Product Information / Maklumat Produk
| Product Name : GONAL-F® 450 IU/0.75 ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION |
Registration No : MAL20112175AZ |
| Holder : MERCK SDN. BHD. |
Holder Address : B-23A-1, LEVEL 23A, THE ASCENT PARADIGM NO.1, JALAN SS7/26A, KELANA JAYA, |
| Phone No : 03-74943688 |
|
| Manufacturer : Merck Serono S.p.A. |
Manufacturer Address : VIA DELLE MAGNOLIE 15 (LOC FRAZIONE ZONA INDUSTRIALE)
700 26- MODUGNO (BA) ITALY |
| Importer : MERCK SDN. BHD. |
Importer Address : LEVEL 3, MENARA SUNWAY ANNEXE
|
Ingredients Information / Maklumat Bahan Aktif
| No | Active Ingredient |
| 1 | FOLLITROPIN ALFA |
Packaging Information / Maklumat Bungkusan
| No | Quantity |
| 1 | 1Units Units |
Label (mock-up) for Immediate Container / Label Dalam Bekas
| No | Attachment |
| 1 | Currently Approved LAB GONAL-F 450 IU (1).pdf |
| 2 | Proposed Clean LAB GONAL-F 450 IU.pdf |
| 3 | Proposed Annotated LAB GONAL-F 450 IU (1) - ASP.pdf |
Label (mock-up) for Outer Carton / Label Luar Bekas
| No | Attachment |
| 1 | Proposed Clean D2 Outer Carton Clean GONAL-F 450.pdf |
| 2 | Proposed Annotated D2 Outer Carton Clean GONAL-F 450.pdf |
| 3 | Currently Approved D2 Outer Carton Clean GONAL-F 450.pdf |