

contains a moisturizer complex of lecithin, medium chain triglycerides and Polysorbate 80.

IV.2

Pharmacokinetics

In a clinical study in acne patients receiving either the claimed 15 % gel formulation or 20 % Skinoren

Cream, there was no difference in the urinary excretion of azelaic acid between the two formulations.

After topical administration of AzA (applied as Skinoren Cream), the systemic exposure is low; the

percutaneous absorption of AzA is about 3.6 % of the topically applied dose.

IV.3

Pharmacodynamics

The applicant has submitted a series of publications dealing with the mode of action of AzA.

In summary, the special pharmacodynamic effects of AzA in acne are considered to be based

on a normalisation of the disturbed infundibular keratinisation by modulation of terminal

differentiation processes, on a bacteriostatic effect on Propionibacterium acnes and on a direct effect

on inflammatory processes in acne. No effect on the sebaceous glands has been found.

These results are well in accordance with the results from experimental studies presented in Part III of

the dossier.

The gel concentration of 15 % was selected for galenical reasons: A gel concentration of 20 % (in

analogy to the authorized Skinoren 20 % cream) is galenically unstable.

In healthy volunteers the local tolerability of an azelaic acid containing gel formulation which is

similar to the claimed composition has been proven to be more irritant in the scarified skin than the

authorized Skinoren Cream preparation, but less irritant than a benzoyl peroxide hydrogel 5 %

preparation; the vehicle itself was not locally irritant.

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

5/11

In healthy volunteers the claimed gel formulation had no phototoxic potential and at least no

pronounced photosensitising potential.

IV.4

Clinical efficacy

The applicant has performed two phase II/III clinical studies with Skinoren Gel as multicenter, double-

blind, randomised, parallel-group comparisons controlled by the AzA-free vehicle (“Placebo“, 129

patients) and 5 % benzoyl peroxide hydrogel (366 patients), respectively. Moreover the applicant has

performed a phase II study as an exploratory single center double blind, randomised, controlled

parallel group comparison between Skinoren Gel and Skinoren Cream in small groups of 15 patients

each.

With respect to the primary efficacy parameter (median reduction in facial inflammatory papules and

pustules), in the vehicle-controlled study the overall mean reduction in the Skinoren Gel group was

67.0% (95 % C.I. 63.6-71.9 %), while in the vehicle group it was 50.0 % (27.3 – 73.7 %) (p< 0.01). In

the active control study the mean reduction in facial inflammatory papules and pustules was 76.0 %

(70.0 – 82.1 %) in the Skinoren Gel group and 82.0% (76.5 – 85.7 %) in the benzoyl peroxide group

(indicating clinical equivalence). No statistical tests were performed for the comparison between

Skinoren Gel and Skinoren Cream, however no noticeable differences have been found between the

two treatment groups.

Secondary parameters (Comedone reduction, sum of facial lesions, overall improvement) showed a

trend which was similar to the primary efficacy parameter: Skinoren Gel was superior to the vehicle

and comparable or slightly inferior to benzoyl peroxide.

The applicant has made an integrated summary of historical clinical studies performed with Skinoren

Cream in comparison to the data gathered for Skinoren Gel. Both Skinoren preparations have been

shown to be of comparable efficacy in the range of about 60 to 70 per cent reduction in papules and

pustules.

IV.5

Clinical safety

Overall, 84 patients (31.2 %) of the 269 patients considered in the safety evaluation encountered one

or several cutaneous adverse events during treatment with Skinoren Gel: Subjective sensory adverse

symptoms such as burning and itching prevailed while the symptoms of an irritant dermatitis (skin

dryness, erythema and scaling) were noted less frequently. Except for one patient with severe pruritus,

the intensity of local adverse events was rated as mild or moderate in the Skinoren Gel treatment

groups. Only five patients (1.9 % of all patients) prematurely discontinued Skinoren Gel therapy due

to cutaneous adverse events. The incidence rate of cutaneous adverse events due to Skinoren Gel was

only slightly higher than to the vehicle control (20.5 versus 17.6 %) and at least not higher than in

previous studies performed with Skinoren Cream. On the other hand, the incidence rates of primary

irritant local adverse events were clearly higher for benzoyl peroxide than for Skinoren Gel. There

were no systemic adverse events causally related to the topical administration of Skinoren Gel.

