Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sucrose, Glacial acetic acid, Polysorbate 80, Sodium hydroxide (for pH adjustment), Water for injection (for volume adjustment)

6.2   Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.


AIM API Aug23 V8                              Page 12 of 14                      EU SmPC July23 6.4   Special precautions for storage

Pre-filled syringe

Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
After removal from the refrigerator, Aimovig must be used within 7 days when stored at temperature up to 30°C), or discarded. If it is stored at a higher temperature or for a longer period it must be discarded.

Pre-filled pen

Store in a refrigerator (2°C - 8°C). Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light.
After removal from the refrigerator, Aimovig must be used within 7 days when stored at temperature up to 30°C), or discarded. If it is stored at a higher temperature or for a longer period it must be discarded.

6.5   Nature and contents of container

Pre-filled syringe
Aimovig is supplied in a pre-filled syringe (1 ml, Type 1 glass) with a stainless steel staked needle, elastomeric needle shield, bromobutyl elastomeric plunger-stopper laminated with a fluoropolymer film.

Aimovig is available in packs containing 1 pre-filled syringe.

Pre-filled pen
Aimovig is supplied in a pre-filled pen (1 ml, Type 1 glass) with a stainless steel staked needle, elastomeric needle shield, bromobutyl elastomeric plunger-stopper laminated with a fluoropolymer film.
The pre-filled syringe is assembled into the pre-filled pen.

Aimovig is available in packs containing 1 pre-filled pen.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Before administration, the solution should be inspected visually. The solution should not be injected if it is cloudy, distinctly yellow or contains flakes or particles.

Pre-filled syringe

To avoid discomfort at the site of injection, the pre-filled syringe(s) should be left to stand at room temperature (up to 25°C) for at least 30 minutes before injecting. It should also be protected from direct sunlight. The entire contents of the pre-filled syringe(s) must be injected. The syringe(s) must not be warmed by using a heat source such as hot water or microwave and must not be shaken.

Pre-filled pen

To avoid discomfort at the site of injection, the pre-filled pen(s) should be left to stand at room temperature (up to 25°C) for at least 30 minutes before injecting. It should also be protected from direct sunlight. The entire contents of the pre-filled pen(s) must be injected. The pen(s) must not be warmed by using a heat source such as hot water or microwave and must not be shaken.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


AIM API Aug23 V8                               Page 13 of 14                      EU SmPC July23 7.    REGISTRATION HOLDER and IMPORTER

Novartis Israel Ltd.
P.O.B. 7126, Tel Aviv.