This brand name is authorized in Austria, Brazil, Cyprus, Ecuador, Finland, France, Ireland, Israel, Malta, Netherlands, Poland, Romania, Spain, Tunisia, Turkey, UK.
The drug RHOPHYLAC contains one active pharmaceutical ingredient (API):
1
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UNII
48W7181FLP - HUMAN RHO(D) IMMUNE GLOBULIN
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Human anti-D immunoglobulin contains specific antibodies (IgG) against the Rh(D) antigen of human erythrocytes. It can also contain antibodies to other Rh antigens, e.g. anti-Rh C antibodies. The mechanism by which anti-D immunoglobulin suppresses immunisation to Rh(D) positive red cells is not known. |
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Below package inserts are available for further reading:
| Document | Type | Information Source | |
|---|---|---|---|
| RHOPHYLAC Solution for injection | MPI, EU: SmPC | Medicines & Healthcare Products Regulatory Agency (GB) |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC Group | Classification | |
|---|---|---|
| J06BB01 | Anti-D (rh) immunoglobulin | J Antiinfectives for systemic use → J06 Immune sera and immunoglobulins → J06B Immunoglobulins → J06BB Specific immunoglobulins |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| BR | Câmara de Regulação do Mercado de Medicamentos | 502601901159412 |
| EC | Agencia Nacional de Regulación, Control y Vigilancia Sanitaria | 220-MBE-1221 |
| ES | Centro de información online de medicamentos de la AEMPS | 69377 |
| FI | Lääkealan turvallisuus- ja kehittämiskeskus | 013172 |
| FR | Base de données publique des médicaments | 62468162, 68484547 |
| GB | Medicines & Healthcare Products Regulatory Agency | 81737 |
| IL | מִשְׂרַד הַבְּרִיאוּת | 9326 |
| MT | Medicines Authority | MA665/00601 |
| NL | Z-Index G-Standaard | 14873729 |
| NL | Z-Index G-Standaard, PRK | 117757, 117765 |
| PL | Rejestru Produktów Leczniczych | 100183180 |
| RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | W59124001 |
| TN | Direction de la Pharmacie et du Médicament | 13813011 |
| TR | İlaç ve Tıbbi Cihaz Kurumu | 8681624980231 |
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