| Product Information |
|
| Registration Number |
BR-1393
|
| Generic Name |
Human Fibrinogen + Human Thrombin
|
| Brand Name |
TachoSil
|
| Dosage Strength |
5.5 mg/2.0 IU per cm2
|
| Dosage Form |
Medicated Sponge
|
| Classification |
Prescription Drug (Rx)
|
| Packaging |
Each medicated sponge is packed in PET-GAG and HDPE (Tyvek) blister foil. The blister is packed in aluminum foil sachet with a desiccant bag and enclosed in folding carton of the following pack sizes: (1) 3.0 cm x 2.5 cm (Box of 1's and 5's); (2) 4.8 cm x 4.8 cm (Box of 2's); and 9.5 cm x 4.8 cm (Box of 1's)
|
| Pharmacologic Category |
Local Hemostatic Agents
|
| Manufacturer |
TAKEDA AUSTRIA GMBH
|
| Country of Origin |
Austria
|
| Trader |
|
| Importer |
PE Pharma ENTERPRISES OPC
|
| Distributor |
PE Pharma ENTERPRISES OPC
|
| Application Type |
Renewal
|
| Issuance Date |
07 April 2024
|
| Expiry Date |
04 March 2029
|