application refers to the Recommendation 4 which clarifies that formulations of same product but in there is very little or significant the medicine, different strengths and difference between the identified particularly therefore, it is expected Norspan and Transtec risks. where the other that the RMP for Norspan formulations being equally applied for have Transtec. Consequently, the substantially RMP in its current version more is deficient and has to be market corrected prior to potential experience. approval. The deficiencies in the summary of safety concerns are further discussed below (see recommendation 4). 3. It is recommended that The ASA has been reworked to provide The evaluator the sponsor reworks the the information as outlined in the TGA acknowledges structure and content of ASA template. the sponsor’s the ASA, to provide all revisions. The ASA now includes a summary table relevant information of the safety concerns and the risk outlined in the TGA ASA minimisation measures in the template. This document Australian context. This table includes will be revisited to the the actual wording of the EU SmPC and Advisory Committee on proposed Australian PI and CMI for all Prescription Medicines of the safety concerns. (ACPM). 4. The sponsor should add A comparison and justification for the The evaluator all ongoing safety concerns difference in the ongoing safety accepts the were accepted and concerns of the Transtec RMP compared sponsor’s requested for Norspan to the Norspan RMP is provided in Table handling of the patches to the table 18. risks Drug Abuse ongoing safety concerns for and Addiction Based on the justifications in the above Transtec, or provide which are table and the response to compelling justification for included as recommendation 2 the sponsor does not not doing so. identified risks in think any alterations are required to the Pharmacovigilance and the Transtec Transtec RMP. risk-minimisation activities RMP/ASA. The ongoing safety concerns that the should be assigned to all The evaluator TGA requested to be added as potential ongoing safety concerns accepts that risks for Norspan were: and the pharmacovigilance accidental and risk-minimisation plan 1. The interaction with CYP3A4 overdose will of the EU-RMP/ASA be inhibitors. continue to be amended accordingly. monitored under 2. CNS depression, in particular the the umbrella effects on driving ability. identified risk 1. The interaction with CYP3A4 Overdose. inhibitors. This is not accepted.
application refers to the same product but in different strengths and therefore, it is expected that the RMP for Norspan being equally applied for Transtec. Consequently, the RMP in its current version is deficient and has to be corrected prior to potential approval. Recommendation 4 which clarifies that there is very little or significant difference between the identified Norspan and Transtec risks. formulations of the medicine, particularly where the other formulations have substantially more experience. The deficiencies in the summary of safety concerns are further discussed below (see recommendation 4). 3. It is recommended that the sponsor reworks the structure and content of the ASA, to provide all relevant information outlined in the TGA ASA template. This document will be revisited to the Advisory Committee on Prescription Medicines (ACPM). The ASA has been reworked to provide the information as outlined in the TGA ASA template. The ASA now includes a summary table of the safety concerns and the risk minimisation measures in the Australian context. This table includes the actual wording of the EU SmPC and proposed Australian PI and CMI for all of the safety concerns. The evaluator acknowledges the sponsor’s revisions. 4. The sponsor should add all ongoing safety concerns were accepted and requested for Norspan patches to the table ongoing safety concerns for Transtec, or provide compelling justification for not doing so. Pharmacovigilance and risk-minimisation activities should be assigned to all ongoing safety concerns and the pharmacovigilance and risk-minimisation plan of the EU-RMP/ASA be amended accordingly. A comparison and justification for the difference in the ongoing safety concerns of the Transtec RMP compared to the Norspan RMP is provided in Table 18. Based on the justifications in the above table and the response to recommendation 2 the sponsor does not think any alterations are required to the Transtec RMP. The ongoing safety concerns that the TGA requested to be added as potential risks for Norspan were: 1. The interaction with CYP3A4 inhibitors. 2. CNS depression, in particular the effects on driving ability. 1. The interaction with CYP3A4 inhibitors. The evaluator accepts the sponsor’s handling of the risks Drug Abuse and Addiction which are included as identified risks in the Transtec RMP/ASA. The evaluator accepts that accidental overdose will continue to be monitored under the umbrella identified risk Overdose. This is not accepted. market
auspar-buprenorphine-161213.docx