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Biocidal product factsheet - Last updated: 12/04/2024

Biocidal Product details

Trade name:

Betadine oldat

Бетадин разтвор

Product-type:

PT01

Active Substance details

Substance name:

IUPAC name:

EC number:

607-771-8

CAS number:

25655-41-8

BAS number:

1349

The Active Substance is a candidate for substitution

Authorised
map
Authorisation information

Authorisation type:

National authorisation

Legal act:

Assessment reports:

2 authorisations in the product cluster
Authorisation number SPC Decisions

Betadine oldat

PT01

Hungary

Egis Pharmaceuticals PLC HU-0016892-0000 HU-2018-PA-01-00228-0000 10/12/2018 01/12/2028

Single SPC  (en)

Authorisation Betadine solution.pdf (hu)

3310-12_2020_KBKHF_Betadine oldat_decision.pdf (hu)

Authorised

Бетадин разтвор

PT01

Bulgaria

Egis Pharmaceuticals PLC BG-0032579-0000 3567-1 28/03/2024 01/12/2028

Single SPC  (bg)

Authorised
Reference authorisation
Trade name: Betadine oldat
Authorisation number: HU-0016892-0000| Market area: Hungary

3 assessment records available

National authorisation minor change on request

Evaluating authority:

Hungary

Conclusion date:

29/09/2020

Validity of authorisation

Start date:

10/12/2018

End date:

01/12/2028

SPC

Single SPC  (en)

Amendment of national authorisation

Evaluating authority:

Hungary

Conclusion date:

11/12/2018

Validity of authorisation

Start date:

10/12/2018

End date:

01/12/2028

SPC

SPC not available

Application of national authorisation

Evaluating authority:

Hungary

Conclusion date:

10/12/2018

Validity of authorisation

Start date:

10/12/2018

End date:

01/12/2028

SPC

SPC not available

Mutual recognition
Trade name: Бетадин разтвор
Authorisation number: BG-0032579-0000| Market area: Bulgaria

1 assessment record available

Mutual recognition in sequence

Evaluating authority:

Bulgaria

Conclusion date:

11/04/2024

Validity of authorisation

Start date:

28/03/2024

End date:

01/12/2028

SPC

Single SPC  (bg)