Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe

Österreich - Deutsch - AGES (Agentur für Gesundheit und Ernährungssicherheit)

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Gebrauchsinformation Gebrauchsinformation (PIL)

23-02-2021

Fachinformation Fachinformation (SPC)

23-02-2021

Wirkstoff:
NICOBOXIL; NONIVAMID
Verfügbar ab:
sanofi-aventis GmbH
ATC-Code:
M02AB
INN (Internationale Bezeichnung):
Nicoboxil; nonivamide
Verschreibungstyp:
Arzneimittel zur Abgabe ohne aerztliche Verschreibung
Produktbesonderheiten:
Abgabe durch eine (öffentliche) Apotheke
Zulassungsnummer:
138271
Berechtigungsdatum:
2018-04-17

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Bundesamt für Sicherheit im Gesundheitswesen, Traisengasse 5, A-1200 Wien

www.ages.at, DVR: 2112611, Konto Nr.: 50670 871 619

BLZ: 12000, IBAN: AT971200050670871619; UID: ATU 54088605, BIC/SWIFT: BKAUATWW

1 von 1

Die gegenständliche Arzneispezialität wurde in einem europäischen Zulassungsverfahren

geprüft.

Die Vermarktung des Produktes in Österreich ist derzeit seitens des Zulassungsinhabers nicht

geplant, daher liegen zur Zeit keine deutschsprachigen Übersetzungen der Fach- und

Gebrauchsinformation vor.

Traisengasse 5, 1200 Wien

Bundesamt für Sicherheit im Gesundheitswesen, Traisengasse 5, A-1200 Wien

www.ages.at, DVR: 2112611, Konto Nr.: 50670 871 619

BLZ: 12000, IBAN: AT971200050670871619; UID: ATU 54088605, BIC/SWIFT: BKAUATWW

1 von 1

Die gegenständliche Arzneispezialität wurde in einem europäischen Zulassungsverfahren

geprüft.

Die Vermarktung des Produktes in Österreich ist derzeit seitens des Zulassungsinhabers nicht

geplant, daher liegen zur Zeit keine deutschsprachigen Übersetzungen der Fach- und

Gebrauchsinformation vor.

Traisengasse 5, 1200 Wien

Lesen Sie das vollständige Dokument

CMDh/223/2005

February 2014

Public Assessment Report

Scientific discussion

Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe

NONIVAMIDE, NICOBOXIL

Date:

05.06.2020

This module reflects the scientific discussion for the approval of Nonivamid + Nicoboxil

Sanofi 4 mg/g + 25 mg/g Salbe. The procedure was finalised on 14.03.2018.

information on changes after this date please refer to the module ‘Update’.

INTRODUCTION

Based on the review of the quality, safety and efficacy data, the Member States have granted a

marketing authorisation for Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe, from

sanofi-aventis GmbH.

The product is indicated for:

Stimulation of blood flow in the skin for treating muscle and joint complaints.

Treatment of acute low back pain with no signs of neuropathic origin.

Stimulation of blood flow in the skin before taking a capillary blood sample, e.g. from the

earlobe or the digital pulp.

A comprehensive description of the indications and posology is given in the SmPC.

marketing

authorisation

been

granted

pursuant

Article

10(3)

Directive

2001/83/EC.

Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe contains two vasodilating active

substances, which produce an intensive thermal stimulus on the skin for many hours.

Nonyl vanillylamide (nonivamide) is a synthetic capsaicin-analogue with analgesic properties,

which are assumed to result from depletion of substance P in the peripheral nociceptive C fibres

and A delta-nerve-fibres upon repetitive application on the skin. By stimulating the afferent

nerve endings in the skin, nonylic vanillylamide has a dilatatory effect on the surrounding blood

vessels accompanied by an intense, long-lasting feeling of warmth.

Nicotinic acid is a B vitamin which has vasodilatatory properties mediated by prostaglandin.

The hyperaemic effect of β-butoxyethylester of nicotinic acid (nicoboxil) has an earlier onset

and it is more intense than the nonivamide hyperaemic effect.

Nonylic vanillylamide and β-butoxyethylester of nicotinic acid both have complementary

vasodilatatory properties reducing the time to hyperaemic skin reaction upon application.

This leads to a local increase of the circulation of the skin. By this Nonivamid + Nicoboxil

Sanofi 4 mg/g + 25 mg/g Salbe produces a sustainable feeling of warmth.

Topical administration of the nonivamide/nicoboxil increased the concentration of oxygenated

haemoglobin and tissue oxygen saturation significantly towards arterial levels in skin as well

as the concentration of oxygenated haemoglobin in muscle of the treated legs already after 15

minutes,

with

stronger

faster

effects

skin.

topical

application

nonivamide/nicoboxil increased blood flow in smaller vessels of skin and muscle tissue.

QUALITY ASPECTS

II.1

Introduction

Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g is an ointment, which is presented in an

aluminium tube with 20 g.

II.2

Drug Substance

The active substances in Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe are nonylic

acid vanillylamide (nonivamide) and β-butoxyethylester of nicotinic acid (nicoboxil). The

specification of the active substances meets the current scientific requirements. The adequate

quality of the active substances has been shown by submitting the appropriate control data.

