PIL - Pollenshield Hayfever® (Cetirizine hydrochloride): Change history
View Patient Information Leaflet (PIL - Pollenshield Hayfever® (Cetirizine hydrochloride))
Last updated on this site: 18 Jul 2023
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to bring in line with the reference product Zirtek Allergy 10 mg film-coated Tablets (PL 00039/0542, MAH: UCB Pharma Ltd). Consequently, the PIL has been updated. In addition, the adverse reactions in SmPC section 4.8 have been reordered in line with MedDRA SOC database. There are additional editorial updates to SmPC sections 4.8, 5.2 and the PIL.
PIL sections updated – 1, 2, 4 and 6.
Last updated on this site: 18 Jul 2023
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to bring in line with the reference product Zirtek Allergy 10 mg film-coated Tablets (PL 00039/0542, MAH: UCB Pharma Ltd). Consequently, the PIL has been updated. In addition, the adverse reactions in SmPC section 4.8 have been reordered in line with MedDRA SOC database. There are additional editorial updates to SmPC sections 4.8, 5.2 and the PIL.
PIL sections updated – 1, 2, 4 and 6.
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Changes: (Updated: 18 Jul 2023)
Description of update: To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 5.3 of the SmPC to bring in line with the reference product Zirtek Allergy 10 mg film-coated Tablets (PL 00039/0542, MAH: UCB Pharma Ltd). Consequently, the PIL has been updated. In addition, the adverse reactions in SmPC section 4.8 have been reordered in line with MedDRA SOC database. There are additional editorial updates to SmPC sections 4.8, 5.2 and the PIL.
PIL sections updated – 1, 2, 4 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload