- New Zealand Registered Drug Product
- MEDSAFE Registered Drug Database
- New Zealand Medicines
- New Zealand Drugs
- MEDSAFE Drugs
- New Zealand Drug Products
- NZ Drug Database
- Drug Risk Profile
- Drug Product Status
New Zealand Drug Product Database
The dataset New Zealand Drug Product Database lists all drug products that have been given consent to market in New Zealand by the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE).
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New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) expects that medicines supplied in New Zealand meet all applicable national and international standards unless adequately justified by the product owner.
Justifications are assessed and accepted on the basis that the overall risk profile of the medicine is not compromised by the use of an alternative standard.
The regulatory status of the medicinal product is detailed in the Registration Situation and has the following meanings:
– Approval lapsed: where consent has lapsed due to a product being not available and there being no regulatory activity on it for more than five years, or where provisional consent has expired or where a sponsor has advised in writing that the product is no longer distributed in New Zealand.
– Clinical trial: where a product is for clinical trial only.
– Consent given: where a product has been granted consent to market in New Zealand under section 20 of the Medicines Act 1981 and is actively marketed or is available upon request.
– Consent refused: where a product has been refused consent under section 20 of the Medicines Act 1981.
– Consent Revoked: where consent has been revoked under section 35(1)(a) of the Medicines Act 1981.
– Excluded product: where a product is declared by regulation 58A of the Medicines Regulations 1984 not to be a medicine or related product.
– Export only: where a product is for export only and is not to be marketed in New Zealand.
– File closed: where a product has been rationalized. This may mean that some of the previous product histories are on another file.
– Never approved: where an application is still pending but it is no longer possible to contact the applicant to either obtain additional information or confirmation of withdrawal.
– NMA withdrawn: where the applicant has advised in writing that they no longer want to proceed with the application.
– Not available: where a product has been granted consent but the company has advised in writing that they do not supply the product upon request or actively market it.
– Pending: where an NMA (New Medicine Application) is still under assessment.
– Provisional consent: where provisional consent has been granted under section 23 of the Medicines Act 1981.
About this Dataset
1962-01-01 to 2019-05-31
John Snow Labs; New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE);
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New Zealand Medicines, New Zealand Drugs, MEDSAFE Drugs, New Zealand Drug Products, NZ Drug Database, Drug Risk Profile, Drug Product Status
New Zealand Registered Drug Product, MEDSAFE Registered Drug Database
|Product||Drug product name||string||required : 1|
|Active_Ingredients||Active ingredients of the drug||string||-|
|Sponsor||Product sponsor name||string||-|
|Status||Current status of the product||string||-|
|Approval_Date||Date of approval||date||-|
|Notification_Date||Date of notification||date||-|
|Product||Active Ingredients||Sponsor||Status||Approval Date||Notification Date|
|Potassium chloride; Sodium chloride||Baxter Healthcare Ltd||Consent given||1980-09-29|
|0.15% Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Solution for infusion, (Biomed) (General sale)||Glucose; Potassium chloride; Sodium chloride||Biomed Limited||Approval lapsed||1974-06-19||2013-08-02|
|0.5% Marcain Dental with Adrenaline 1:200,000 Solution for injection, . (Prescription)||Adrenaline; Bupivacaine||Dentsply Sirona (NZ) Limited||Approval lapsed||1992-09-29||2012-10-30|
|0.9% Sodium Chloride Solution for infusion, 0.9 %, Baxter (General sale)||Sodium chloride||Baxter Healthcare Ltd||Consent given||2014-05-15|
|0.9% Sodium Chloride Solution for infusion, 0.9% w/v, Viaflo (General sale)||Sodium chloride||Baxter Healthcare Ltd||Consent given||2019-01-31|
|2% Xylocaine DENTAL with Adrenaline (epinephrine) 1:80,000 Solution for injection, Dental cartridge (Prescription)||Adrenaline; Lidocaine||Dentsply Sirona (NZ) Limited||Consent given||1969-12-31|
|Adrenaline; Lidocaine||Dentsply Sirona (NZ) Limited||Consent given||1969-12-31|
|3% Citanest DENTAL with Octapressin Solution for injection, . (Prescription)||Felypressin; Prilocaine||Dentsply Sirona (NZ) Limited||Consent given||1969-12-31|
|30mmol Potassium chloride in Hartmanns Solution Solution for infusion, 30 mmol/L, (Baxter) (General sale)||Calcium chloride; Lactic acid; Potassium chloride; Sodium chloride||Baxter Healthcare Ltd||Approval lapsed||1980-09-29||2008-07-24|
|Glucose; Potassium chloride||Baxter Healthcare Ltd||Consent given||1980-09-29|