The stability of the active substances has been tested under ICH conditions. The results of the

stability studies support the established retest-period.

II.3

Medicinal Product

Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe contains the following excipients:

1 g ointment contains 2 mg sorbic acid

citronella oil

diisopropyl adipate

silica colloidal anhydrous

paraffin white soft

water purified

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 36 months (can be used for 6 months after

first opening). This medicinal product does not require any special storage conditions.

The pharmaceutical quality of Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe 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.

III.

NON-CLINICAL ASPECTS

Pharmacodynamic, pharmacokinetic and toxicological properties of nonylic acid vanillylamide

(nonivamide) and β-butoxyethylester of nicotinic acid (nicoboxil), are well known. As nonylic

acid vanillylamide (nonivamide) and β-butoxyethylester of nicotinic acid (nicoboxil) are

widely used, well-known active substances, the applicant has not provided additional studies

and further studies are not required.

III.1

Ecotoxicity/environmental risk assessment (ERA)

A final conclusion on potential risk of Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe

to the environment cannot be drawn as the applicant did not provide the required ERA studies

in this procedure. The applicant has proposed to provide a study on ready biodegradability in

accordance with OECD 301 A-F as recommended in the ERA guideline as post-marketing

measure.

CLINICAL ASPECTS

IV.1

Introduction

This is a hybrid product; therefore, new clinical studies are generally neither required nor

submitted.

dossier

contains

adequate

review

published

literature

concerning

aspects

pharmacology,

pharmacodynamics,

efficacy

safety

nonylic

acid

vanillylamide

(nonivamide) and β-butoxyethylester of nicotinic acid (nicoboxil).

IV.2

Pharmacokinetics

nonylic

acid

vanillylamide

(nonivamide)

β-butoxyethylester

nicotinic

acid

(nicoboxil) are widely used, well-known active substances, no further studies are required for

this application and the applicant provides none.

IV.3

Pharmacodynamics

The pharmacodynamics profile of nonylic acid vanillylamide (nonivamide) and β-

butoxyethylester of nicotinic acid (nicoboxil) is well established. No additional

pharmacodynamics study has been submitted by the applicant and none is required.

IV.4

Clinical efficacy/safety

The indications claimed are in accordance with those of the reference product Finalgon - Salbe

(4 mg/25 mg, ointment).

The efficacy of nonylic acid vanillylamide (nonivamide) and β-butoxyethylester of nicotinic

acid (nicoboxil), is established and documented in controlled clinical studies. No new efficacy

or safety data have been submitted and none are required for this hybrid application.

IV.5

Risk Management Plan and Summary of the Pharmacovigilance System Master

File

Risk Management Plan

The MAH has submitted a risk management plan, in accordance with the requirements of

Directive

2001/83/EC

amended,

describing

pharmacovigilance

activities

interventions designed to identify, characterise, prevent or minimise risks relating to Nonivamid

+ Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe.

- Summary table of safety concerns as approved in RMP

Important identified risks

Application site reactions

Important potential risks

None

Missing information

Use in children <18 years of age

Use in pregnant or lactating women

- Summary of Safety Concerns and Planned Risk Minimisation Activities as approved in RMP

Safety Concern

Routine Risk Minimisation

Measures

Additional Risk

Minimisation Measures

Important Identified Risks

Application site reactions

Warnings in sections 4.2, 4.3,

4.4, and 4.9 of the SmPC

Not applicable

Important Potential Risks

None

Missing Information

Use in children <18 years of age

Warnings in section 4.2 of the

SmPC

Not applicable

Use in pregnant or lactating

women

Warnings in section 4.6 of the

SmPC

Not applicable

- If applicable: Table of Ongoing and Planned Additional Pharmacovigilance Studies /

Activities in the Pharmacovigilance Plan as approved in RMP

Summary of the Pharmacovigilance System Master File

The applicant submitted the summary of the pharmacovigilance system in the scope of this

procedure.

The summary includes the following elements:

Proof that the applicant has at his disposal a qualified person responsible for

pharmacovigilance

The Member States in which the qualified person resides and carries out his/her tasks

The contact details of the qualified person

A statement signed by the applicant to the effect that the applicant has the necessary

means to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC

IV.6

Discussion on the clinical aspects

The clinical overview on the clinical pharmacology, efficacy and safety is adequate.

USER CONSULTATION

The package leaflet has been evaluated via a user consultation study in accordance with the

requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. 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.

OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND

RECOMMENDATION

The pharmaceutical quality of Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe has been

adequately shown,

and no new non-clinical or clinical concerns have been identified.

A final conclusion on potential risk of Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe

to the environment cannot be drawn as the applicant did not provide the required ERA studies

in this procedure. The applicant has proposed to provide a study on ready biodegradability in

accordance with OECD 301 A-F as recommended in the ERA guideline as post-marketing

measure.

The benefit/risk relation is considered positive.

Public Assessment Report

Update

Nonivamid + Nicoboxil Sanofi 4 mg/g + 25 mg/g Salbe

NONIVAMIDE, NICOBOXIL

This module reflects the procedural steps and scientific information after the finalisation

of the initial procedure.

Procedure

number

Scope

Product Information

affected

Date of end of

procedure

Approval/

non approval

Summary/ Justification for refuse

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