IV.6

Discussion on the clinical aspects

Skinoren Gel (active substance: 15 % azelaic acid) is a new formulation (gel) of the established and

rather untoxic active substance azelaic acid which is authorized as Skinoren Cream (20% formulation)

for the topical treatment of acne for more than 10 years. Skinoren Gel has been proven to be more

effective than the vehicle control. Skinoren Gel is as effective as Skinoren Cream and comparable to

the efficacy of the established anti-acne agent 5 % benzoyl peroxide. The local tolerability of Skinoren

Gel is comparable to that of Skinoren Cream, while it is better tolerated than benzoyl peroxide. No

systemic adverse events have been reported.

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

6/11

V.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

The pharmaceutical quality of Skinoren has been adequately shown.

Skinoren Gel can be regarded as another medicinal product for the local treatment of mild to moderate

acne vulgaris with a positive benefit/risk ratio. The efficacy of Skinoren 15 % Gel in the indication

“For the topical treatment of papulopustular rosacea“ was demonstrated adequately in two vehicle-

controlled studies and in one active comparator (metronidazole 0.75 % gel) controlled study (variation

AT/H/124/01/W04).

The safety of Skinoren 15 % Gel is acceptable; there are predominantly cutaneous adverse events.

Mutual recognition of the authorization of Skinoren Gel / Azelainsäure “Schering” Gel is

recommended.

User consultation

package

leaflet

been

evaluated

user

consultation

study

accordance

with

requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC (variation AT/H/0124/001/II/023

The language used for the purpose of user testing the PIL was German.

The results show that the package leaflet meets the criteria for readability as set out in the Guideline

on the readability of the label and package leaflet of medicinal products for human use.

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

7/11

This module reflects the procedural steps and scientific information after the finalisation of the initial procedure.

Scope

Procedure number

Product information

affected

Y/N

Date of start of

procedure

Date of end

of procedure

Approval/

non approval

Assessment report

attached

Y/N (version)

Change in the qualitative

composition of immediate

packaging material

AT/H/0124/001/V001

14.03.2003

15.04.2003

Approved

Change in test procedure

for a starting material or

intermediate used in the

manufacture of the active

substance

AT/H/0124/001/V002

09.04.2003

29.04.2003

Approved

Change in test procedure

of active substance

AT/H/0124/001/V003

09.04.2003

29.04.2003

Approved

Change in quality

specification

AT/H/0124/001/V005

22.07.2003

11.08.2003

Approved

New indication "for the

topical treatment of

papulopustular rosacea"

AT/H/0124/001/W004

12.05.2003

18.11.2003

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/006

20.11.2003

10.12.2003

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/007

20.11.2003

10.12.2003

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/008

20.11.2003

10.12.2003

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/009

20.11.2003

10.12.2003

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/010

20.11.2003

10.12.2003

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/011

20.11.2003

10.12.2003

Approved

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

8/11

Scope

Procedure number

Product information

affected

Y/N

Date of start of

procedure

Date of end

of procedure

Approval/

non approval

Assessment report

attached

Y/N (version)

Change in the name of

the medicinal product

AT/H/0124/001/IB/012

20.11.2003

10.12.2003

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/013

20.11.2003

10.12.2003

Approved

Change in batch size of

active substance or

intermediate: Up to 10-

fold compared to the

original batch size

approved at the grant of

the marketing

authorisation

AT/H/0124/001/IA/014

21.04.2004

05.05.2004

Positive

Change in test procedure

of the finished product:

Minor change to an

approved test procedure

AT/H/0124/001/IA/016

21.04.2004

05.05.2004

Positive

Change in test procedure

of the finished product:

Minor change to an

approved test procedure

AT/H/0124/001/IA/017

21.04.2004

05.05.2004

Positive

Minor change in the

manufacturing process of

the active substance

AT/H/0124/001/IB/015

21.04.2004

21.05.2004

Approved

Change in the name

and/or address of the

marketing authorisation

holder

AT/H/0124/001/IA/018

29.12.2004

12.01.2005

Positive

Change in the name

and/or address of a

manufacturer of the

finished product

AT/H/0124/001/IA/019

13.05.2005

27.05.2005

Positive

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

9/11

Scope

Procedure number

Product information

affected

Y/N

Date of start of

procedure

Date of end

of procedure

Approval/

non approval

Assessment report

attached

Y/N (version)

