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Biocidal product factsheet - Last updated: 18/07/2019

Biocidal Product details

Trade name:

BRODITEC GEL-50

BRODITOP GEL

DEVILTOP GEL

MASSORRAT SOFT

MS Rodetox Brodi Active Gel

PROTEMAX GEL BF50

RODETOX BRODI CREAM

RODIBROD GEL HC

ROMAX Venom Paste

Product-type:

PT14

Active Substance details

Substance name:

IUPAC name:

3-[3-(4'-bromobiphenyl- 4-yl)-1,2,3,4-tetrahydro -1-napthyl]-4-hydroxycoumarin

EC number:

259-980-5

CAS number:

56073-10-0

BAS number:

11

The Active Substance is a candidate for substitution

Authorised
Authorisation information

Authorisation type:

National authorisation

Legal act:

8 authorisations in the product cluster
Authorisation number SPC Decisions

BRODITOP GEL

MS Rodetox Brodi Active Gel

ROMAX Venom Paste

PT14

United Kingdom

ZAPI S.p.A. UK-0004941-0000 UK-2016-1041 18/11/2016 18/11/2020

Single SPC  (en)

Authorised

BRODITEC GEL-50

BRODITOP GEL

DEVILTOP GEL

PT14

France

ZAPI S.p.A. FR-0017482-0000 FR-2018-0004 18/11/2016 18/11/2020

Single SPC  (fr)

BRODITOPGE_BC-DE032320-73_NA-MRS_D2.pdf (fr) (19/04/2018)

BRODITOPGE_BC-DE032320-73_NA-MRS_D.pdf (fr) (09/03/2018)

Authorised

BRODITEC GEL-50

BRODITOP GEL

DEVILTOP GEL

MS Rodetox Brodi Active Gel

RODETOX BRODI CREAM

PT14

Germany

ZAPI S.p.A. DE-0005121-0000 DE-0005121-14 14/12/2016 18/11/2020

Single SPC  (de)

Authorised

BRODITEC GEL-50

BRODITOP GEL

DEVILTOP GEL

PROTEMAX GEL BF50

RODETOX BRODI CREAM

RODIBROD GEL HC

PT14

Italy

ZAPI S.p.A. IT-0005122-0000 it/2017/00394/mrp 18/11/2016 18/11/2022

Single SPC  (it)

broditop gel.pdf (it)

Authorised

BRODITOP GEL

MS Rodetox Brodi Active Gel

PT14

Netherlands

ZAPI S.p.A. NL-0005124-0000 - 18/11/2016 18/11/2020

Single SPC  (nl)

Authorisation BRODITOP GEL 20145052.doc (nl) (23/02/2017)

181116_NL-0005124-0000_art48 change.doc (nl)

Authorised

BRODITOP GEL

PT14

Norway

ZAPI S.p.A. NO-0005123-0000 NO-2017-0127 18/11/2016 18/11/2020

Single SPC  (no)

Broditop Gel_authorisation letter_NO.pdf (en) (26/01/2017)

Authorised

BRODITOP GEL

PT14

Poland

ZAPI S.p.A. PL-0005125-0000 PL/2017/0259/MR 21/08/2017 18/11/2020

Single SPC  (pl)

PL.2017.0259.MR.pdf (pl) (25/08/2017)

Authorised

BRODITOP GEL

DEVILTOP GEL

MASSORRAT SOFT

RODETOX BRODI CREAM

PT14

Spain

ZAPI S.p.A. ES-0005127-0000 ES/MR(NA)-2017-14-00401 07/02/2017 18/11/2020

Single SPC  (es)

00401 BRODITOP GEL. DEVILTOP GEL. RODETOX BRODI CREAM. MASSORRAT SOFT.pdf (es) (04/08/2017)

00401 Broditop Gel.pdf (es) (07/03/2017)

R4BP_ES-0005127-0000_Authorisation.pdf (es)

Authorised
Reference authorisation
Trade name: BRODITOP GEL , MS Rodetox Brodi Active Gel , ROMAX Venom Paste
Authorisation number: UK-0004941-0000| Market area: United Kingdom

3 assessment records available

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

13/12/2018

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

Single SPC  (en)

Amendment of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

22/05/2018

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Application of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

28/11/2016

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

SPC not available

Mutual recognition
Trade name: BRODITEC GEL-50 , BRODITOP GEL , DEVILTOP GEL
Authorisation number: FR-0017482-0000| Market area: France

3 assessment records available

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

17/07/2019

Validity of authorisation

Start date:

18/11/2016

End date:

18/11/2020

SPC

Single SPC  (fr)

Amendment of national authorisation

Evaluating authority:

France

Conclusion date:

19/04/2018

Validity of authorisation

Start date:

09/03/2018

End date:

18/11/2020

SPC

SPC not available

Mutual recognition in sequence

Evaluating authority:

France

Conclusion date:

09/03/2018

Validity of authorisation

Start date:

09/03/2018

End date:

18/11/2020

SPC

SPC not available

Trade name: BRODITEC GEL-50 , BRODITOP GEL , DEVILTOP GEL , MS Rodetox Brodi Active Gel , RODETOX BRODI CREAM
Authorisation number: DE-0005121-0000| Market area: Germany

4 assessment records available

Amendment of national authorisation

Evaluating au