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Atgam 50 mg/ml concentrate for solution for infusion

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Pharmacy Only: Prescription

Updated on 15 October 2024

File name

Reg SPC AG 4_0 IE clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 15 October 2024

File name

Reg PIL AG 4_0 UK clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 31 January 2024

File name

RegSPCAG32IEclean.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: 

Section 3 – Updated description of pharmaceutical form.

Section 4.1 – Minor update to indication wording

Section 4.3 – Minor typographical change

Section 5.2 – Updated with information on special populations

 

Section 6.6 – Updated with information on preparation of infusion solution


Updated on 31 January 2024

File name

RegPIL32UKIEclean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 11 August 2023

File name

Reg SPC AG 2_1 IE clean.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 11 August 2023

File name

Reg PIL AG 2_1 UK & IE clean.pdf

Reasons for updating

  • New PIL for new product