Change in test procedure

for active substance or

starting material, inter-

mediate, or reagent used

in the manufacturing

process of the active

substance: Other

changes to a test

procedure, including

replacement or addition

of a test procedure

AT/H/0124/001/IB/020

08.07.2005

28.07.2005

Approved

Minor change in the

manufacture of the

finished product

AT/H/0124/001/IB/022

15.12.2006

14.01.2007

Approved

Change in the name of

the medicinal product

AT/H/0124/001/IB/024

20.04.2007

20.05.2007

Approved

Update Modul 3

AT/H/0124/001/II/021

22.12.2006

06.06.2007

Approved

Update SPC, PL and Lab.

AT/H/0124/001/II/023

22.12.2006

06.02.2008

Approved

Change in the name

and/or address of the

marketing authorisation

holder

AT/H/0124/001/IA/025

02.10.2008

16.10.2008

Positive

Renewal

AT/H/0124/001/R/001

20.06.2008

28.01.2009

Approved

Change in the name

and/or address of a

manufacturer of the

active substance where

no Ph.Eur.Certificate of

Suitability is available

AT/H/0124/001/IA/027

12.05.2009

26.05.2009

Positive

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

10/11

Scope

Procedure number

Product information

affected

Y/N

Date of start of

procedure

Date of end

of procedure

Approval/

non approval

Assessment report

attached

Y/N (version)

Change in the name

and/or address of the

marketing authorisation

holder

AT/H/0124/001/IA/028

12.05.2009

26.05.2009

Positive

Change in the name

and/or address of the

marketing authorisation

holder

AT/H/0124/001/IA/029

12.05.2009

26.05.2009

Positive

Change to a test

procedure of the

immediate packaging of

the finished product:

Minor change to an

approved test procedure

AT/H/0124/001/IA/030

12.05.2009

26.05.2009

Positive

Change in the

specification of the

finished product:

Tightening of

specification limits

AT/H/0124/001/IA/031

12.05.2009

26.05.2009

Positive

Change in the name of

the medicinal product

AT/H/0124/001/IB/026

19.05.2009

08.06.2009

Approved

Change in pack size of

the finished product:

Change in the fill-

weight/fill volume of non-

parenteral multi-dose

products

AT/H/0124/001/IB/032

03.09.2009

23.09.2009

Approved

Change in the name

and/or address of the

marketing authorisation

holder

AT/H/0124/001/IA/033

06.10.2009

20.10.2009

Positive

Bundesamt für Sicherheit im Gesundheitswesen

Schnirchgasse 9 l A-1030 Wien l www.basg.at l www.ages.at

DVR: 2112611 l Konto Nr.: 50670 871 619 l BLZ: 12000 l IBAN: AT97 1200 0506 7087 1619 l BIC/SWIFT: BKAUATWW

11/11

Scope

Procedure number

Product information

affected

Y/N

Date of start of

procedure

Date of end

of procedure

Approval/

non approval

Assessment report

attached

Y/N (version)

Variation related to

significant modifications

of the Summary of

Product Characteristics

due in particular to new

quality, pre-clinical,

clinical or pharmaco-

vigilance data

AT/H/0124/001/II/034

14.06.2010

27.10.2010

Approved

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

944524_F_GI_16-09-14_Skinoren GelCCDS

Gebrauchsinformation: Information für Anwender

Skinoren

®

15 % Gel

Azelainsäure

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Anwendung dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals

lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter.

Es kann anderen Menschen schaden, auch wenn diese die gleichen Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt

auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Siehe

Abschnitt 4.

Was in dieser Packungsbeilage steht

Was ist Skinoren Gel und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von Skinoren Gel beachten?

Wie ist Skinoren Gel anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist Skinoren Gel aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

Was ist Skinoren Gel und wofür wird es angewendet?

Skinoren Gel enthält den Wirkstoff Azelainsäure und gehört zur Gruppe der Aknemittel, die zur

äußeren Anwendung (zum Auftragen auf die Haut) bestimmt sind.

