Revised: 31 May 2019
Medicines
Medsafe Product Detail | ||
|---|---|---|
| File ref: TT50-3162/2a |
| Trade Name | Dose Form | Strength | Identifier |
| Verpamil SR | Modified release tablet | 240 mg | |
| Sponsor | Application date | Registration situation | Classification |
| Viatris Limited P O Box 11183 Ellerslie AUCKLAND 1542 | 9/3/1987 | Approval lapsed Approval date: 26/6/1987 Notification date: 30/11/2022 | Prescription |
| Reference product: Isoptin SR Modified release tablet 240 mg | |||
Composition
| Component | Ingredient | Manufacturer |
| modified release tablet, Formulation to 31 March 2008 | Active | |
| Verapamil hydrochloride 240mg | Teva Pharmaceutical Fine Chemicals SrL Strada Statale Briantea Km 36 Building No 83 Bulciago Lecco 23892 ITALY | |
| Recordati Industria Chimica E Farmaceutica S.P.A. Campoverde Facility via Mediana Cisterna 4 I-04011 Campoverde di Aprilia, Latina ITALY | ||
| Excipient | ||
| Carnauba wax | ||
| Diethyl phthalate | ||
| Ethanol | ||
| Hypromellose | ||
| Magnesium stearate | ||
| Methylene chloride | ||
| Microcrystalline cellulose | ||
| Opaspray green K-1F-3108 | ||
| Opaspray white K-1R-7000 | ||
| Povidone | ||
| Purified talc | ||
| Purified water | ||
| Sodium alginate | ||
| modified release tablet, Formulation to 10 February 2009 | Active | |
| Verapamil hydrochloride 240mg | ||
| Excipient | ||
| Carnauba wax | ||
| Diethyl phthalate | ||
| Ethanol | ||
| Hypromellose | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opaspray green K-1F-3108 | ||
| Opaspray white K-1R-7000 | ||
| Povidone | ||
| Purified talc | ||
| Purified water | ||
| Sodium alginate | ||
| modified release tablet, Formulation from 10 February 2009 to 9 March 2010 | Active | |
| Verapamil hydrochloride 240mg | ||
| Excipient | ||
| Carnauba wax | ||
| Diethyl phthalate | ||
| Ethanol | ||
| Hypromellose | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opaspray green K-1F-3108 | ||
| Opaspray white K-1R-7000 | ||
| Povidone | ||
| Purified talc | ||
| Purified water | ||
| Sodium alginate | ||
| modified release tablet, Formulation from 9 March 2010 to 24 July 2014 | Active | |
| Verapamil hydrochloride 240mg | ||
| Excipient | ||
| Carnauba wax | ||
| Diethyl phthalate | ||
| Ethanol | ||
| Hypromellose | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opaspray green K-1F-3108 | ||
| Opaspray white K-1R-7000 | ||
| Povidone | ||
| Purified talc | ||
| Purified water | ||
| Sodium alginate | ||
| modified release tablet, Formulation from 24 July 2014 | Active | |
| Verapamil hydrochloride 240mg | ||
| Excipient | ||
| Magnesium stearate | ||
| Microcrystalline cellulose | ||
| Opadry green 85F510048 | ||
| Povidone | ||
| Purified talc | ||
| Purified water | ||
| Sodium alginate |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| Manufacture of Final Dose Form | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| Overlabelling | Viatris Limited 2B George Bourke Drive Mt. Wellington Auckland 1060 |
| Packing | Intas Pharmaceuticals Ltd Plot Nos. 457-458 Sarkhej Bavla Highway Matoda Sanand, Ahmedabad Gujarat 382 210 INDIA |
| NZ Site of Product Release | Viatris Limited 2B George Bourke Drive Mt. Wellington Auckland 1060 |
Packaging
| Package | Contents | Shelf Life |
| Blister pack, | 60 tablets | 18 months from date of manufacture stored at or below 25°C |
| Bottle, glass, | 60 tablets | 24 months from date of manufacture stored at or below 25°C |
| Bottle, plastic, | 60 tablets | 36 months from date of manufacture stored at or below 25°C |
| Bottle, plastic, | 250 tablets | 36 months from date of manufacture stored at or below 25°C protect from moisture. Keep container tightly closed |
Indications
· Essential Hypertension.
· Secondary Prevention Post Myocardial Infarction: For secondary prevention after acute myocardial infarction, especially where ß-blocking agents are not tolerated such as in patients with asthma, diabetes, peripheral vascular disease with intermittent claudication, etc.
· Angina pectoris: For the prophylaxis and treatment of coronary insufficiency: Chronic stable angina pectoris; angina at rest including vasospastic (Prinzmetal's, variant angina) and unstable angina (crescendo, pre-infarction angina); angina pectoris post myocardial infarction.
Latest Regulatory Activity
| Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
| 10/7/2020 | Self-Assessable Change Notification | Data sheet - miscellaneous changes (Self assessable) | Notified | 15/7/2020 |
