Regarding changes to the prescribing information for medicinal products containing human normal immunoglobulin (IgG) [human normal immunoglobulin (IgG)]

In accordance with paragraph 8 of Section IV of the Procedure for Expert Evaluation, the applicant must amend the instructions for medical use of the medicinal product upon receipt of new data, including bringing the instructions for medical use into line with the approved instructions for medical use of the original (reference) medicinal product, and ensure that the information on the medicinal product corresponds to current scientific knowledge.

Taking into account the report of the Pharmacovigilance Risk Assessment Committee (PRAC) on the evaluation of periodic safety update reports (PSURs) for medicinal products containing human normal immunoglobulin (IgG), the scientific conclusions of PRAC are as follows.

Taking into account the available data on “exfoliative dermatitis”, the PRAC considers that a causal relationship between the use of medicinal products containing human normal immunoglobulin (IgG) [human normal immunoglobulin (IgG and the occurrence of exfoliative dermatitis is at least a reasonable possibility. The PRAC concluded that the instructions for medical use of medicinal products containing human normal immunoglobulin (IgG) [human normal immunoglobulin (IgG)] should be amended accordingly.

Having considered the PRAC recommendations, the Committee for Medicinal Products for Human Use (CHMP) agreed with the overall conclusions and grounds for the recommendations.

Based on the scientific conclusions on human normal immunoglobulin (IgG), the CHMP considers that the benefit/risk balance of medicinal products containing human normal immunoglobulin (IgG) remains unchanged, provided that the proposed changes are made to the instruction for medical use.

Changes to be made to the relevant sections of the instruction for medical use (new text underlined and in bold).

“Adverse reactions” section

The following adverse reaction should be added to the System Organ Class (SOC) “Skin and subcutaneous tissue disorders” with a frequency of “not known”:

exfoliative dermatitis

Changes to the safety information of medicinal products containing human normal immunoglobulin following the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of 12 – 15 January 2026

The European Medicines Agency (EMA) has published the minutes of the meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) of January 12 – 15, 2026. Following the meeting, a decision was made on the need to introduce safety-related changes to the registration materials/instructions for medical use of medicinal products containing human normal immunoglobulin (human normal immunoglobulin).

Human normal immunoglobulin (human normal immunoglobulin) –DEQSIGA; FLEBOGAMMA DIF; HIZENTRA; HYQVIA; KIOVIG; PRIVIGEN – PSUSA/00001633/202505

Human normal immunoglobulin (IgG) [human normal immunoglobulin (IgG)] belongs to the category of immunotherapeutic medicinal products, in particular to the group of immune sera and immunoglobulins. Obtained from pooled human plasma, it is used as a means of passive immunization for the treatment of primary/secondary immunodeficiencies, infections and autoimmune diseases, under certain conditions.

Based on the evaluation of Periodic Safety Update Reports (PSURs), PRAC reviewed the benefit/risk balance of the use of medicinal products containing human normal immunoglobulin (IgG) and provided relevant recommendations.

Summary of recommendations and conclusions

• Based on the analysis of safety and efficacy data, the benefit/risk balance of medicinal products containing human normal immunoglobulin (IgG) [human normal immunoglobulin (IgG)] for the approved indications remains unchanged.
• At the same time, the instructions for medical use of medicinal products containing human normal immunoglobulin (IgG) should be updated by adding exfoliative dermatitis to the list of adverse reactions with the frequency “not known.” Accordingly, the current provisions of the instructions for medical use must be amended¹.
• In the next PSUR, the registration certificate holder (RCH) of Privigen must provide an assessment of cases associated with exfoliative dermatitis, generalized exfoliative dermatitis, and erythroderma, and consider the need to update the instructions for medical use if necessary. The RCH of Hizentra must carefully monitor renal adverse events to further assess whether renal failure should be included in the list of safety concerns as a potential risk. The RCHs of Yimmugo and Intratect must provide data on use outside the approved indications (off-label use), and these RCHs, as well as the RCH of Pentaglobin, must continue to carefully monitor any cases of drug interaction between intravenous IgG and monoclonal antibodies (mAb). The RCH of Xembify must provide an assessment of serious infusion site reactions, as well as, separately, of cases associated with ulcers and necrosis, and consider the need to update the instructions for medical use if necessary. Finally, the RCH of Cuvitru must provide detailed information on two fatal cases after the use of Cuvitru in pregnant and breastfeeding women, as well as on seven fatal cases in newborns or children under 2 years of age.
• The Grifols MAH of the medicinal product Xembify must update the important potential risk “hypersensitivity reactions, including anaphylactic reaction” to an important identified risk at the next regulatory procedure or no later than 12 months, and submit a risk management plan (RMP) to the relevant national competent authorities.

_________________________________________________________________

¹Update of the “Adverse reactions” section of the instructions for medical use. The risk assessment report and the PRAC recommendation are forwarded to the CHMP for a decision.

TO ANALYZE THE PUBLISHED INFORMATION AND SUBMIT THE RELEVANT APPLICATION FOR AMENDMENTS TO THE REGISTRATION MATERIALS, THE APPLICANT MUST USE THE ORIGINAL TEXT AVAILABLE AT THE FOLLOWING LINKS: