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Biocidal product factsheet - Last updated: 26/02/2024

Biocidal Product details

Trade name:

Iodopharm

Presan

VIROPHOR 2.8%

Product-type:

PT03

Active Substance details

Substance name:

Iodine

IUPAC name:

EC number:

231-442-4

CAS number:

7553-56-2

BAS number:

1319

The Active Substance is a candidate for substitution

Authorised

Expired

Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

6 authorisations in the product cluster

Trade name	Product-type	Market area	Authorisation holder	Authorisation number		Authorisation start	Authorisation end	SPC	Decisions	Authorisation status
Trade name	Product-type	Market area	Authorisation holder	R4BP 3 asset	National	Authorisation start	Authorisation end	SPC	Decisions	Authorisation status
Iodopharm Presan Virophor 2.8%	PT03	United Kingdom	Kilco (International) Ltd	R4BP 3 asset	National	UK-0013443-0000	UK-2019-1224	01/10/2019	31/12/2020	SPC not available	Expired
-	PT03	Cyprus	HYPRED SAS	CY-0024724-0000	ΚΥ-0177	11/09/2020	01/10/2029	Single SPC (el)	Virophor 2.8.pdf (el) Virophor 2.8.pdf (el)	Authorised
Iodopharm Presan Virophor 2.8%	PT03	Czech Republic	HYPRED SAS	CZ-0025488-0000	CZ-0025488-0000	01/10/2019	01/10/2029	Single SPC (cs)	podminky-povoleni_PUBLIC(1).doc.pdf (cs)	Authorised
Iodopharm Presan Virophor 2.8%	PT03	Ireland	HYPRED SAS	IE-0021570-0000	IE/BPA 70451	01/10/2019	01/10/2029	Single SPC (en)	IE-BPA 70451 Authorisation Certificate.pdf (en)	Authorised
VIROPHOR 2.8%	PT03	Poland	HYPRED SAS	PL-0014223-0000	PL/2019/0430/MR	14/01/2020	01/10/2029	Single SPC (pl)	PL.2019.0430.MR_zm.pdf (pl) PL.2019.0430.MR.pdf (pl)	Authorised
-	PT03	Romania	HYPRED SAS	RO-0025473-0000	RO/2020/0290/MRA/UK-2019-1224	01/10/2019	01/10/2029	Single SPC (ro)	copie Certificat nr. 290 VIROPHOR 2.8 PERCENTS.docx (ro) ANEXA CERTIFICAT nr. 290 VIROPHOR 2.8 PERCENTS.docx (ro) Certificat nr. 290 VIROPHOR 2.8 PERCENTS.docx (ro) COPIE ANEXA CERTIFICAT nr. 290 VIROPHOR 2.8 PERCENTS.docx (ro) MSCA-Romania Authorization Certificate for Virophor 2.8 percents NA-MRP BC-JP019440-38-.pdf (ro) 30.09.2021 ANEXA CERTIFICAT nr. 290 VIROPHOR 2.8 PERCENTS.docx (ro) copie 30.09.2021 ANEXA CERTIFICAT nr. 290 VIROPHOR 2.8 PERCENTS.docx (en)	Authorised

Reference authorisation

Trade name: Iodopharm , Presan , Virophor 2.8%
Authorisation number: UK-0013443-0000| Market area: United Kingdom

1 assessment record available

Application of national authorisation

Evaluating authority:

United Kingdom

Conclusion date:

01/10/2019

Validity of authorisation

Start date:

01/10/2019

End date:

01/10/2029

SPC

SPC not available

Mutual recognition

Trade name: -
Authorisation number: CY-0024724-0000| Market area: Cyprus

2 assessment records available

Transfer of a national authorisation

Evaluating authority:

Cyprus

Conclusion date:

22/12/2020

Validity of authorisation

Start date:

11/09/2020

End date:

01/10/2029

SPC

Single SPC (el)

Mutual recognition in parallel

Evaluating authority:

Cyprus

Conclusion date:

14/09/2020

Validity of authorisation

Start date:

11/09/2020

End date:

01/10/2029

SPC

SPC not available

Trade name: Iodopharm , Presan , Virophor 2.8%
Authorisation number: CZ-0025488-0000| Market area: Czech Republic

2 assessment records available

Transfer of a national authorisation

Evaluating authority:

Czech Republic

Conclusion date:

28/12/2020

Validity of authorisation

Start date:

01/10/2019

End date:

01/10/2029

SPC

Single SPC (cs)

Mutual recognition in parallel

Evaluating authority:

Czech Republic

Conclusion date:

28/12/2020

Validity of authorisation

Start date:

01/10/2019

End date:

01/10/2029

SPC

SPC not available

Trade name: Iodopharm , Presan , Virophor 2.8%
Authorisation number: IE-0021570-0000| Market area: Ireland

4 assessment records available

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

12/11/2020

Validity of authorisation

Start date:

01/10/2019

End date:

01/10/2029

SPC

Single SPC (en)

Amendment of national authorisation

Evaluating authority:

Ireland

Conclusion date:

10/11/2020

Validity of authorisation

Start date:

01/10/2019

End date:

01/10/2029

SPC

SPC not available

Transfer of a national authorisation

Evaluating authority:

Ireland

Conclusion date:

31/01/2020

Validity of authorisation

Start date:

31/01/2020

End date:

01/10/2029

SPC

SPC not available

Mutual recognition in parallel

Evaluating authority:

Ireland

Conclusion date:

31/01/2020

Validity of authorisation

Start date:

31/01/2020

End date:

01/10/2029

SPC

SPC not available

Trade name: VIROPHOR 2.8%
Authorisation number: PL-0014223-0000| Market area: Poland

2 assessment records available

Transfer of a national authorisation

Evaluating authority:

Poland

Conclusion date:

31/01/2020

Validity of authorisation

Start date:

14/01/2020

End date:

01/10/2029

SPC

Single SPC (pl)

Mutual recognition in parallel

Evaluating authority:

Poland

Conclusion date:

15/01/2020

Validity of authorisation

Start date:

14/01/2020

End date:

01/10/2029

SPC

SPC not available

Trade name: -
Authorisation number: RO-0025473-0000| Market area: Romania

2 assessment records available

Transfer of a national authorisation

Evaluating authority:

Romania

Conclusion date:

03/12/2021

Validity of authorisation

Start date:

01/10/2019

End date:

01/10/2029

SPC

Single SPC (ro)

Mutual recognition in parallel

Evaluating authority:

Romania

Conclusion date:

22/12/2020

Validity of authorisation

Start date:

01/10/2019

End date:

01/10/2029

SPC

SPC not available