Skinoren Gel wird zur Linderung von leichter bis mittelschwerer, papulopustulöser Akne des

Gesichtes sowie zur Behandlung der papulopustulösen Rosazea angewendet. Papulopustulöse Akne

und Rosazea zeichnen sich aus durch Papeln (=entzündliche knötchenartige Erhebungen) und Pusteln

(=eitrige Bläschen).

2.

Was sollten Sie vor der Anwendung von Skinoren Gel beachten?

Skinoren Gel darf nicht angewendet werden,

wenn Sie allergisch gegen Azelainsäure oder einen der in Abschnitt 6 genannten sonstigen

Bestandteile dieses Arzneimittels sind.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Skinoren Gel anwenden.

Skinoren Gel ist ausschließlich zur äußeren Anwendung (zum Auftragen auf die Haut) bestimmt.

Vermeiden Sie Kontakt mit Augen, Mund und anderen Schleimhäuten. Bei versehentlichem Kontakt

spülen Sie Augen, Mund und/oder betroffene Schleimhäute mit reichlich Wasser. Sollte eine

Augenreizung andauern, suchen Sie bitte einen Arzt auf.

Waschen Sie bitte nach jeder Anwendung von Skinoren Gel Ihre Hände.

Es wird empfohlen, während der Anwendung von Skinoren Gel zur Behandlung von Rosazea auf

alkoholische Reinigungsmittel, Tinkturen und Adstringentien, abrasive Mittel und Peelings zu

verzichten.

944524_F_GI_16-09-14_Skinoren GelCCDS

Bei einigen Patienten mit Asthma, die mit Azelainsäure behandelt wurden, wurde in seltenen Fällen

eine Verschlechterung der Asthma-Symptome beobachtet.

Kinder und Jugendliche

Die Sicherheit und Wirksamkeit der Behandlung von Akne bei Jugendlichen von 12-18 Jahren wurde

untersucht (siehe Abschnitt 3. “Wie ist Skinoren Gel anzuwenden?“). Die Behandlung von Akne mit

Skinoren Gel bei Kindern unter 12 Jahren wird nicht empfohlen aufgrund fehlender Daten zur

Sicherheit und Wirksamkeit.

Die Behandlung von Rosazea mit Skinoren Gel bei Kindern und Jugendlichen unter 18 Jahren wird

nicht empfohlen aufgrund fehlender Daten zur Sicherheit und Wirksamkeit.

Anwendung von Skinoren Gel mit anderen Arzneimitteln

Es liegen keine Studien zu Wechselwirkungen von Skinoren Gel mit anderen Arzneimitteln vor.

Verwenden Sie während der Anwendung von Skinoren Gel für Ihr Gesicht keine anderen

Arzneimittel; sonstige Gesichtsbehandlungen sollten ebenfalls nicht vorgenommen werden.

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen/anwenden,

kürzlich andere Arzneimittel eingenommen/angewendet haben oder beabsichtigen, andere

Arzneimittel einzunehmen/anzuwenden.

Schwangerschaft und Stillzeit

Zur Anwendung von Azelainsäure während der Schwangerschaft liegen keine ausreichenden

Erfahrungen vor. Wenn Sie schwanger sind oder stillen, wird Ihr Arzt entscheiden, ob Sie Skinoren

Gel anwenden können.

Säuglinge sollten nicht mit der behandelten Haut oder Brust in Kontakt kommen.

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein oder beabsichtigen,

schwanger zu werden, fragen Sie vor der Anwendung dieses Arzneimittels Ihren Arzt oder Apotheker

um Rat.

Verkehrstüchtigkeit und das Bedienen von Maschinen

Skinoren Gel hat keinen Einfluss auf die Verkehrstüchtigkeit und das Bedienen von Maschinen.

Skinoren Gel enthält Benzoesäure und Propylenglycol.

Benzoesäure kann leichte Reizungen an Haut, Augen und Schleimhäuten hervorrufen.

Propylenglycol kann Hautreizungen hervorrufen.

3.

Wie ist Skinoren Gel anzuwenden?

Wenden Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt oder Apotheker an.

Fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht sicher sind.

