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Safety Information

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Guideline for reporting Adverse Events in South Africa

Guidelines - Human Medicines (old)

Product recalls

Safety Alerts

Category List(s)

Guideline for reporting Adverse Events in South Africa

Guidelines - Human Medicines (old)

Implementation of the post-registration amendment guideline (zipped MS-Word 36)

package Inserts for Human Medicines (MS-Word 174)

Post-importation testing (zipped MS-Word 36kb)

Reporting adverse drug reactions in South Africa (zipped MS-Word 49kb)

Stability (zipped MS-Word 60kb)

Product recalls

Safety Alerts

21.2 - Medicine Safety Alert : Promethazine Contraindicated in children under two years of age (Ms-Word 69kb)

21.5 - Medicine Safety Alert : MSA Gamma Benzene Hexachloride (Ms-Word 74kb)

9.13 - Package insert amendments concerning urgent safety restrictions (USRN)(MS-Word 64kb)

Medicine Safety Alert : Rotarix Vaccine for Oral administration: Reports of the incorrect route of administration (66kb)

Medicine Safety Alert: Interaction between Ketoconazole and Domperidone and the risk of QT prolongation (Ms-Word 62kb)