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Biocidal product factsheet - Last updated: 08/03/2024

Biocidal Product details

Trade name:

Sterile IPA 70% in WFI Alcohol Wipes

Product-type:

PT02

Active Substance details

Substance name:

Propan-2-ol

IUPAC name:

propan-2-ol

EC number:

200-661-7

CAS number:

67-63-0

BAS number:

1355

Authorised
map
Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

210518_Final_PAR_Public.pdf (en)

240307_Final_PAR_Public.pdf (en)

5 authorisations in the product cluster
Trade name
Product-type
Market area
Authorisation holder
Authorisation number
Authorisation start
Authorisation end
SPC Decisions
Authorisation status
R4BP 3 asset
National

Sterile IPA 70% in WFI Alcohol Wipes
PT02

Germany

 Agma Europe Limited DE-0026187-0001 DE-0026187-00-0000-02 18/05/2021 18/05/2031

Family SPC  (de)

Member SPC  (de)

 Authorised

Sterile IPA 70% in WFI Alcohol Wipes
PT02

Spain

 Agma Europe Limited ES-0028650-0001 ES/MRF(NA)-2022-02-00819 19/05/2022 18/05/2031

Family SPC  (es)

Member SPC  (es)

R4BP3-ES-0028650-0000-Authorisation.pdf (es)

 Authorised

Sterile IPA 70% in WFI Alcohol Wipes
PT02

Ireland

 Agma Europe Limited IE-0026188-0001 IE/BPA 70468 18/05/2021 18/05/2031

Family SPC  (en)

Member SPC  (en)

IE-BPA 70468 Authorisation Certificate Ver 1.1.pdf (en)

 Authorised

Sterile IPA 70% in WFI Alcohol Wipes
PT02

Italy

 Agma Europe Limited IT-0027755-0001 IT/2022/00785/MRS 18/05/2021 18/05/2031

Family SPC  (it)

Member SPC  (it)

decreto bc-fg069599-25 MRS AGMA IPA product family.pdf (it)

 Authorised

Sterile IPA 70% in WFI Alcohol Wipes
PT02

Portugal

 Agma Europe Limited PT-0027518-0001 PTDGS mrs 99/2021 to PTDGS mrs 103/2021 09/11/2021 18/05/2031

Family SPC  (pt)

Member SPC  (pt)

mrs103-2021_PT2_P_Agma.pdf (pt)

mrs101-2021_PT2_P_Agma.pdf (pt)

mrs99-2021_PT2_P_Agma.pdf (pt)

mrs102-2021_PT2_P_Agma.pdf (pt)

mrs100-2021_PT2_P_Agma.pdf (pt)

 Authorised
Reference authorisation
Trade name: Sterile IPA 70% in WFI Alcohol Wipes
Authorisation number: DE-0026187-0001| Market area: Germany

3 assessment records available

Amendment of national authorisation

Evaluating authority:

Germany

Conclusion date:

07/03/2024

Validity of authorisation

Start date:

18/05/2021

End date:

18/05/2031

SPC

Family SPC  (de)

Member SPC  (de)

National authorisation administrative change on request

Evaluating authority:

Germany

Conclusion date:

20/12/2021

Validity of authorisation

Start date:

18/05/2021

End date:

18/05/2031

SPC

SPC not available

Application of national authorisation

Evaluating authority:

Germany

Conclusion date:

18/05/2021

Validity of authorisation

Start date:

18/05/2021

End date:

18/05/2031

SPC

SPC not available

Mutual recognition
Trade name: Sterile IPA 70% in WFI Alcohol Wipes
Authorisation number: IE-0026188-0001| Market area: Ireland

3 assessment records available

National authorisation administrative change on request

Evaluating authority:

Ireland

Conclusion date:

01/11/2022

Validity of authorisation

Start date:

18/05/2021

End date:

18/05/2031

SPC

Family SPC  (en)

Member SPC  (en)

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

07/03/2022

Validity of authorisation

Start date:

18/05/2021

End date:

18/05/2031

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Ireland

Conclusion date:

19/08/2021

Validity of authorisation

Start date:

18/05/2021

End date:

18/05/2031

SPC

SPC not available

Trade name: Sterile IPA 70% in WFI Alcohol Wipes
Authorisation number: IT-0027755-0001| Market area: Italy

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Italy

Conclusion date:

23/02/2022

Validity of authorisation

Start date:

18/05/2021

End date:

18/05/2031

SPC

Family SPC  (it)

Member SPC  (it)

Trade name: Sterile IPA 70% in WFI Alcohol Wipes
Authorisation number: PT-0027518-0001| Market area: Portugal

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Portugal

Conclusion date:

09/11/2021

Validity of authorisation

Start date:

09/11/2021

End date:

18/05/2031

SPC

Family SPC  (pt)

Member SPC  (pt)

Trade name: Sterile IPA 70% in WFI Alcohol Wipes
Authorisation number: ES-0028650-0001| Market area: Spain

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Spain

Conclusion date:

31/05/2022

Validity of authorisation

Start date:

19/05/2022

End date:

18/05/2031

SPC

Family SPC  (es)

Member SPC  (es)