Skinoren Gel ist ausschließlich zur äußeren Anwendung (zum Auftragen auf die Haut) bestimmt.

Art der Anwendung

Reinigen Sie vor dem Auftragen von Skinoren Gel Ihre Haut sorgfältig mit Wasser und

trocknen Sie sie ab. Sie können ein mildes Hautreinigungsmittel verwenden.

Verwenden Sie keine luft- und wasserundurchlässigen Verbände oder Abdeckungen

(Okklusivverbände), und waschen Sie nach dem Auftragen des Gels Ihre Hände.

944524_F_GI_16-09-14_Skinoren GelCCDS

Übliche Dosierung und Häufigkeit der Anwendung

Tragen Sie Skinoren Gel zweimal täglich (morgens und abends) auf die befallenen Hautstellen auf und

reiben Sie das Gel vorsichtig in die Haut ein. Etwa 2,5 cm Gel entsprechen 0,5 g und reichen für die

gesamte Gesichtsfläche aus.

Um eine optimale Wirkung zu erzielen, ist es wichtig, dass Skinoren Gel ohne Unterbrechung

angewendet wird.

Bei Hautreizungen (siehe Abschnitt 4. Welche Nebenwirkungen sind möglich?) ist die Menge von

Skinoren Gel pro Anwendung zu verringern oder die Häufigkeit der Anwendung auf einmal täglich zu

beschränken, bis die Hautreizung abgeklungen ist. Falls erforderlich, ist die Behandlung für einige

Tage auszusetzen.

Anwendung bei Kindern und Jugendlichen

Eine Anpassung der Dosis ist nicht erforderlich für die Behandlung von Akne mit Skinoren Gel bei

Jugendlichen im Alter von 12-18 Jahren.

Dauer der Behandlung

Die Anwendungsdauer von Skinoren Gel kann individuell unterschiedlich sein und hängt auch vom

Schweregrad der Hauterkrankung ab.

Ihr Arzt wird Ihnen erklären, wie lange Sie Skinoren Gel anwenden sollen.

Akne

Je nach Behandlungsergebnis kann Skinoren Gel über mehrere Monate angewendet werden. Eine

deutliche Verbesserung wird für gewöhnlich nach 4 Wochen beobachtet.

Sollte nach einem Monat noch keine Besserung eingetreten sein oder sich Ihre Akne verschlechtert

haben, unterbrechen Sie die Anwendung von Skinoren Gel und suchen Sie Ihren Arzt auf.

Rosazea

Je nach Behandlungsergebnis kann Skinoren Gel über mehrere Monate angewendet werden. Eine

deutliche Verbesserung kann nach 4 Wochen beobachtet werden.

Sollte nach zwei Monaten noch keine Besserung eingetreten sein oder sich die Rosazea verschlechtert

haben, unterbrechen Sie die Anwendung von Skinoren Gel und suchen Sie Ihren Arzt auf.

Wenn Sie eine größere Menge von Skinoren Gel angewendet haben, als Sie sollten

Selbst wenn Sie versehentlich eine größere Menge von Skinoren Gel angewendet haben, ist eine

schädliche Wirkung (Vergiftung) unwahrscheinlich.

Bitte setzen Sie die Anwendung wie beschrieben fort und fragen Sie bei Ihrem Arzt nach, wenn Sie

sich nicht ganz sicher sind.

Wenn Sie die Anwendung von Skinoren Gel vergessen haben

Tragen Sie nicht die doppelte Menge auf, wenn Sie die vorherige Anwendung vergessen haben,

sondern setzen Sie die Behandlung wie von Ihrem Arzt vorgeschrieben fort.

Wenn Sie die Anwendung von Skinoren Gel abbrechen

Wenn Sie die Anwendung von Skinoren Gel vorzeitig beenden, kann sich Ihre Hautkrankheit

verschlechtern. Sprechen Sie bitte mit Ihrem Arzt, ehe Sie die Behandlung mit Skinoren Gel

abbrechen.

Wenn Sie weitere Fragen zur Anwendung von Skinoren Gel haben, fragen Sie Ihren Arzt oder

Apotheker.

944524_F_GI_16-09-14_Skinoren GelCCDS

4.

Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei jedem

auftreten müssen.

Es können Hautreizungen (zum Beispiel Brennen und Juckreiz) auftreten. In den meisten Fällen sind

diese Beschwerden leicht oder mittelschwer, wobei die Häufigkeit im Verlauf der Behandlung

abnimmt.

Die am häufigsten beobachteten Nebenwirkungen beinhalten Juckreiz (Pruritus), Brennen und

Schmerzen am Verabreichungsort.

Die folgenden Nebenwirkungen können während der Behandlung mit Skinoren Gel auftreten. Sie

betreffen ausschließlich die Haut am Verabreichungsort.

Akne

Sehr häufig (kann mehr als 1 von 10 Anwendern betreffen): Brennen, Schmerzen, Juckreiz

(Pruritus) am Verabreichungsort

Häufig (kann bis zu 1 von 10 Anwendern betreffen): Ausschlag, Kribbeln oder Taubheitsgefühl

(Parästhesie), Hauttrockenheit am Verabreichungsort

Gelegentlich (kann bis zu 1 von 100 Anwendern betreffen): Entzündliche Hautreaktionen auf

bestimmte Substanzen (Kontaktdermatitis), Hautrötung (Erythem); Abschilferung der Haut,

Wärmegefühl, Veränderung der Hauttönung am Verabreichungsort

Selten

(kann bis zu 1 von 1.000 Anwendern betreffen): Überempfindlichkeit, die zusammen mit

einer oder mehreren der folgenden Nebenwirkungen auftreten können: Angioödem (rasches

Anschwellen der Haut, v.a. im Gesicht), Schwellungen der Augen, Dyspnoe (Atemnot),

Hautreizungen, Urtikaria (Nesselsucht), Verschlechterung von Asthma.

Diese Nebenwirkungen wurden von Patienten, die Azelainsäure verwenden, seit Markteinführung berichtet.

Rosazea

Sehr häufig (kann mehr als 1 von 10 Anwendern betreffen): Brennen, Schmerzen, Juckreiz

(Pruritus) am Verabreichungsort

Häufig (kann bis zu 1 von 10 Anwendern betreffen): Kribbeln oder Taubheitsgefühl (Parästhesie),

Hauttrockenheit, Ausschlag, Schwellung (Ödem) am Verabreichungsort

Gelegentlich (kann bis zu 1 von 100 Anwendern betreffen): Akne, entzündliche Hautreaktionen auf

bestimmte Substanzen (Kontaktdermatitis), Hautrötung (Erythem); Hautausschlag (Nesselsucht),

Beschwerden am Verabreichungsort

Selten

(kann bis zu 1 von 1.000 Anwendern betreffen)

Überempfindlichkeit, die zusammen mit

einer oder mehreren der folgenden Nebenwirkungen auftreten können: Angioödem (rasches

Anschwellen der Haut, v.a. im Gesicht), Schwellungen der Augen, Dyspnoe (Atemnot),

Hautreizungen, Urtikaria (Nesselsucht), Verschlechterung von Asthma.

Diese Nebenwirkungen wurden von Patienten, die Azelainsäure verwenden, seit der Markteinführung berichtet.

Im Allgemeinen bilden sich lokale Hautreizungen im Laufe der Anwendung zurück.

Kinder und Jugendliche

Behandlung von Akne (Acne vulgaris) bei Jugendlichen im Alter von 12-18 Jahren:

In klinischen Studien, an denen auch Jugendliche teilnahmen, war die Häufigkeit der Nebenwirkungen

nach Anwendung von Skinoren Gel ähnlich wie die aller teilnehmenden Patienten.

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt auch

für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind.

944524_F_GI_16-09-14_Skinoren GelCCDS

Sie können Nebenwirkungen auch direkt anzeigen (siehe folgende Details). Indem Sie

Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen über die Sicherheit

dieses Arzneimittels zur Verfügung gestellt werden.

Deutschland

Bundesinstitut für Arzneimittel und Medizinprodukte

Abt. Pharmakovigilanz

Kurt-Georg-Kiesinger Allee 3

D-53175 Bonn

Website:

http://www.bfarm.de

Österreich

Bundesamt für Sicherheit im Gesundheitswesen

Traisengasse 5

1200 WIEN

ÖSTERREICH

Fax: + 43 (0) 50 555 36207

Website: http://www.basg.gv.at/

5.

