Annex I SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)

Transcription

1 Annex I SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)

2 Scientific conclusions Taking into account the PRAC Assessment Report on the PSUR for bimatoprost, the scientific conclusions of CHMP are as follows: During the reporting period of this PSUR, a certain number of cases from routine pharmacovigilance activities were reported and indicated a causal relationship with the use of bimatoprost containing medicinal products. Based on the available data and analysis presented in this PSUR, the PRAC considered that the summary of product characteristics and package leaflet of bimatoprost (all formulations) containing medicinal products should be amended to reflect the following adverse drug reactions: hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis, asthma, asthma exacerbation, COPD exacerbation and dyspnea, with a frequency not known. The summary of product characteristics and package leaflet of bimatoprost (formulations 0.01%) should be amended to reflect the following adverse drug reactions: iris hyperpigmentation, macular oedema, blepharal pigmentation, periorbital and lid changes including deepening of the eyelid sulcus and dry eye with a frequency not known. Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing bimatoprost were warranted. The CHMP agrees with the scientific conclusions made by the PRAC. Grounds for the variation to the terms of the Marketing Authorisation(s) On the basis of the scientific conclusions for bimatoprost the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing bimatoprost is favourable subject to the proposed changes to the product information. The CHMP recommends that the terms of the Marketing Authorisation(s) should be varied. 2

3 Annex II AMENDMENTS TO THE PRODUCT INFORMATION OF THE NATIONALLY AUTHORISED MEDICINAL PRODUCT(S) 3

4 Amendments to be included in the relevant sections of the Summary of Product Characteristics (new text underlined and in bold, deleted text strike through) For all bimatoprost formulations: Section 4.8 The following adverse reactions should be added under the SOC Immune system disorders with a frequency not known: Hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis. The following adverse reactions should be added under the SOC Respiratory, thoracic and mediastinal disorders with a frequency not known : Asthma, asthma exacerbation, COPD exacerbation and dyspnoea. For bimatoprost 0.01% formulations: The following adverse reactions should be added under the SOC Eye disorders with a frequency not known: Iris hyperpigmentation, macular oedema, blepharal pigmentation, periorbital and lid changes including deepening of the eyelid sulcus and dry eye. Amendments to be included in the relevant sections of the Package Leaflet (new text underlined and in bold, deleted text strike through) For all bimatoprost formulations: 4. Possible side effects The following side effects should be added under Side effects where the frequency is not known and Affecting the Body : Symptoms of allergic reaction (swelling, redness and rash of the skin and eye) Asthma Worsening of asthma Worsening of the lung disease called chronic obstructive pulmonary disease (COPD) Shortness of breath For bimatoprost 0.01% formulations: 4. Possible side effects The following side effects should be added under Side effects where the frequency is not known and Affecting the Eye : Darker iris colour Cystoid macular oedema (swelling of the retina within the eye leading to worsening 4

5 vision) Darker skin colour around the eye Eyes appear sunken Eye dryness 5