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Pivmecillinam hydrochloride Karo Pharma 400 mg film-coated tablets

*
Pharmacy Only: Prescription

  • Company:

    Karo Pharma AB

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Pivmecillinam Hydrochloride

    *Additional information is available within the SPC or upon request to the company

Updated on 14 June 2024

File name

SmPC 20240528 Pivmecillinam hydrochloride KP 400 mg IE_cl.pdf

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 June 2024

File name

SmPC 20240528 Pivmecillinam hydrochloride KP 400 mg IE_cl.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 10 June 2024

File name

PL 20240528 Pivmecillinam hydrochloride KP 400 mg tab IE_cl.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 21 February 2023

File name

20200806 SmPC Pivmecillinam hydrochloride KP 400 mg IE.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 February 2023

File name

20200806 PL Pivmecillinam hydrochloride KP 400 mg tab IE.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Uploading anew to comply with the correct format

Updated on 23 September 2020

File name

20200806 SmPC Pivmecillinam hydrochloride KP 400 mg IE.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 23 September 2020

File name

20200806 PL Pivmecillinam hydrochloride KP 400 mg tab IE.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 October 2019

File name

SmPC.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)