Wie ist Skinoren Gel aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf dem Umkarton und der Tube angegebenen Verfalldatum

nicht mehr anwenden. Das Verfalldatum bezieht sich auf den letzten Tag des angegebenen Monats.

Für Skinoren Gel sind keine besonderen Lagerungsbedingungen erforderlich.

Entsorgen Sie Arzneimittel nicht im Abwasser oder Haushaltsabfall. Fragen Sie Ihren Apotheker, wie

das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr verwenden. Sie tragen damit zum Schutz der

Umwelt bei.

6.

Inhalt der Packung und weitere Informationen

Was Skinoren Gel enthält

Der Wirkstoff ist Azelainsäure (1 Gramm Skinoren Gel enthält 150 mg Azelainsäure)

Die sonstigen Bestandteile sind: Benzoesäure (E 210), Carbomer, Dinatriumedetat, Lecithin,

Polysorbat 80, Propylenglycol, gereinigtes Wasser, Natriumhydroxid und mittelkettige

Triglyceride.

Wie Skinoren Gel aussieht und Inhalt der Packung

Skinoren Gel ist ein weißes bis gelblich-weißes undurchsichtiges Gel.

Skinoren Gel ist in Tuben zu 5, 30, 50 und 100 g (2 x 50 g) Gel erhältlich.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer

Deutschland:

Österreich:

Jenapharm GmbH & Co. KG

Bayer Austria Ges.m.b.H.

Otto-Schott-Straße 15

1160 Wien

07745 Jena

Tel.: 03641 648888

Fax: 03641 648889

E-Mail: hautgesundheit@jenapharm.de

944524_F_GI_16-09-14_Skinoren GelCCDS

Hersteller

Bayer HealthCare Manufacturing S.r.l.

Via E. Schering 21

20090 Segrate (Mailand)

Italien

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR)

unter den folgenden Bezeichnungen zugelassen:

Finacea: Vereinigtes Königreich, Dänemark, Schweden, Norwegen, Island, Italien, Spanien,

Frankreich

Skinoren: Deutschland, Finnland, Irland, Österreich, Griechenland, Portugal

Diese Packungsbeilage wurde zuletzt überarbeitet im September 2016.

Deutschland:

Zul.-Nr. 15302.00.01

Österreich:

Z.Nr.: 1-24583

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. 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 endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

FDA issues a qualified health claim for oleic acid oils based on data showing it reduces cholesterols levels.

FDA - U.S. Food and Drug Administration

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

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

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

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

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

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

15-10-2018

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Dollar Novelty (Karapelle Inc) recalls Barrel-O-Slime Toy

Health Canada's sampling and evaluation program has determined the Barrel-O-Slime toy does not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

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

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Kangaroo Manufacturing Inc. recalls Kangaroo's Super Cool Slime

Health Canada's sampling and evaluation program has determined the Super Cool Slime products donot meet the Canadian toy safety requirements related to boric acid content.

Health Canada

14-8-2018

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Genius Premium Craft Boxes recalls Do-It-Yourself Slime Kits

Health Canada’s sampling and evaluation program has determined the Do-It-Yourself Slime Kits do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

18-7-2018

Sodium glucose co-transporter 2 inhibitors

Sodium glucose co-transporter 2 inhibitors

Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

21-11-2018

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Pharma Gateway AB)

EU/3/18/2081 (Active substance: 3-(3-(3,5-dimethyl-1H-pyrazol-4-yl)propoxy)-4-fluorobenzoic acid) - Orphan designation - Commission Decision (2018)7790 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/096/18

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

24-10-2018

Otobacid® N Ohrentropfen

Rote - Liste

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

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)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

7-9-2018

Klacid® Filmtabletten

Rote - Liste

7-9-2018

Klacid Saft® Forte 250 mg/5 ml

Rote - Liste

7-9-2018

Klacid Saft®

Rote - Liste

7-9-2018

Klacid® Uno, 500 mg Retardtablette

Rote - Liste

7-9-2018

Klacid® Pro, 250 mg Filmtabletten

Rote - Liste

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety